Psguide 22 June 09

MasterControl
Products and Services Guide
PLAN
DISCOVER
CONFIGURE
Toll Free: 800.825.9117

Fax: 801.942.7088 VALIDATE
support@mastercontrol.com
www.mastercontrolcustomers.com
DEPLOY
Copyright MasterControl, 2009
All rights reserved
Version 6-09
No part of this publication may be reproduced, stored in or introduced into a retrieval system, or
transmitted, in any form or by any means (electronic, mechanical, photocopying, recording or
otherwise), without the prior written permission from MasterControl.
The scanning, uploading, and distribution of this book via the Internet or via any other means without
the permission of MasterControl is illegal and punishable by law. Please obtain only authorized
electronic or printed editions and do not participate in or encourage piracy of copyrightable materials.
Your support of the publishers rights is appreciated.
Additional copies of this publication can be obtained by contacting your CRM or RSM.
Less Paper. Less Effort. Less Risk.
Welcome to MasterControl,
At MasterControl we believe that the best way to succeed in our business is to help you succeed in
your business. When the customer is happy, everyone is happy! Because of this MasterControl has
developed over 150 different products and services to help you automate all of your GxP processes
throughout the entire product lifecycle. However, weve learned from experience that the most
important aspect of helping you succeed occurs during the implementation and validation phases
of deploying your new, automated processes. This is where the real benefits of our software to your
company can be identified and employed to their fullest to help you realize the highest possible return
on your investment.
Due to the highly regulated nature of most of our customers, the manner in which you configure and
deploy MasterControl applications is important to your long-term success. We have strived and will
continue to make every effort to provide you with everything you need to experience a smooth and
cost effective implementation process. The services and education courses offered by MasterControl
are provided to help you with this transition. We encourage you to take full advantage of them. Our
team of professionals is happy to assist you in whatever way we can.
This booklet is designed to make you aware of the many ways MasterControl can help you get the
most out of your investment, especially during the implementation and validation phases. It covers
best practices and provides you with a list of products and services to make implementation smoother,
more cost effective, and of higher long-term value to your company.
Please dont hesitate to ask anyone at MasterControl how we can help you have the best possible
experience with our software and services. Your complete satisfaction is our ultimate goal.
We look forward to a long and successful relationship!
Kind regards,
Kevin Ash
Senior Vice President of Services
MasterControl
Page 1
Contents
Helps and Guides
Customer Reference Program7
Your Customer Relationship Manager (CRM)8
Where to go for Help10
Customer Events11
Customer Website13
Customer Store21
Best Practices for Successful Software Implementation22
MasterControl Products and Services Guide
Services
Data Migration Services 31
Educational Services32
QMS CAPA Workshop34
QMS Root Cause Investigations Workshop36
Process Consulting & Implementation Services38
Implementation Best Practices40
Integration Services41
Project Management Services42
Software as a Service44 Equipment Calibration109
Technical Support Services46 Equipment Maintenance 111
Validation Services and Solutions48 HR Finance113
Configuration Services51 Nonconformance115
Applications Out-of-Specification (OOS)117
Version 8.0: Whats New?57 Risk Analysis119
QAAD61 Supplier Deviation120
Analytics63 Industry-specific Products
Documents65 Bill of Materials (BOM)125
Process67 DHF Express127
Supplier70 DHF JumpStart129
Training72 eMDR131
Add-ons GCPDocs Express133
Collaboration77 GCPDocs JumpStart135
Copies79 PDM Connectors137
Enterprise81 Submissions Gateway139
Exams83 Submissions Locker142
Forms QuickView85 Integrations and Connectors
Global Licensing Server86 API Toolkit 147
Projects88 Document Connections149
Rules90 Kofax Connector151
Transfer OQ92 MS Word Integration153
Business Processes Outlook E-mail Integration154
Audit95 PDMWorks Connector156
Business Process Library97 Pro/Intralink Connector158
CAPA99 QAAD API Suite160
Change Control101 SharePoint Connector161
Customer Complaints103 WindChill Connector163
Deviations105
Electronic Batch Records (EBR)107
2009 MasterControl Products and Services Guide

Helps and Guides
Helps and Guides

Helps and Guides

Customer Reference Program................................................. 7
Your Customer Relationship Manager (CRM)......................... 8
Where to go for Help................................................................ 10
Customer Events..................................................................... 11
Customer Website................................................................... 13
Customer Store........................................................................ 21
Best Practices for Successful Software Implementation......... 22

MasterControl Customer Reference Program

MasterControl is committed to customer success. This commitment is at the core of everything we do. In turn, many
of our customers have reciprocated by generously giving their time in the form of product recommendations and
referrals.
To show our appreciation, we have created a Customer Reference Program that rewards customer efforts with credits
toward the purchase of MasterControl products and services. As a successful MasterControl user, we encourage you
to consider becoming a part of this program. Heres how it works:
Your MasterControl representative will request your permission and verify your availability to act as a reference in
advance. This ensures that each reference is counted toward your reward credits.
Your participation in the program is renewable on a yearly basis.
Credits can be applied toward purchase of products*.
There are different levels of participation under this program. The credit for each level is as follows:
$2,000 credit for completion of a case study

$2,000 credit for video testimonial
$1,000 credit for hosting a MasterControl User Group in your city
$1,000 credit for attending Masters Summit
$1,000 credit for attending Users Group Meeting
$1,000 credit for each on-site hosting of a MasterControl prospect
$1,000 credit for each business referral that purchases MasterControl
$250 credit for each telephone reference call/survey response
$50 credit for product enhancement suggestions, which are built into MasterConrol
*Does not include services or MSA
For additional information, please contact your Account Manager, or Robert Palmer at (800) 825-9117 x1727,
rpalmer@mastercontrol.com.
Page 7
Your Customer Relationship Manager (CRM)

The role of your MasterControl Customer Relationship Manager (CRM) is to ensure that your needs are fully satisfied
throughout your experience with MasterControl. In essence, your CRM serves as an advisor and advocate, as well as
NEW PRODUCTS
an interface with MasterControl as a company. This means that he or she is responsible for ensuring your complete
& SERVICES
satisfaction and the overall success of your MasterControl solutions.
CRMs are industry experts with a working knowledge of the common problems and issues facing your business.
They are well-suited to discussing the challenges and solutions that may be unique to your industry, products, and
processes.
MasterControl provides you with a CRM because your success is important to us and a core value of our
company. In other words, providing you with a CRM is the best way we know how to optimize your success. One
of the responsibilities of your CRM is to manage and facilitate your relationships with the various areas within
MasterControl, as illustrated in the following diagram.
AT IONSHIP MA
R EL NA
GE
ER
M
R
PROFESSIONAL
CUSTOMER
O
(C
& VALIDATION
SUCCESS PROGRAMS
ST
SERVICES
RM
CU
)
R EXPER
ME I
O
EN
ST
NEW PRODUCTS PRODUCT

CU
CE
& SERVICES ENHANCEMENT

CUSTOMER
PROJECT GxP & BUSINESS

MANAGEMENT PROCESS SERVICES
TECHNICAL SUPPORT
& ISSUE RESOLUTION
Touchpoints in a Customers Experience with MasterControl

Technical Support, Professional Services, Products and Services, etc., are some of the many touchpoints in a
customers experience with MasterControl. The purpose of your CRM is to help ensure that every experience you
have with MasterControl is positive and beneficial.
Page 8
MasterControl has a growing list of over 50 different products and several different services to help make life easier
and organizations more successful. Your CRM will be in contact with you regularly to provide advice and guidance
on how your MasterControl solution can best meet the needs of your organization. Whether it be assisting with the
implementation of software, answering questions on maintenance, or acquainting you with our expert staff, your
CRM is always there to help. He or she will also provide you with the latest information on our products and services,
including software Project and Implementation Services, Validation Services, Process Implementation Services, and
Education Services.
Another important part of the CRMs role is to send out occasional customer surveys to ensure that your needs are
being met in the best possible manner. This also provides you with an additional avenue for addressing issues,
asking questions, or making suggestions.
Summary of How Your CRM Can Help

Because your CRM is well acquainted with both your industry and MasterControls products and services, he or she
can help you in many different ways. For example, s/he can
Help you use the solutions you have purchased from MasterControl more efficiently.
Suggest other ways in which to use the software, thereby increasing its value to you.
Obtain your Customer Success rating after you have been using MasterControl for a while.
Monitor any ongoing services requested by interfacing with Process Consulting, Validation, Education Services,
and other areas within MasterControl.
Introduce you to new MasterControl products and services that may make life easier and increase your
companys profitability.
Send out occasional customer surveys.
Introduce you to MasterControls Customer Success program.
Visit you onsite, as needed, and continue to serve as an advisor.
Page 9
Where to go for Help

Throughout the MasterControl implementation, configuration, validation, deployment and post-implementation
stages, you are likely to have a variety of questions for MasterControl experts, and for customers who have already
experienced successful implementation and usage.
To provide you with the best possible service for your needs and the best answers to your questions, MasterControl
provides a variety of customer support options:
Customer Website and Self-Service Portal

As a MasterControl customer, you have full and complete access to the MasterControl customer website
(www.mastercontrolcustomers.com). The customer website provides quick links to product downloads, product
release notes, white papers and a variety of additional resources, as well as links to self-service options that allow
you to log enhancement requests, report bugs and view the knowledge base.
The MasterControl customer website also allows you to view information regarding product support lifecycles and
technical support services as well as links to quickly contact your Customer Relationship Manager (CRM) or Regional
Sales Manager (RSM).
If you need a login and password for the customer website, simply contact MasterControls technical support team via
email at support@mastercontrol.com or by calling (001) 800-825-9117. QAAD specific tech support calls should go to
1-866-673-2776.
Customer-to-Customer Support
MasterControl understands your need to communicate with other groups and individuals who face challenges
similar to your own. To help aid customer-to-customer discussion, MasterControl provides a Customer-to-Customer
discussion area where you can participate in customer controlled forums and live chat room discussions. FAQs
(frequently asked questions) will also be provided and you can always contact technical support via any of the normal
channels found throughout the site. For more information about Customer-to-Customer please see the related
section within this Products and Services Guide.
Maintenance Support
Via e-mail or telephone, maintenance support includes software upgrades, validation upgrades and unlimited tech
assistance Monday thru Friday from 6 a.m. to 6 p.m. (Mountain Standard Time). You can contact MasterControls
technical support team via email at support@mastercontrol.com or by calling (001) 800-825-9117.
Customized Support Options

To meet the unique needs and unique budgets of a wide range of clients regulated by diverse laws and market
conditions, MasterControl provides fee-based customer support. These support services can be customized to meet
the challenges that can be faced in a global marketplace.
Page 10
Customer Events
Each year MasterControl hosts a series of events designed to help customers make the most of the software and
services theyve purchased from MasterControl. These events provide great opportunities to learn best practices,
tips, and tricks from the experts at MasterControl as well as from other customers who have experienced the same
challenges that you face on a daily basis. There are two basic types of customer events. They are the Masters
Summit and Regional User Group Meetings.
Masters Summit
The Masters Summit occurs once per year and was created to allow all MasterControl customers to gather into one
place at the same time. The goal of the Masters Summit is to inform and educate all MasterControl customers about
industry best practices, regulatory trends, current MasterControl features, and the direction of all product lines. The
three-day event is set up in a friendly, casual environment where customers can share experiences and advice,
as well as join technical discussions with guest speakers from MasterControl, its user community, and partners.
Visit MasterControls Customer Website (www.mastercontrolcustomers.com) to view customer testimonial videos,
presentations, photos, and attendee comments from previous Masters Summits.
Highlights of the annual Masters Summit include:
Tips and tricks for using MasterControl products

Exciting Guest Speakers
Latest Product Usability Lab
Roundtable Discussions
User Presentations
Practical Applications of MasterControl Products
Advanced Training Topics
Advice from Industry Experts
Hands-on Training Sessions
Networking Opportunities
Highlights of the annual Masters Summit include:
Receive extensive training on MasterControl products and services

Gain insight into MasterControls Product Roadmap
Come away with a broader understanding of industry best practices
Gain a greater understanding of validation practices
Gain insight about general industry directions and trends
Benefit from experiences of other MasterControl users
Meet and converse with MasterControl experts face-to-face
You can sign up for this years Masters Summit by visiting the MasterControl Customer Store at
www.mastercontrolcustomers.com/shop/index.cfm
Regional User Group Meetings
MasterControl Regional User Group Meetings are designed to be casual and relaxed, but most importantly,
educational. The goal of a Regional User Group Meeting is to economically further the education of MasterControl
users through sharing and exchanging ideas. Since they are hosted regionally, travel time and expense are usually
minimal.
Page 11
What are the Advantages of Attending?

Whether your industry is subject to FDA regulations, ISO standards, or other quality or document control stipulations,
a Regional User Group Meeting can provide a dynamic setting where relevant industry issues can be addressed and
MasterControls technology enablers discussed. Additional benefits for attendees include:
Learning new tips, tricks, and best practices for using MasterControl products;
Introducing MasterControl to other members or departments throughout your organization;
Gaining an increased understanding of industry topics and technology strategies;
Getting face-to-face assistance from MasterControl product and industry experts;
The opportunity to attend a valuable educational meeting at little or no cost;
The opportunity to help determine themes and specific topics that are of special interest to you and your
company;
Credit for purchasing additional MasterControl products.
Host a Regional User Group in Your Area?

Hosting a Regional User Group Meeting is a great experience for you, your company, and other MasterControl
customers in your area. As a user group host, you can help to determine customer-focused themes, presentations,
and workshops while receiving the support of MasterControl experts, your Customer Relationship Manager (CRM),
your RSM (Regional Sales Manager), and the optional support of a Customer Advisory Board (CAB) member. Youll
also receive $1,000 in credit for new MasterControl products!
To host a MasterControl Regional User Group Meeting, you need access to a conference room for up to 25 people,
projectors for presentations, and white boards. Access to food and restrooms should also be taken into consideration.
Each participant will be responsible for his or her own travel and lodging (if needed).
Once you have expressed your interest in hosting a Regional User Group Meeting, MasterControl representatives
will help you mold workshop themes and discussion topics as well as provide support for invitations, announcements,
agendas, facilities, maps, food basically everything you need to make your User Group Meeting a great success.
To learn more about attending or hosting a Regional User Group Meeting in your area contact a MasterControl
representative at usergroups@mastercontrol.com.
Page 12
Customer Website
As a MasterControl customer, there are many ways that you can learn best practices and helpful strategies from
both new and experienced MasterControl customers. In order to help facilitate that interaction between customers,
MasterControl offers a Customer Website where users can have one-on-one or group discussions with other
MasterControl customers from across the world. Your discussions may range from topics as broad as CAPA
strategies and quality system methodologies to topics as simple as organizing your tasks and discussing the benefits
of new software version features.
In essence, the Customer Website is designed to make peer-based information easy to access. To participate, simply
log on at www.mastercontrolcustomers.com. If you need a login and password, simply contact your sys admin or
MasterControls technical support team via email (support@mastercontrol.com) or call (001) 800-825-9117.
Accessing the MasterControl Website
MasterControls Customer Website allows you to participate at any level you desire. You can simply read the infor-
mation other customers are submitting or become a major contributor yourself. Either way, the site has a tremen-
dous amount of valuable information to offer.
The MasterControl Customer Website can be accessed via the http://www.mastercontrolcustomers.com link. The site
is a MasterControl users gateway to training and support services and an excellent means of connecting with other
MasterControl users throughout the world. The Customer Website is loaded with useful information and features
that can help all MasterControl users the MasterControl community discussion forum, product-related information,
educational opportunities, and the self-service technical support portal are just a few of the available features of the
MasterControl Customer Website.
The MasterControl Customer Website is available to all MasterControl customers with a valid Maintenance
and Support (MSA) agreement. The site is an interactive source of the most up-to-date information relating to
MasterControl Services, Products, and the Company.
Customers that have upgraded to MasterControl version 8.0 or higher can also access both the Customer Website
and the community discussion forum directly via links in the Public Links area.
Entry to the MasterControl Customer Website requires a user ID and password, which can be obtained in three ways:
1. Contact MasterControl technical support either by phone (800-825-9117) or e-mail (support@mastercontrol.

com)
2. Click on the red Need a Login banner at www.mastercontrolcustomers.com
3. Contact your organizations system administrator.
Page 13
What Can You Find on the MasterControl Customer Website?
The following list outlines just a few of the helpful topics you can find on the Customer Website.
Technical Support
Find multiple ways to contact MasterControl technical support
Log technical issues and receive a tracking number
Log change requests for product improvements
Track the status of previously logged issues
Find useful information such as release notes and critical notifications
User Group Meetings and the Annual Masters Summit

Find out how to register for regional user group meetings or the annual Masters Summit
Submit an abstract to present at either a user group meeting or the Masters Summit
Suggest topics for presentations for either the user group meetings or the Masters Summit
Learn how to host a regional user group meeting at your facility
Download presentations from previous Masters Summits
View customer videos, photos, and comments about previous Masters Summits
Offer suggestions for upcoming Masters Summits
Find the locations, dates, and costs for the upcoming user group meetings and Masters Summit
Customer-to-Customer Community
Search the MasterControl community forum for answers to your questions
Ask a question in the community forum and learn from other MasterControl users
Browse current topics and join discussion groups in the community forum
Use the community index to communicate with other MasterControl users with similar products, services, and
experiences
Add your name to the community index so other MasterControl users can invite you to relevant forums and share
information, documents, and templates
Help the MasterControl community by sharing your experience, templates, and opinions with other MasterControl
users
Subscribe to automated notifications when you receive a response to your questions and comments
Education
View a calendar of upcoming MasterControl courses
Easily schedule and purchase MasterControl education courses online
Recommend and comment to others on courses you have taken
Subscribe to or read MasterControls customer newsletter online
Access industry white papers and recorded webinars
Product and Service Information

Learn about new products, features, and services available from MasterControl
Download product data sheets
Easily purchase and download products online
Learn about and order services quickly and easily online
Order the latest version of MasterControls Products and Services Guide
Page 14
Getting Started In addition to the navigation at the top of each page,

Entry to the site requires a user ID and password. You youll also find a Quick Links box in the upper right
can get your own login from your system administrator corner of each page throughout the site. These Quick
or directly from MasterControls technical support depart- Links provide easy access to the most popular areas of
ment. If you do not have a login ID or if you have forgot- the Customer Website.
ten your password, contact your system administrator or
a MasterControl technical support representative.
Enter your user ID and password in the fields provided.

If you have logged in previously but have forgotten your
password, enter your user ID and click on the Forgot
Password? link to receive a message helping you with
your password.
Upon successful login you will be taken to the Welcome Quick Links are the easiest connection to
page. This page has been designed to help you find and the website pages MasterControl users
access the many services and benefits available on access most frequently. Click on any link of
MasterControls Customer Website. The site is a smart interest to access the associated page.
website in that it customizes certain pages specifically
for you and your company based on your login.
The What Do You Want to Do Today? section of the
The site is easy to navigate with comprehensive pull- Welcome page gives users easy access to additional
down menus along the top of each page. information such as user group meetings, the C2C
Community Discussion Forum, newsletters, education
opportunities, services, technical support, and more.
Simply point your mouse to a section title to see the listed

options displayed in the white area. Click on the listed
Navigate by topic using the item of interest to open the desired page of the Customer
Customer Website Toolbar. Website.
Page 15
Simply point your mouse to a section title to see the listed The Customer Forum is loaded with helpful features
options displayed in the white area. Click on the listed specifically designed to help users get the most out of
item of interest to open the desired page of the Customer MasterControl, such as:
Website.
The Advanced Search feature allows Forum
Key Areas of Interest participants to search for the phrases, topics, words,
and messages most relevant to the individual user
C2C Community Forum and Customer Index The Jump to drill-down list allows users to directly
How to get there: access discussions about specific, relevant topics
(i.e., tips, frequently asked questions, product-
By clicking on the Customer Discussion Forum link specific discussions, the Masters Summit, etc.)
on the upper right hand corner of the Welcome page
Click on the Forum Preferences icon in the
customers are able to view current topics, learn more
upper left corner of the Forum main page to change
about subjects of most interest to them, find customers
your publicly viewable information and viewing
with similar interests, and send a private message to
preferences
other MasterControl customers.
By clicking on the Members link located in the
middle of the task bar at the top of the page you can
access a list of forum members, their profiles, and
contact information, as well as their recent posts
The Customer Discussion Community Forum is the area

of the site where MasterControl users can talk directly to MasterControl users can use the Customer 2 Customer
and learn from other customers. Click on the Customer section of the site to create their own personal Customer
Discussion Forum link in the Quick Links box to start Index profiles and share information with other
new topic discussions, or join ongoing discussions about MasterControl users with similar interests and utilization
existing topics in a customer panel-managed forum of MasterControl products. To create a profile, go to the
area. Participate in C2C Forum and Index section of the
What Do You Want to Do Today menu and select the
To join a discussion, click on the Thread Reply button Create your personal Customer Index profile link.
of the post you are reading. To start a new discussion,
select the general area applicable to your topic and click Technical Support (via Multiple Methods)
the New Topic icon in the lower left corner at the bottom How to get there:
of the list of threads. Check the box below the message
text box of the discussion you have joined or started to Click on the Support tab on the upper right corner of
receive e-mail notifications when new posts are added to any page on the Customer Website or click on the Self-
the thread you have joined or started. Service Portal link in the Quick Links box to access the
self-service support options.
Page 16
User Group Meetings and the Annual Masters

Summit)
How to get there:
Simply move the mouse over the Participate in User

Group Meetings bar in the What Do You Want to Do
Today? section of the Welcome page for the latest user
group meeting and annual Masters Summit information.
This is the area of the site MasterControl customers
can get information about hosting regional user group
meetings and view presentations, comments, customer
videos, and photos from previous Masters Summits.
Customers can also access this section of the site to
find out the location, dates, and cost for the upcoming
Masters Summit and offer suggestions for future Masters
Summits.
Education
How to get there:
The self-service support portal allows MasterControl
customers to send an e-mail or online request form
With a single click on the Education Calendar link in
to MasterControl support technicians. Users are also
the Quick Links box, customers can view the calendar of
provided with other helpful links on the self-service page
upcoming MasterControl courses and purchase courses
such as system recommendations, release notes, product
online.
support lifecycle information, critical notifications, and an
overview of MasterControls technical support.
The technical support area of the Customer Website

allows MasterControl users to:
Log technical issues and receive a tracking number

Log change requests for product improvements
Track the status of previously logged issues
MasterControl customers can also seek support guidance

from their fellow customers in the customer-to-customer
Community Forum. Click on the Customer Discussion
Forum Quick Link or point your mouse to the Support
tab in the upper right corner and select the first option
in the drop-down list, Customer-to-Customer to get
started.
(Please note that MasterControl QAAD training is currently

provided on an as-needed basis. If an occasion should
arise that a standardized training would be appropriate,
such courses will be displayed on the education calendar
and available for purchase via the Customer Website as
well.)
Page 17
Education Center courses that are presented at By hovering your mouse cursor over the Get Educated
MasterControls Salt Lake City facility can be booked tab on the What Do You Want to Do Today box on
directly on the website using the familiar shopping the Welcome page, customers can also access other
cart process. Simply click on the calendar date for the education opportunities such as industry white papers and
course you are interested in attending and you will be recorded webinars, the e-Learning center, newsletters, a
automatically linked to the registration page for that glossary of terms, and helpful information for coordinating
course. travel arrangements to the MasterControl Education
Center in Salt Lake City, Utah.
To recommend other MasterControl courses that you

would like to see offered, click on the Feedback link
located on the menu at the bottom of every page of the
Education Calendar section of the site.
To view information and register for upcoming

MasterControl events such as user groups, regional
meetings, partner trainings, and Masters Summits, click
on the MasterControl Events tab on the Education
Calendar main page.
Page 18
MasterControl products and services can be also The Validation and Support tabs lead to information
purchased from the shopping cart area of the Customer pages about the many services MasterControl has to
Website by clicking on the Products & Services tab. offer as well, including:
Technical support services

Validation best practices services
Validation training services
Onsite/remote protocol execution services
GxP documentation services
GxP documentation services
Webinars and Other Educational Materials

How to get there:
To access MasterControls extensive library of helpful

educational materials, simply mouse over the Library
tab on the upper right side of the screen and select the
appropriate choice from the drop-down list. Resources
such as webinars, white papers, case studies, product
data sheets, newsletters, industry links and more are
provided to MasterControl customers to help resolve
Product and Service Information
issues and enhance their usage of MasterControl
How to get there:
products. New educational materials are released every
month so check back often.
MasterControl customers can download electronic
versions of product release notes without being required
to contact support directly. Just click on the Product
Release Notes link in the Quick Links box on the upper
right corner of any Customer Website page to access a
listing of downloadable release notes for MasterControl
products.
By navigating through the drop down menus of the

Solutions tab, Customer Website users can view and get
more information about the full range of MasterControl
products.
Enhancement Requests
How to get there:
Note: Logging enhancement requests entails a separate

user name and password than is normally required to
enter the Customer Website in order to connect with
MasterControls SalesForce knowledge base. To obtain
this unique login information, please contact Customer
Service at (800) 825-9117.
Page 19
Once you have received the new login username and

password, go to the Self-Service Portal and enter
the login information in the Case Management Login
section. From this self-service support portal, authorized
customers will be able to log and track tech support
cases, enhancement requests, and customer service
requests, as well as search MasterControls knowledge
base for technical solutions.
Summary
As a MasterControl customer you have complete
access to MasterControls Customer Website (www.
mastercontrolcustomers.com). The Quick Links to
self-service options, product information, educational
downloads, release notes, customer community forums,
and additional helpful resources are all designed to
enhance your experience as a MasterControl user and
ensure that no question goes unanswered. All of the
useful information and features the site has to offer are
just a mouse click away!
Page 20
Customer Store
Everything is easier online and your next MasterControl product is only a few clicks away. MasterControls
training courses, software solutions, validation products, and events are moving to the Customer Store area of the
MasterControl Customer Website where customers can access them anywhere, anytime.
MasterControl customers can currently access the Customer Store area of the MasterControl Customer Website to
schedule training courses and/or purchase products. To visit the Customer Store and view available products and
services, upcoming MasterControl events, and calendar of upcoming educational courses, please go to https://www.
mastercontrolcustomers.com/shop/ (login ID and password required).
Training courses currently available in the Customer Store include:
MasterControl Documents
MasterControl Portal
MasterControl Training
MasterControl Process SysAdmin
MasterControl Process Automation
MasterControl Upgrade Configuration Service Packages are also currently available directly from the Customer
Store. The Configuration Service Packages includes upgrade configuration, end-user training, and, for customers
doing business in regulatory environments, validation consultation.
How Does it Work?

To access MasterControls online shopping options, simply log in to the MasterControl Customer Website. If you
dont have a user name and password, contact your system administrator or a MasterControl technical support
representative at (001) 800-825-9117. Then feel free to browse through the product and course options that
MasterControl offers online. New products and services are continually being added to the Customer Store so please
check often to see the latest offerings.
What Payment Types are Accepted?

Credit card payments (e.g., MasterCard, Visa, American Express, and Discover) are accepted on the Customer
Store.
Course Confirmation
After registering for a training course using MasterControls Verisign-secure shopping cart, customer registrants will
receive an e-mail with payment confirmation and course detail information.
Page 21
MasterControl Best Practices for

Successful Software Implementation
Introduction
The purpose of this MasterControl Best Practices Guide is to help ensure that the implementation of the software
you have purchased runs as smoothly as possible. The process of researching, evaluating, and buying software is
often long and arduous. The transition from sale to implementation is often no less demanding. At MasterControl, a
customer communicates primarily with a Regional Sales Manager (RSM) during the evaluation process and purchase
of software. After a sale is concluded the project moves to implementation and our Services Department takes over
and becomes your key contact at MasterControl. During implementation, you will work closely with the Technical
Support, Professional Services, and Validation Services teams, as well as with your Customer Relationship Manager
(CRM), who has the overall responsibility of ensuring a successful implementation. The implementation process
typically lasts anywhere from several weeks to several months, depending on the complexity of your specific situation
and your readiness to begin the process.
This Best Practices Guide discusses strategies for efficient software deployment based on MasterControls
experience with hundreds of implementation projects. (Over 90 percent of our life science customers have rated their
implementation projects successful.) For your convenience, weve also provided a concise list of DOs and DONTs at
the end of this section. We strongly encourage you to read carefully through these Best Practice Guidelines and put
their recommendations into practice. In addition, we encourage you to become familiar with the products and services
outlined in this booklet. Within these pages youll find many ways that MasterControl can make your job easier and
add value to your company. Please contact MasterControls Project Office, Technical Support team, or your CRM if
you need any help or have questions about any portion of this booklet.
MasterControl Best Practices Guidelines

Although all implementations are unique, there are certain requirements that MasterControl considers essential to
any successful project.
1. Define Your Needs and Objectives
Be as Specific as Possible: A companys objectives might be as broad as improve our paper-based system
through automation, or it might be as specific as implement an electronic document control system with
automatic notification and escalation in order to reduce document approval time from one month to one week.
This is actually a better objective because the MasterControl team knows exactly what its aiming for, and all
efforts can be directed toward helping you to achieve this objective. Also, the more specific you are, the easier it
is to measure whether the team has reached its objectives.
Know your Configuration Requirements: With MasterControls help, your company needs to define how the
solution you have purchased should be configured in order to automate your processes and meet your specific
requirements. Determining which configuration options are appropriate for your company not only speeds up
the implementation, it enhances user adoption. A customer who buys the training module, for example, with only
a vague idea of wanting to automate the training process, will have a harder time implementing an acceptable,
efficient and expandable solution. A better way to proceed is to:
a) Make a list of training courses needed;

b) Decide which employees need training;
c) Decide whether exams are necessary;
d) Determine what the verification process will be; and
e) Create a training schedule.
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Know Who will be Using your Software: Take an inventory of your stakeholders (personnel, consultants,
partners, etc.), so that youre clear about who will be using your new software, and who will be responsible for
ensuring that everything runs smoothly. Make sure you understand how MasterControl can be used throughout
your company and verify that youve purchased enough licenses to accommodate a smooth implementation
process for each different user. This is especially important when using MasterControl to manage inter-
departmental processes. Examples of employees who may end up using MasterControl on a regular basis
include those in quality, R&D, regulatory, product development, manufacturing, sales and marketing, etc.
Examples of people you may want to make responsible for ensuring the smooth-running of your software
investment are software training specialists, system administrators, etc.
A good way to start to define your needs and objectives is to create a table that lists processes you plan to automate,
current challenges associated with these processes, people involved with these processes, and the benefits
(financial, increased speed, decreased effort, higher quality, or otherwise) expected from automation. Also list the
urgency or priority level of each process, and the target date for automation. This will help crystallize your needs and
objectives and prioritize processes. The table below is an example.
Processes Challenges People and Expected Priority Target

that Need Associated with Departments Benefits from Date for
to be Processes Involved Automation Automation
Automated
Document Paper forms containing Quality Faster processing of High Within next 4
Control blood donor info are Manager, forms, more secure months
difficult to locate; easy R&D Manager, system for storing
to misplace. Forms take manufacturing confidential blood
time to process. supervisors. donor information.
Training Control When there is a change All five Automatic trigger Medium Within next 6
in an SOP, it takes department of training tasks as months
weeks before training managers soon as SOPs are
tasks are sent out on and the revised.
the revised SOP. manufacturing
floor supervisor.
2. Emphasize Executive Sponsorship / Obtain Buy-in from Users
One of the greatest barriers to success is slow user adoption. This occurs because users dont see the advantages
of automation, or theyre uncomfortable changing their traditional way of doing things. Getting user input during the
design phase, and providing adequate, ongoing training are key to bringing users onboard. Strong management
sponsorship is also imperative. While management undoubtedly agreed to purchase the software, shifting priorities
can divert attention and resources. As a result, the project may lose a powerful force for encouraging users to adopt
the new system. To summarize the effective strategies for encouraging rapid user adoption:
Get input from Users during the Design Phase: Getting input from users during the design phase helps them
to feel part of the process and enrolls them in using the new software.
Provide Ongoing Training: Ongoing training helps users to feel comfortable with the new software and
increases their preparedness to use it.
Use Executive Sponsorship as a Trigger for Rapid Adoption: Make sure all personnel know that adopting the
new system is of high priority and strongly supported by executive management.
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3. Assess Potential Risks
It is important to identify potential risks that could hinder the implementation process and take the steps necessary to
mitigate those risks.
Identify potential risks: Make a list of all the potential risks or hurdles that could prevent a successful
implementation.
Identify actions necessary to avoid potential hurdles: Make a list of all the actions necessary to avoid the
hurdles you listed as potential risks.
Be proactive: Actively implement the actions you listed as necessary for avoiding potential risks.
4. Provide the Resources Needed for Successful Implementation
Some companies spend a lot of money buying new software only to fall short in allotting the resources needed to
successfully implement it. Most customers have a smoother experience during implementation if they have the
resources listed below.
Provide at Least Two Trained System Administrators: At least two trained system administrators are
necessary to ensure that a backup is available in the event that one system administrator becomes suddenly
unavailable. This is particularly critical when MasterControl software is used to manage documents, processes,
and training requirements throughout multiple departments. Another advantage of multiple administrators is
that each can specialize in the specific needs of different departments. If deployment is over several time zones
consider having an administrator available to cover the standard working day across all time zones. Depending
on the time range (language may also need to be considered) this may mean additional administrators will be
needed.
Provide a Non-Dedicated Resource for MasterControl Forms: MasterControl Forms is a very flexible tool for
automating any forms-based process. Its capabilities are limited only by your companys needs and resource
capacity to add new processes. An ideal resource should have enough computer/programming savvy to be able
to construct new form templates that may involve some programming. MasterControl provides consultants who
can help with this effort, and offers training for your qualified employees.
Assign a Non-Dedicated Resource to Training: MasterControl Training offers several different methods
for delivering and tracking user training. Make sure that you have a non-dedicated resource available, who
understands these different methods, and can deploy and expand the solution as necessary. A non-dedicated
resource is also required for QAAD. This is not only due to the technical requirements of the system but also due
to the sensitive nature of the material.
Assign a Non-Dedicated Resource to Business Requirements: Assign someone who has a thorough
understanding of your companys business processes and practices to coordinate collecting the diverse
requirements within each department, then have that person prioritize the long-term system rollout.
Assign a Non-Dedicated Resource to Software Validation: This person is essential if your company
is performing validation testing on its own. Most MasterControl customers take advantage of the array of
MasterControl products (including Transfer OQ), as well as MasterControl Validation Services, to help reduce
the time, pain, and cost of validating a system. For customers doing their own validation, MasterControl offers
a two-day training course on how to manage and complete a validation project, as well as how to use optional,
purchased validation tools. The course includes hands-on activities on aspects of IQ, OQ, and PQ.
Provide IT Support: It helps to have experienced and accessible IT personnel involved early in the
implementation process. MasterControls Tech Support team will perform the initial phase of implementation for
you, usually with the support of your IT department. While the need for ongoing IT support is minimal, it is helpful
if your IT department knows how to back up the system and provide ongoing maintenance. MasterControls Tech
Support team is happy to provide customized instruction for your IT personnel on topics ranging from database
setup to custom report generation.
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5. Have a Realistic Schedule
Many customers underestimate the time needed and the effort required for such things as customizing forms, training
users on the new system, and validating the software. As a result, they are surprised when unexpected issues arise
and they have to adjust the schedule.
Below, we provide a sample estimate of the time required for a basic implementation project, involving the
deployment of three modules (MasterControl Documents, MasterControl Process, and MasterControl
Training). In this example the implementation might have fewer than a dozen users, only two simple forms
needed initially, and fewer than 1,000 documents to be managed. This example assumes that the customer bought
MasterControl IQ/OQ protocols and a Validation Toolkit (includes SOPs, templates, and risk assessment forms) to
facilitate system validation, and that the customer performed validation on its own.
Project Phase Activities Duration

Planning: Kickoff, definitions, identify team, scheduling, etc. 510 days
Discover: Customer training, installation, configuration homework, etc. 59 wks
Configure: Portal, Documents, Process, Training configuration 515 days
Validate: IQ/OQ Execution, PQ documentation, PQ execution 68 wks
Deploy: End-user training, go live 510 days
Total No. of Weeks 1322 wks
Please note that the durations shown above could grow significantly if a project involves more users, more sites,
customized forms, or more documents (tens of thousands vs. hundreds). Validation is another critical factor that
affects implementation. By taking advantage of MasterControl validation products, such as MasterControl Transfer
OQ, and services such as onsite IQ, OQ, and PQ execution, you can reduce the validation time of non-QAAD
products by as much as 50 percent.
Another factor that can affect the duration of the project is the availability of your companys employees and
MasterControl resources. For example, even though system administration training takes only a few days, the
classes may not always be immediately available. Likewise, configuration and validation professionals (from both
your company and MasterControl) may be working across multiple departments within your company. As a result of
these variables, what initially seemed like a few weeks of implementation can turn into a few months.
6. Provide Continuous Monitoring and Communication
The process of software implementation is dynamic; therefore, its important to develop milestones, continuously
monitor your progress, and promptly address any issues that arise. A project leader typically performs this task.
MasterControls Project Office and your CRM will facilitate the delivery of all services (billable and non-billable)
necessary to ensure successful software deployment. Your company needs to nominate similar individuals to
facilitate communication within the group of internal stakeholders. For large, complex projects, the MasterControl
Project Office offers dedicated project management services for coordinating and managing activities throughout the
implementation lifecycle. Please contact your CRM for more information.
Common Reasons for Problems During the Implementation Process
Although the vast majority of MasterControl customers deploy our software successfully, there will always be some
customers that experience more challenges than others. The reasons for this are as varied as the customers
themselves, but in most cases, the reason projects have problems or experience delays is due to either poor
planning, or because of circumstances that were not (and sometimes could not) have been foreseen by either you or
MasterControl. Our purpose in preparing this booklet is to help you be fully prepared, so that poor planning is not an
issue and you can anticipate (and take measures to mitigate) as many potential risks as possible.
Page 25
Common reasons for failure include:
Lack of support from appropriate personnel and departments: This has to do with the failure to ensure
executive sponsorship and comprehensive user buy-in throughout all departments that will benefit by
using MasterControl, as well as the failure to allot the human resources that are necessary for successful
implementation.
Lack of understanding of internal requirements and needs: Your internal teams may know what they
need, but without formal documentation of those needs, there can be confusion or inconsistency during the
implementation process. By clearly defining your objectives, needs/requirements, and stakeholders beforehand,
as discussed within these guidelines, you can avoid this pitfall.
Lack of resource persons: Assigning a document control specialist to be the only resource for Forms, Training,
Validation, and all other MasterControl modules that were purchased is usually ineffective. As indicated in the
MasterControl Good Practices Guidelines, it is critical that you provide the appropriate human resources for
successful implementation.
Unrealistic schedule: A schedule can turn out to be unrealistic when you underestimate the amount of
consultation, validation, and other services needed for a smooth implementation. For example, booking only eight
hours of engagement for a MasterControl Forms consultant to customize dozens of forms may be unrealistic.
Misalignment between project requirements and what was purchased: Despite everyones best intentions,
sometimes the wrong product mix is purchased, or the capabilities of the product mix purchased are inadequate
to bring about the desired outcome. MasterControl makes every effort to adjust the product mix as necessary to
achieve a successful outcome. Generally this effort is limited only by the confines of the actual investment. If you
have any questions about whether or not the products and services you have purchased will meet your ultimate
goals, both now and in the future, please contact either the Project Office or your CRM. They will be happy to
help you assess your goals and make recommendations to make sure that you are completely satisfied.
Shift in priorities: Implementations occur over time, during which a companys fortunes and priorities may
change. Such changes may negatively affect resource availability, solution requirements, management support,
and user adoption. This type of situation neednt derail the implementation, but it can set it back considerably.
Please let us know if you encounter a shift in priorities, as there are usually ways we can help you work around
such challenges.
For the minority of customers who struggle with their implementation, our Client Services team continuously monitors
your needs to find ways to help you resolve issues and achieve your goals in the best possible manner. Solutions
may include everything from simple bug fixes to additional training, to the utilization of MasterControls experienced
consultants to assist you with specific issues. Barring any serious internal issues, most problematic implementations
can be put back on track without too much difficulty.
Post-Implementation Stage
After you go live with MasterControl, your Customer Relationship Manager (CRM) remains your primary contact
with MasterControl, with the Tech Support team providing maintenance services, as needed. This includes software
upgrades and technical assistance via email (support@mastercontrol.com). You may also reach the Tech Support
team (or your CRM) at (001) 800-825-9117.
You can also get help by visiting MasterControls Customer Website (www.mastercontrolcustomers.com). Through
this virtual center, you can submit a problem report at any time, submit enhancement ideas, review the status of a
problem or enhancement request, and download helpful information. You will receive periodic information about new
releases, and you will have the ability to interact with industry peers and MasterControl staff through the User Group
conferences held both online and in various cities across the country.
In addition, you will be sent a copy of MasterControls monthly email newsletter called GxP Lifeline. In this newsletter
youll find insightful articles written by industry experts, helpful tips for getting the most out of your investment in
MasterControl, specials to help you save money, as well as industry information regarding events, industry websites,
terminology, and other helpful information. If you are not receiving your copy of GxP Lifeline please visit
www.mastercontrol.com/newsletter to view past editions and subscribe.
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Your Customer Relationship Manager (CRM) and your Regional Sales Manager (RSM) will continually monitor all of
your software and services needs to make sure that youre getting the highest possible value from your relationship
with MasterControl. CRMs regularly communicate with customers and conduct surveys twice annually with all non-
QAAD customers to get input on how MasterControl can improve its products and services.
Under our Customer Success program, you will get a chance to rate the success of your projects. You can also rate
individual MasterControl modules on a scale of one to five, with five being the highest rating. It is a MasterControl
tradition to celebrate each customers success by adding the customers logo to our Wall of Success at our
headquarters, in a ceremony attended by all employees. We look forward to adding your companys logo to this wall
in the near future.
Summary
MasterControls best practices for implementation continue to evolve as customer needs grow and our software and
services are enhanced to better meet those needs. The best practices discussed in this section should be considered
as merely a starting point for planning your software implementation and for avoiding common pitfalls. There are
many ways MasterControl can help you to attain implementation success. But in the end, your goal in software
deployment should be to deliver a system that meets your companys business, process, and compliance needs at
a cost acceptable to your organization. Please dont hesitate to contact us to see if there are any additional ways we
can help you achieve that goal.
MasterControl Best Practice Guidelines DOs and DONTs
Develop a project plan that includes a definition of your needs and objectives, as well as your
DO configuration requirements.
Take an inventory of your stakeholders (personnel, consultants, partners, etc.), so that you know who
will be using your new software and who will be responsible for helping to ensure smooth operations
DO
(software training specialists, system administrators, etc.).
Develop a strategy for ensuring user buy-in that includes strong executive sponsorship, getting user
DO feedback during the design phase, and providing adequate, ongoing training.
Put together a risk assessment and mitigation plan.

DO
Make a list of the dedicated and/or non-dedicated human resources necessary for successful
DO implementation.
Have a plan for continuously monitoring the implementation and promptly communicating/addressing any
DO problems that arise.
Provide continuous monitoring of your system, and promptly communicate any issues.
DO
Overlook the need for internal support from the appropriate people and departments.
DONT
Neglect to create a formal document that states your requirements and needs (document should include
DONT list of your stakeholders).
Assign inappropriate or untrained employees as the resource person for forms, validation, training, etc.
DONT
Create an inflexible schedule that provides no room for unforeseen events or problems.
DONT
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Services
MasterControl
Services
Services
Data Migration Services........................................................... 31
Educational Services............................................................... 32
QMS CAPA Workshop............................................................. 34
QMS Root Cause Investigations Workshop............................. 36
Process Consulting & Implementation Services...................... 38
Implementation Best Practices................................................ 40
Integration Services................................................................. 41
Project Management Services................................................. 42
Software as a Service.............................................................. 44
Technical Support Services..................................................... 46
Validation Services and Solutions............................................ 48
Configuration Services............................................................. 51

Data Migration Services

For companies using MasterControls client/server system who now want to upgrade to the MasterControl web-based
platform, the Professional Services team coordinates the entire migration effort. This helps maximize the benefits of
new technology while minimizing disruptions to your day-to-day operations.
Since our web-based platform is by far the more preferred system, many of our customers have successfully
migrated from their client/server system. This includes tens of thousands of documents, SOPs, drawings,
specifications, technical reports, and other records. Our automated data migration utility simplifies the challenges that
seemingly even simple data migrations can present. This is particularly true when information needs to be transferred
between dissimilar storage systems without substantially disrupting requirements for continuous, around-the-clock
data.
When employing MasterControls Data Migration Services, all migrations are implemented using our proven project
methodology. This methodology utilizes a full test migration at our facility prior to the live data migration at your site.
This ensures that any data integrity issues are identified and corrected prior to the final migration of your critical
data. Following a successful test at our facility, the consultant assigned to your project will repeat this comprehensive
migration test plan when onsite.
Please note that these data migration services are not applicable to the QAAD product.
Feel free to contact either your CRM or your RSM if you have any questions regarding our Data Migration Services.
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MasterControl Educational Services

Owning a powerful tool can be extremely valuable, but without thorough knowledge of how to use that tool, its value
is wasted. MasterControl Inc. provides a variety of educational resources to help you gain a complete understanding
of the MasterControl software suite, with the ultimate goal of improving your organizations productivity and efficiency.
Whether your needs focus on enabling a new system or building a stronger understanding of a current system,
MasterControl is ready to help you meet your goals. Our Education Services Department offers a variety of
instructional materials and courses designed to teach both users and administrators how to get the most from
MasterControls products.
Our team of instructors is made up of professionals that have years of real-world experience in regulated industries.
They follow best practices guidelines to not only teach the form and function of the software but also to present the
material within a problem-solving framework. This adds more value to our customers educational experience than
what they would get from a typical classroom or selfstudy environment.
Salt Lake City Education Center

Hands-on training in a classroom environment is offered at MasterControls Education Center, located at the
companys headquarters in Salt Lake City, Utah. The Education Center is a working classroom designed to help
administrators, engineers, quality professionals, and others in your organization become proficient with the array of
MasterControl products. Our state-of-the-art facilities provide each student with a workstation loaded with the most
current applications, allowing them to explore every component of MasterControl. Courses are taught by subject
matter experts from our various departments and professional services consultants that make their living in the field.
Students that raise questions in class often find themselves being handed a flash drive with a solution that was just
implemented at a customers site by one of our instructors.
Our courses allow for plenty of one-on-one time with the instructors and youll also have the opportunity to meet with
colleagues in your industry and share experiences about utilizing MasterControl products. Our staff will also prepare
for your visit with materials, agendas, lodging, food, and help with local travel.
By simply clicking on the Education Calendar link in the Quick Links box on the MasterControl customer
website, customers can view the calendar of upcoming courses and purchase courses online.
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Educational Materials
The Education Center can also provide training at a site of the customers choosing. MasterControl Instructors will
provide the same content and materials used at MasterControls Corporate Headquarters. However, the examples
and exercises are custom tailored to fit your specific needs. Our team will work with you in advance to ensure your
facilities, equipment, and software are all properly configured before the course begins.
Flash Drives Includes presentations, courses, units, utilities, and reference information.
Manuals Available within MasterControls HELP, at the sysadmin level, creator-reviser level, and user level.
Courses/Units/Reference Materials Educational materials in electronic format are available through the
MasterControl Customer Website (www.mastercontrolcustomers.com).
Padded Notebook with Paper Pad and Pens Provided to participants at the Salt Lake City Education Center.
Access to Student HTTPS Training Website for One Month
On-Site Training
The Education Center can also provide training at a site of the customers choosing. MasterControl Instructors will
provide the same content and materials used at MasterControls Corporate Headquarters. However, the examples
and exercises are custom tailored to fit your specific needs. Our team will work with you in advance to ensure your
facilities, equipment, and software are all properly configured before the course begins.
Online Training
The Education Center offers a variety of instructional methods including:
Instructor-Led Webinars
Interactive Computer-Based Training Courses
Pre-Recorded Training Materials
Instructor-Led Webinars This is an excellent solution for organizations with many trainees at different locations. It
is also a low-cost option for trainees that do best when a live instructor is readily available.
Interactive Computer-Based Training (CBT) Courses CBT courses are the next best thing to sitting in front of a
live instructor. These courses are interactive and can be purchased online through the shopping cart in our Customer
Website (www.mastercontrolcustomers.com). Each of the purchased Units contains up to 15 segments of essential
MasterControl tasks totaling approximately one hour of one-on-one training experience with each Unit. Other Units
provide additional learned tasks that build on one another and provide the most experienced avenue of learning
MasterControl products for all of your users needs. Individually trained, each user can be supplied with a Unit that
best suits his or her own requirements for using MasterControl.
Pre-Recorded Training Materials Finally, MasterControl offers a library of pre-recorded training materials. Both
administrators and general users will find a wide variety of courses, archived Webinars, and other reference materials
available on a 24/7 basis.
You can find more information about MasterControls training programs on our customer website
(www.mastercontrolcustomers.com), such as:
A calendar of upcoming MasterControl courses

A means of easily scheduling and purchasing MasterControl education courses online
A forum for recommending and commenting to other MasterControl users on courses you have taken
Access to all current and past editions of MasterControls customer newsletter
Access to industry white papers and recorded Webinars
Page 33
MasterControl QMS CAPA Workshop

The Life Science industry needs to have trained personnel that can be counted on to identify and investigate root
causes and effectively implement solutions for corrective and preventive actions. MasterControl has custom fit the
PathWise CAPA course for those companies that are integrating electronic systems and applying CAPA skills into
those forms. It is designed to effectively develop these individuals and provide them with the skills and tools to
become superb investigators and problem solvers.
The Problem
Many organizations are experiencing death by CAPA: They are unable to properly utilize resources to solve
problems according to priority, they have more open CAPAs than can possibly be resolved, and/or they have
ineffective risk filters to discriminate between inputs. CAPA pains common to many organizations include:
Countless open CAPAs with no resolution and too many people involved.
Internal investigators who cant solve problems and find causes.
Ineffective processes to utilize with personnel presenting data for root cause analysis.
CAPA processes that dont pass FDA standards.
No uniform, solid method for investigating problems.
No process for verifying and validating corrective actions that work.
The MasterControl Solution

MasterControls QMS CAPA is a workshop that incorporates the proven PathWise methodology to teach critical
thinking skills that will help any organization deploy and follow a best-practice CAPA system. Participants will
learn the best processes to analyze data and make decisions that will allow them to solve both major and minor
problems. Workshop participants dont need years of experience in investigating root causesthey can depend on
MasterControls logical testing processes to eliminate incorrect causes and focus on the best corrective solutions.
The methodology taught in the course is FDA-approved and easy to understand and get results.
Course Overview
Issue Review Identify and prioritize events based on risk. Set up risk gateways into electronic solutions.
Root Cause Analysis Investigate systemic issues to identify underlying causes.
Implementation and Effectiveness Checking Solution selection, verify and validate, implement, monitor and
confirm success.
The course is taught using a blended approach of classroom and real-life application. This how-to approach to
learning significantly increases knowledge retention and allows participants to apply the skills theyve learned in
training into a work setting. For those implementing electronic systems analysis will be tracked and demonstrated
with MasterControls new QMS CAPA Solutions Package. The course is conducted by MasterControl facilitators who
have a deep understanding of both CAPA systems and electronic process management.
Skills Learned
Throughout the course, participants improve their ability to:
Assess and prioritize each event based on risk and map form to form risk filters.
Gather relevant information through specific, focused questioning.
Pinpoint root causes using facts instead of guesswork or opinion.
Integrate intelligence into forms and set up paths to guide based upon regulations.
Avoid costly experiments and trial fixes by logically testing possible causes.
Target potential problems before they happen and develop actions to prevent them.
Effectively involve others in the investigation process.
Check effectiveness of corrective/preventive actions.
Document the analysis in an easy-to-use, logical and defensible format.
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Audience
This course is appropriate for individuals who are regularly called upon to resolve problems or whose input would
aid in preventing problems. Examples include investigators, laboratory, QA/RA functions, managers, manufacturing
supervisors, technicians, and engineers.
Application
QMS CAPA Workshop participants will gain proficiencies necessary to solve real-work problems as much as three
times faster than they are at present. The skills taught through the course can help participants solve problems and
reduce rework, downtime, and scrap. The root cause analysis processes taught in the course allow participants to
create their own replicable, audit-ready processes.
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MasterControl QMS Root Cause Investigations Workshop

Getting burned by fire fighting? Too often expensive problems are never resolved and reoccur because those working
on them lack the experience or skills needed to quickly find the root cause. Good problem solvers are worth their
weight in gold, and in most companies are just as rare. The MasterControl QMS Root Cause Investigations workshop
can develop personnel into superb problem solvers. MasterControl has teamed with PathWise, a leader in CAPA
training, to offer this workshop series.
The Problem
The role of the troubleshooter has traditionally stressed reacting to problems. Personnel charged with solving
problems tend to take a shotgun approachwhen something goes wrong, do whatever it takes to correct it. As a
result, many problems reoccur due to focusing on symptoms instead of the root cause. Pains common to many
organizations include:
Product or equipment problems with unknown causes that result in delays, scrap, rework, and/or downtime
Investigators lack expertise and are unable to solve problems and find causes
Countless open CAPAs with no resolution
Inadequate processes to utilize when root cause analysis data is brought forward
Inability to easily communicate and transfer step-to-step investigation knowledge

MasterControls QMS Root Cause Investigations is a workshop designed for individuals who must quickly resolve
problems. The program provides the troubleshooter with advanced skills in root cause analysis and probable cause
testing. Through practical instruction and hands-on application, participants also learn to focus on the source of the
problem, not just the symptom. Real applications will be made for those who use electronic processes and reporting.
By establishing a solid method for investigating and a common approach to problem solving, QMS Root Cause
Investigations also enables participants from different levels and disciplines to work together to resolve problems.
MasterControls proven methodology will help workshop participants develop replicable root cause processes
by utilizing deduction techniques to uncover data and provide clues. Workshop participants dont need years of
experience in investigating root causesthey can depend on MasterControls logical testing processes to eliminate
incorrect causes and focus on the best corrective solutions.
Course Delivery
QMS Root Cause Investigations blends self-paced pre-work with live classroom instruction to significantly reduce the
amount of time in the classroom. The fundamental concepts of the process are delivered via a 90 minute pre-work
CD prior to attending the workshop. The one day workshop is then free to concentrate on immersive learning through
case studies, activities, and working on participants real-work problems.
Problem solving consulting services are also available in combination with the Root Cause process. MasterControl
consultants have used this proven problem solving method with companies around the world to resolve the toughest
issues they face. Please talk with a MasterControl representative for details on this option.
Audience
QMS Root Cause Investigations is appropriate for all who are regularly called upon to resolve problems. Examples
include QA managers, manufacturing supervisors, technicians, engineers, and field or in-house customer service
representatives.
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Skills Learned
Using the knowledge gained in the QMS Root Cause Investigations workshop, investigators and problem solvers
improve their ability to:
Gather relevant information on problems through specific and focused questioning.

Uncover clues that have been hidden or difficult to find.
Pinpoint root causes using facts, not guesswork or opinion.
Avoid costly experiments and trial fixes by logically testing possible causes.
Involve other people in the troubleshooting efficiently, i.e., whenand only whenneeded.
Check effectiveness of corrective actions.
Use software and analyze data and build reports.
Reduce resources and man hours required for solving problems.
Be in compliance with FDA or ISO in terms of having a sound process for investigating.
Application
The QMS Root Cause Investigations workshop is designed to maximize the transfer of skills to the job. Participants
bring real on-the-job problems to the workshop and leave with real solutions developed during the course.
Approximately 40 percent of the program is devoted to real-time activities or working with specific problems from the
participants jobs. Participants leave the course with the confidence that if something goes wrong, there is a definitive
solution and in case of an audit, there is a sound process to demonstrate.
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MasterControl Process Consulting & Implementation Services

Companies with outdated business processes can find themselves tied up in bureaucratic knots. MasterControls
experts analyze your business processes, suggest new ways to manage them, and lead the way to automated
systems that put you back in control and most importantly save you time and money.
Precarious world economies, heated competition, and the search for new business strategies compel todays GxP life
sciences companies to find new ways to be creative and profitable. New technology, regulatory compliance, growth
and consolidations make for a fast-paced environment requiring associated changes in business processes.
MasterControl helps life sciences and quality oriented companies streamline their business processes for greater
effectiveness and profitability using the MasterControl software suite. Our experts meet with your stafftypically
employees in IT, quality, regulatory compliance, manufacturing and financeto review your business flows and
design better ways to accomplish organizational goals.
MasterControl Process, an integrated part of the MasterControl suite, automates, streamlines, and effectively
manages forms-based processes to help ensure compliance with FDA regulations, ISO standards, and other
regulations.
MasterControls Business Process Consultants are experts in identifying areas of paper congestion and workflow
inefficiencies that hinder productivity. They offer several types of productivity improvement for customers using the
MasterControl Process software:
Implementation and Conversion Services

Analysis and Design Services
Analytics and Trending
Implementation and Conversion Services

Our experts can create new form templates or convert existing paper-based forms for customers who need this time-
saving service. Consultants can also add automation to the form using MasterControl Keywords and JavaScript, as
well as integrate processes with other databases. Additionally, we can create a defined path for the form to follow,
add the correct people in the proper order to enter and approve data and/or receive notifications.
The MasterControl Process platform supports both HTML and PDF forms without any additional cost. Our process
designers have the flexibility to determine which forms technology will be best suited for each process that they are
automating. Depending on customer needs, our experts can design or convert forms to either PDF or HTML formats.
Analysis and Design Services

Our experts can create new form templates or convert existing paper-based forms for customers who need this time-
saving service. Consultants can also add automation to the form using MasterControl Keywords and JavaScript, as
well as integrate processes with other databases. Additionally, we can create a defined path for the form to follow,
add the correct people in the proper order to enter and approve data and/or receive notifications. Forms analysis and
design is a natural byproduct of Business Process Consulting. Consultants gather customer requirements and define
existing processes and workflows for the departments that will be using MasterControl software. Next, they tailor the
customers processes into MasterControl workflows, using first-hand experience from various industries to maximize
efficiency. During forms analysis and design, consultants can also recommend best practices for automating
manual processes in the customers company.
Consultants help define, identify and/or resolve:
Critical data to be collected

Individuals or groups to be included in the process
Bottlenecks in existing processes and how to reduce or eliminate them in new processes
Time constraints for processes (escalations)
Possible User Requirement Specification (URS) and Functional Requirements Specification (FRS) for use with
validation
Individuals or groups to be included in the process
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Analytics and Trending Services

As information is collected and routed via electronic forms, aggregate data is available for analysis and reporting.
Our experts can identify and highlight key indicators and metrics that make managing your business easier. This
information provides valuable insight into your quality processes. Services include creating custom views of key data
and automatic report distribution.
How could it work for you?

Consider the following example: Operators at Company X filled out approximately 20 paper-based Adverse Event
forms per day. The paper forms were reviewed for accuracy by Quality Assurance. Key summary information from
each form was then transcribed into an Excel spreadsheet for tracking and trending purposes. The QA review and
transcription activities took about 15 minutes per form to complete.
20 forms per day

x 15 minutes per form
x 250 business days per year
= 1,250 hours per year
Once the Adverse Event form was created in MasterControl, electronic field validation enforced data entry rules and
eliminated the need for Quality Assurance to review each form. Custom analytics reports allowed real-time views to
aggregate data for tracking and trending and eliminated the need to maintain summary spreadsheets. Rules-based
e-mail notifications alerted key personnel if values outside of established thresholds were entered. Weekly (daily,
monthly, etc.) status reports were sent to designated managers, increasing overall awareness and cutting down on
the amount of time spent in meetings.
Company X increased productivity by 1,250 hours per year, year after year, by automating one process in
MasterControl. What can it do for you?
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Implementation Best Practices

Successful implementation is all about achieving the desired results as soon as possible and with the least amount
of interruption to your normal workflow. At MasterControl, one of our main measurements of success is making sure
that your implementation process is smooth and trouble-free. During an implementation, our consultants are with
you every step of the way, engaging your team in analyzing problems, devising solutions that make the most of your
MasterControl software and configuring the system to provide maximum value for your investment.
During the implementation process MasterControls Professional Services consultants will:
Deliver faster results by working with and coaching you on Implementation Best Practices, rather than you trying
to configure the system on your own
Accelerate the adoption of the software across departments through professional collaboration
Help you avoid false starts by clearly defining implementation goals up front
Assist your SysAdmin in organizing a global software rollout
Answer any perplexing questions that may occur during implementation
An initial consultation is generally recommended prior to the consultants arrival for configuration of your system. This
time is dedicated to helping you answer any questions about your homework materials and ensuring that youre on
the right track. A typical Implementation Best Practices session is conducted onsite, and lasts from three to five days,
depending upon the software solution purchased and your specific requirements in the areas of budget and desired
deadlines.
Our experienced consultants will work closely with your internal teams to identify business processes, workflow
processes and potential stumbling blocks. Company processes that have been used in the past might change as a
result of efficiencies gained by implementing the software. Brainstorming also frequently yields organization changes
for process improvement.
By the end of the implementation process the software will be ready for validation. Once validation has been
completed, a MasterControl consultant may return to your site at your request to help you achieve go live status and
train your employees.
As with all MasterControl products and services, please feel free to contact either your CRM or your RSM if you have
any questions regarding our Implementation Best Practices Services.
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Integration Services
In addition to using MasterControl software to automate your internal processes, companies frequently deploy a
variety of other third-party software applications as well. Examples may include enterprise resource planning (ERP),
customer resource management (CRM), clinical trial management system (CTMS), manufacturing execution systems
(MES), and product data management (PDM) applications. Youll be happy to know that MasterControl integrates
nicely with many major software applications typically used by our customers. In some cases there are many
connection points between MasterControls system functionality and the functionality of other applications. When
properly configured, these connection points can vastly improve the overall performance and automation of your
entire company. The MasterControl Connections Toolkit and QAAD API Toolkit enables companies to bridge that
functionality by integrating MasterControl products with third party systems.
After purchasing MasterControls Connections Toolkit or the QAAD API Toolkit, your company may elect to have
specialists from our Integration Services team help with the necessary technical scripting or programming activities.
Integration Services specialists have the knowledge and expertise to initiate actions from MasterControl for sending
or receiving data or files and for bridging MasterControl components with interfaces to ERP, CTMS, CRM, or other
third-party applications.
If youre interested in specific types of third-party software but have not yet completed the selection process,
MasterControl would be happy to introduce you to some of our technology partners with whom we have already
experienced successful integrations.
any questions regarding our Integration Services.
Page 41
MasterControl Project Management Services

Successful and timely deployment of your MasterControl system is crucial to your companys compliance initiative
and overall competitiveness in the market. For many companies, the implementation process is hindered by limited
resources or tight deadlines. This can make managing a large project daunting and frustrating.
MasterControl offers Project Management Services to help alleviate the challenges of project management and
ensure successful implementation of your new software. Through this service, MasterControl will provide the continu-
ity and quality that you need throughout the deployment process. An experienced MasterControl project manager will
provide management expertise, serve as a project champion, coordinate activities, and communicate critical mile-
stones. This provides a single-point of accountability and communication for the entire project.
How Project Management Services Can Help You

As projects grow in size and scope, you may need professional project management services to assist in the
MasterControl implementation process. Having such an expert at the ready will:
Ensure quality and continuity of delivery based on MasterControl Project Methodology

Guarantee you a dedicated resource for MasterControl products and services for the duration of the project
Navigate MasterControl processes to give you maximized results
Provide a single point of accountability for you
Manage your project plan and ensure the services you purchased are adding the most value to the project
Coordinate and communicate crucial project milestones and activities with you and your team
The implementation process typically undergoes two major phases: project planning and project execution. The
entire process could last anywhere from several weeks to several months, depending on the complexity of your
specific needs. With MasterControl Project Management Services, you can take advantage of dedicated support
throughout the project lifecycle.
Project Planning
This phase will pave the way for smooth project execution. It includes planning, definition of goals and expectations,
and documentation of the plan, all of which could be revisited and revised as necessary.
The Kickoff: Planning begins with a project kickoff. This is the implementation planning (IP) call that starts
project planning. The agenda covers an intro to many of the planning activities, and includes: a services intro,
project office intro, training class overview, project plan review, integrated team overview, and success overview.
This meeting is facilitated by the Project Manager and is the official kickoff of the project.
Defining Customer Success: The Project Manager works with the customer team to determine the customers
success criteria. The customer success definition is very critical to defining scope and the business objectives to
be achieved by the project.
Identify Project Team and Stakeholders: The Project Manager works with the customer team to define the
integrated project team resourced to the project. These are included in a project planning document.
Document Project Assumptions: The Project Manager documents any assumptions based on the sales
process and ensures they are learned and communicated. At this point, youll provide your input based on any
assumptions that have been determined.
Identify Project Risks and Mitigation: The Project Manager documents any risks to the project and how the
team plans to mitigate these.
Project Plan Development: The Project Manager works with the project team to complete the project
schedule and determines tasks and deliverables for both MasterControl and the customer. This is based on
MasterControls implementation methodology, the products purchased, and the services purchased. This includes
determining the task to be completed as well as planning the sequencing of the tasks. The plan also includes
scheduling your MasterControl product training.
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Communication Plan: At this stage, the Project Manager determines communication requirements for the
project team. This may include status meetings, status reports, meeting minutes, and project plan updates on a
specified frequency. These will be included in the project planning document. This will be done in the plan phase
and can be revisited as necessary.
Pre-Onsite / Remote Services Readiness: Where appropriate, the Project Manager facilitates the review of
homework and/or other requirements and determines readiness for planned on-site service activities and project
plan tasks. The Project Manager also ensures readiness for onsite validation activities. These include checklists
based on project requirements. The Project Manager facilitates teleconferences in advance of site meetings with
MasterControl consultants and finalizes agendas and tasks to be accomplished.
Project Execution
Direct Project Team: The Project Manager performs activities to accomplish project objectives, manages
project communication channels, and ensures the project team is prepared to complete task assignments and
is completing task assignments as planned. This activity is conducted throughout the MasterControl project
lifecycle.
Managing the Projects Scope: The Project Manager influences the factors that create scope change and
control for those factors. After the scope is determined in the Plan and Discover phase, the project plan is
updated. The Project Manager ensures that scope for each task is understood and documented accordingly. Any
changes to the project need to be planned and resources may need to be changed, added or removed. This may
be coordinated with an overall change control process when needed. This activity is conducted throughout the
MasterControl project lifecycle.
Conduct Project Status Meetings: The Project Manager plans and leads all status meetings. This includes
setting the agenda. This activity is conducted throughout the MasterControl project lifecycle.
Day-to-Day Meetings and Issue Management: As issues and questions arise, the Project Manager facilitates
meetings and the resolution of items. This activity is conducted throughout the MasterControl project lifecycle.
Pre-Onsite / Remote Services Readiness: Where appropriate, the Project Manager facilitates the review of
homework and/or requirements and determines readiness for planned on-site service activity and project plan
tasks. The Project Manager also ensures readiness for onsite validation activities. These include checklists
based on project requirements. The Project Manager facilitates teleconferences in advance of site meetings
with MasterControl consultants and finalizes agendas and tasks to be accomplished. This activity is conducted
throughout the MasterControl project lifecycle as needed.
Project Close: The Project Manager ensures Go Live readiness based on the project plan, facilitates the
transition to customer support, and supports the development of any support procedures. The Project Manager
facilitates a project close gate review, which is a meeting with stakeholder(s) reviewing the project and the results
of the project based on customer success definition. Typically this is completed after the Go Live milestone
during the Deploy phase of the project.
Project management services can eliminate a great deal of the confusion and delay that can accompany
implementation of any software product. An ounce of project management is often worth more than a pound of
hindsight!
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Software as a Service
If your company is under pressure to comply with FDA or ISO requirements and at the same time burdened
with concerns about initial cash outlay and long-term maintenance of an electronic quality management system,
outsourcing may be what you need.
MasterControl Inc., the leading provider of quality management software solutions for companies in regulated
environments, offers Software as a Service program as an alternative resource for companies like yours. Under this
program, the Internetbased MasterControl solution is remotely hosted and deployed in a collocation environment
whose network, security, and maintenance capabilities far exceed the typical customer environment. Applications are
fully configured and administered by MasterControl experts, sparing you from the technical and financial demands of
start-up and maintenance of in-house servers. With Software as a Service, you will enjoy all the powerful features of
the MasterControl quality management suite, which has consistently helped hundreds of companies worldwide in
complying with FDA and ISO requirements. In addition, you will enjoy the following:
Security
Your data is protected by MasterControls private network and firewalls that are continuously monitored 24/7.
Firewall logs are audited on a biweekly basis. Intrusion Detection Service is available at additional cost.
Physical access to the MasterControl servers is tightly controlled. To get into the data center, an electronic
access card, a numeric pass code, and digital hand scan are required, virtually eliminating the risk of
unauthorized access. Furthermore, cameras record all access to the center.
Maintenance
Software installation, configuration, and connectivity policies and procedures will be provided by MasterControl
experts.
Application upgrades, anti-virus, and system patches will be provided automatically.
MasterControl will monitor hardware and software environments for performance, connectivity, and uptime.
Network backups are conducted on a daily incremental basis, with full weekly and monthly backups. Tapes are
stored at an off-site location, as well as in a fire-proof safe on site.
Maintenance
For Internet access, MasterControl uses at least two diverse upstream bandwidth paths through multiple Tier
1 providers. The network is fully meshed for maximum uptime. Diverse fiber optic providers are also utilized
for redundancy to ensure uninterrupted traffic flow even if one route fails. The network, backed by service and
performance level agreements, can handle traffic spikes for specific bandwidth and burstable capabilities. Fixed
and burstable bandwidth options with speeds ranging from 256K to 100 Mbps are available.
MasterControl uses a dual Cisco Pix solution for maximum availability and reliability. Customers are in a shared
environment, but they are isolated from each other. Completely isolated network solutions are available at
additional cost.
MasterControl provides a premier power system that features continuous, redundant, and protected AC power
through Uninterrupted Power Supply. Redundant power enables equipment to run continuously even in the
event of a significant power outage. MasterControl has backup generators with 24-hour fuel supply and 24/7
maintenance contracts.
Page 44
MasterControl uses FM-200 fire suppression systems, which utilize a clean gaseous agent contaminating no
particulates or oily residues. It removes heat energy from the fire to the extent that the combustion reaction
cannot sustain itself. After FM-200 is discharged, it can be removed from the protected space by simple
ventilation.
Cost-Effective
The Software as a Service program means you can get the quality management system you want - and need -
instead of sticking with an inadequate and inefficient manual system. The MasterControl solution is available for
a low and fixed monthly fee.
Complying with FDA and ISO quality requirements is tough as it is without being burdened by additional software
expenses and technical issues involved in maintaining a system. With MasterControls Software as a Service,
you can eliminate these worries and concentrate on your core competencies.
Compliant. Connected. Complete.
For details of the features and benefits of the MasterControl quality management suite, refer to accompanying
product literature. For other information, visit www.mastercontrol.com, or call (001) 800-825-9117.
Page 45
Technical Support Services

Even the most proficient users of MasterControl occasionally have questions about its specific features, functions or
benefits. Technical support is the service provided by MasterControl to answer questions and provide solutions to
customers using the software. MasterControl maintains several levels of support, ranging from online self-help via the
customer website to one-on-one, in-person assistance. Our goal is to provide 100% customer satisfaction.
The Technical Support program includes:
Self-Service Web Portal: Accessible via the customer website (www.mastercontrolcustomers.com), you may
use this Web portal to search the Solutions Knowledge Base to find answers to common questions; to contact
a customer support representative directly, to submit a problem report at any time night or day; to submit
enhancement ideas; to review the status of a problem or enhancement report, and much more. The self-service
portal is a quick, convenient way to get the help you need, when you need it.
Maintenance Support Service: This service provides software and validation product upgrades along with
unlimited technical assistance either through e-mail or via the telephone during regular business hours.
IT Training: Customers may purchase additional training for their IT personnel for technical information remotely
via Webex. The Tech Support team can provide customized instruction based on customer needs. The topics can
range anywhere from database set-up to custom-report generation. Contact your sales representative if you are
interested in obtaining this option.
MasterControl Installation: The Tech Support team performs the initial installation of products for all new
customers.
Custom Support Options: In todays worldwide marketplace, MasterControl understands that local laws, market
conditions, and support requirements may vary by location and by industry sector. Therefore, MasterControl
offers custom, fee-based support relationships designed to meet your unique needs and budget. Customers can
contact their MasterControl customer account representative for more information.
Our Customer Website allows you to access a variety of information that will also support you in your use of the
software. Youll get immediate access to industry white papers, product technology papers, MasterControl software
tips and tricks, release notes, tech support documents and much more. Please visit www.mastercontrolcustomers.
com to find out how this valuable tool can help you become more knowledgeable and productive.
MasterControl Product Support Phases

MasterControl products are supported according to the following time-based phases:
Mainstream Support
Is provided for three years following the products release date.
Provides live technical support via phone or e-mail during MasterControls stated business hours.
MasterControl will provide engineering-level support for critical issues that risk data integrity for products in
the mainstream support phase. A series of critical issues are accumulated in a fix release for products in the
mainstream support phase.
Customers with active MSA may upgrade to the most recent version of a product at any time with no upgrade
fees.
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Extended Support
Is provided for five years following the products release date.
Provides live technical support via phone or e-mail during MasterControls stated business hours.
MasterControl will not provide engineering patches or fix releases for products during the Extended Support
phase.
fees.
Ongoing Support
Is provided for at least seven years following the products release date.
By using MasterControls self-service Web site to access product-specific information, many customers can
quickly resolve their issue without contacting MasterControl directly.
MasterControl will not accept requests for support, design changes, or new features during the ongoing
support phase.
fees.
MasterControl Fix Releases

Updates and fixes are created to address critical and important issues with released versions of MasterControl soft-
ware and validation products. These issues are combined into a single package called a Fix Release, which is made
available for installation. Fix releases are cumulative, meaning each new fix release contains all the fixes that were
included with the previous fix releases plus any new fixes. Fix releases are indicated by incrementing the third digit in
the version number, such as version 1.0.x, where X represents the number of fix releases provided for version 1.0.
When support for a specific version of a product ends, as defined by the Lifecycle table, support of the fix releases
for that product will also end. For customers with Validation Scripts or a Transfer OQ subscription, the appropriate
validation updates are also distributed with fix releases.
This MasterControl Product Support Lifecycle policy has no effect on how long a customer that purchased perpetual
licenses can use a product. (Subscription and ASP licenses expire based on the date specified in the customers
contract.)
MasterControl Customer Website

MasterControls Customer Website provides a vast amount of information and tools to help you become more
productive. On this Website you can find technical support documents, e-mail support, product and education
information and more. This password-protected site is updated regularly to provide the latest support information to
make using your MasterControl software an easier and more productive experience every day. The Customer
Website can be accessed by pointing your browser to www.mastercontrolcustomers.com.
any questions regarding our technical support solutions.
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Validation Services and Solutions

At MasterControl we understand how important validation is to our customers success. We also understand how
much of a headache it can be if done improperly using an inefficient validation process or inadequate tools. Because
of this, MasterControls Validation Services and Solutions (VSS) group provides industry best practice-based services
and products to meet all of your compliance, validation and process change management needs.
Our team of highly skilled experts has a wide range of industry backgrounds and collective experience performing
software validation. Whether your looking for a completely outsourced model, formal training, or just a little advice to
assist your internal efforts, our team of seasoned professionals will help you meet todays regulatory requirements
and complete your systems process compliance.
Services Offered
Due to constraints in resources, deadlines, or internal priorities, many MasterControl customers request an
outsourced model to help with their validation requirements. MasterControl stands ready to assist with this effort
at all levels including project assessment and planning, project management, executing protocols, systems audits,
conducting third-party reviews, and more. And since we communicate with you frequently throughout the entire
validation process you can rest assured that problems are being addressed and that the entire project is moving
forward as efficiently as possible.
It has been our experience that each customer has unique needs and often requires a tailored approach to validation.
Because of this, we take great care to understand the scope of each project before it begins. Contact your Customer
Relationship Manager (CRM) to learn more and to request a customized proposal that focuses on your specific
needs.
Validation Best Practices Service

Some MasterControl customers prefer to execute our protocols and validate products independently. If this is your
preference, MasterControls Validation Best Practices consulting team will assist you with the organization of your
validation project, filling in the gaps to ensure a smooth execution and successful implementation.
Custom consulting services can include:
Validation Project Planning

Procedure Development/Consultation
Protocol Development Training/Consultation
Systems Audits for Regulatory Compliance
Third-party review of Customer Documentation/Project Materials
Validation Training
If youre new to validation, MasterControls Validation Training Course may be just what you need to get up to speed.
This two-day course guides you through the FDA and GAMP regulations and methodologies for validating automated
systems, applications, or processes. The course familiarizes you with the proper methods for planning and executing
a computer systems validation project and provides examples and exercises on the usage of the MasterControl
validation toolkit and validation test protocols. Discussions during the course include information on common
mistakes that can be made during execution that could cause overall project delays. Contact either your Customer
Relationship Manager (CRM) or your Regional Sales Manager (RSM) to find out more about how MasterControls
Validation Training Course can help you experience a smoother, faster validation process.
Custom Protocol Design Services

Our consultants can assist you in the complete development of customized Performance Qualification protocols.
Consultants begin the development process through the collection of the onsite configuration and usage procedures/
work instructions for the MasterControl Quality Suite Application. The data collected will then be used to create
a baseline protocol that covers Data Integrity, Security Integrity, and Electronic Approval Integrity testing from
processes covering record creation, approval, and secure retrieval. Testing supports multiple sites and users
performing simultaneous operations, proving both system stability and overall usage integrity. This service is normally
contracted as a part of the PQ Execution process, providing a full Performance Qualification solution.
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Custom Protocol Execution Services

If you dont want to go it alone, a consultant from the MasterControl Validation Services group can guide your
test team through every feature and function of the MasterControl Quality Suite application. The protocols are
based on industry standards and provide full traceability back to the feature definitions of the products Functional
Requirements Specifications. They contain all of the necessary guidelines for both full validation and re-qualification
testing for systems upgrades.
IQ Execution: The Installation Qualification execution services may be conducted either remotely via secure
Internet connections or at your site. In both executions, our consultants will lead your personnel in the inventory
and installation check of your server hardware to ensure it meets the necessary requirements for systems
operation.
OQ Execution: The Operational Qualification execution services are conducted manually at your location using
MasterControls industry standard-based protocols to test and execute the various functions and operational
features of the MasterControl Quality Suite application. The validation professional assists your personnel in the
completion of the protocol test activities throughout the OQ process. Upon test completion, the finished protocols,
test execution notes and collected screen shots become the objective evidence of the system performing to the
functional design.
PQ Implementation: The Performance Qualification implementation services include a tailored PQ

protocol detailing the baseline systems usage. A validation professional will then assist your test team in the
implementation of the protocol test instructions, providing overall guidance and coaching during the test activities
to ensure proper records and compliance.
GxP Documentation Services

MasterControl offers three types of GxP documentation services:
Pre-IQ/OQ Documentation Services: We develop the Validation project management documentation for
you, defining the validation project activities, requirements and risks. The deliverables for this task include the
Validation Plan, Risk Management Plan and User requirements specification. Upon delivery, the validation
professional will review the document contents with you.
Test Reporting Documentation Services: Our consultant will develop the Testing Summary reports and Final
Validation report for the project. Included in this documentation delivery is a review of all of the testing and
project milestone information for the creation of the IQ/OQ Test Summary Report, PQ Test Summary Report and
Final Validation Project Report. Our validation professional will perform a basic general review of the document
contents with the customer upon delivery.
Usage SOP Documentation Services: This service tasking is the development of the general usage SOPs
for the project. Included in this documentation delivery is the development of the Systems Administration /
Configuration SOP as well as the User Account Management SOP. In addition the Validation professional will
perform a basic general review of the document contents with the customer on delivery.
Products
Installation and Operational Qualification Protocols

MasterControl has developed predefined protocols covering all aspects of the Installation and Operational
Qualification requirements based on industry standard formats. The IQ/OQ protocols allow the manual execution
of validation efforts in just a few weeks versus the lengthy task of program engineering review and self-creation of
protocols that an off-the shelf or homegrown system would require.
Validation Toolkit
MasterControls Validation Toolkit is a detailed collection of procedural templates, validation test protocols, forms and
scripts designed to help your validation project team members complete the requirements for validation projects. The
toolkit consists of project-level and corporate-level templates of validation documentation items and procedures such
as Validation Plan, User Requirements Specification (URS), Functional Requirements Specifications (FRS), Risk
Management plans and various procedures based on industry examples.
Page 49
Transfer Operational Qualification (TOQ)

MasterControl Transfer Operational Qualification (TOQ) was especially developed for companies looking to reduce
the cost and pain of validation. Based on a companys corporate policy and risk assessment, it may choose to
assimilate or transfer OQ documentation as part of its overall validation effort, saving both time and money.
The implementation of the TOQ product is completed in two (2) separate service delivery parts:
1. TOQ Implementation Review: This service consists of the overall review of the TOQ Product Records from the
CD ROM. A MasterControl consultant will review the complete TOQ record with you while training you to use
the record in a regulated audit. During the review, the consultant will also assist you in identifying the high risk
sections or functions of the system. These high risk items will be collected into a Risk Management Plan, adding
the identified items to the future Performance Qualification testing effort or scheduling an additional Operation
Qualification execution effort.
2. Installation Qualification Execution: This service consists of the execution and delivery of the completed IQ
protocol with the customer.
More information about all of these products can be found in the Products section of this guidebook.
any questions regarding our validation solutions.
Page 50
MasterControl Configuration Services

MasterControl understands the challenges customers may face when upgrading from one major software version
to the next. New hardware/software requirements, features, configuration options, end-user training and validation
requirements are all elements that should be considered during your software upgrade project.
MasterControls Upgrade Configuration Services are designed by our expert staff to help you maximize the benefits
of your upgraded software by providing proven and highly effective services in an economy-savvy package.
These services are available for remote delivery or onsite. Additional services may be added for more complex
engagements.
MasterControls Upgrade Configuration Services will assist current MasterControl customers by providing the
necessary knowledge and skills to quickly update, configure, train and plan the required validation and project
activities needed to implement the newly upgraded features of the MasterControl system.
Upgrade Configuration Services may be purchased via MasterControls customer website or by

contacting your Regional Sales Manager or Customer Relationship Manager.
Page 51
MasterControl
Products
Applications Industry-specific Products

Version 8.0: Whats New?................................ 57 Bill Of Materials (BOM).................................. 125
QAAD............................................................... 61 DHF Express.................................................. 127
Analytics.......................................................... 63 DHF JumpStart.............................................. 129
Documents....................................................... 65 eMDR............................................................. 131
Process............................................................ 67 GCPDocs Express......................................... 133
Supplier............................................................ 70 GCPDocs JumpStart..................................... 135
Training............................................................ 72 PDM Connectors........................................... 137
Submissions Gateway................................... 139
Add-ons Submissions Locker....................................... 142
Collaboration.................................................... 77
Integrations and Connectors
Copies.............................................................. 79
Enterprise........................................................ 81 API Toolkit...................................................... 147
Exams.............................................................. 83 Document Connections................................. 149
Forms QuickView............................................. 85 Kofax Connector............................................ 151
Global Licensing Server................................... 86 MS Word Integration...................................... 153
Projects............................................................ 88 Outlook E-mail Integration............................. 154
Rules................................................................ 90 PDMWorks Connector................................... 156
Transfer OQ..................................................... 92 Pro/Intralink Connector.................................. 158
QAAD API Suite............................................. 160
Business Processes SharePoint Connector................................... 161
WindChill Connector...................................... 163
Audit................................................................. 95
Business Process Library................................ 97
CAPA................................................................ 99
Change Control.............................................. 101
Customer Complaints.................................... 103
Deviations...................................................... 105
Electronic Batch Records (EBR).................... 107
Equipment Calibration................................... 109
Equipment Maintenance.................................111
HR Finance.....................................................113
Nonconformance............................................115
Out-of-Specification (OOS).............................117
Risk Analysis...................................................119
Supplier Deviation.......................................... 120

Applications
MasterControl Applications
Version 8.0: Whats New?
QAAD
Analytics
Documents
Process
Supplier
Training
MasterControl Version 8.0: Whats New?

MasterControl Version 8.0 brings stunning enhancements to existing MasterControl modules and an exciting
assortment of new products, all designed to enhance overall functionality and maximize ease of use. MasterControl
Inc. produces software that enables regulated companies to get their products to market faster, while reducing
overall costs and increasing internal efficiency. MasterControl Version 8.0 provides these benefits through several
new products plus an unprecedented number of enhancements to existing products. This document provides a brief
overview of the key new products and existing product improvements.
New 8.0 Solutions
MasterControl Supplier
MasterControl Supplier gives companies the capability to efficiently manage and approve vendor lists and effectively
track supplier quality and supplier status. With MasterControl Supplier, all supplier status and quality information
(such as non-conforming material reports) is automatically contained in a single, easy to access location. Goods
or services can be added to the approved to supply list simply by linking the goods/services to a specific supplier
in MasterControl. Suppliers, conversely, can be added the same way. If a part is linked to a supplier that is not
approved, the link is disabled until the supplier becomes approved or reapproved. All of this information is easily
obtainable via MasterControls built-in reporting tool. Other benefits of MasterControl Supplier include:
Users have a variety of functionality options, such as creating new suppliers in the system, viewing lists of
suppliers, searching for suppliers, and importing supplier information
All goods/services and supplier links operate bi-directionally within MasterControl
Virtual Folders and analytics reports can be embedded in the Supplier tab, essentially converting the supplier
InfoCard into a dashboard
Users are able to configure templates to choose from based on the type of supplier being added
MasterControl QMS CAPA Solutions

MasterControl QMS CAPA solutions are three distinct holistic software solutions designed to automate and effectively
manage the CAPA process and integrate it with other quality processes, such as change control, audit, training,
nonconformance resolution, and customer complaints. The intelligent MasterControl QMS CAPA system guides users
through the CAPA process with the assistance of embedded decision mechanisms. The product includes not only
a best-of-breed CAPA methodology but also comes complete with best practices training, services, and consulting.
MasterControl QMS CAPA solutions offer more than just data managementthey lead companies to faster
resolutions by offering guiding mechanisms that result in more effective decision points.
MasterControl MS Word Integration

With the MasterControl MS Word Integration, the MasterControl document management solution can be easily
accessed via a MasterControl add-on toolbar in Word 2007. Users can stay in the environment where they are
most comfortable and where they work on a daily, if not hourly, basis. The integration allows users to search, access,
review, and collaborate on critical documents within MS Word. The seamless integration between MasterControl and
Word merges two applications into one thereby streamlining processes that allow users to avoid extra steps while
ensuring the proper control over critical documents.
MasterControl Outlook E-mail Integration

The MasterControl Outlook E-mail Integration allows everyday and infrequent users alike to access MasterControl
tasks from any HTML e-mail client, including Microsoft Outlook. The interface facilitates vastly improved efficiency
by providing quick connections via a familiar tool used by all employees every day. Benefits of the integration include:
The familiar, modern interface is intuitive and user friendly

Executives and managers can efficiently complete critical approvals using nothing more than their e-mail
Users enterprise-wide can perform everyday tasks in a familiar interface without needing an extensive knowledge
of MasterControl
MasterControl SharePoint Connector

MasterControl offers a seamless, out-of-the-box integration with SharePoint that capitalizes on the benefits
of SharePoint while adding truly robust compliance solutions. Rather than forcing users to access disparate
solutions, MasterControl connects the two robust systems so processes may be fulfilled within the same platform of
customizable, unified solutions. Without leaving SharePoint, users are able to log in to MasterControl and locate
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important documents or export a document from SharePoint into MasterControl. The SharePoint Connector also
ensures that users are working with the most current version of a document. The most recent versions of documents
are stored in MasterControls secure, centralized repository and are simple to access with a mere click of a mouse.
Links to these documents are easily added to the SharePoint library, simplifying access for the SharePoint user.
Users can continue to use the SharePoint interface with which they are already familiar and simply enhance its
capabilities by adding unparalleled document control and other MasterControl business process functionalities.
MasterControl Data
An extension of the MasterControl Process platform, MasterControl Data provides a new set of tools that allows
administrators to create customized data repositories. The records stored in these repositories can be viewed and
maintained by end users within the MasterControl system and can be linked to electronic forms, thereby enabling
complex process modeling and simplifying data entry. Benefits of MasterControl Data include:
Customer, supplier and business partner information can be stored and linked to complaints, audits, and supplier
deviations
Equipment master lists can be maintained from within MasterControl and linked to calibration work orders,
maintenance work orders, and batch records
MasterControl Classes
MasterControl Classes is an add-on to the MasterControl Training solution that helps customers manage classes.
For example, users are able to schedule training resourcestrainers, locations, and traineesby creating classes.
Administrators can specify the number of slots for various training classes and allow trainees to sign up for them. This
helps customers more easily manage fixed classroom resources, such as the number of trainees that can be trained
in a common training room.
MasterControl Taxonomy Organizers

MasterControl Taxonomy Organizers allows each group within the enterprise to have its own unique taxonomy with
the capability to have a single document exist in one or more taxonomies. Critical documentsSOPs, drawings,
contracts, clinical documents, or any type of submission documentationcan be automatically categorized and
updated by the MasterControl system. MasterControl allows you to take your organizers to the next levelor as
many levels as you want. Benefits of Taxonomy Organizers include:
Easy to use interface similar to Windows Explorer with a folder structure defined by MasterControl InfoCards
and custom metadata
Multiple folder structures allow individual users or groups of users to view information in the way that makes the
most sense to them.
Documents are automatically updated in one or more hierarchies as soon as the documents are entered into
MasterControl
Version 8.0 Enhancements to Existing Modules
MasterControl Version 8.0 brings many enhancements and expanded functionality to existing MasterControl
solutions, such as:
MasterControl Portal
New User-friendly Interface: MasterControl 8.0 boasts a streamlined new user interface, including a new but
familiar look-and-feel, intuitive module landing pages, home page quick links, and the ability for users to change
skins and themes.
Firefox Browser Support and Browser Page Resizing: MasterControl now features support for the Mozilla
Firefox web browser. Also, pages in the MasterControl system are dynamically resized as the browser is resized,
meaning more content can be viewed with higher resolution settings and larger monitors.
HTML E-mail Integration: Users can directly sign off on straightforward tasks directly from their HTML e-mail
client, such as Microsoft Outlook, without needing to access the MasterControl web-based user interface.
Role Owners and Rights Inheritance: Roles have owners, limiting the visibility of role assignment. Users can
grant rights for only the roles they have, which enables greater control over distribution administration.
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End-user Password Reset: The administrative burden of managing password resets is reduced since end users
can request new passwords once they successfully answer security questions.
Other Portal Enhancements: Other improvements include shorter, user-set expiration times, out of office
notification upon login, vault creation from the login page, link to InfoCards from the Publishing queue, filter by
nulls in queries, mandatory sign-off meaning option, InfoCard searching from Tracking, longer route step names,
and file size display.
Word Integration: Word 2007 users can connect to MasterControl directly from Word to access documents
located in their open collaborations, search for documents, check documents in and out, and easily start a new
collaboration.
Enhanced Change Control Multiple Packet Types: Complex change control processes can be streamlined
now that MasterControl Documents offers the capability to create multiple packet types in conjunction with a new
route step type. The new packet types can be configured both with custom fields and pre-configured fields to
capture data about the change control, such as work in process, disposition, etc.
Revision Indication: The system indicates from the list page and the InfoCard if a later revision of the InfoCard
exists. This helps the user who may not have access to the draft vault know that an update is in process.
Taxonomy Organizers: A new type of organizer allows the user to determine desired hierarchies based on
metadata fields. These hierarchies are automatically and dynamically maintained without further administrative
intervention. In addition, users can now right-click on the InfoCard to perform various actions such as checking
out documents or viewing native documents or PDFs.
MasterControl Process
HTML Forms: In addition to PDF forms, the Process module supports HTML forms. The form designer can
choose which forms technology is most appropriate on a process by process basis. HTML forms can reuse the
same keywords, workflows, and reports that already exist in the system.
Data Management: Process designers now have the capability to easily manage lists of data within the system
by creating datasets that are managed outside of a form. These datasets can be simple lists or data tables to
capture more complex entities such as pieces of equipment.
Launch Retraining: Users with appropriate rights can launch retraining tasks directly from a form. For example,
if the result of a CAPA investigation determines that trainees should be retrained, the retraining can be invoked
for the affected trainees directly from the CAPA form.
Accidentally Launched Form Cancellation: Users who launch a form can now abort the form if no one has
completed any data.
Process Route Detail Report: Process routes can now be defined by detailed reports.
MasterControl Projects
Task Highlighting: After editing them in the workspace, recent tasks can be highlighted, so a user wont lose his
or her place when working on large projects.
Abort In-process Tasks and Modify Route Users: Projects now offers the capability to modify route users and
abort in-process tasks directly within Projects.
Retraining Launched by Users Other than Supervisors: A new right enables users to launch retraining tasks
for users they do not directly supervise.
MasterControl BOM
Adding Additional Fields to BOM Workspace: Additional fields can be added to the BOM workspace that will
appear in both the workspace and part detail pages.
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BOM Export: MasterControl can export BOMs to Excel spreadsheets and has the ability to export BOMs for use
in third party software such as enterprise resource planning (ERP) systems.
Mass BOM Importing: BOMs can now be imported in bulk. The enhanced system also offers the capability to
upload multiple BOMs from a single import spreadsheet.
MasterControl PDM Connectors

Custom Attribute Mapping: Attributes defined with Pro/INTRALINK or PDMWorks may be mapped to
existing fields in PDM systems. Attributes may now be mapped to specific InfoCard fields within MasterControl,
including custom fields, allowing users to leverage existing metadata in their PDM system.
Configuration Support for SolidWorks: Users can now import multiple configurations from PDMWorks. The
system automatically creates separate InfoCard in MasterControl for each configuration in SolidWorks files.
MasterControl Business Process Library

Centralized Data Management: Many drop-down fields can now be easily configured for one of multiple
options: static drop-down options, external data sources, or a data structure stored in MasterControl. This change
no longer requires customization. For example, a Product field on a form can display the products stored
in the ERP system and the Equipment Calibration form directly links to the Equipment Master List stored in
MasterControl.
Improved Configuration Management: During installation, templates require much less manual configuration
because field properties are automatically detected. Roles associated with Solution Packages are now prefaced
with SP_ which improves navigation on the roles list page.
MasterControl Complaints Advanced: The new Complaints Advanced solution features reportable event
decision trees, better alignment with CAPA, and integration with the customers complaint database.
MasterControl CAPA Advanced: MasterControls CAPA Advanced solution utilizes the PathWise
methodology for the investigation and recording of CAPA. It offers refined root cause investigation, detailed task
tracking, formalized verification and validation for CAPA implementation, and more flexible forms with expanding
fields. The CAPA Advanced solution also features new layers with filtering, allowing for an initial review to take
place prior to deciding whether or not an event should go to CAPA.
MasterControl Analytics
Improved Process Report Improvements: Process reports are now based on datasets that administrators can
configure for each template. Changes to data storage and retrieval have dramatically enhanced Process report
performance.
Reporting Across Form Templates: By joining datasets together to create dataset profiles, users can display
data from multiple Process templates on the same report.
Filter by Null Values: Users have the option to filter text fields using an Is Null or Is Not Null operator.
Enhanced Custom Fields Report: The custom field report now includes all the main InfoCard fields so they can
be reported on and filtered against. Also, datasets can be can be created for a custom field, allowing the custom
field report to filter specific custom field data.
Custom Naming of Aggregate Columns: Users can rename the system-generated aggregate data columns in
a report to provide more meaningful, customized names.
MasterControl Copies
Multiple Network Printer Support: Users can select the network printer from which selected documents should
be printed. The network printers can be configured and filtered by business unit in enterprise configurations.
For more details about specific module enhancements, contact your MasterControl CRM.
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MasterControl QAAD
A Complete Quality and Compliance Solution
Quality products and processes are increasingly important in todays global market. Ineffective quality management
systems jeopardize submissions, lead to regulatory agency findings, cost time and money, and, worst case,
adversely affect consumers health. Companies are increasingly turning their attention to QMS solutions that provide
corporate control and oversight of all quality and compliance activities and actions.
Chosen by more than 50% of the top 20 pharmaceutical companies alone, MasterControl QAAD is a comprehensive,
user-configurable and validated, off-the-shelf software tool designed and developed by people who have years of
experience in Quality and, as a result, truly understand your business.
How Can MasterControl QAAD Help You?

By enabling companies to deploy a single, flexible solution for ensuring quality and compliance, MasterControl QAAD
simplifies implementation, validation, maintenance, support and training. It is cost-effective, easy-to-learn and use,
and supported by Compliance departments and Corporate Management because it fully meets their needs.
MasterControl QAAD guarantees in-house expertise during each phase of your project and solution rollout. You can
be assured of dedicated personnel at all times, as no aspect of our services is ever outsourced.
MasterControl QAAD Features and Benefits:
MasterControl QAAD allows you to:
Define quality activities, processes and workflows

Plan
Schedule and perform audits
Record observations and actions
Report audit findings
Track observations and actions to closure
Trend across projects, audits, findings actions
And much more
Plan using point, click and drag technology
Manage all quality activity events
Analyze resources
Record ongoing products, projects and studies
Record activities associated with a project.
Directly enter findings and attach supporting evidence
Perform peer reviews and define approval processes
Issue findings into a secure Web browser or into a document with enabled response and action capture
Share as much, or as little, information as you desire across groups
Use single and multi-byte language capabilities
QAADs web-based response entry interface allows response and CAPA tracking:
Records events directly into the database

Provides complete CAPA recording and tracking
Employs automatic escalation features
Trending is an important tool when used effectively. MasterControl QAAD allows you to:
Analyze all data for trend and metrics reporting

Refine searches across disciplines and groups
Export data to Microsoft Excel for further analysis
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MasterControl QAAD is a reliable, easy-to-use reporting tool, with functionality that allows users to:
Create and print customized reports without having to possess knowledge of the database schema
Export to EXCEL, PDF or CSV
View reports through the QAAD secure web browser
Schedule reports to run on a one-time basisor, daily, weekly or monthly
Specific regulatory requirements built into the software meet the specific needs of research quality
assurance (RQA) groups:
GLP (OECD, FDA, EPA):

Master schedule
QA statements
Multi-site studies
Study-based process inspections
GCP (ICH, GCVP)

Compliance statement
Clinical trial key data
Ethics Committee information
GMP (FDA, EU): Vendor/supplier management, inspections; batch release; evaluation by qualified person
facilitated
In addition to GCP, GLP and GMP audits, QAAD is also used for the following quality assurance
activities:
Pharmacovigilance audits
Computer systems audits
Third-party evaluations and assessments
Regulatory inspections
Corporate audits
Environmental audits
Audit CAPA
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MasterControl Analytics
MasterControl Analytics is an easy-to-use software application that enables non-technical users to develop
sophisticated, customized reports. Its a practical alternative to creating reports manually (for example, using
spreadsheets), or investing in costly third-party reporting software that requires specialized training or a programming
background.
How Can MasterControl QAAD Help You?

MasterControl Analytics enables users to retrieve and analyze data within MasterControl. With MasterControl
Analytics, any user can easily create a new report and customize it to meet their needs. Additionally, any report
can be scheduled to execute on a regular basis. MasterControl automatically retrieves the appropriate data in real
time, generates the report and emails it as a PDF or Excel attachment to each designated user. With MasterControl
Analytics, there is virtually no limit to the number of reports and report variations users can create.
Challenges MasterControl Solution

Disconnected: Non-automated tools for creating reports Connected: With the MasterControl Analytics
are time-consuming and labor-intensive. First, all of the application, once the report template is created, the
data has to be gathered. Next, the data has to be manually users work is done. Because the Analytics application
input into the reporting tool (for example, a spreadsheet). is connected with the rest of the MasterControl
Another drawback to non-automated tools is that they system, data from other areas (for example, CAPA,
cannot report on data in real time. Audit, Employee Training, etc.) are automatically
retrieved, analyzed and reported on in real time.
Inefficient System: When a report is created using a Efficient System: Using MasterControls intuitive,
nonautomated system such as a spreadsheet, the process easy-to-use Analytics software, the user tells the
of creating the same report a month later requires the user system once what s/he wants to see in the report. If
to go through the same time-consuming, labor-intensive desired, s/he may then schedule the report to execute
process of gathering the data, transferring it to the manual on a regular basis (weekly, monthly, etc.). As each
tool, putting the report into a user-friendly format and scheduled date arrives, the software automatically
emailing the report to the desired recipients. retrieves the appropriate data in real time, performs
the specified operations, and emails the report to all
designated recipients.
Requires Technical Expertise: Companies that opt for Can be used by all users: The MasterControl
specialized reporting tools (as an alternative to creating Analytics solution fills the gap for the customer who
customized reports with a spreadsheet, for example) face wants customized reports, but doesnt want the cost
another set of problems. Generally, specialized reporting of a stand-alone reporting tool or the burden of getting
tools are expensive and require users to have a high level the IT department involved. The easy-to-learn,
of technical expertise. As a result, the person who needs intuitive application makes it possible for non-technical
the report must request it from the IT department, which users to create reports with ease, thereby drastically
can lead to significant delays, as well as divert technical reducing the turnaround time and increasing a
resources needed for other tasks. companys overall efficiency and productivity.
Features and Benefits:
The MasterControl Analytics module includes 45 standardized reports. These standard, preconfigured reports can be
easily customized by non-technical usersor new reports can be created from scratch.
The powerful, yet easy to use, MasterControl Analytics application provides the following important functions:
Web-based reporting and graphing

Ability to aggregate data in terms of count/sum/average/minimum/maximum, etc.
Advanced, easy-to-use features such as filtering, multiple sort levels and report scheduling
Drill down capabilities
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Trending capability (which enables users to chart data by week, month, etc.)
Dashboard capability for consolidating multiple trend charts onto a single page (this facilitates viewing
relationships)
Ability to join parent and child datasets together into a single report
Standard Reports
MasterControl Analytics provides over 150 real-time standardized reports across all modules, including training,
document control/management, project, portal business process library, supplier management, and Bill of Materials
(BOM). Listed below are a few examples of these standard reports:
Approved Vendor List: Lists all approved vendors

BOM Where Used: Lists all the BOMs where an item is used
Process Cycle Time: Provides the average time each process takes to complete
Open CAPAs: Lists open CAPAs and can be grouped by various attributes such as department, issue source,
process step, etc.
Complaints Trend: Displays the trend of the number of complaints opened over time
Pending Training: Shows employees who have not completed assigned training by job code or course
Project Status: Provides percent complete information for all active projects
Document Master List: Lists all effective documents
Action Tracking: Displays the complete history of the actions taken on a document each time it was viewed,
edited, revised, etc.
User Rights by Module: Lists the rights assigned to each user by module
Charting and Trending

A user can optionally create a chart based on a customized hierarchical report. The user may also display the chart
as a trend. An example of a trend chart is the number of sales created each month over the entire year.
Drill-down Reports
When a chart is created for reports that have multiple levels of aggregation, the user has the ability to click on a data
element in the chart to drill-down. This will display the previous level of aggregation, with the results filtered by the
data element selected by the user. For example, a user can create a trended line chart displaying the number of
nonconformances per month over the last year. If the user clicks a specific month, the system can be configured to
display a pie chart of all the nonconformances that occurred in that month grouped by product.
Drill-down levels are not limited to specific number. A user can navigate back through the levels or jump to a specific
level by clicking on the displayed bread crumb. (The bread crumb lists the various levels the user has clicked as
hyperlinks, and enables the user to jump backward to any desired point.)
Real-time Dashboards
Dashboards help management view relationships between multiple trends by consolidating trend charts onto a single
page. For example, a dashboard can be created to show the number of sales each month over the past five years,
as well as the average amount of time it takes to process a purchase order, and the number of sales broken out by
geographic region.
Another example is a quality trends dashboard that displays the number of nonconformances over the past year,
the number of CAPAs grouped by department, the number of CAPAs grouped by root cause, and the number of
customer complaints by product trended over the past year.
Summary
With MasterControl Analytics, there is no limit on the number of reports and report variations users can create.
Users simply tell the analytics tool which data they want to report on (e.g., documents, CAPAs, completed training
records, pending training records, etc.), what users want the report to show, and the format desired. Alternatively,
users can copy and modify standard reports to create new reports. The applications charting, filtering and drill-down
capabilities, in addition to trending, dashboard, and scheduling features, provide non-technical users with the ability
to generate the reports needed by management to make well-informed business decisions.
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In regulated environments, document management and document control are vital to attaining quality and
compliance. To control quality, the organization must effectively control quality documentation, such as SOPs,
policies, quality manuals, CAD files, and engineering change orders.
How can MasterControl help you?

MasterControl Documents, a core application in the MasterControl integrated business process management
suite, automates and effectively manages the document control process to help ensure compliance with FDA
regulations, ISO quality standards, and other regulatory requirements.
MasterControl also offers a line of validation products and services addressing different levels of validation needs
based on individual risk assessment. They are designed to allow continuous validation for companies doing busi-
ness in regulatory environments by making validation of software upgrades easier, faster, and more cost-effective.
Heres how MasterControl addresses some of the major challenges that companies face in managing and controlling
documents:

Inefficient System: Manual systems are inefficient, requiring Efficient System: MasterControl automates routing,
tremendous man-hours in terms of routing documents, delivery, escalation, and approval of documents. It
obtaining approval and signatures, face-to-face meetings can handle all types of documents regardless of the
to discuss changes, and search and retrieval of documents software used to create them. MasterControl features
during inspections and audits. a centralized, secure repository that makes search and
retrieval easy during inspections and audits.
Disconnected Processes: Communication breakdown is Connected Processes: MasterControl connects all

likely to happen in companies that rely on disparate tools quality sub-systems like CAPA, change management,
and processes to manage the quality system. Ineffective audit, and training. For example, any CAPA that results
communication can lead to significant delays and adverse in a document change will automatically invoke training
outcomes. once the change is approved. MasterControl is Web-
based so documents are accessible to all authorized
users from virtually anywhere.
Lacks Visibility: Its difficult to generate accurate and timely Increases Visibility: MasterControl provides advanced
reports and trends using disparate electronic spreadsheets analytics and reporting capability, including customizable
and flowcharting tools. Without a coherent reporting system, reports and online charting. Through the reports, manag-
managers are unable to get the big picture of the quality ers get a real-time view of the quality processes and can
management system. be more proactive about improving the quality system.
Compliant: MasterControl allows continuous compliance by keeping an organizations quality system always ready
for inspections and audits.
Automated Routing, Escalation, and Approval: Reduces document cycle time by automating routing and
approval and incorporating escalation for overdue tasks. Automation helps sustain compliance by simplifying and
streamlining processes.
Effective Change Control: MasterControls change control functionality allows users to track the changes
between revisions of an item in the MasterControl system.
Autoload Feature: Allows users to drag and drop new documents into preconfigured network folders, making
document creation infinitely easier. MasterControl can even automatically launch a collaboration for the new
document or send it automatically on the appropriate approval route.
InfoCard Metadata Linked to Document: This feature helps eliminate a common problem with out-of-synch
metadata during the revision process. When revising a Microsoft Word document, updated information such
as document number and revision number can be automatically transferred to the document header from the
InfoCard, the MasterControl tool that provides basic information about a document.
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Revision Control: Automatic revision control ensures that only the current version of a document is available, so
users will not make the mistake of using obsolete or unapproved documents.
Advanced Tracking: The system tracks documents by status (in process, complete) or history. The revision or
approval history can be easily reviewed.
Analytics and Reporting: MasterControls advanced analytics and reporting capabilities provide standard and
customized reports to help increase management oversight. It includes dashboard, drill-down, and scheduling
features.
Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic
signature capabilities that fully satisfy FDAs 21 CFR Part 11 requirements. Security features include dual
passwords for document approval; password expiration, encryption, and certification; and account lockout to stop
unauthorized users from gaining system access.
Connected: MasterControl connects the document control process with other quality processes to promote
continuous improvement.
Web-Based Platform: MasterControl is Web-based so it can connect all employees involved in document and
quality control from virtually anywhere.
Word Integration: Word 2007 users can connect to MasterControl directly from Word to access documents
located in their open collaborations, search for documents, check documents in and out, and easily start a new
collaboration.
Integrates with Other Applications: MasterControl integrates with systems like ERP, LIMS, accounting, and
human resources applications to connect different departments and operations within an enterprise.
Organizers: MasterControls Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find
and access documents quickly. Users will usually have access to Organizers related to their jobs, connecting
them directly with data they need. Document-level actions allow users to work on a document without leaving
the Organizer. Users can view both native and PDF versions of a file, check it in or out, or create a copy or
external link, all from the Organizer. External and view-only users can have access to Organizers via external
links. Clicking the link opens an Organizer in a browser window that is independent of MasterControls navigation
menus and search functions.
Taxonomy Organizers: MasterControl Taxonomy Organizers allows each group within the enterprise to have
its own unique taxonomy with the capability to have a single document exist in one or more taxonomies. Critical
documentsSOPs, drawings, contracts, clinical documents, or any type of submission documentationcan
be automatically categorized and updated by the MasterControl system. MasterControl allows users to take
organizers to the next levelor as many levels as are required.
Complete: MasterControl offers robust software plus the appropriate tools and services necessary for successful
implementation and validation.
Continuous Validation: For companies in regulatory environments, MasterControl offers a continuous

validation approach that dramatically cuts the time, pain, and cost involved in validation. MasterControls
continuum of innovative products and services include MasterControls unique Transfer OQ.
Product Training: MasterControls Professional Services team, consisting of former ISO auditors and system
administrators, has developed a comprehensive training program that serves as a foundation for successful
project implementation and helps companies realize software ROI faster. Customers have the choice of recorded
training courses, live training at MasterControls Education Center in Salt Lake City, or on-site training at
customers facilities.
Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project
success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customers needs, from
initial installation to regular maintenance.
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MasterControl Process
Many companies use paper forms to gather, secure, and process information. Some of this information may pertain
to commonplace business processes, others may be critical to regulatory compliance. Whatever the purpose,
MasterControl Process converts paper based processes to electronic ones, unlocking the power of electronic
tracking, concurrent routing, and instant access to all records.

The MasterControl Process software application provides a powerful and intuitive toolset to model any process,
using a graphical workflow designer. User access security, complete audit trails, and electronic signature capabilities
enable compliance with the most stringent regulations and standards, such as FDA and ISO.
For the lowest cost and fastest implementation, MasterControl offers many solutions that are based on MasterControl
Process. For more demanding customers, an experienced services team is on hand that can modify these according
to specific requirements. Finally, our team can also create custom solutions from scratch for the best possible fit for
your organization.
MasterControl also offers a line of validation products and services addressing different levels of validation needs
based on individual risk assessment. These services have proven to make the validation of software upgrades easier,
faster, and more cost-effective.
Heres how MasterControl addresses some of the major challenges that companies face in managing their business
and quality processes.

Inefficient System: A paper-based forms process can be Efficient System: Users ability to launch processes
plagued with inefficiency caused by such issues as filling is rights based, reducing the potential for mistakes.
out the wrong form, misplaced forms, having to send the Electronic tracking indicates where any task is within
form to one person at a time, and sending the form to the a process. Configurable workflows automate routing
wrong person. to appropriate participants and can escalate the task
if timelines are not met. Tasks can be processed
concurrently by multiple users or even groups. These
features taken together achieve the most efficient
turnaround possible.
Poor Data Capture: With paper forms, the onus lies with Accurate Data Capture: Companies can use a
the operator to input accurate and complete information on variety of field formats along with field validation for
a form. accurate and accelerated data collection. With the
click of a mouse, a user can select from a number of
pre-configured options. For ease of administration,
these pre-configured options can be stored centrally
and used across multiple processes.
Poor Data Access: In order to analyze data across Real-time Data Access: MasterControls Analytics
multiple paper forms, an analyst must manually and module contains user-configurable reports that always
accurately transfer this information to a spreadsheet or show the latest data at the click of a button.
other analysis tool. This is a slow, error-prone process that
is unlikely to be used widely.
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Disconnected Processes: In manual systems, every Connected Processes: MasterControl processes

form is an independent entity that has to be completely are connected to other related processes, controlled
and accurately filled out. The relationships between forms documents, external data repositories, and internal
cannot be easily navigated, such as when a Complaint data structures. For example, a Change Control
triggers a CAPA, because these forms might be stored can be launched directly from a CAPA, connecting
in different locations. Getting the big picture is difficult one process to the next and allowing for easy
because data analysis is a tedious manual process. navigation between the two. Relevant information is
automatically passed to the new process, reducing
data entry and avoiding mistakes common in manual
transfer of information. Product information can
be pulled from an ERP system, documents can be
attached to a Change Control, and Error Codes
for Complaints, Deviations, OOS and other quality
processes can be administered from a single internal
location.
Compliant: MasterControl helps companies attain continuous compliance by simplifying and optimizing workflows,
enforcing procedures, and lowering overall compliance cost.
Automated Processes: Automation helps simplify the compliance environment by enforcing the procedures
related to each process while enabling the decision making abilities of qualified personnel.
Flexibility in Workflow Design: Process designers can configure all aspects of a workflow, including the
assigned users, what users can do with the task (such as rejecting or approving it), the number of approvers
required to move to the next step, which pages are viewable or editable, which users are allowed to change user
assignments to the step, and when the task escalates to another set of users. These features and many more
ensure that virtually any process can be accommodated.
Streamlined Performer/Witness Signoff: A process step can be configured to allow two people to sign off
from a single screen. This is necessary for tasks that require a witness during completion (e.g., electronic batch
records) and eliminates the need for one user to log out and another to log back in so the second signature can
be committed.
Concise Signature Meaning: The signature meaning can be configured for each step and is displayed in all
views of the signature record: the sign-off dialog, the tracking entry, and on the signature manifest.
Analytics and Reporting: Pre-configured reports for a process are created in MasterControls Analytics tool, allowing for advanced
data analysis. These reports can include any user-entered data as well as metadata on the process task. Reports can also include pie
charts, bar charts, trend charts with drill-down capabilities, and are easily modified by end users. Chart dashboards provide a quick
overview of current activity and scheduled reporting assists in regular reviews of key data.
Part 11-Compliant Features: MasterControl provides time-stamped audit trail, reporting, and electronic
signature capabilities that fully satisfy FDAs 21 CFR Part 11 requirements. Security features include dual
passwords for document approval; password expiration, encryption, and certification. Account lockout stops
Connected: MasterControl connects processes to each other as well as centralized data repositories in
MasterControl or third-party databases eliminating duplicate repositories.
Web-Based Platform: MasterControl is Web-based and connects all employees and other authorized users
regardless of location.
Integrates with Other Applications: MasterControl integrates with applications like ERP, LIMS, accounting, and
human resources applications to connect different departments and operations within an enterprise.
Offline Forms: Off-site users or external parties (customers, vendors, etc.) can complete forms, such as CAPA
or a customer complaint, even without being connected to the MasterControl system. They can complete forms
offline and then upload.
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Process-to-Process Launching: A process can be launched directly from another process, generating a link
between the two for easy navigation. The child process is automatically populated with data from the parent
process minimizing manual effort and ensuring data accuracy.
Access to Centralized Data: Processes can display and let the user select data from central repositories,
whether they are stored in a third party application or administered internally in what is called a data structure.
Common examples are product information from an ERP system or an Equipment Master in a MasterControl
data structure. MasterControl data structures are fully configurable and can accommodate anything from a simple
picklist to a full-blown table of records. If desired, data can even be changed directly from a Process.
Document Approval via Process: Some processes are tightly connected with the document approval process,
requiring the same signatures for both. With this feature, a process task and the documents linked to it can be
approved at once, avoiding repetitive steps.
Complete: MasterControl offers robust software, plus the appropriate tools and services necessary for successful
Flexible Platform: Process designers can choose from two design platforms. PDF forms provide straightforward,
easy to implement design tools that create document-like forms. Processes designed in HTML can take
advantage of powerful application-like functionality, such as expandable fields, a layout that can be dynamically
rearranged, and tabs that can arrange data in intuitive ways.
Continuous Validation: For FDA-regulated companies, MasterControl offers a continuous validation approach
that dramatically cuts the time, pain, and cost involved in validation. MasterControls continuum of innovative
products and services include MasterControl Transfer OQ.
project implementation and helps companies realize software ROI faster. The team conducts training at
MasterControls state-of-the-art Education Center in Salt Lake City and also at customers facilities.
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MasterControl Supplier
Vendors providing goods and services to companies doing business in regulated environments are only
qualified to supply specific products and services. As such, these suppliers must be accurately tracked on
a companys approved vendor list (AVL). The AVL must be continually managed and monitored, a complex
process that becomes exponentially more difficult as product designs and manufacturing processes change
over time. Further complexities arise as increasing numbers of suppliers interface with or are managed by
different departments and divisions across the company.

Heres how MasterControl Supplier is giving companies the capability to efficiently manage and approve
vendor lists and effectively track supplier quality and supplier status.

Tracking AVL manually: Maintaining and controlling Centralized, connected system: With MasterControl,
an approved vendor list is complex and error prone, all supplier status and quality information (such as
particularly when supplier quality information is kept in nonconforming material reports) is automatically contained
separate systems or tracked manually via in a single, easy to access location. In addition to
spreadsheets. providing an easily maintainable AVL, MasterControl
Supplier features a user-friendly interface for accessing
all documentation and records related to each supplier.
Complications with new parts and manufacturers: Automated tracking: MasterControl automatically
As engineering teams develop new designs, contract tracks and stores supplier information derived from
manufacturers and parts must be identified and added audits, non-conformance reports, supplier deviations,
to the AVL. To be placed on the AVL, a supplier and CAPAs. This electronically managed information
must be monitored on an ongoing basis and must can then be easily compiled for supplier quality
successfully fulfill a number of qualifications, such ratings. Furthermore, suppliers can be approved using
as supplier surveys, supplier audits, and process MasterControls robust approval workflow technology.
validation.
Difficulty to add and track approved parts and Simplified adding and tracking of parts and
suppliers: As new parts and suppliers are added suppliers: With MasterControl, goods or services
and as suppliers approval status changes, accurate can be added to the approved to supply list simply
and current tracking of parts and suppliers becomes by linking the goods/services to a specific supplier in
increasingly more elaborate and difficult. MasterControl. Suppliers, conversely, can be added
the same way. If a part is linked to a supplier that is
not approved, the link will be disabled until the supplier
becomes approved or reapproved. All of this information
is easily obtainable via MasterControls built-in reporting
tool.
Duplication of supplier qualification efforts: As Web-based platform: MasterControls Web-based

new goods and services are added and as suppliers platform makes accessing supplier data easy and
approval status changes, accurate and current efficient. Geographically dispersed divisions have the
tracking of outsourced goods and/or services ability to share supplier qualification data with others in
becomes increasingly more elaborate and difficult. the corporation, potentially cutting out costly duplication
of effort and speeding time to market.
Connected System: MasterControl securely maintains each suppliers vital informationapproval status,
contact information, recent audits, non-conformances, CAPA reports, contracts, approved goods/services
lists, supplier ratings, and links to analytics reportsin a single, centrally located repository.
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Functionality: MasterControl Supplier provides users with a variety of functionality options, including:
creating new suppliers in the system, viewing lists of suppliers, searching for suppliers, and importing
supplier information.
Reporting Capabilities: MasterControl can run Approved Vendor reports that include lists of the goods
or services a supplier is approved to supply, contact information for each supplier returned, and those
suppliers ratings. Reports can also be run for all suppliers, regardless of status. Furthermore, reports are
available for tracking and trending supplier quality events such as CAPAs and deviations.
Simplified Status View: The Supplier view in the MasterControl system displays a Supplier Status field for
each supplier, indicating if that vendor is approved or not.
Bi-directional Links: All goods/services and supplier links operate bi-directionally within MasterControl.
The MasterControl system automatically checks approval status to determine which links should be marked
as inactive or if they should be displayed at all.
Templates: MasterControl users are able to configure templates to choose from based on the type of
supplier being added. Similar to a MasterControl InfoCard Type, templates include custom fields and
template options such as numbering series and lifecycle as well as dynamically filtered analytics reports
and virtual folders.
Virtual Folders and Analytics Reports: Default Virtual Folders and analytics reports can be set and new
ones can be created and added. Virtual Folders can be previewed right in the window and then the full
folder can be run from that point.
Dashboard Capability: Virtual Folders and analytics reports can be embedded in the Supplier tab,
essentially converting the supplier InfoCard into a dashboard. Users can configure the Supplier tab to
include appropriate Virtual Folders and links to analytics reports.
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In regulated industries, such as the FDA and ISO environments, companies are required to implement and document
employee training to ensure that their personnel know how to perform their duties within company and industry
guidelines. As a result, training control is critical to compliance.

MasterControl Training is a robust and easy-to-use software application that automates, streamlines, and
effectively manages the training process. A part of the MasterControl integrated quality suite, this module
connects training control with corrective/preventive action (CAPA), change control, audit, customer complaints,
nonconformance disposition, and other quality processes.
MasterControl offers a line of validation products and services addressing different levels of validation needs based
on individual risk assessment. They are designed to allow continuous validation for FDA-regulated companies by
making validation of software upgrades easier, faster, and more cost-effective.
Heres how MasterControl addresses some of the major challenges that companies face in training management.

Inefficient System: The more employees a company Efficient System: MasterControl automates the routing,
has, the harder it is to track, follow-up, and verify their tracking, and follow-up of training tasks and even grading
training, especially if theyre in different locations. A of online exams. Users are automatically notified about
paper-based system is likely to result in voluminous new training tasks. Upon task completion, the verifier is
paperwork, delays, or incomplete training tasks. also automatically notified.
Disconnected Processes: Changes made to SOP Connected Processes: MasterControl integrates the
and other key documents almost always require new training process with the rest of the quality system for a
training. If the training process is not connected to holistic approach to management. If theres any change
change control and other quality processes, training in a document linked to a required course because
tasks are likely to fall through the cracks. of a revised SOP, policy, etc., all affected trainees will
immediately receive new training tasks.
Lacks Visibility: With a manual system, its hard to Increases Visibility: MasterControls advanced analytics
determine who needs what training when, or how and reporting capability includes customizable reports and
many employees passed or failed the training. Its online charting. The system automatically performs gap
almost impossible to get the status of the training analysis for all training tasks.
program in a timely manner.
Compliant: MasterControl helps companies attain continuous compliance by optimizing the training control process
and keeping training documentation always ready for inspections and audits.
Automates Training Tasks: Automates assignment, monitoring, and verification of training tasks. A link points
directly into the users My Task box. Trainees have access to their training records with a personalized folder
that shows past training, course due dates, and future training.
Proof of Competency: Automates grading of online exams to ease training control burden. Test results and
related documentation that serve as proof of personnel competency will always be ready for inspections and
audits.
Random Exam Questions: Courses that require an exam can be configured so there will be a pool of questions
prepared in advance from which the exam can pull questions randomly. This will ensure that a user who has
failed the exam will not get the same questions in the same order during his/her second try.
Optional Training Verification: For basic courses that dont require verification, training tasks can be configured
to bypass it, greatly streamlining the process and reducing the burden on supervisors, who typically act as
verifiers.
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Documents Effectivity Tied to Training Completion: A course can be configured so that the associated
document only becomes effective after all required trainees have completed the course.
More Timely Verification: Assigning a course verifier role allows sending the verification task to multiple users.
When a certain supervisor is not available to verify a training task, another verifier can do it to ensure timely
verification.
Revision Control: With automatic revision control, only one authorized user at a time can revise a particular
training material to ensure that there are not multiple versions of a course being acted upon.
Analytics and Reporting: MasterControls advanced analytics and reporting capability provides standard
and customized reports to show the status of a training program. The system tracks and shows any training
deficiencies that might jeopardize compliance. MasterControl includes dashboard, drill-down, and scheduling
capabilities.
Part 11-Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities
that fully satisfy FDAs 21 CFR Part 11 requirements. Security features include dual passwords for document
approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from
gaining system access.
Connected: MasterControl connects the training process with other quality processes for a holistic approach to
quality management.
Web-based Platform: MasterControl is Web-based so it can connect trainees, trainers, verifiers, and the training
coordinator regardless of location.
Integrates with Existing Repositories: Integrates with existing document repositories and enterprise
applications like ERP, LIMS, etc., without expensive custom coding.
Integration with CAPA: Seamlessly integrates with the CAPA process for a more efficient and effective system.
For example, a CAPA that causes a change in product design or function will invoke training tasks upon approval
of the change.
Sequencing of Courses: Allows implementation of a progressive training program by sequencing training

courses. Once a prerequisite is completed, the next course is automatically launched.
MasterControls state-of-the-art Training Center in Salt Lake City and also at customers facilities.
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Add-ons
MasterControl Add-ons
Collaboration
Copies
Enterprise
Exams
Forms QuickView
Global Licensing Server
Projects
Rules
Transfer OQ
MasterControl Collaboration
The collective knowledge of employees in an organization constitutes a valuable intellectual asset for the company
that can translate into increased profitability. The challenge lies in bringing people together to share their knowledge
in an efficient and effective way.

MasterControl Collaboration helps companies maximize their intellectual assets by automating, simplifying, and
optimizing the process of collaboration in documents-based projects.
Heres how MasterControl addresses key issues faced by companies in implementing collaborative projects.

Limitations in Time and Place: Having brilliant Virtual Collaboration Space: Web-based MasterControl
people in your team is not enough. You still have provides a virtual workspace for collaboration. Team
to bring them all together. Since these people have members can review, comment on, revise, or approve a
many responsibilities, their inability to meet is an document without having to be physically present with the
obstacle in collaborating successfully. rest of the team.
Inefficient Process: Collaboration under a manual Efficient Process: Automates tasks pertaining to
system involves passing a document around collaborative projects, including routing, follow-up, and
physically or via e-mail. When a team member is approval. Escalation is automatic so after a period of
unable to act on it, the document languishes in that inaction, the document moves on to the next person in
persons desk or e-mail inbox, causing delay. line. MasterControl avoids duplication of efforts by allowing
participants to see other peoples input.
Lack of Revision Control: In a paper-based or Automatic Revision Control: Provides automatic

hybrid system, there could be multiple (unwanted) revision control to ensure that only the current version of
versions of documents. Modifying a document also a document is available. Also, only one authorized user at
entails time-consuming meetings and manual change. a time can revise the document so there are not multiple
versions available.
Compliant: Regulatory compliance requires collaborative work in different levels. MasterControl streamlines and
optimizes the collaboration process needed in any compliance effort.
Automates Tasks: MasterControl automates all tasks pertaining to collaborative projects, including notification,
follow-up, escalation, and approval. Automation helps simplify the compliance environment, making it easier to
stay compliant.
Automatic Life Cycle Management: MasterControl provides secure virtual vaults for effective management
of the collaboration life cycle. For example, a document will reside in the draft vault while team members are
working on it. The document automatically moves to the released vault once its approved. When a released
document is revised and the revision is approved, the original document automatically moves to the archive
vault.
Enhanced E-Signature Functionality: Documents can be approved electronically. Signature manifestation

(name, date, time, and meaning of electronic signature) can be appended automatically to each document as
required by FDAs 21 CFR Part 11. The e-signature can be configured to include a users title and the route step
name in the manifest to distinguish the different kinds of approval a document gets (e.g., format approval made
by a document control specialist vs. procedure approval made by the quality director).
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Part 11-Compliant Features: In addition to electronic signature capability, MasterControl provides time-
stamped audit trail and security features that meet 21 CFR Part 11 requirements. Security features include dual
passwords for document approval; password expiration, encryption, and certification; and account lockout to stop
users will not make the mistake of using obsolete or unapproved documents. Only one authorized user at a time
can revise the document so there are not multiple versions available.
Draft Retention: A company can choose to either retain or expunge drafts during the collaboration process
depending on its policy.
Connected: MasterControl connects the collaboration process with other quality processes to promote continuous
improvement.
Web-based Platform: MasterControl is Web-based so it can connect all users involved in a collaborative project
from virtually anywhere.
Integrated Quality Management: MasterControl Collaboration can be integrated with other MasterControl
applications and solutions for a holistic approach to quality management. This connectivity helps streamline
workflow, increases efficiency, and helps ensure that quality issues dont fall through the cracks. For FDA-
regulated companies, implementing an integrated solution also means system validation can be performed just
once.
Integrates with Existing Repositories for Optimization: Integration of MasterControl with existing document
repositories and enterprise applications (ERP, LIMS, etc.) can be made easily and immediately, without
expensive custom coding.
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MasterControl Copies
Regulated companies, like most businesses, try to control their critical documents and avoid the myriad problems
associated with rogue copies. Yet, regulated companies, also like most businesses, realistically could not survive
without electronic and paper copies. MasterControl Copies enables regulated companies to make these copies but
still remain in control, all the while saving time, resources, and money.
How Can MasterControl Help You?

MasterControl Copies combines several beneficial features related to creating multiple copies into a single product.
Functional elements of MasterControl Copies include Multiple File Copy, Multiple File Print, Controlled Copies and
PDF Binder.
Heres how MasterControl addresses the common challenges faced by companies that must balance the need to
copy, print and distribute considerable amounts of documentation in a streamlined manner while still remaining in
control:
Challenges MasterControl Solutions

Inefficient Copying: Most Web-based document Efficient Copying: By selecting any number of InfoCards
management systems can only copy one file at a multiple files can be copied simultaneously from
time. When large volumes of files must be copied, this MasterControls Web-based system.
slows down the entire production process.
Inefficient Printing Process: Many document Efficient Printing Process: MasterControls Multi-File
control systems require files to be individually Print feature makes it possible to spool multiple files to a
selected and downloaded for printing. Additionally, network printer at the same time. In addition, MasterControl
these systems may not be able to prevent employees will only print documents for users who have assigned
from printing documents that they should not be able rights.
to access, which can jeopardize enterprise-wide
control capabilities.
Out-of-Control Copies: Outdated SOPs, Controlled Copies: MasterControl users with the
incorrect work instructions, lack of audit trails and appropriate rights can print controlled copies that are
similar document mismanagement inevitably lead to uniquely numbered, watermarked and tracked. Owner,
manufacturing mistakes and production inefficiencies. location and date information are also recorded in the
system, insuring that only the most current documentation
is in effect.
Unwieldy Multi-File Management: Many companies Streamlined Multi-File Management: Using the PDF
have to distribute multiple files, often in different Binder feature, MasterControl can combine multiple
formats to suppliers and customers in documentation files into a single PDF for distribution, complete with a
packets. Assembling and distributing these packets bookmarked table of contents.
can be a cumbersome process.
Multi-File Print: Users have the option of selecting and printing multiple files at once, eliminating the tedious
process of selecting each file, selecting the location of each file on the users PC, then printing each file one at a
time.
Controlled Copies: Companies in regulated industries must keep accurate and up-to-date controlled copies
of many types of documents in order to maintain compliance. MasterControl users can print controlled copies
that are given unique controlled copy numbers and tracked and watermarked separately from standard copies.
Different publishing settings can be applied to controlled copies, allowing flexible management of their format.
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Accessibility: Remote employees who need to utilize large numbers of files will be able to quickly copy all the
files they require. This indispensable feature is useful in situations such as moving a large number of files to a
laptop for a remote event, making CDs of relevant documentation for suppliers or FDA inspectors, or any other
similar circumstance where large numbers of files need to be duplicated.
Multi-File Copy Flexibility: MasterControl Copies not only allows users to select the content they wish to copy
but also lets them choose how the output should be grouped (individual files, new folder or a single PDF), and
designate if the files are to be controlled or not.
PDF Binder: Multiple files can be copied together and published to a single PDF. The binder file created by
MasterControl includes a table of contents and is bookmarked for ease of use.
Rights: To assure quality document control, different levels of rights can be assigned to prevent or permit
user activities such as printing controlled copies, printing non-controlled copies (reference prints), tracking the
distribution of electronic controlled copies, and changing the publish settings for both printed and electronic
controlled copies. Print drop-down menus will only show the options for which a user has rights.
User Friendly: With MasterControl Copies file selection options are in the hands of the user. Several types of
file options are available for creating copies, including main files, attachments, native files, PDFs, and/or linked
files. The Select All feature permits users to copy all files from a list.
Efficient: MasterControl is a robust software system that provides all the tools necessary to copy and print
documents quickly and efficiently.
Connected: By simplifying and streamlining copy and print tasks, MasterControl improves employee productivity
and unites quality processes across the enterprise.
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MasterControl Enterprise
A company with hundreds or tens of thousands of employees spread across multiple sites faces a unique challenge:
maintaining efficiency in every level without sacrificing overall control and effectiveness. While such a company would
need an enterprise-wide system to connect its different business units, it also needs the flexibility to allow individual
offices to control their own processes.

MasterControl Enterprise, a part of the MasterControl integrated quality management suite, provides powerful
filtering capability that allows individual business units to manage certain aspects of their processes independently,
while enabling the corporate entity to manage corporate-wide processes.
Continuous Validation
MasterControl considers validation an integral part of software solutions for FDA-regulated customers. Our
continuous validation approach dramatically cuts the time, pain, and cost involved in validation, making it easier to
re-validate future upgrades.
MasterControls continuum of products and services address different levels of validation needs based on individual
risk assessment. They include innovative products and services such as MasterControl Transfer OQ.
Here is how MasterControl addresses common challenges in managing an enterprise-wide system involving multiple
business units:

Prone to Mistakes: When all routes, vaults, roles, Helps Avoid Mistakes: By using filters based on business
etc. are made available to all business units, it is units, access to certain items will be limited, and so is the
easier to make mistakes. One administrator may potential for making mistakes. Fewer mistakes mean less
inadvertently change items that would adversely affect rework is required by administrators.
another site.
Inefficiency: Being a part of a large organization, an Efficiency: MasterControl provides filters based on
administrator in one site may have to contend with business unit, so an administrator can focus only on items
huge lists of routes, users, vaults, training courses, relevant to his/her site. If at some point, theres a need
and other items that are company-wide in scope. The to include corporate headquarters or another site in a
situation is time-consuming, inefficient, and frustrating. route, or if it becomes necessary to import data from other
business units, the administrator would have the ability to
change the filter accordingly. This functionality helps save
time and increase efficiency.
Optimization Hard to Attain: The larger the Optimization Made Easy: Business units need not
company, the more complicated enterprise-wide depend on corporate headquarters for management of
system management becomes. It is almost impossible their systems. With MasterControl, they have the ability to
to expect the system administrator from corporate optimize their systems by filtering data. They can easily
headquarters to manage the minutiae of every sites streamline their own processes.
processes.
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MasterControl Enterprise provides the flexibility that large-scale companies need in managing their quality
management systems. It provides robust filters that allow individual business units to optimize their processes by
limiting the amount of data that their users must choose from. Below are the solutions highlights.
Business Unit Filter: The filter can be configured either by assigning a role to a particular unit, or by adding the
unit through the user profile. With the latter, a user creating a new item (InfoCard type, vault, etc.) will see only
the list of choices associated with the business unit specified in his/her user profile.
Assigning Business Units: Specific business units can be the basis for filtering list pages and drop-down
selection lists when configuring the following:
Vaults
Lifecycle
InfoCard type
Users
Roles
Document/Form routes
Numbering series
Filtered Reports: When a user views a report, the data displayed in the report is filtered based on the users
assigned business unit.
Flexible Business Unit: The business unit is a flexible concept, enabling filtering based on a variety of
organizational demographics, such as geographic sites, companies, divisions, departments, etc.
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MasterControl Exams
MasterControl Exams is a simple, effective way to ensure (and demonstrate to global regulatory bodies)
that all employees have the competency to perform their job responsibilities. By eliminating the need to have
employee competencies witnessed by a verifier, and by helping employees focus on what they need to learn
by providing pre-exams, the application also saves companies time and money.

The MasterControl Exams module, an optional upgrade to MasterControl Training, automates administering
and grading exams, as well as documenting employee competencies.

Disconnected: Without a method for testing Connected: Because the MasterControl Exams
employee competencies thats connected module is connected to MasterControl Training, once
electronically with the rest of a companys quality an employee completes a training course or receives
system, companies can spend inordinate amounts of a new SOP, s/he is immediately notified electronically
time administering, grading and recording the results of the need to take an exam. If an employee takes
of exams, or, alternatively, witnessing and verifying and fails an exam, s/he can be allowed to retake
employee competencies. it. (Exam questions can be randomized so that
employees receive different questions.)
Inefficient System: With a manual system the Efficient System: After an employee takes an
process of having to physically update training files online exam, his or her exam is auto-graded and
can also result in omissions or errorsa significant instantaneously recorded. If the employee passes the
drawback in a quality system. exam, his or her training file is immediately updated.
System Overload: Another drawback to a manual Automatic Tracking: By monitoring the training
system is that it can easily become overloaded, status of all employees, the MasterControl Exams
resulting in some employees inadvertently slipping module ensures that every employee who takes a
through the cracks and not reading an SOP training course or is affected by a new SOP takes the
associated with their job responsibilities. required exam.
With MasterControl Exams, authorized users can create a variety of different types of exams. The user can set
a time limit on taking the exam, and specify whether the exam is open book or closed book.
Exam questions
Exams can consist of any number of the following types of questions:
True/False
Multiple Choice
Matching
Sequencing
Numeric (numeric questions require that employees perform calculations enter the results using their numeric
keypad)
Other design options

An authorized user designing a test may also:
Include weighted questions (employees receive more points for answering these questions correctly)
Require that employees answer certain required questions correctly in order to pass the exam
Specify that questions be randomized (required questions will be on all versions of a randomized exam)
Specify the number of exam retakes allowed
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The purpose of the pre-exam

If a pre-exam is associated with a course, a trainee will not be able to take the final exam until s/he completes
the pre-exam. The pre-exam can be useful in highlighting important or new topics/information that employees
should focus on when taking a course or reviewing a new SOP.
Taking exams
An employee selects the exam s/he needs to take from a list of training tasks. When the exam opens, the
employee can begin answering questions. When s/he is finished, the exam is auto-graded and the grade is
recorded. The employee is shown which questions s/he answered correctly and which answers were incorrect,
and whether s/he passed or failed the exam. If a failing grade is received, and the course option allows
employees to retake the exam, the employee will be required to do so (i.e., the signoff button will be grayed-out/
inactivated).
Alternatively, if the employee has retaken the exam the allotted number of times permitted and has no retakes
left, the signoff button will be activated, and the action button to start the exam will be removed.
The results for all exams will be recorded and visible for the verifier when reviewing the task.
If an employee passes the exam, s/he can sign off on the training task and the task will be sent to the verifier if
verification is required. If verification is not required the task will be marked complete and the employees training
file will be updated automatically.
If an employee fails the exam (including all exam retakes), s/he is required to sign off on the task, which then
goes to the verifier, whose only option is to send the task back to the employee. The verifier and employee can
then work together to help the employee pass the exam.
Summary
The MasterControl Exams module is connected to the rest of the MasterControl quality system, streamlining
the exam administration process. This greatly enhances the value of a companys quality system by
ensuring that there is evidence of employee competency necessary for the effective performance of their job
responsibilities. It can also save companies a great deal of time and money, primarily by eliminating the need
to have employee competencies witnessed by a verifier and by providing pre-exams that help employees focus
on what they need to learn.
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MasterControl Forms QuickView

For MasterControl, speed is one of the cornerstone benefits of effective process management and control solutions.
For example, customers who implement MasterControl routinely decrease approval cycle times from months to days.

The MasterControl Processes QuickView product saves managers, and all MasterControl users who approve
processes, valuable time by improving the speed for handling each approval process.

Unmanageable Approval Loads: Managers and Faster Approval Capabilities: The MasterControl Forms
additional personnel assigned to specific approval QuickView product provides the speed that managers
tasks often find themselves overburdened. Managers desire for the quick approval of voluminous processes.
want to use their time for the most productive activities
and might find themselves wondering if they are With the click of an icon, a view of the form quickly
spending more time than is necessary approving PTO, appears and another short click approves the form.
budget request, change control, new hire and other
processes.
Adobe Reader Performance: Viewing form data via Alternative Viewer Technology: The Forms QuickView
Adobe Reader has many advantages: product provides an alternative viewer, in the form of a
web browser. Instead of waiting upwards of 10 seconds for
1. Cost (Adobe Reader is freely downloadable); Adobe Reader to load, users can view a form that needs to
be approved almost instantaneously. Over time, each busy
2. What you see is what you get, whether files are approver (often a management level employee) will save
printed or viewed on screen; dozens (even hundreds) of hours!
3. Existing paper forms can be transferred to the Its also important to keep in mind that PDF Form
automated solution, thereby minimizing required technology is used only for the data collection and form
training. viewing features of the larger MasterControl Process
solution, which also includes a graphical route builder for
To provide all of this functionality, the Adobe Reader designing and controlling workflows, and a robust analytics
application requires more time to load than most web engine for creating the business information companies
pages. In fact, load time can reach up to 10 seconds, need to take action.
which isnt always a problem, but does present
significant challenges to those who are required to
approve multiple forms daily.
The MasterControl Forms QuickView solution provides the following features and benefits:
Provides more time for managers and other professionals assigned to voluminous approval tasks;
Accelerates the approval of voluminous forms such as PTO, budget request, change control, new hire forms, etc;
Provides an alternate view, via a browser, that can be loaded more quickly than an Adobe Reader file;
Integrates with additional features such as the graphical route builder and the Analytics engine.
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MasterControl Global Licensing Server

For those companies with multiple locations, keeping the MasterControl system available to each corporate entity
may be a top priority. However, purchasing multiple MasterControl licenses to cover peak times (i.e. time periods
during audits, training sessions, the release of new documentation, etc.) for each company location can become
expensive, especially as companies grow, expand and subsequently require additional licenses.

The MasterControl Global Licensing Server, a MasterControl version 7.0 product release, assists companies that
dont share large amounts of data on a regular basis to pool/share MasterControl licenses. The Global Licensing
Server not only enables companies to access MasterControl GxP process technology but also enables more efficient
license utilization.
The MasterControl Global Licensing Server is also suited to those companies that have slow-to-moderate bandwidth
connections between sites. Each site maintains a separate installation of MasterControl so data and files do not have
to be transferred across slow connections.
Challenges and MasterControl Solutions

The MasterControl Global Licensing Server also addresses the following challenges:

Difficulty Managing Licenses Across Multiple Easily Manage Licenses Across a Global Enterprise:
Locations: Companies with multiple locations will The MasterControl Global Licensing Server module
often purchase licenses for each location. Each allows companies to purchase fewer licenses and still
group of licenses for each respective company must maintain peak times by sharing those licenses with loosely
cover peak times (audits, training, change control coupled sister companies. For example, a company that
peaks, etc.). For example, company A may require would normally purchase 60 licenses may purchase 60
60 licenses to cover peak times while company B licenses that 2 additional sister companies may share as
requires 50. This results in inefficient license usage well. When company A is at a peak time company B
during non-peak times with paid license rights lying may be using fewer licenses or may not be using them at
dormant. all, especially if the company locations are separated by
multiple time zones.
Some Users Require Constant Access: Shared Licenses Can be Reserved: The MasterControl
licenses are helpful but when licenses are pooled and Global Licensing Server module allows administrators
an administrator needs to login, delays and frustration (or additional approved users) to reserve licenses. For
can result. example, company A may have 5 administrators that
require the ability to access the system at any time. With
the MasterControl Global Licensing Server module, 5 (or
any other variable number) of their 60 shared licenses may
be reserved for their particular access, leaving a potential
55 licenses to be shared among fellow co-workers and
sister companies.
Uncontrollable Events: Server crashes, power Fail-Over Licenses: Fail-Over Licenses are also available
failures, lost connectivity, etc. can disrupt systems that for remote or dependent sites.
share resources.
These licenses allow remote sites to have access to the
MasterControl system during emergencies such as server
crashes, power failures, lost connectivity, etc.
The Fail-Over licenses will remain active and usable for a

period of 24 hours.
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The features and benefits of the MasterControl Global Licensing Server product include the following:
Pool and Share: The Global Licensing Server product allows companies under the same corporate umbrella to
pool and share MasterControl licenses.
Reserved Licenses: Reserved licenses for site administrators.
Fail-Over Licenses: Fail-Over licenses for 24 hour periods after a power failure, system failure, etc.
Enterprise Solution: Can be utilized in conjunction with the MasterControl Enterprise solution.
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MasterControl Projects
Whether your project involves launching a new product or performing software validation as part of FDA compliance,
the goal is to successfully implement your plan in a timely manner and within budget. Yet, the vast majority of
companies manage most projects with inadequate tools, such as spreadsheets, which require extensive manual
effort and unnecessarily prolong a project.

MasterControl Projects automates the process of controlling projects, particularly those that are document and/
or process-based. It automates task assignment, routing, escalation, and tracking. It streamlines the workflow and
provides project transparency that fosters accountability.
re-validate future upgrades. MasterControls continuum of products and services address different levels of validation
needs based on individual risk assessment. They include innovative products and services such as MasterControl
Transfer OQ.
Here is how MasterControl addresses common challenges in project management:

Disconnected: Even expensive, dedicated project Connected: With MasterControl Projects, the plan is
management tools are disconnected entities. It means connected to the tasks. For example, MasterControl knows
a project manager must manually query task owners when a document is approved or a process is completed.
prior to manually updating task completion data. When this occurs, MasterControl automatically updates
the project plan with no manual intervention required.
No Standard Process: Managers without a formal Standardized Process: MasterControl will standardize
project management tool or process are essentially project management by providing an effective framework
flying by the seat of their pants. Project results for the process, from project definition to completion. All
are likely to be inconsistent or ineffective. Meeting tasks, schedules, and resources related to a project will be
deadlines and staying within budget could be major coordinated under a single system, fostering efficiency.
challenges.
Poor Tracking: Tracking tasks manually can be Automatic Tracking: MasterControl automates tracking
cumbersome and time-consuming. Some tasks are of tasks and monitoring of progress for a more efficient
likely to fall through the cracks without a proper tool process. Users can create dependencies for a more
for monitoring and escalation. effective workflow.
Poor Turnaround: Every project comes with a target Fast Turnaround: MasterControl automates scheduling,
completion date. In projects such as a product launch task assignment, routing, tracking, escalation, and
or a quality audit, timeliness is critical. Managing approval, greatly speeding up the process. The system
a project using a manual process entails time- provides project transparency to help avoid bottlenecks.
consuming legwork, meetings, and follow-up work that
are likely to drag project completion.
Poor Communication: Each project has multiple Real-Time Communication: MasterControl provides
stakeholders who need to know the current status of a central location for task and milestone status that is
various tasks and/or milestones. Without an enterprise updated automatically. Stakeholders can easily determine
tool, determining and communicating status of tasks is what is on track and what is behind schedule.
inefficient and time-consuming.
Lacks Visibility: With disparate tools, its hard to Improved Visibility: MasterControls advanced analytics
determine a projects progress (or lack of it) because and reporting capability will provide team members with
there is not one tool for analyzing data. the big picture through customizable reports and online
charting.
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Features: MasterControl Projects, a part of the MasterControl integrated suite, is a robust application that provides
a connected framework for managing a project. MasterControl is 100 percent Web-based so team members can
access it from virtually anywhere. Below are some of its powerful features.
Project Template: Most companies carry out similar projects time and again. MasterControl provides the ability
to create a preconfigured template for each type of project to help reduce the time involved in starting a project.
The template automatically includes basic information about high-level project groupings such as design,
development, pilot/test, launch, and manufacturing/deployment, with each grouping depending on the prior one.
The template includes basic tasks as well as document-based or form-based tasks that are typically required by
the project.
Microsoft Project File Import: Project managers can use MasterControl to complement Microsoft Project.
They can create a new project in Microsoft Project and then manage it in MasterControl, including tracking of
tasks and monitoring of milestones.
Microsoft Outlook Calendar Integration: As project tasks are assigned to users in MasterControl, they can
be configured to automatically appear in the users Outlook calendar. By synchronizing MasterControl project
tasks with Microsoft Outlook, users can have a consolidated view of their pending appointments and tasks.
Best-Practice Workflow: MasterControl incorporates the different steps of a typical project. Through this
workflow, a user can:
Define a new project;

Define tasks and group them accordingly;
Define tasks that are dependent on other tasks;
Schedule tasks;
Assign tasks to users;
Assign target date for each task;
Escalate tasks after a period of inaction;
Route the tasks electronically;
Track and monitor tasks electronically; and
Approve and close completed project.
Project Lifecycle Management: A project typically involves several phases: project definition, planning,
execution, and completion. MasterControl provides virtual vaults for effective management of the project lifecycle.
Definition and Planning: A new project resides in the draft vault, which allows editing of tasks, schedules,
dependencies, etc.
Execution: A project in the execution phase moves to the release vault, where tasks are automatically
assigned to the appropriate users as defined by the project. Tasks and milestones can be added and
modified as needed throughout the execution phase.
Completion: When all tasks are completed, the project moves to the archive vault. Completed projects
will be available for review as needed.
Project Workspace: A user can view a hierarchical tree of tasks and groups of tasks through the workspace.
The user can add, delete, and make changes to tasks, dependencies, and target dates. The project workspace
also allows the user to easily determine the current status of tasks and project milestones.
Filtering Capability: A powerful filtering capability allows users to view tasks by categories: tasks on the critical
path, overdue tasks, tasks assigned to a specific user, etc. This feature serves as a critical-path planning tool.
Capability to Baseline a Project: Project managers will be able to see how their projects have evolved or
expanded because MasterControl archives all changes for easy comparison of the current project with any prior
baseline.
Gantt Chart View: This important tool will provide a visual representation of a projects progress. It will illustrate
a projects schedule, including start and finish dates, and also show a work-breakdown structure of the project.
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MasterControl Rules
Companies in FDA and ISO environments must manage different processes in multiple areas (R&D, manufacturing,
regulatory, etc.) plus the complex relationships among these processes. Business rules help managers and
employees streamline operational functions, solve issues in a more proactive way to ensure compliance, and
maximize productivity.

MasterControl Rules, a part of the MasterControl integrated quality management suite, is a configurable and
easy-to-use solution for effective monitoring and management of critical quality events and tasks. It also empowers
individual users to manage their own tasks more efficiently and effectively.
Transfer OQ.
Heres how MasterControl addresses some of the key challenges that companies face in monitoring and managing
quality events:

Ineffective, Reactive Monitoring: Its critical for Effective, Proactive Monitoring: Through MasterControl
companies to discover serious problems with products Rules, a manager can set thresholds for quality events
and/or services in a timely manner. For FDA-regulated such as CAPA, customer complaints, and raw material
and ISO-certified companies, this is a matter of nonconformances, which will trigger notification. For
compliance. But many companies dont have the example, MasterControl can send automatic notification to
ability to monitor issues on a real-time basis. They rely the manager when a certain product receives 10 customer
on periodic reports, or simply trust certain people to complaints. This will alert the manager to take appropriate
take the initiative to report serious issues. action (i.e., launch a CAPA investigation) as soon as
possible, instead of waiting for the weekly or monthly
customer complaints report.
Lack of Accountability: For most automated Encourages Accountability: MasterControl empowers

systems, control rests on the system administrator, individual users by giving them the capability to manage
coordinators, and managers. They are responsible their own tasks. From the system administrator to basic
for monitoring the system and they must be vigilant users, individuals will be accountable for monitoring and
in tracking tasks and deadlines. This setup does not completing their tasks with the help of rules.
foster individual user accountability.
Information Overload: Automation is likely to Eases Information Overload: This solution provides
produce more data at a faster rate. If employees are business rule capability in all user levels to help them stay
unable to keep up with increased data, turnaround is on top of things. Creating rules that prompt the next step in
likely to be slow. a process also speeds up turnaround.
Features: MasterControl Rules provides management with the ability to monitor quality events and tasks on a real-
time basis, which is crucial in problem solving. Managers who are not involved in a quality process on a daily basis,
but are still responsible for overall compliance, will be able to monitor the process through rules. It also gives users
the flexibility they need to make the system respond better to their individual requirements based on their roles and
rights.
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A MasterControl rule has three major components: source data (tasks, InfoCards, form data), criteria (the rule itself,
i.e., notify if three days past due), and action (send e-mail). Below is a summary of the solutions features.
Configurable Rules: Rules can be configured based on a companys needs, but the most common type is
notification rule, which triggers an alert to affected users, who will then need to take an appropriate action. The
notification rule provides a high degree of customization, including frequency, subject line, e-mail text, recipients,
etc.
Criteria Functionality: Depending on source data selected by a user, triggers may be based on when criteria
are met (i.e., every time theres a task past its due date), or based on a number of records (i.e., every time the
system finds an accumulation of 15 CAPAs for a specific product).
Rights-Based Capability: The extent of an employees rules capability is based on his/her system rights. The
two types of rights are rules administration and My Rules. The latter is available on basic and advanced levels.
Rules Administration: Users with rules administration rights have the ability to:
Create, copy, edit, and delete rules;

Suspend a rule without deleting it;
Mark notification rules as mandatory to prevent basic and advanced users from disabling them in their
My Rules access page; and
Create notification rules that involve other users.
My Rules: Basic Users: Access includes setting notification rules for themselves, and setting frequency of
notification for other, non-mandatory rules that affect them.
My Rules: Advanced Users: Access includes all of basic users capabilities plus the ability to create rules
notifying others.
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MasterControl Transfer OQ
For FDA-regulated industries, especially life sciences companies, software validation is a critical step in ensuring
that software-automated operations will consistently produce results meeting predetermined specifications. Since the
FDA requires computer systems to be in a constant state of validation, companies must make a substantial validation
investment both time and money not just when they first install the software, but each time the application is
upgraded, and re-validated. For most companies, software validation represents the single largest expense when
automating or upgrading their quality management systems.
MasterControl Continuous Validation Approach

MasterControl believes that validation is an integral part of software solutions for FDA-regulated customers. We
provide a continuum of innovative validation products and services designed to allow continuous validation by
making future upgrades easier, faster, and more cost-effective.
MasterControl Transfer OQ: Benefits

Computer software validation involves a series of tests, namely: installation qualification (IQ), operational qualification
(OQ), and performance qualification (PQ) tests. The FDA validation requirement allows each company to decide the
level and intensity of testing depending on the organizations policy, risk assessment, and confidence level.
MasterControl Transfer OQ (TOQ) is a key part of MasterControls continuous validation approach. Based on a
companys corporate policy and risk assessment, it may choose to assimilate or transfer OQ documentation as
part of its overall validation effort, saving both time and money. TOQ provides completed validation and support
documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that basic
functions of a MasterControl application perform correctly against a specification, both functional tests performed on
individual components of the system and operational tests of the whole system.
With MasterControl TOQ, customers can:
Dramatically reduce validation time, thereby reducing the probability of project failure due to prolonged
implementation time.
Dramatically reduce overall validation cost.
Allocate more validation focus on PQ testing, which is tailored to test the customers more unique intended uses.
Simplify requalification testing, which allows customers to more frequently install upgrades that provide enhanced
functionality and address technical problems.
Features: Highlights
MasterControl TOQ test scripts are available for MasterControl Portal, MasterControl Documents, MasterControl
Processes, MasterControl PDF Publishing, MasterControl Collaboration, MasterControl Training,
MasterControl Analytics, and MasterControl Submissions Gateway.
The TOQ package includes:
Electronic copy of OQ scripts executed at MasterControl

Validation Project Plan
User Requirements Specification
Risk Management Plan
Final Validation Report, which covers Test Summary
Depending on customer need, MasterControl provides Uniform Validation Audit Response and additional
supporting documents.
Implementation Assistance: Customers who choose MasterControl TOQ will get onsite or offsite support for the
integration of transfer documents, as well as assistance in the execution of test scripts. MasterControl validation
professionals can also help in documenting test activity, including issues or bugs encountered during the test
process.
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Business Processes
MasterControl Business Processes

Audit
Business Process Library
CAPA
Change Control
Customer Complaints
Deviations
Electronic Batch Records (EBR)
Equipment Calibration
Equipment Maintenance
HR Finance
Nonconformance
Out-of-Specification (OOS)
Risk Analysis
Supplier Deviation
MasterControl Audit
A quality audit is to a regulated company what a medical examination is to a patient. It is a necessary procedure
for evaluating a quality systems general health and for diagnosing problems in order to correct them. In the
FDA and ISO environments, quality audits are required to help improve product quality and safety and to ensure
compliance.

MasterControl Audit, an integrated part of the MasterControl quality suite, is an easy-to-use software solution
that automates, streamlines, and effectively manages the audit process.
Heres how MasterControl addresses common challenges of both performance and compliance audits:

Disconnected: For regulated companies, audit Connected: Connects the audit process with the rest
findings may lead to corrective/preventive actions of the quality system for a holistic approach to quality
(CAPAs). But in manual systems, the audit process management. A CAPA form can be launched directly from
is not connected to CAPA. Disconnected processes an audit finding form, greatly streamlining the process.
could mean poor data collection and slower CAPA
and change implementation.
Inefficient Scheduling: Audit is a recurring process. Advance Scheduling: Automates scheduling of all
The types of audit (internal, customer, compliance) recurring audit-related activities so they wont be
conducted and their frequency depend on company overlooked. Allows planning and scheduling of tasks well in
size and nature of business. Manual scheduling can advance.
be a major stumbling block especially for companies
with numerous audits.
Lacks Visibility: Its difficult to generate accurate and Increases Visibility: Provides powerful analytics and
timely reports and trends using disparate electronic reporting capability, including customizable reports and
spreadsheets and paper documents. Without an online charting. Through the reports, managers get a real-
effective reporting tool, managers are unable to see time view of the audit process and can be more proactive
the big picture of their audit program. about improving the quality system.
Compliant: MasterControl allows continuous compliance by keeping your quality system always ready for
inspections and audits.
Automates Tasks: Automates all tasks pertaining to the audit process, including notification, follow-up, and
escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to
stay compliant.
Best-Practice Audit Forms: MasterControl provides two important forms for collecting and tracking data.
Audit Summary: This form tracks basic information about an audit (type of audit, date, description,
objective, scope, audit area, and lead auditor). It is also the tool for gathering such information as
standard or regulation that serves as the basis for the audit, audit agenda, audit team members, and
checklists.
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Audit Finding: This form tracks all the findings resulting from the audit. It integrates risk management
by providing a section for evaluating risks and gathering the following information: risk category, severity,
risk of recurrence, and whether CAPA is required. It ensures proper closure by tracking verification of the
process owners response to the finding.
Advance Scheduling and Routing: All recurring tasks related to an audit can be scheduled in advance so they
will not be overlooked. This capability eliminates the need to remember to launch tasks manually.
Analytics and Reporting Tool: MasterControls powerful reporting capabilities include dashboard, drill-down,
and scheduling features, and the following customizable reports.
Audit Summary: Gives a concise view of all the in-process audits and their status, as well as future
audits.
Audit Detail: Gives a detailed view of the audit findings, including related CAPAs.
Findings by root cause.
Audits by Standards: Lists audits categorized by standard (i.e., ISO 9001:2000, Sec. 8.2.2) or by
regulation (e.g., FDA GMP Part 820.22).
Audits by Auditor: Lists audits categorized by the auditors conducting them.
Open Findings: Lists open findings categorized by owners.
Connected: MasterControl Audit connects the audit process with the rest of the quality system to promote
continuous improvement.
Web-based Platform: MasterControl is Web-based so it can connect all employees involved in audit from
virtually anywhere.
Form-to-Form Launching: A CAPA form can be launched directly from another form, such as an Audit Finding
form. Pertinent information from the Audit Finding form will be automatically entered into the CAPA form, reducing
data entry. It also shows the history of the entire process. Links are maintained so users can review a completed
process and see what triggered the CAPA.
Integrates with Existing Applications: Integrates with existing document repositories and enterprise
Organizers: MasterControls Organizer, similar to Windows Explorer, is an easy-to-use tool for grouping audits
by area, or location, or standard/regulation. Users will have access to Organizers related to their jobs, connecting
them directly with data they need.
project implementation and helps companies realize software ROI faster.
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MasterControl Business Process Library

One size software solutions does not fit all. Each company has unique business processes, circumstances, and
requirements that must be addressed by a variety of different solutions.

MasterControl offers Business Process Library subscriptions that allow companies to pick and choose suitable
solutions according to their specific needs. Each subscription permits customers to access all MasterControl solutions
for a 12-month period. The ever-expanding number of solutions available through the Business Process Library, in
conjunction with implementation assistance and ongoing technical support, make it possible for MasterControl to offer
customers those solutions most appropriate to their particular needs.
Here are some examples of how MasterControls versatile Business Process Library helps companies automate their
critical business processes more rapidly.

Limited Access: Most out-of-the-box GxP software Unlimited Access: The Business Process Library
solutions must be purchased either as an entire provides companies access to any and all of the solutions
suite or a single system. ROI can be adversely that comprise MasterControls integrated suite during the
affected when companies buy an entire suite and course of their 12-month subscription. Users have the
only use a portion of its capabilities. Purchasing flexibility to start with one solution and grow into others as
software solutions system by system can be costly requirements demand without spending additional funds on
and stunt the growth and development of burgeoning software.
companies.
Disconnected System: Using different software Connected System: Rather than forcing users to manage
solutions for diverse GxP processes requires that disparate solutions, the Business Process Library uses
manufacturers devote extra resources to manage processes under the same platform of customizable,
separate systems. robust solutions.
Slow Process: Installing, validating and deploying Expedited Process: The Business Process Library
automated GxP process management systems can facilitates automating more processes faster. The
be a burdensome, time-consuming procedure. solution package relieves the pain of automating
additional processes by offering instant access to a suite
of best practice solutions. MasterControls renowned
implementation assistance and technical guidance helps
customers roll out solutions more rapidly.
Mismatched System: Most companies offering Customized System: The Business Process Library
document control and GxP process management allows companies to utilize only those solutions that
solutions push software systems that customers may best fit their processes. As new needs arise or future
not want or need or that dont match the companys MasterControl enhancements are made, companies can
processes. elect to add more solutions during the period of their
subscription without extra cost.
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Business Process Library Subscription: Each subscription offers 12 months of access to the contents of the
Business Process Library, which includes:
All current solution packages plus those that become available in the next 12 months
Coding samples, form samples, and form development utilities
Access to a Business Process Expert who will provide technical support on the solution packages
One day (eight hours) of remote Business Process implementation services
Notification of new solution packages as they become available
Business Process Library Subscription Renewal: Subscription renewal provides an additional 12 months
of access to the Business Process Library, which will continue to expand based on MasterControls ongoing
product development. Renewal also provides continued access to Business Process Technical Support and one
additional day of Business Process Implementation Services.
Solution Package PQ Library Subscription: PQ Library Subscriptions include 12 months of access to all
Solution Package PQ templates available during that timeframe. Customers will be notified of new solution
packages as they are developed. Subscription renewals provide an additional 12 months of access to the
continually expanding Solution Package PQ Library.
Additional Available Services:
Implementation Services: Extra days of remote or onsite Business Process Implementation Services can be
purchased by Business Process Library customers in addition to the one day provided with the subscription.
Business process implementation services include:
Installing and configuring the Solution Package(s) according to specific installation checklists
Customization of Solution Package (e.g., adding, removing, modifying fields or route steps during the
installation)
Troubleshooting, changing, or updating an existing operational business process
Designing or implementing a new business process, including advanced forms creation and JavaScript
coding
Business Process Consulting: MasterControls Business Process Consulting service can provide a detailed
design document that delineates clear specifications for forms implementation by either the user or MasterControl
services. Once requirements are gathered onsite, a design is created incorporating the necessary form(s) to
enable the defined process.
PQ Develpment and Execution Services: MasterControl Validation Services can assist customers with
the complete development of customized Performance Qualification protocols for specific forms processes.
MasterControl starts the development process by assessing usage procedures or work instructions for the forms
process. A baseline protocol is then created that covers Data Integrity, Security Integrity and Electronic Approval
Integrity testing for these processes.
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MasterControl CAPA
Corrective and Preventive Action (CAPA) the overall effort to investigate and correct quality issues to prevent
recurrence is the crux of any quality system. It is a regulatory requirement that both FDA inspectors and ISO
auditors consider singularly critical.

MasterControl CAPA is an easy-to-use software solution designed to automate and effectively manage the CAPA
process and integrate it with other quality processes, such as change control, audit, training, nonconformance, and
customer complaints, for a holistic quality management.
Heres how MasterControl addresses some of the major challenges that companies face in implementing CAPA:

Inefficient System: Manual CAPA systems are Efficient System: Automates routing, delivery, escalation,
inefficient, requiring tremendous man-hours in terms and approval of CAPAs and all related documents.
of routing, obtaining approval and signatures, and Provides a centralized repository for all documents, making
search and retrieval of documents during inspections search and retrieval easy during inspections and audits.
and audits.
Disconnected Processes: A CAPA may be triggered Connected Processes: Integrates the CAPA process with
by Form 483 or audit findings, customer complaints, the rest of the quality system. For example, the resolution
or some other source. With manual systems, these of a CAPA might trigger an SOP change and retraining of
sources are disconnected, making data collection employees on the new SOP. This connectivity also means
slow, incomplete, or even inaccurate. that a CAPA form can be launched directly from another
form (i.e., customer complaint, nonconformance) to
streamline the process.
Lacks Visibility: The lack of ability to track and Automatic Tracking: The system tracks all routing
monitor CAPA cases could result in delayed resolution information and data entered into the electronic form,
of issues. Without a coherent reporting system, allowing the nonconformance owner to identify bottlenecks
managers are unable to see the big picture of the and understand the sequence of events during processing.
quality management system.
Automates Routing, Escalation, Approval: Automates all CAPA tasks, including routing, notification, follow-up,
escalation, and approval. Automation helps sustain compliance by simplifying processes.
Best-Practice Forms: Provides best-practice forms and workflow that can be used as is or customized. The
solution includes an 8D process to guide the quality team through every step of CAPA implementation. The
CAPA form can be configured to simplify the process of initiating a CAPA by showing the user only the relevant
information and to require completion only of fields related to data entry.
users will not make the mistake of using obsolete or unapproved documents.
Analytics and Reporting: MasterControls advanced analytics and reporting capability provides standard and
customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root
cause. MasterControl includes dashboard and drill-down features. With its scheduling functionality, CAPA reports
can be automatically sent to a user on a regular basis, or on specific dates in the future.
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Analytics and Reporting: MasterControls advanced analytics and reporting capability provides standard and
customized reports. CAPAs can be summarized in multiple levels such as by product, department, and root
cause. MasterControl includes dashboard and drill-down features. With its scheduling functionality, CAPA reports
can be automatically sent to a user on a regular basis, or on specific dates in the future.
Connected: MasterControl connects the CAPA process with other quality processes for a closed loop approach to
management.
Web-based Platform: MasterControl is Web-based so it can connect all employees involved in CAPA from
virtually anywhere.
Form-to-Form Launching: A CAPA form can be launched directly from another form (i.e. customer complaint,
deviation report), connecting one process to the next. Relevant data from a form are automatically entered
into the CAPA form, reducing data entry and eliminating errors from manual transfer of information. Links are
maintained so users can review a completed process and see what triggered a process.
Anonymous Access: Through the Internet, customers, vendors, and others outside the company can submit a
form (i.e., customer complaint, product issue report) that could lead to CAPA.
Integrates with Training: Seamlessly integrates with the training process so a CAPA that causes an important
change (in product design, SOP, etc.) will automatically invoke training tasks upon approval of the change.
Offline Forms: Off-site users or external parties (customers, vendors) can complete a CAPA form, even without
being connected to the MasterControl system. They can complete forms offline and then upload.
Document Approval via Form: A CAPA form and documents linked to it can be approved all at once, avoiding
repetitive steps.
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MasterControl Change Control

Just as with life in general, the only constant in quality management and business is change. In FDA and ISO
environments, change control is required as a way of improving product quality and safety and ensuring
compliance.

MasterControl Change Control is designed to automate and effectively manage every step of the change control
process, from submission through actual implementation, verification, and close of project.
Heres how MasterControl can ease some of the major challenges in change control:

Disconnected Processes: Communication break- Connected: MasterControl is an integrated solution that
down is likely to happen in a quality management effectively connects users, data, and processes under
system that consists of disconnected tools and a centralized system. This connectivity vastly improves
processes. In the context of change control, this could communication and efficiency, and helps ensure that
mean lack of follow-up, late notifications, and delays issues dont fall through the cracks.
in task completion.
Poor Turnaround: Timeliness is essential in change Excellent Turnaround: Integrates and streamlines the
control. A manual system that relies on paper-based entire change control process for faster turnaround. It
documents to generate necessary data, and legwork offers a best-practice form that incorporates priority level,
to route and track submissions is likely to have poor as well as escalations. Plus, reports provide real-time
turnaround for change implementation. status for all change control tasks.
Training not Integrated with Change: In a manual Integrates Training: With MasterControl, the change
system, it is difficult for employees to keep up with control process can be integrated with training control. Any
all the changes in SOPs, policies, and other critical change to a document/process that warrants new training
documentation because the training process is not will automatically invoke training tasks.
connected to the rest of the quality system.
Automates Tasks: Automates all tasks pertaining to change control, including routing, notification, follow-
up, escalation, and approval. Automation helps simplify the compliance environment, making it easier to stay
compliant.
Best-Practice Form: A pre-configured, multi-page form helps collect and track data throughout the change
control process.
A section in the change submission form captures such information as description of change, justification,
and impact. Both original and revised documents can be attached for easy comparison.
An initiator can use one form for multiple changes. For example, the form for a change in a component
used in making 10 products can have 10 attachments, greatly streamlining the process.
The initiator is asked to evaluate the change in terms of training, validation, and regulatory requirements,
prompting risk assessment. It also asks for classification of the change as low, medium, and high. Any
high-level change implies great impact on the product and is likely to require regulatory filing.
The ability to prioritize is incorporated because the form asks the initiator to categorize the change
submission as routine or temporary or emergency.
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Revision Control: Provides automatic revision history through the InfoCard, the MasterControl tool that
summarizes basic information for every record. All changes made to the InfoCard are tracked, including reason(s)
for every change.
Analytics and Reporting: Provides standard and customized reports. Data can be summarized in multiple
levels, so change orders can be reported by product, department, root cause, etc. MasterControls advanced
analytics and reporting capability includes dashboard, drill-down, and scheduling features.
Connected: MasterControl connects the change control process with other quality processes to promote continuous
improvement.
Web-based Platform: MasterControl is Web-based so it can connect all users involved in change control from
virtually anywhere.
Form-to-Form Launching: A change submission form can be launched directly from a corrective/preventive
action (CAPA) form, connecting one process to the next. MasterControl maintains the links so one can review
a completed process and see what triggered the change. Relevant information from the CAPA form will be
automatically entered into the change submission form.
Integrates Training: The change control process can be integrated with training control. Any change to a
document or process that calls for new training will automatically invoke training tasks. Automates the process of
distributing online exams and grading.
Organizers: MasterControls Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users
find and access documents quickly. All documents related to a particular change can be grouped together in
Organizers.
project implementation and helps companies realize software ROI faster.
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MasterControl Customer Complaints

Customer complaints are inevitable in any kind of business. They are especially critical in the life sciences and
general manufacturing industries, where complaints may indicate serious safety issues. In both FDA and ISO
environments, customer-complaint handling is considered an essential part of the quality system and an important
factor in ensuring compliance.
How Can MasterControl Benefit You?

MasterControl Customer Complaints is a complete and easy-to-use solution that will help you automate complaint
handling, integrate it with the quality system, and manage complaint resolution more effectively. Heres how it can
answer key challenges in the customer complaint process:
Customer Complaints Handling Challenges MasterControl Customer Complaints

Different Sources: In a manual system, customer Centralized Source: MasterControl Customer Complaints
complaints may come from different sources (e-mail, software provides a secure and centralized platform for
phone, fax, letters, corporate Web site, sales reps, receiving customer complaints and storing all subsequent
etc.). These complaints may languish in someones documentation pertaining to investigation and correction
in box, especially if there is no formal and standard of the problem. A single, cohesive system makes search
procedure for processing them. Without a cohesive and retrieval of complaints and related data easy. The
structure that captures complete information in a solution offers the capability to formalize and standardize
timely manner, it is almost impossible to formulate a complaint handling through a simple three-step process.
strategy for complaint resolution. MasterControl is Web-based, so customers can log
complaints from virtually anywhere.
Disconnected Processes: When a company Connected Software System: MasterControl connects

uses different tools that are not connected, the customer-complaint process to the rest of the quality
tracking complaints and follow-up work can be a system, providing links to corrective actions and adverse-
major obstacle. If Connected Software System event handling. Via an external link, customers can
MasterControl connects the customer-complaint integrate MasterControl Customer Complaints with other
process to the rest of the quality there is no computer systems. For example, a link can be provided
standardized response to complaints, the required on a company Web site within a CRM application (or
documentation may fall through the cracks and any application that supports URL links), so employees,
correction of the problem may be delayed. customers, or partners can easily initiate a customer
complaint. Connectivity will help managers track a
complaint from initiation to completion and give them the
ability to proactively improve the complaint process.
Inefficient Complaint Process: A manual Efficient Complaint Process: MasterControl reduces the
system is plagued by bottlenecks: misplaced or life cycle of the complaint process by streamlining different
overlooked complaints coming from disparate steps and consolidating multiple sources of complaints
sources, incomplete information, lack of follow up, under a single platform. It provides a customizable form
and inadequate response. All of these can result in that captures all necessary information, provides automatic
delayed complaint resolution. follow-up via e-mail notification, and incorporates
escalation to ensure timely response.
Features: MasterControl Customer Complaints is a robust software solution that manages complaint handling more
efficiently and effectively with the help of the following features:
Simple Three-Step Process: This best-practice process is incorporated in a pre-configured, multi-page form
that starts with the processing of a customer complaint by the coordinator/manager, automatically moving to the
internal investigation step (conducted either by an expert or a team of experts), and culminating with a resolution
of the issue as approved by the appropriate manager. Additional forms can be customized according to a
companys special needs.
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Compliant System: 21 CFR Part 11 requires an audit trail as a key control in making electronic records reliable.
MasterControl maintains a secure, time-stamped audit trail that documents the identity of anyone who creates,
modifies, or deletes an electronic record (such as a customer complaint file), when the action occurred, and
the changes made to the record. MasterControl meets FDA requirements for electronic signature and software
validation. It facilitates compliance with regulatory standards such as ISO 9000, ISO 14000, and ISO 13485.
Analytics and Reporting Tool: MasterControls advanced reporting capabilities increase management oversight
and demonstrate appropriate controls to regulatory agencies. The solution includes the following customizable
reports:
Complaint summary
In-process complaints
Complaints categorized by type, product, and department
Trending categorized by complaint type, product, and department
MedWatch Form: For an FDA-regulated company, a customer complaint may turn out to be the reporting of an
adverse event, which comes with its own set of regulatory requirements. MasterControl Customer Complaints
includes the FDAs MedWatch 3500A form for mandatory reporting of adverse events, allowing a seamless
handover to an adverse events specialist while ensuring that all required data is immediately collected.
CAPA Integration: MasterControl gives you the option to integrate customer-complaint handling with the
corrective and preventive action CAPA process to automatically escalate any serious quality problem.
Sustained Compliance: Regulated companies cannot ignore customer complaints. They are the ultimate
indicators of product/service quality. Every complaint has to be properly evaluated, investigated, and the situation
corrected. MasterControl Customer Complaints is designed to streamline and simplify the complaint process,
foster efficiency throughout the enterprise, and keep compliance costs down. MasterControl will not only help you
attain FDA and ISO compliance but sustain it year after year. With MasterControl, you can count on a partner
that will support your compliance efforts over the long haul.
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MasterControl Deviations
In the FDA and ISO environments, the concept of quality is made tangible by written procedures and specifications,
and any deviation from them must be documented and either justified or investigated. Such deviations may occur
during sampling and testing, raw material and finished product acceptance, manufacturing, and product distribution.
Effective investigation and resolution of deviations are an essential component of quality improvement and
compliance.

MasterControl Deviations automates and manages the process of documenting, investigating, and resolving
operational deviations from written procedures and specifications. This solution provides the capability to resolve a
deviation efficiently and to use data collected as a basis for continuous quality improvement.
validate future upgrades. MasterControls continuum of products and services address different levels of validation
needs based on individual risk assessment.
Heres how MasterControl addresses some of the major challenges that companies face when resolving deviations.

Disconnected Processes: A paper-based or hybrid Connected Processes: MasterControl Deviations is a part
system, which consists of disconnected processes, of the MasterControl integrated suite, allowing connectivity
faces a significant challenge in enforcing uniform with other MasterControl applications that control other
incident response. The scope of a deviation is usually quality processes. For example, deviation incidents can be
focused on a single event, rather than a series of correlated to nonconformances and customer complaints.
events over time. Trends and patterns in occurrence MasterControl leverages the data collected for use in
remain hidden, so the quality system fails to make continuous quality improvement.
best use of available data. For example, a paper-
based system may overlook repeated occurrences of
deviations over a span of 30 days, and consequently
fail to alert managers about the need to investigate
it, or perhaps launch a corrective/preventive action
(CAPA).
Poor Turnaround: For those with paper-based Faster Turnaround: MasterControl automates data
systems, paperwork often ends up in a pile on collection, routing, follow-up, and escalation of deviation
somebodys desk, creating a significant turnaround cases. The electronic in-box tracks all active tasks for a
challenge in a sequential process, even if that process user and provides the tools to stay up-to-date.
involves a small group.
Poor Tracking: Its time-consuming to physically Automatic Tracking: The system tracks all routing
track paperwork. A manual system makes it almost information and data entered into the electronic form,
impossible to identify and avoid bottlenecks. allowing the deviation owner to identify bottlenecks and
understand the sequence of events during processing.
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Summary of Features: MasterControl Deviations is an ideal solution for controlling deviation incidents, for helping
avoid their recurrence, and for taking a proactive approach to continuous quality improvement. Below is a summary
of its key features.
Best-Practice Form and Process: A pre-configured, multi-page form prompts participants to collect and track all
relevant data and guides them through the process while allowing responsible personnel to make the appropriate
decisions. The form is automatically routed to the appropriate personnel and can escalate if not processed in a
timely manner.
Four-Step Process with Electronic Approval Signatures: This best-practice workflow will guide users
through the entire process of resolving a deviation incident, beginning with initiation through investigation,
resolution, and approval.
Integrated with CAPA Process: MasterControl Deviations can be integrated with MasterControl
CAPA, so serious cases can immediately move on to the process of corrective/preventive action
investigation and resolution.
Integrated with Nonconformance Process: When integrated with MasterControl Nonconformance,
any deviation that results in a material nonconformance will automatically move to the nonconformance
disposition process.
Integrated with Electronic Batch Records Process: MasterControl Deviations connects with
MasterControl Electronic Batch Records to create a complete automated solution for manufacturing
operations.
Form-to-Form Launching: A CAPA form or a nonconformance form can be launched directly from the deviation
form. By the same token, a deviation form can be launched from a control recipe form in the MasterControl
Electronic Batch Records solution. MasterControl also maintains the links so a completed process can easily be
reviewed to see what triggered it. Relevant information from the deviation form is automatically transferred to the
launched form, reducing data entry and increasing accuracy.
Analytics Reporting Tool: This built-in tool comes with a standard set of pre-configured reports that can be
adjusted and customized by the end user. Deviations can be trended and analyzed by process, product, vendor,
etc. These data-mining capabilities can give important insight into systemic quality issues and serve as yet
another starting point for CAPA.
Compliant System: As with all software developed by MasterControl, the deviation solution is fully compliant
with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail, reporting, and electronic
signature capabilities. Security features include dual passwords for document approval, and password expiration,
encryption, and certification. MasterControl Deviations exceeds good-business practice requirements of
companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.
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MasterControl Electronic Batch Records (EBR)

For pharmaceutical companies, accountability is an important component of quality management and FDA
compliance. Batch records, required under the FDAs Current Good Manufacturing Practice (CGMP) regulations,
demonstrate accountability by providing proof of proper handling of every significant step in the production of each
batch of a drug product. In addition, manufacturers that execute and document batch records electronically must
comply with 21 CFR Part 11 requirements.

MasterControl Electronic Batch Records, designed based on the Instrumentation, Systems and Automation
Societys S88 model (ISA-S88 or S88), is a powerful solution for automating and controlling batch processes.
This solution will help ensure GMP compliance and increase efficiency in creating and managing master recipes
and control recipes. For manufacturers automating their paper-based batch record systems for the first time,
MasterControl meets all software-related requirements of Part 11.
validate future upgrades. MasterControls continuum of products and services address different levels of validation
needs based on individual risk assessment.
Heres how MasterControl addresses some of the major challenges that companies face in their batch record
systems.

Inefficient Process: Batch operations conducted Efficient Process: MasterControl automates routing,
manually are inherently slow, cumbersome, and error- follow-up, and escalation of batch records for more
prone. efficient process management. Pre-configured forms
simplify data collection and help minimize errors common
in manual data collection. The electronic in-box tracks all
active tasks for a user and provides the tools to stay up-to-
date. This solution is based on the S88 standard, providing
an FDA-compliant framework to model a wide range of
manufacturing processes.
Poor Tracking: Physically tracking logs, test Automatic Tracking: MasterControl tracks all routing
results, and other records from different areas is information and data entered into the electronic form,
time-consuming. A manual process makes it almost allowing the batch coordinator to follow the overall
impossible to avoid bottlenecks, a serious problem in process, identify bottlenecks, and understand the
case of a need to identify defective batches. sequence of events during processing.
Disconnected Processes: Under a paper-based or a Connected Processes: MasterControl EBR is a part of

partially electronic batch record system, data are kept the MasterControl integrated suite, allowing connectivity
in different repositories that are disconnected, making with other MasterControl applications that control other
reporting, trending, and analysis difficult. quality processes. For example, production data can
be correlated to deviations, material nonconformances,
and customer complaints. Through its robust analytics
capability, MasterControl leverages all data collected by
the system for use in continuous quality improvement.
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Summary of Features: MasterControl EBR is an ideal solution for automating and optimizing management of batch
records. Below is a summary of its key features.
Framework for Master Recipes and Control Recipes: This solution creates a flexible framework to model a
wide range of manufacturing processes in accordance with the S88 model for electronic batch records. It can
handle a mix of parallel and sequential processing steps or unit procedures under the same recipe. The system
helps ensure the capture of all data critical to GMP compliance in the following documents:
Master Recipes (the documents that outline the details of a manufacturing process).
Control Recipes (authorized copies of the currently effective Master Recipe that governs an individual
manufacturing run).
Best-Practice Forms and Process: A set of four pre-configured, multi-page forms instruct users on the
manufacturing steps and allows them to record all relevant data.
Each step is electronically signed by a performer and a witness, in accordance with industry-standard
documentation practice.
This solution helps enforce processes involving serial steps by requiring users to complete recording and
verification of information before moving on to the next step.
Integrated with the Deviation Process: Every manufacturing process needs a mechanism to deviate from the
prescribed procedure, but controls have to be in place to ensure that a deviation is acceptable. MasterControl
Deviations can be integrated to seamlessly integrate the recording, assessment, and approval of a planned
or unplanned deviation into the overall manufacturing process. Deviations also serve as the link to other
MasterControl quality management modules such as MasterControl Nonconformance and MasterControl
CAPA.
Form-to-Form Launching: A Control Recipe can be created through form-to-form launching from a Master
Recipe form. This allows relevant data to be transferred automatically from one form to the other, linking the
forms and reducing manual data entry. By the same mechanism, a Deviation form can be launched from a
Control Recipe form, triggering a separate quality review process.
adjusted and customized by the end user. Production records can be trended and analyzed by product, recipe,
etc. These data-mining capabilities can give important insights into overall production activities such as
turnaround, quality issue rates, etc.
Compliant System: As with all software developed by MasterControl, the EBR solution is fully compliant with
21 CFR Part 11. It provides a secure, time-stamped audit trail, reporting, and electronic signature capabilities.
Security features include dual passwords for document approval and password expiration, encryption, and
certification.
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MasterControl Equipment Calibration

Accurate functioning of instruments, apparatus, gauges, and recording devices is critical in the manufacturing and
analysis of product. The FDA therefore mandates a written program for the routine calibration of such equipment as
well as the retention of calibration records. Besides the obvious quality benefits, such a program also helps minimize
downtime in manufacturing and laboratory operations.
How Can MasterControl Equipment Calibration Help You?

MasterControl Equipment Calibration manages your calibration schedule and automatically triggers calibration events
before they are due. The solution routes calibration tasks containing specific instructions to the appropriate personnel
for completion and review. A complete record, including calibration data, is stored for inspection by regulatory
agencies or other auditors.
Validation Services
MasterControl considers validation an integral part of software solutions for FDA-regulated customers. For
FDA-regulated companies, MasterControl provides several flexible validation offerings and services to meet each
companys individual risk requirements for validation. These offerings dramatically cut the time, pain, and cost
involved in validation to ensure compliance.
Heres how MasterControl addresses some of the major challenges that companies face in administering a
calibration program:
Equipment Calibration Challenges MasterControl Equipment Calibration Software

System Solutions
Disconnected Processes: When a company uses Connected Processes: MasterControl Equipment
tools that are not integrated, support costs increase, Calibration is a part of the MasterControl integrated suite,
work is duplicated due to overlapping functionality, enabling anything from single-site to global, multi-site
and vital information is not linked in a quality context. implementations. MasterControl collects compliance-
This results in a loss of efficiency and less control over related data in a single repository for use in continuous
quality issues. quality improvement.
Lack of Control: A calibration program depends Reliability: MasterControl manages the entire calibration
heavily on the reliability of task creation and schedule and automatically generates calibration tasks
reminders. The sheer number of pieces of equipment before the due date is reached. Complete records are
requiring calibration tasks, even in a moderately-sized maintained and advanced reporting capabilities provide
program, makes it a challenge to maintain orderly insight into calibration activities.
records, avoid missing due dates and incur delays.
Poor Tracking: Its time-consuming to physically Automatic Tracking: The MasterControl Equipment
track paperwork. A manual system makes it almost Calibration system tracks all routing information and
impossible to identify and avoid bottlenecks. data entered into the electronic form, allowing a program
manager to identify bottlenecks and understand the
sequence of events during processing.
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Summary of Features: MasterControl Equipment Calibration is an ideal solution for managing calibration programs
with the help of the following features:
The calibration schedule manages and automatically triggers all calibration tasks.
The calibration process, including task completion and review, is automated and overdue assignments can be
escalated to supervisors.
Specific instructions, including measuring parameters, adjustment limits, and failure limits, are administered.
Calibration data, including As Found and As Left data, is recorded and stored.
Third-party calibration certificates can be imported in lieu of in-house testing.
Checkpoints guide participants to initiate further actions, such as failure investigations, requesting a repair and
taking the equipment offline if needed.
Electronic approval signatures eliminate the need for paper-based records.
The analytics reporting tool comes with a standard set of pre-configured reports that can be adjusted and
customized by the end user. The solution includes the Calibration History; Current Calibration Tasks; Calibration
Tasks Past Due; Failure Incidence By Equipment; Failure Incidence By Task; and Failure Incidence One Year
Trend.
As with all software developed by MasterControl, the Equipment Calibration solution provides all the features
necessary to fully comply with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail,
reporting, and electronic signature capabilities. Security features include dual passwords for document approval
and password expiration, encryption, and certification. MasterControl solutions exceed good business practice
requirements for companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.
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MasterControl Equipment Maintenance

Accurate functioning of automatic, mechanical, or electronic equipment is critical in the manufacturing and analysis
of product. The FDA therefore mandates a written program for the routine maintenance and inspection of such
equipment as well as the retention of maintenance records. Besides the obvious quality benefits, such a program
also helps minimize downtime in manufacturing and laboratory operations.

MasterControl Equipment Maintenance manages your maintenance schedule and automatically triggers maintenance
tasks before they are due. The solution routes tasks containing specific instructions to the appropriate personnel
for completion and review. A complete record, including captured information, is stored for inspection by regulatory
agencies or other auditors.
Flexible Validation
MasterControl considers validation an integral part of software solutions for FDA-regulated customers. For FDA-
regulated companies, MasterControl provides several flexible validation offerings and services to meet each
companys individual validation and risk requirements. These offerings dramatically cut the time, pain, and cost
involved in validation to ensure compliance.
Heres how MasterControl addresses some of the major challenges that companies face in administering a
maintenance program:
Equipment Maintenance Challenges MasterControl Equipment Maintenance

Software System Solution
Disconnected Processes: When a company uses Connected Processes: MasterControl Equipment
tools that are not integrated, support costs increase, Maintenance is a part of the MasterControl integrated
work is duplicated due to overlapping functionality, suite, enabling anything from single-site to global, multi-
and vital information is not linked in a quality context. site implementations. MasterControl collects compliance-
This results in a loss of efficiency and less control related data in a single repository for use in continuous
over quality issues. quality improvement.
Lack of Control: A maintenance program depends Reliability: MasterControl manages the entire
heavily on the reliability of task creation and maintenance schedule and automatically generates
reminders. The sheer number of equipment pieces preventive maintenance tasks before the due date is
with their associated maintenance tasks, even in a reached. Complete records are maintained. Advanced
moderately-sized program, makes maintaining orderly reporting capabilities provide insight into maintenance
records a challenge. activities.
Poor Tracking of Paperwork: Its time-consuming to Automatic Tracking: The system tracks all routing
physically track paperwork. A manual system makes it information and data entered into the electronic form,
almost impossible to identify and avoid bottlenecks. allowing a program manager to identify bottlenecks and
understand the sequence of events during processing.
Summary of Features: MasterControl Equipment Maintenance is an ideal solution for managing maintenance
programs with the help of the following features:
The maintenance schedule manages and automatically triggers all preventive maintenance tasks.
Corrective maintenance can be requested manually as a work request by personnel.
The maintenance process, including task preview, completion, and review is automated and overdue
assignments can be escalated to supervisors.
Specific instructions, including spare parts lists and required equipment lists, are created during schedule setup.
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Maintenance data, including instrumentation used and observations, are stored as a permanent record.
Third-party materials can be imported to supplement internal data.
Checkpoints guide participants to initiate further actions, such as failure investigations, or taking the equipment
offline as needed for re-qualifications and recalibrations.
Electronic approval signatures eliminate the need for paper-based records.
An analytics reporting tool comes with a standard set of pre-configured reports that can be adjusted and
customized by the end user. The solution includes customizable reports including Maintenance History; Current
Maintenance Tasks; Maintenance Tasks Past Due; and Corrective Maintenance by Cause.
As with all software developed by MasterControl, the Equipment Maintenance software system provides all the
features necessary to comply with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit trail,
reporting, and electronic signature capabilities. Security features include dual passwords for document approval
and password expiration, encryption, and certification. MasterControl solutions exceed good business practice
requirements for companies that comply with ISO quality standards such as ISO 9000 and ISO 13485.
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MasterControl HR Finance
While managing multiple processes at multiple rates and in multiple directions, human resource professionals
are likely to face complex issues that affect not only their respective HR departments but the health of their entire
business organizations.

MasterControl helps automate the administrative processes that bottleneck the flow and timely completion of
essential HR tasks. The MasterControl HR Finance solution automates the following processes:
New Employee Checklist Management

Employee Exit Checklist Management
PTO Requests (i.e. vacation requests) Management
Purchase Order Fulfillment
Challenges and Solutions

These process automation tools allow MasterControl to resolve common challenges in the HR environment. The
following HR challenges and corresponding solutions are addressed below in the following table:

Paper-Based Form Management: In the HR HR Process Automation: MasterControl HR Finance
environment many processes are still managed provides electronic HR forms that are pre-configured and
primarily via paper-based processes. These automatically routed to participants/approvers. The solution
processes include the manual routing of paper forms, also automates the delivery of notifications and follow-ups
hand-written signatures for the approval of forms and and proffers the ability to approve forms with electronic
the archival of forms in filing cabinets or applications signatures.
with little protection or version control. These
processes easily lead to document loss, document In addition to a variety of automation capabilities, a full
pile-up, unnecessary manpower and hundreds set of configurable standard reports are provided (there
of annual hours spent on the management of HR are a total of 11) and all reports can be customized via
documentation. MasterControl Analytics.
Hybrid Form Management: Most HR departments Centralized Data and Functionality: MasterControl HR
manage both data and processes with a mix-and- forms are automatically routed to appropriate personnel
match conglomeration of applications (e.g. Word and utilize a full set of built-in process management
and Excel). These applications allow HR to get-by tools; forms en route can be located anytime, and can be
but essentially deliver a manual process: documents escalated to supervisors if a response is not timely. Data
are emailed; follow-ups occur by email, phone or in is entered and stored in a centralized and accessible
person; records are updated by hand; files are stored repository.
on a file server and are difficult to search, difficult to
audit and provide little version control capability.
Communication Gaps: Communication gaps are the Streamlined Control: MasterControl HR Finance allows
major culprits in any business environment and for HR departments to track forms from start to finish and
any business department. For an HR department it report on forms that have been completed and returned to
can be difficult to ensure that all tasks and HR related the HR department. The ability to route these forms quickly
forms are completed and returned to HR without a without danger of form loss or destruction is also a boon to
significant amount of HR hours being spent on these busy HR employees.
administrative endeavors.
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Requirements for Purchase: MasterControl Process should be installed prior to the installation of HR Finance. All
processes offered in this package will be launched from the Process platform.
Summary of Features: MasterControl HR Finance features include the following:
Four configurable forms: New Employee Checklist, Employee Exit Checklist, Vacation Request, and Purchase
Order forms;
Dynamic configuration items allow users to predefine roles and HR processes;
HR Groups features allow users to quickly add and remove approved users from HR working groups;
Users ability to participate in the HR/Finance processes are managed through the following roles: HR Group,
Help Desk, PTO, PO Employee Entry Manager, Employee Exit Manager and Admin User Groups;
When a form is launched an InfoCard New is automatically created and provides the traceable meta-data
required to search HR forms quickly and effectively;
Auto-generated request date, request originator and approving manager;
Ability to locate forms by searching on form data;
Automatic routing to appropriate personnel; ability of managers to add additional participants;
Electronic tracking of in-process and completed forms.
Note: The MasterControl Process solution is the complementary solution to MasterControl HR Finance. Learn more
about MasterControl Process by contacting a Regional Sales Representative.
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MasterControl Nonconformance
In the stringent FDA and ISO environments, a nonconforming product, material, or component could lead to costly
rework and scrapping, or worse, a product recall. A products quality, reliability, and safety depend to a great extent
on its conformance to specifications and parameters that have been tested, proven safe, and approved. FDAs
Current Good Manufacturing Practice (CGMP) regulations and the most popular ISO standards (ISO 9001, ISO
13485, ISO 14001) all require proper disposition of nonconformances.

MasterControl Nonconformance is a configurable and easy-to-use solution designed to automate, manage,
and streamline the process for identifying, evaluating, reviewing, and handling of nonconforming materials,
components, parts, and finished products. Heres how it can answer key challenges faced by companies in handling
nonconformances.

Disconnected Processes: In manual or hybrid Connected Solution: MasterControls best-practice form
systems, the reporting of and response to a and five-step process connect all responsible personnel
nonconformance are likely to be disconnected, which for effective and timely disposition of a nonconformance.
could result in delayed resolution. A nonconformance MasterControl offers the choice of maintaining a stand-
process thats not connected to the corrective/ alone nonconformance process for small-scale, localized
preventive action (CAPA) system could pose incidents, or you may connect it to the CAPA process for
serious problems in terms of the timeliness and automatic escalation when the situation warrants it.
accuracy of data collection and the thoroughness of
documentation, all of which are critical to compliance.
Poor Turnaround: A manual system is inherently Fast Turnaround: MasterControl automates data
inefficient. Paperwork may languish in someones collection, routing, follow-up, and escalation of
desk, and for a sequential process such as nonconformance cases. The electronic in box tracks
nonconformance, it could mean a delay in resolution all active tasks for a user and provides tools for staying
of the incident. on top of things. Approvers can also review and sign
electronically. All of these things help shorten cycle time.
Poor Tracking: It is time-consuming to physically Automatic Tracking: The system tracks all routing
track paperwork. A manual system makes it almost information and data entered into the electronic form,
impossible to identify and avoid bottlenecks. allowing the nonconformance owner to identify bottlenecks
and understand the sequence of events during processing.
Compliant: MasterControl is designed not only to help attain FDA and ISO compliance but to sustain it over the long
term by optimizing the nonconformance disposition process, speeding up turnaround from initiation to approval, and
keeping the overall quality system always ready for inspections and audits.
Best-Practice Form: A pre-configured, multi-page form simplifies the process and accelerates evaluation and
disposition of nonconforming materials by prompting the appropriate departments to collect and track all relevant
data. The form is automatically routed to responsible personnel and escalates accordingly if the case is not
processed promptly.
Best-Practice Process: This solution incorporates a five-step process that will help the quality unit make timely
and appropriate decisions. The process will guide the team from initiation through investigation, recommendation,
disposition, and management approval.
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Analytics Reporting Tool: The Nonconformance solution includes a standard set of pre-configured reports that
can be customized by end users. Nonconformances can be trended, and incidents analyzed by material, shift,
machine, supplier, etc. These data-mining capabilities can give important insight into systemic quality issues
and serve as another starting point for CAPA.
Audit Trail, Electronic Signatures: MasterControl provides time-stamped audit trail, reporting, and electronic
signature capabilities that fully satisfy FDAs 21 CFR Part 11 requirements.
Connected: MasterControl connects the nonconformance process with other quality processes for a holistic
approach to quality management.
Web-based Platform: MasterControl is Web-based so it can connect employees, customers, suppliers, and
others involved in nonconformance disposition regardless of location.
Flexible Process: MasterControl can be used as a stand-alone process for the purpose of small-scale,
localized disposition of nonconforming materials. But the system is flexible and it allows integration with the
corrective/preventive action (CAPA) process if the situation warrants a separate CAPA handling while the initial
nonconformance is independently processed and closed.
Form-to-Form Launching: A CAPA form can be launched directly from a nonconformance form, connecting
one process to the next. Not only does MasterControl streamline this process, but it also maintains the links
so one can review a completed process and easily see what triggered the CAPA. Relevant information from
the nonconformance form will be automatically entered into the CAPA form, reducing data entry and increasing
accuracy.
Complete: MasterControl offers a robust integrated quality management solution plus the appropriate tools and
services for successful implementation and validation.
Validation: For FDA-regulated companies, MasterControl offers a continuum of products and services that
address different levels of validation needs based on individual risk assessment. MasterControl makes
continuous validation possible by dramatically cutting the time involved in validating a system, reducing the risks
of project implementation, and making it easier to validate software upgrades, all of which help lower validation
cost.
initial installation to routine troubleshooting.
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MasterControl Out-of-Specification (OOS)

In the FDA environment, specifications are essential in maintaining quality. CGMP regulations for finished
pharmaceuticals, specifically 21 CFR Parts 210-211, require strict conformance to approved specifications. The
Out-of-Specification (OOS) software solution from MasterControl Inc. automates OOS processes to help companies
comply with FDA CGMPs and 21 CFR Part 211 regulatory requirements.
Under Parts 210-211, acceptance or rejection of a product rests, to a large extent, on the products adherence to
specifications. For example, testing for conformity to written specifications is required for every component of the
product (Sec. 211.84). In the same vein, finished drug products that fail to meet established standards, specifications,
or other relevant quality control criteria will be rejected (Sec. 211.165). Where theres an out-of-specification test
result, an investigation must be conducted and its results documented (Sec.211.192).
In addition, the FDA has issued a guidance called Investigating Out-of-Specification Test Results for Pharmaceutical
Production, which reinforces the importance of appropriate handling of OOS. The guidance applies to chemistry-
based laboratory testing performed on active pharmaceutical ingredients (API), excipients and other components,
in-process materials, and finished drug products.

Many of MasterControls FDA-regulated customers rely on our integrated solutions suite to automate the process of
collecting and controlling data critical to compliance. MasterControl OOS offers the necessary flexibility in terms of
design, routing, and user and security roles. It provides advanced tracking functionality, incorporates escalation, and
offers best-practice features that prompt users with selected data to reduce data entry and avoid mistakes common
in manual data entry. Data captured on forms is automatically entered in an ODBC-compliant database and can be
used for analysis.
MasterControls robust features make it an ideal solution for managing Out-of-Specification processes. Heres how
MasterControl OOS addresses some of the major challenges companies face in establishing and maintaining forms-
based processes.

Inefficient Paper Forms System: A paper-based Cost-effective Automated System: MasterControl
forms process can be plagued with inefficiency Process automates any forms-based process and offers
and such issues as: filling out the wrong form, not best-practice features that prompt users with selected data.
completing the right form, and sending the form It automates routing, notification, escalation, and approval
to the wrong person. for faster turnaround. MasterControl is Web-based, so
employees, customers, and suppliers can participate in
forms-based processes (i.e., data input and verification)
from virtually anywhere.
Poor Data Capture: Forms are designed to gather Accurate Data Capture: In creating new forms or
accurate and complete information critical in improving existing ones, companies can use a variety of
compliance. With paper forms, the onus lies with the field formats for accurate and accelerated data collection.
operator to input accurate and complete information, With a click of a mouse, a user can select common
and then for an analyst to accurately transfer this responses keyed in the form fields that allow a list of data
information to a spreadsheet or other analysis tool. options previously entered. This helps ensure data is
entered correctly into the form. Fields can also be set up
to calculate data using simple or complex math operations.
Disconnected Processes: Manual systems dont Connected Processes: MasterControl integrates different
connect forms-based processes (audit findings, quality processes for more effective and efficient quality
corrective action, etc.), making continuous management. For example, a CAPA form can be launched
improvement almost impossible. For example, if the directly from an OOS form, connecting one process to the
customer complaint process is not linked to the next. Relevant information will be automatically entered
corrective action process, a critical complaint may into the new form, reducing data entry and avoiding
languish indefinitely before it can be acted upon and mistakes common in manual transfer of information.
remediation is initiated.
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Efficient Processes: MasterControls robust functionality streamlines OOS processes, specifically:
The OOS guides appropriate users through defined process steps: Laboratory Assessment, Laboratory
Investigation, Production Investigation, and Batch Disposition and Closeout.
Designated Lab Managers, Production Managers and Quality Assurance Personnel are automatically involved in
every OOS.
Appropriate corrective actions can be handled within the OOS process or escalated to a full-blown CAPA.
Investigation Reports can be attached directly to the OOS form or linked from MasterControls document control
module.
Efficient Forms: MasterControl automates any forms-based process, including routing, notification, escalation, and
approval:
Routes can be created based on a companys unique needs. For example, forms can be routed for data entry/
data collection and approval. MasterControl also incorporates escalation of overdue tasks. System administrators
can easily create a variety of individually tailored user and security roles.
MasterControl is Web-based so employees, customers, vendors, and others involved in forms-based processes
can perform their tasks from virtually anywhere. The system provides a centralized repository for easy access,
search, and retrieval of forms by all authorized users.
MasterControl tracks forms by status or history. A document will show as either in process or complete if
tracked by status. The revision or approval history of documents can also be reviewed using the history feature.
Completed forms are indexed and stored, so users can search on the contents of the form.
Forms can be signed and approved electronically. Signature manifestation name, date, time, and meaning of
electronic signature can be appended automatically to each document. MasterControls electronic signature
features comply with the FDAs 21 CFR Part 11 requirements.
Flexible Form Design: Forms created in Microsoft Word, Excel, or PowerPoint can be converted to PDFs as
is, allowing end users to all see the same form without requiring new training. A company may also improve
existing forms or design new ones to suit its needs. The solutions package is customizable, either in-house or by
MasterControls Professional Services team.
Form-to-Form Launching: A CAPA or Nonconformance form can be launched directly from OOS forms, connecting
one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one
can review a completed process and readily view what triggered that process.
Conditional Routing: Quality-related tasks can be routed to different users depending on data entered into the form.
For example, a complaint can be routed to the appropriate product team by selecting the product from a dropdown
field.
Supervisor Route: Many forms-based processes require approval by a supervisor no matter who initiates the
process. With MasterControl, you can add the supervisor to forms routes. It can also be added in succession, so
the route will move from a supervisor to that persons supervisor, and so on, along the hierarchy.
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MasterControl Risk Analysis

Risk management is one of the central goals of quality operations. Whether reporting a nonconformance, a
deviation or a CAPA, each process is intended to evaluate and mitigate the immediate risk posed by an issue.
Long-term systemic risks are then exposed by tracking and analyzing the recurrence of similar issues. A
consistent approach in assessing risk is an important factor for successful quality management.

MasterControl Risk Analysis establishes risk evaluation as a separate process. The output is a risk score
based on a consistent process, which enables quality departments to reduce the oftentimes subjective nature
of quality decision making.
Here are some examples of how MasterControl Risk Analysis is helping companies efficiently manage a
consistent risk evaluation process as an input to different quality-related processes such as nonconformance,
deviation, CAPA, and more.

Lacking Support for Decisions: Actions taken, or Introduce Objective Metrics: Many of
not taken, on quality issues are often challenged by MasterControls quality solutions include triggers to
internal employees, in customer audits or in FDA perform a risk analysis. This enables a methodology
audits. Without a formal risk assessment it can be that establishes objective risk metrics. These can
difficult to defend your decisions. then be used as thresholds for decision-making.
Risk Assessments are Inconsistent: In Create a Standardized Risk Analysis Process: A

environments where risk assessments are performed team of risk experts is designated in your company
but are not standardized, risk evaluations vary from and automatically involved in every risk analysis.
one performer to the next. Whether an action is taken MasterControl supplies the risk metrics which can
on a quality issue depends on the particular assessor then be further defined in your program to match your
and similar issues end up being treated differently. specific needs. This results in consistent, objective
and defensible quality decisions.
Disconnected Processes: Manual systems create Connected Processes: MasterControl integrates

separate data repositories (e.g. a risk analysis and different quality processes for more effective and
its corresponding CAPA), making it hard to locate efficient quality management. For example, a
complete documentation later. deviation might trigger a risk analysis. Based on
the results from the risk analysis, a CAPA may be
launched. All this is coordinated from the deviation
form, and data on the forms stays associated
electronically for easy traceability and reporting.
Best Practice Form: A pre-configured, multi-page form prompts participants to collect and track all relevant data
and guides them through the process while allowing responsible personnel to make decisions appropriately.
The form is automatically routed to the appropriate personnel and can be escalated if not processed in a timely
manner.
Best-Practice Process: MasterControl incorporates a two-step process that guides users through the process,
including Risk Analysis Performance and Risk Analysis Approval.
adjusted and customized by the end user. Risk Analyses can be analyzed by source and other parameters.
These data-mining capabilities can give important insight into systemic quality issues and serve as yet another
starting point for CAPA.
Audit Trail and Electronic Signatures: MasterControl provides time-stamped audit trail, reporting, and
electronic signature capabilities that fully satisfy FDAs 21 CFR Part 11 and other global regulatory requirements.
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MasterControl Supplier Deviation

The supply chain for FDA-regulated companies poses many challenges. Suppliers are considered an extension of
the company and thus must be shown to be FDA-compliant themselves. They have to be evaluated, audited and
monitored. Their shipments have to be tested for compliance with a materials specifications. Under very specific
circumstances, exceptions from the written specifications can be made after appropriate review by the quality and
engineering departments. However, waiting for this assessment until after the shipment has arrived at your loading
dock puts undue pressure on your quality department and creates unnecessary costs in the event that a delivery is
declined.

Many of MasterControls regulated customers rely on our integrated suite to automate the process of collecting and
controlling data critical to compliance. MasterControl Supplier Deviation creates a formal process where suppliers
can request an exception to written specifications. Materials are shipped only after the appropriate individuals have
reviewed and approved the request and provided proper justification.
The solution offers flexibility in terms of design, routing, and user and security roles to adjust to the way you work. It
provides advanced tracking functionality, incorporates escalation, and offers best-practice features that prompt users
with selected data to reduce data entry and avoid mistakes common in manual data entry. Captured data is stored in
an ODBC-compliant database, enabling reporting and in-depth analysis through our powerful built-in Analytics tools.
Heres how MasterControl Supplier Deviation addresses some of the major challenges companies face in
establishing and maintaining forms-based processes.

Unavailability of Objective Data on Supplier Collection and Analysis of Supplier Deviation Data:
Performance: In environments without a formalized MasterControl Supplier Deviation stores all data on every
or with a paper-based supplier deviation process, requested supplier deviation. This data can be analyzed in
objective data on a suppliers performance can be detail and serve as an input to your supplier management
hard to come by. program.
Arrival of Nonconforming Material at your Loading Communication of Issues before Material is Shipped:
Dock: Without a formalized supplier deviation MasterControl Supplier Deviation allows a supplier to
program, suppliers may ship rather than investigate request an exception to specification before material
in case of minor non-conformances. Processing at is shipped. This eases the pressure on your quality
the loading dock and returning unacceptable material department to accept the material and increases efficiency.
after undergoing the incoming QC process creates
unnecessary costs and delays.
Inefficient Paper Forms System: A paper-based Cost-effective Automated System: MasterControl

forms process can be plagued with inefficiency automates forms-based processes such as Supplier
and such issues as: filling out the wrong form, not Deviation and offers best-practice features that
completing the right form, and sending the form to the prompt users with selected data. It automates routing,
wrong person. notification, escalation, and approval for faster turnaround.
MasterControl is Web-based, so employees, customers,
and suppliers can participate in forms-based processes
(i.e., data input and verification) from virtually anywhere.
Poor Data Capture: Forms are designed to gather Accurate Data Capture: In creating new forms or
accurate and complete information critical in improving existing ones, companies can use a variety of
compliance. With paper forms, the onus lies with the field formats for accurate and accelerated data collection.
operator to input accurate and complete information, With a click of a mouse, a user can select common
and then for an analyst to accurately transfer this responses keyed in the form fields that allow a list of data
information to a spreadsheet or other analysis tool. options previously entered. This helps ensure data is
entered correctly into the form. Fields can also be set up to
calculate data using simple or complex math operations.
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Disconnected Processes: Manual systems dont Connected Processes: MasterControl integrates different
connect forms-based processes (audit findings, quality processes for more effective and efficient quality
corrective action, etc.), making continuous management. For example, a CAPA form can be launched
improvement almost impossible. For example, if directly from an OOS form, connecting one process to the
the customer complaint process is not linked to the next. Relevant information will be automatically entered
corrective action process, a critical complaint may into the new form, reducing data entry and avoiding
languish indefinitely before it can be acted upon and mistakes common in manual transfer of information.
remediation is initiated.
Best Practice Form: A pre-configured, multi-page form prompts MasterControl users to collect and track all
relevant data and guides them through the process while allowing responsible personnel to make appropriate
decisions with the information. The form is automatically distributed to designated personnel on a pre-determined
route and can escalate if not processed in a timely manner.
Best-Practice Process: The MasterControl Supplier Deviation module incorporates a three-step process that
guides users through the process, beginning with the Supplier Deviation Request through Supplier Deviation
Disposition and QA Disposition.
Analytics Reporting Tool: MasterControl includes a built-in tool that comes with a standard set of pre-
configured reports that can be adjusted and customized by the end user. Supplier Deviations can be analyzed
by product, specification, category, disposition, etc. These data-mining capabilities can give important insight into
systemic quality issues and serve as an input to supplier evaluations.
Audit Trail and Electronic Signatures: MasterControl provides reporting, electronic signature, and time-
stamped audit trail capabilities that fully satisfy the FDAs 21 CFR Part 11 regulatory requirements.
Change Control Integration: When integrated with MasterControl Change Control, MasterControl users are
enabled to seamlessly initiate the change control process to update specification or other internal documents as
required.
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Industry-specific Products
MasterControl Industry-specific
Products
Bill of Materials (BOM)
DHF Express
DHF Jumpstart
eMDR
GCPDocs Express
GCPDocs JumpStart
PDM Connectors
Submissions Gateway
Submissions Locker
MasterControl Bill of Materials (BOM)

Each manufacturing company has its own unique production flow. But every companys production is reliant on a
Bill of Materials (BOM) that can accurately identify and list the components required to produce a particular product
at any given revision level. Simplifying and standardizing BOM management across departments is essential to
dynamic and profitable manufacturing.

Heres how MasterControl BOM streamlines the handling of BOMs and helps companies overcome common BOM-
related predicaments.

Inefficient and Mistake-prone System: Managing Efficient, Integrated System: MasterControl BOM
BOMs with spreadsheets is extremely tedious and controls all BOM iterations generated during the design
prone to error, especially when distributed product process and enables users to exchange BOM data with
development teams, contract manufacturers, or suppliers. All departments get an updated, accurate view
outside sources are involved. of revision levels of every component in their particular
configurations. Documents defining components are easily
viewed from the BOM, insuring that the right documents
and revisions are used in manufacturing.
Poor Supply Chain Communication: Changes Connected Processes: MasterControl BOM is traceable
arent communicated through the supply chain rapidly and secure and provides instantaneous electronic
enough, leading to the wrong revision of a component communication. Because the BOM is integrated with the
being built or excessive scrapping and reworking document management system, in-process changes are
of products. Manually mailing, emailing or faxing readily viewed by buyers/planners and costly mistakes
changes is time consuming and problematic. can be avoided. All parties involved in the supply chain are
accountable for actions once changes are approved and
communicated.
Ineffective Collaborations: Collaborating with Effective Collaborations: Authorized suppliers can have
contract manufacturers is inefficient, slow and costly. restricted access to MasterControl BOM, allowing them
Difficulties frequently arise when allowing or restricting to make markups to design files and associated BOMs at
various suppliers access to collaborations. any point in the design process designated by the user.
This saves time and money by eliminating the need to
implement suppliers modifications into reworked designs
after manufacturing has commenced.
Unpredictable Costs: Cost estimates are Predictable Costs: MasterControl BOM estimates the
unpredictable, making it difficult to keep pricing cost of the final product and sub-assemblies, allowing
competitive. users to focus design changes on the most expensive
components.
Repetitive Data Entry: Companies that use Integrate Data Automatically: MasterControl extracts
multiple systems frequently have to re-enter the BOM data from PDM systems and pushes that data
same information in each of the different systems to through to ERP systems automatically.
maintain consistency.
Revision Control: Each BOM is stored on a separate MasterControl InfoCard, allowing multiple revisions to
be approved and used for reference. BOMs can be sent on collaboration routes, allowing users to redline and
propose changes without affecting the approved version.
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Familiar Structure: MasterControl provides a configurable yet consistent approach to creating, viewing and
handling BOMs. Users already accustomed to working with BOMs will be able to effortlessly organize product
data using a familiar tool. Any BOM may also be copied by MasterControl to be used as the basis for new BOMs.
Auto-update: BOMs in MasterControl automatically update with new revisions of component InfoCards, creating
a new instance of the BOM in the process.
In Sync: MasterControl keeps engineering BOM data synchronized with manufacturing BOMs by enabling
integration with ERP systems and providing BOM control. Different teams or departments can all have access to
BOMs throughout the design process.
Establish Connections and Track Changes: The where-used feature displays exactly where a part is used
across multiple BOMs, permitting users to determine the impact of a single part change and updating subsequent
changes where needed. Assembly or sub-assembly InfoCards can be readily located in the MasterControl
system so users are aware of parts under construction and sub-assemblies to which particular components
belong.
Bulk Replace: A single part used in many locations can be replaced simultaneously by using MasterControl to
select assemblies to be updated, components to be substituted or components that require new revisions.
PDM Connector: BOMs can be created or edited manually or through PDM interfaces like MasterControls PDM
connectors. MasterControl can take a BOM from a PDM solution and keep all the hierarchal relationships intact.
BOM Views: MasterControl offers three unique methods of viewing BOMs:
1. The Indented (Hierarchical) View features dynamic navigation and display of all the structures and
sub-structures of a BOM. The same part may be displayed multiple times if it is included in multiple sub-
assemblies. The indented view also gives access to all documentation associated with each component,
including metadata.
2. In the Summarized (Flat) View each part is displayed just once in a list, allowing the user to view the total
quantity of each part required and rolled up costs.
3. Comparison View makes it possible to view the differences between two versions of the same BOM,
showing additions, deletions and modifications.
BOM View Actions: MasterControl also provides the capability to view files associated with any item from the
BOM (CAD drawings, manufacturing procedures, inspection plans, etc.) as well as point-in-time views of exact
BOM configurations in effect with specific revisions. MasterControl can also add documents and non-geometric
parts (grease, labels, etc.) to BOMs.
Advanced Analytics & Exporting: New where-used reports are created for all single parts and assemblies to
show every occurrence of a given item numbers utilization. Hyperlinks within the reports connect to associated
BOMs. Users can also configure how data is exported and synchronized with ERP systems via the MasterControl
API Toolkit.
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MasterControl DHF Express

Class I and Class II manufactured medical devices must be supported by appropriate documentation which
demonstrates that their development followed the Food and Drug Administrations (FDA) design control guidelines.
A design history file (DHF) is established for each device to house this documentation for the FDA.

MasterControl DHF Express provides a solution for collecting, organizing, and reviewing all the documents required
to meet FDA requirements. The software is specifically created for automating the design control process at a price
affordable for startup and small-sized medical device companies.
Heres how MasterControl DHF Express addresses some of the major challenges that medical device companies
face in controlling documentation to meet FDA requirements:

Disconnected Processes: Communication Connected Processes: MasterControl DHF Express
breakdown is likely to occur in a paper-based system is an integrated solution that connects users, data and
that consists of disconnected tools and processes. processes in a centralized system. This connectivity vastly
Missing a step in the design control process may improves communication and efficiency, ensuring that
cause critical delays in product development. goals and objectives are met and completed in a timely
fashion.
Design Review: All documentation is reviewed at Electronic DHF: Using MasterControl Organizers, industry
each phase of production. If the Design History File best practices, and regulatory guidelines, DHF Express
(DHF) is incomplete, resources are wasted while is configured to swiftly provide documents as needed,
searching for the required documentation. whether for a design review or FDA inspection.
New Product Delay: Design control requires that Faster Turnaround: MasterControl DHF Express
key design documents be reviewed and approved automates collaboration, routing, follow-up, escalation,
by several individuals. Time spent waiting on this and approval of important design control documentation,
process can impede product launch to market. removing this as an obstacle of product launch. Using
electronic signatures further accelerates the approval
process and ensures regulatory compliance.
Training Issues: Training system administrators Minimal Training: System administrator training is
is time consuming and costly. It also means you unnecessary. MasterControl DHF Express is ready out-of-
must designate an employee to specialize in this the-box, requiring minimal user training. MasterControls
role or hire a new employee to assume the system system administrators attend to any system needs.
administration function.
Summary of Features: MasterControl DHF Express is an ideal solution for early stage medical device companies
that need an out-of-the-box, preconfigured document control system based on best practices.
ASP Model: MasterControl DHF Express delivery model is ASP-based. The system is extremely easy to
administer and can usually be installed in a matter of days.
Affordable: The total cost of ownership is minimal because no special equipment is required. The ASP model
makes DHF Express affordable for small companies who are looking for a system that will grow with them.
and customized reports. Design control documents can be summarized in multiple levels such as product,
department, and document type. MasterControl includes dashboard and drill-down features.
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Automated Routing, Escalation, and Approval: Automates all design control document tasks, including
routing, notification, follow-up, escalation, and approval. Automation helps sustain compliance by simplifying
processes.
Best Practice Processes: The system is preconfigured based on industry best practices and design control
guidelines. Users are able to create, collaborate on, and route design documents without having to spend hours
configuring the system.
that dramatically cuts the time, pain, and cost involved in validation.
Electronic Approval Signatures: The system allows documents to display for review, collaboration, and/or
electronic approval, accelerating the approval process.
Grows with Your Business: If required, MasterControls Professional Services staff can make changes to
the preconfigured software to meet new requirements as a company proceeds through its growth cycle. More
importantly, as the company grows, you can move into a full MasterControl system that can include training,
CAPA, process automation, etc. without losing the efficiency of the preconfigured system or changes that may
have been incorporated along the way.
Organizers: MasterControls Organizer, similar to Windows Explorer, is an easy to use tool that helps users find
and access documents quickly. DHFs are structured such that design reviews can be conducted entirely from
within the DHF Organizer.
approval; password expiration, encryption and certification; and account lockout to stop unauthorized users from
Publishing: MasterControl offers automated conversion/publishing to PDF throughout the document lifecycle.
Auto converting of documents to PDF reduces errors commonly associated with manual publishing. PDF
conversion from multiple document types into a common, unalterable format helps improve efficiency and reduce
costs by eliminating additional desktop software that would be required for users to view documents.
Revision Control: Automatic revision control ensures that the history of the design is properly documented.
Rights-based access to documents ensures that the most current, approved version of a document is being
used.
Turnkey Solution: MasterControl DHF Express is ready out-of-the-box. There is no special hardware to buy
or system to configure. Data backup, antivirus protection and redundant hardware are all provided with minimal
upfront costs.
Web-based Platform: MasterControl is Web-based so it can connect all employees involved in the design
process from virtually anywhere.
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MasterControl DHF JumpStart

Medical device companies need an out of the box design control tool to help them organize the myriad drawings,
notes, collaborative pieces and papers that are created during the design process. They want a tool that bridges the
gap between design and manufacturing and provides project management, design control processes, and document
control and approval. MasterControl DHF JumpStart meets their desires, point for point.

MasterControl DHF JumpStart is a tool for medical device developers who work in small-to medium-sized companies.
Its a preconfigured database that helps device developers swiftly organize their work so they spend less time with
administrative duties and more time in development. The software provides multiple simple routes for collaboration,
approval and review and is an affordable solution for companies who want some customization in their document
control process.
Heres how MasterControl DHF JumpStart addresses some of the major challenges that companies face in meeting
FDA requirements:

Design Review: All documentation is reviewed at Electronic DHF: Using MasterControl Organizers,
each phase of production. If the Design History File industry best practices, and regulatory guidelines, the DHF
(DHF) is incomplete, resources are wasted while is configured to swiftly provide documents as needed,
searching for the required documentation. whether for a design review or FDA inspection.
Customization Delays: Smaller companies with Preconfiguration Speeds Your Work: MasterControl
tight deadlines rarely have time to work with software DHF JumpStart is preconfigured to organize documents in
requiring full customization; staffing resources just a complete design history file ready for design review or
arent available. FDA scrutiny.
New Product Delay: Design control requires that Faster Turnaround: MasterControl DHF JumpStart
key design documents be reviewed and approved by automates collaboration, routing, follow-up, escalation,
several individuals. Time spent waiting on this process and approval of important design control documentation,
can impede delivery to market. removing this as an obstacle of product launch. Using
electronic signatures further accelerates the approval
process and ensures regulatory compliance.
Slow Installation and Training: Other document Quick Start for Staff: DHF JumpStart is out-of-the-box
software programs can take months to install, weeks software requiring minimal systems administrator or user
for a systems administrator to set up and many days training that can be installed in a matter of days. LDAP
for a user to learn. integration is available, if desired.
Summary of Features: DHF JumpStart is out-of-the-box software requiring minimal systems administrator or user
training that can be installed in a matter of days. LDAP integration is available, if desired.
Affordable: The total cost of ownership is minimal because no special equipment is required.
and customized reports. Design control documents can be summarized in multiple levels such as product,
department, and document type. MasterControl includes dashboard and drill-down features.
Automated Routing, Escalation, and Approval: Automates all design control document tasks, including
routing, notification, follow-up, escalation and approval to improve efficiency and time-to-market. Automation
helps sustain compliance by simplifying processes.
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Best Practice Processes: The system is pre-configured based on industry best practices and design control
guidelines. Users are able to create, collaborate on, and route design documents without having to spend hours
configuring the system.
Collaboration: MasterControl allows project team members from different departments and key suppliers from
outside the organization to collaborate on crucial design documents, potentially reducing costly errors that must
be corrected late in the development cycle.
electronic approval, accelerating the approval process.
Grows with Your Business: Familiarity with the pre-configured system will allow the customers sysadmin to
make changes to accommodate new processes and procedures. As the company grows, it can move into a full
MasterControl system that can include training, CAPA, process automation, etc. without losing the efficiency of
the preconfigured system or changes that may have been incorporated along the way.
Assistance is Available: MasterControls Professional Services Staff is always available to support the
sysadmin in making these changes, should their help be warranted.
and access documents quickly. DHFs are structured such that design reviews can be conducted entirely from
within the DHF Organizer.
Part 11-Compliant Features: Provides time-stamped audit trail, reporting and electronic signature capabilities
approval; password expiration, encryption and certification; and account lockout to stop unauthorized users from
used.
Turnkey Solution: MasterControl Jumpstart is ready out-of-the-box. Data backup, antivirus protection and
redundant hardware are all provided with minimal upfront costs. Installation is a timesaver because the system
can be installed in a matter of days.
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MasterControl eMDR
The FDAs medical device reporting (MDR) regulation 21 CFR Part 803 requires device manufacturers to
report to the FDA any deaths or serious injuries as well as certain malfunctions associated with their devices.
MasterControl Inc. offers an electronic medical device reporting (eMDR) software solution that enables
MasterControl users to implement their FDA adverse event reporting process electronically.

The MasterControl eMDR solution module has been designed to meet the requirements for forms processes
within the confines of FDA/GxP environments including compliance with 21 CFR Part 11. Heres how
MasterControl eMDR helps companies address challenges that are common to the implementation and
management of MDR systems:

Disconnected Manual Systems: With paper Connected, Secure System: With MasterControl,
systems, it is difficult to ensure that there is sufficient all MDR event files are adequately documented and
documentation of MDR decision-making processes. electronically maintained in a centralized, secure
repository.
Slow, Inefficient Systems: Reporting to FDA via Electronic System: Reporting to FDA electronically
traditional snail mail is slow and inefficient for both is more efficient and saves time and resources.
the FDA and the company reporting to the FDA, MasterControls automated system ensures that
to such a degree that electronic reporting will be reporting and submission of MDR data is timely and
mandatory in the near future. consistent.
Complex Systems: Difficulties frequently arise in Streamlined System: MasterControl forms keep
developing and following written MDR procedures. MDR reporting consistent and according to regulatory
Frequently, personnel are inadequately trained on or requirements. The system also maintains a summary
informed about MDR principles. log of the types of events that have and havent been
reported. MasterControl connects all MDR decision
makers, making certain that information travels through
the proper channels.
Deficient Systems: No standardized review process Efficient Electronic System: MasterControl facilitates
for determining if an event is reportable and ensuring rapid and thorough handling of customer complaints.
that MDR reports are submitted in a timely manner. With MasterControl, adverse events can be reported
Such shortcomings can lead to FDA citations. quickly and consistently.
Robust Reporting Capabilities: MasterControl eMDR features customizable standard reports. The types
of useful reports provided by the system include:
MDR Summary: Presents the most relevant data for all MDRs.
MDRs by Product: Groups MDRs by brand name.
MDRs by Outcome: Complete with charts and number count for each type of outcome.
MDRs Awaiting Acknowledgments: Presents the most relevant data for all MDRs awaiting one or more
acknowledgments.
MDR Time to Report: Presents the time elapsed between the date of event and date of report with an
average time for all MDRs.
MDRs One-Year Trend: Includes a trending chart showing the number of MDRs over the preceding
12-month period.
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Automatic Launch: When a complaint form is filled out, an eMDR can be electronically initiated with appropriate
fields automatically populated based upon certain triggers in the complaint form. In cases where follow-up is
required, authorized users can launch a new MDR form from the parent form. MDRs can also be manually
generated.
Connected, Highly Visible System: MasterControl provides a structured MDR workflow. All designated users
can review MedWatch form sections and MedWatch instruction pages are easily accessible.
Optional Creation of an XML file for electronic submission to FDA: MasterControl allows users to generate
XML packets in the format specified by the FDA.
Effective Data Collection: MasterControl users can record the electronic submission date and add e-mail
confirmations from the FDA Electronic Submission Gateway (ESG) directly into the system.
Integration with Document Control and Other MasterControl Solutions: MasterControl eMDR seamlessly
integrates with the document control system and other MasterControl applications that are useful in conjunction
with the eMDR solution, including MasterControl Process, MasterControl Documents, and MasterControl
PDF Publishing.
Field Mapping from MasterControl Customer Complaints MD: Information entered into MasterControl
Customer Complaints MD (such as descriptions of events or problems) can automatically populate appropriate
eMDR form fields.
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MasterControl GCPDocs Express

For many small pharmaceutical and biotech companies, GCP stands for Great Complicated Paperwork rather than
Good Clinical Practices. The voluminous paperwork is an integral part of meeting the international, ethical, and
scientific quality standards for designing, conducting, recording and reporting trials that involve human subjects, but
that doesnt make it any easier to handle. Small contract research organizations (CROs) commonly feel overwhelmed
by all the documentation required by the standard.

MasterControl GCPDocs Express provides a solution for collecting, organizing, and reviewing all the documents
required to meet the GCP requirements. It is specifically designed to help organize and control nonclinical, clinical,
and regulatory documents for smaller pharmaceutical and biotechnology companies. It helps take the complicated
out of the burdensome paperwork requirements.
Heres how MasterControl GCPDocs Express addresses some of the major challenges that small pharmaceutical
and biotech companies face in meeting GCP requirements:

Disconnected Processes: Communication Connected Processes: MasterControl GCPDocs Express
breakdown is likely to occur in a paper-based is an integrated solution that connects users, documents
document control system that consists of manual, and processes in a centralized system. This connectivity
disconnected approval processes. Missing a step in vastly improves communication and efficiency, ensuring
the GCP process may cause critical delays in product that goals and objectives are met and completed in a
development. timely fashion.
Poor Turnaround: For those with paper-based Faster Turnaround: MasterControl GCPDocs Express
systems, paperwork often ends up in a pile on automates data collection, routing, follow-up, and
somebodys desk, creating a significant turnaround escalation of document review and approval processes.
challenge in a sequential process.
Scarce IT Resources: In the smaller companies, ASP Solution: MasterControl provides GCPDocs Express
IT resources for system implementation, training as an ASP offering to reduce IT resources requirements.
and validation are scarce. Many times this requires Our experts provide rapid deployment, professional
outsourcing to expensive consulting groups. validation services and complete maintenance of your
system.
Training Issues: Training system administrators Minimal Training: System administrator training is
is time consuming and costly. It also means you unnecessary. MasterControl GCPDocs Express is
must designate an employee to specialize in this ready out-of-the-box, requiring minimal user training.
role or hire a new employee to assume the system MasterControls system administrators provide all the
administration function. maintenance required to keep your system working
smoothly.
Poor Tracking: Its time-consuming to physically Automatic Tracking: The MasterControl GCPDocs
track paperwork. A manual system makes it almost Express system tracks the document through the
impossible to identify and avoid bottlenecks. collaboration, review and approval steps, allowing the
document owner to efficiently move the document through
these processes and complete their work quickly.
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Summary of Features: MasterControl GCPDocs Express is an ideal solution for early stage pharmaceutical and
biotechnology companies that need an out-of-the-box, preconfigured document control system based on best
practices.
Best Practice Documents and Processes: The system provides a mechanism to use preconfigured document
templates for participants to begin workflows, including templates for document types, collaboration, out-of-office,
e-mail import, and other features.
Affordable: The total cost of ownership is minimal because no special equipment is required. The ASP model
makes GCPDocs Express affordable for small companies who are not ready for a full-scale document control
system.
ASP Model: MasterControl serves as the Application Service Provider (ASP) for GCPDocs Express. The system
is extremely easy to administer and can usually be installed in less than a week and often just in a matter of
days.
electronic approval, facilitating the approval process.
Turnkey Solution: MasterControl GCPDocs Express is ready out-of-the-box, drastically reducing time required
for implementation. There is no special hardware to buy or system to configure. Data backup, antivirus protection,
and redundant hardware are all provided with minimal upfront costs.
Grows with Your Business: If required, MasterControls Professional Services staff can make changes to
the preconfigured software to meet new requirements as a company proceeds through its growth cycle. More
importantly, as the company grows, you can move into a full MasterControl system that can include training,
CAPA, process automation, etc. without losing the efficiency of the preconfigured system or changes that may
have been incorporated along the way.
Compliant System: As with all software developed by MasterControl, the GCPDocs Express document control
solution is fully compliant with the software-related requirements of 21 CFR Part 11.
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MasterControl GCPDocs JumpStart

For many years, the conducting of clinical trials relied on the integrity of the personnel involved in operating the trial.
The introduction of good clinical practice (GCP) principles established an era of regulation previously unknown in the
pharmaceutical and biotechnology industries.
The detailed documentation needed to meet GCP requirements could conceivably require organization and storage
of thousands of pages. Additionally, a company filing a New Drug Application (NDA) must follow a set of guidelines
which require a specific format. Failing to comply with the formatting directions means costly delays in time to market
and profitability.

MasterControl GCPDocs JumpStart provides a solution for collecting, organizing, and reviewing all the documents
required to meet the GCP requirements. It is specifically preconfigured according to regulatory standards and
industry best practices to help organize and control nonclinical, clinical, and regulatory documents to meet NDA
document requirement needs for growing pharmaceutical and biotechnology companies. The software provides
multiple simple routes for document collaboration, approval, and review. Its an affordable solution for companies who
want to automate their document control process.
Heres how MasterControl GCPDocs JumpStart addresses some of the major challenges that companies face in
meeting GCP requirements:
Document Management System Challenges MasterControl Document Management System

Solutions
Disconnected Processes: Communication Connected Processes: MasterControl GCPDocs
breakdown is likely to occur in a document control JumpStart is an integrated solution that connects users,
system that consists of disconnected processes. documents, and processes in a centralized system. This
Missing a step in the GCP process may cause critical connectivity vastly improves communication and efficiency,
delays in product development. ensuring that goals and objectives are met and completed
in a timely fashion.
Poor Turnaround: For those with paper-based Faster Turnaround: MasterControl GCPDocs JumpStart
systems, paperwork often ends up in a pile on automates version control, document routing, follow-
somebodys desk, creating a significant turnaround up, and escalation of document review and approval
challenge in a sequential process. processes.
Go Configure it Yourself: Smaller companies with Preconfiguration Speeds Your Work: MasterControl
tight deadlines rarely have time to work with software GCPDocs JumpStart is preconfigured to organize
requiring full customization; staffing resources just nonclinical, clinical, and regulatory documents for
arent available. pharmaceutical or biotechnological companies.
Hours of Prep: Other document management Quick Start for Staff: GCPDocs JumpStart is an out-of-
programs can take exorbitant amounts of time for the-box software requiring minimal system administrator or
a systems administrator to set up and for a user to user training. LDAP integration is available, if desired.
learn.
Poor Tracking: Its time-consuming to physically Automatic Tracking: The MasterControl GCPDocs
track paperwork. A manual system makes it almost JumpStart system tracks the document through the
impossible to identify and avoid bottlenecks. collaboration, review and approval steps, allowing the
document owner to efficiently move the document through
these processes and complete their work quickly.
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Summary of Features: MasterControl GCPDocs JumpStart is an ideal solution for early stage pharmaceutical
and biotechnology companies that need an out-of-the-box, preconfigured document control system based on best
practices.
Below is a summary of its key features:
Best Practice Documents and Processes: The system is pre-configured with document types, lifecycles,
workflows, and permissions set that are common to small companies in pharmaceuticals and biotechnology.
Features like collaboration, out-of-office routing, and e-mail import all provide time-savings and process efficiency
that enables small companies to get away from the paper shuffle and back to the business of developing new
medicines and therapies.
Affordable: The total cost of ownership is minimal because no special equipment is required. GCPDocs
Jumpstart can be installed on-site or as an ASP implementation. The ASP model makes GCPDocs JumpStart
more affordable for small companies who have limited IT infrastructure but require a scalable document control
system.
Electronic Approval Signatures: Facilitates the online document control process, reducing the administrative
workload.
Grows with Your Business: If required, MasterControls Professional Services staff can make changes to the
preconfigured software to meet new requirements as a company proceeds through its growth cycle.
21 CFR Part 11 Features: As with all software developed by MasterControl, the GCPDocs JumpStart provides
all the features necessary to comply with 21 CFR Part 11 requirements. It provides a secure, time-stamped audit
trail, reporting, and electronic signature capabilities. Security features include dual passwords for document
approval, and password expiration, encryption, and certification.
and access documents quickly. Using Organizers, documents can be gathered into logical groupings and made
available to workgroups based on a project, study, clinical site or other document attributes. Documents required
for a specific regulatory filing can also be collected and reviewed as a group in preparation for a submission.
used.
Collaboration: MasterControl allows project team members from different departments and key suppliers from
outside the organization to collaborate on crucial design documents, potentially reducing costly errors that must
be corrected late in the development cycle.
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MasterControl PDM Connectors

Every manufacturing company has product data that must be maintained and controlled. This data can include
everything from engineering drawings and manufacturing procedures to 3D CAD files and control plans. Regulated
industries are often forced to manage these types of product data according to strict regulations while juggling
multiple data filesoften in different file formatslocated in separate systems.

MasterControl PDM Connectors are easy to use and connect with the most popular CAD PDM solutions available.
MasterControls PDM interface allows collaboration and redlining on PDF drawings while guaranteeing that the PDF
copy in the MasterControl system stays in sync with native files in the PDM solution.
Here are some examples of how MasterControls PDM integration system facilitates the handling of complex CAD
files and, in so doing, helps companies in regulated environments overcome common product data management
challenges.

Complex Process: CAD file relationships are Simplified Process: MasterControl PDM Connectors
intrinsically complicated and can be disrupted by provide users with straightforward means of applying
introducing inadequate maintenance and control document control to CAD data without forcing designers
systems. into a non-native application for managing their CAD files.
CAD files are maintained by the native PDM solution while
MasterControl creates PDF copies for official document
control purposes such as routing, approval and production.
Inefficient System: Manual systems have inherently Efficient System: MasterControl manages and tracks the
complex structures, which can lead to limited or no creation, change and archiving of all information relating to
workflow capability for routing and approving crucial a product. The automated routing and approval provided
CAD product data. by MasterControl PDM connectors improves workflow
functionality and allows effective, seamless handling of
CAD files.
Disconnected System: Product information is Connected System: When the link between
scattered throughout several different systems and is MasterControl and the PDM solution is initialized, the
often out of sync with data in the PDM solution. system automatically processes packets of files until
there are no more files requiring synchronization. The
MasterControl system can also be manually synchronized
and still identify and rectify any gaps that may exist.
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Supported Systems: Interfaces with the most commonly used PDM solutions in the industry, including
PDMWorks from SolidWorks and PTCs Pro/IntraLink and Windchill. MasterControl links CAD systems
with the highest level of document control to create an ideal master management system.
Security: MasterControl PDM integration keeps companies compliant by insuring that data is kept consistent
between systems. MasterControl features electronic signature capabilities and time-stamped audit trails as well
as dual passwords for document approval and password certification, expiration and encryption.
Collaboration: The MasterControl PDM connectors foster an effective communication environment by allowing
users to collaborate on engineering drawings using nothing more than Adobe Reader. Users across an
organization can redline and collaborate on drawings, even those users who lack intimate knowledge of the
CAD package. When collaboration introduces new changes, collaboration leaders can make the necessary
modifications using the native CAD application. MasterControl then automatically publishes a new PDF file
reflecting the changes made.
Notification: If missing metadata in the PDM system causes the transfer process to fail, MasterControl
automatically notifies assignable users.
Links: MasterControl InfoCards link to native drawing files, which simplifies referencing when the time comes to
revise drawings. The InfoCards also support custom field data that can be directly passed from the PDM solution.
Update Management: MasterControl provides continuous and automatic monitoring for new and revised
released-state drawings in the PDM solution. The system publishes a PDF main file for each new drawing using
the metadata from the PDM solution. Similarly, revised drawings trigger revisions in MasterControl which pushes
the metadata from the PDM solution to updated MasterControl InfoCards.
Integration: MasterControl provides appropriate templates (i.e., NDA, BLA, CTD, IND) to facilitate the dossier-
creation process.
Automated PDF File Generation: To make an electronic submission to the FDA, the agency requires that
electronic files of regulatory information be submitted in PDF format. MasterControl offers automated PDF
conversion of documents, including TOC level bookmarks, streamlining the process by not having to manually
generate or edit the PDF files. Submissions are made easier since the amount of manual effort involved is
reduced.
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MasterControl Submissions Gateway

The FDAs 21 CFR Part 11 allows regulatory information to be signed and submitted electronically and permits the
use of electronic record-keeping systems in complying with predicate rules. While automated submission tools can
cut costs and save time, they can only be as useful as the submissions content will allow. A submission tool is an
advantageous conduit in the submissions process, but just as crucial is a mechanism that can ensure controlled,
quality content in the regulatory submission.

To guarantee submission consistency, companies in regulated environments demand that quality initiatives be
integrated into the corporate culture organization-wide. The MasterControl Submissions Gateway responds to
those demands by ensuring control in assembling and tracking documentation vital to submissions. The enhanced
Submissions Gateway is specifically designed to help companies meet the requirements for good document control
within the confines of FDA-regulated GxP environments, including compliance with 21 CFR Part 11.
While every company preparing a submission uses its submission tool of choice, it still requires an effective means
of controlling documents and maintaining shared submission-related files in a secure submission repository.
MasterControl provides a centralized repository that controls the creation, sharing and documentation of submission-
related files, regardless of the submission tool in use.
Heres how MasterControl addresses key submission preparation challenges:

Inefficient Process: FDA submissions (e.g., for a Efficient Process: MasterControls centralized repository
NDA or IND) can entail thousands of pages that need for all regulatory submission documents makes search
to be managed, compiled, published, and revised. and retrieval easy. A single repository also simplifies
With a paper-based system, the process can be follow-up submissions and reduces potential agency
overwhelming and is prone to error and delay. questions. MasterControl integrates with a companys
existing submission tool to streamline and optimize the
e-submission process.
Lack of Security: Paper submissions compiled Secure Repository: MasterControl controls submission
in binders and folders or stored partially in documents before, during and after publishing. Documents
computers provide little security and might not are stored in secure virtual vaults located in a central
be able to guarantee data integrity. Submissions database for authorized access only. The system uses
documents stored on file shares provide only slightly industry-standard SSL and 128-bit encryption capabilities
more control. Submission documents in these to secure data communications that take place between
circumstances may be uncontrolled during the entire the Web browser and the application.
process.
Lack of Revision Control: In a paper-based or Automatic Revision Control: MasterControl provides

simple file share based system, there could be automatic revision control to insure that only the most
multiple (unwanted) versions of documents. Modifying current version of a document is available, so users will not
a document entails time-consuming meetings and make the mistake of working with unapproved or obsolete
manual change. documents.
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Interfaces with Any Publishing System: Since custom connectors are not required, the Submissions Gateway
will work with any publishing system, present and future. The initial collection and organization of documents
within the Gateway followed by the export to the submissions publishing tool connects the document review and
approval process with the dossier assembly process, accelerating the submission process.
Integration with Submissions Locker: The enhanced Submissions Gateway is designed to work in conjunction
with the MasterControl Submissions Locker to allow early stage organization of submissions documents in
pre-publishing settings. The two solutions working together insure that documents are always up to date and
maintained in a controlled central repository.
Enterprise-wide Collaboration: MasterControl provides a truly enterprise level collaboration tool which allows
diverse teams of users to work together to revise documents. Redlines of documents are stored for all team
members to review, update or eventually upload as the final copy. Different teams can be included on sequential
collaboration steps to promote faster and easier updates to the submission documents.
Lifecycle Management: MasterControl provides complete lifecycle management, from document creation to
submission, with the help of the following tools:
MasterControls Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find
and access documents quickly. Users can arrange files in Organizers and later export them to the
directory structure of a particular submission. This avoids the extra step of integration. Updating files
is easy because system administrators can create virtual folders within Organizers that automatically
retrieve documents based on a pre-defined query.
The InfoCard is a MasterControl tool that provides basic information about a document and serves as
a placeholder for a file in the database. To modify a document, the InfoCard requires a user to enter a
reason. Through the InfoCard, MasterControl then tracks document changes and provides a secure,
time-stamped audit trail as required by 21 CFR Part 11.
Publishing Control: The Submissions Gateway in combination with the Submissions Locker controls the
submission before, during and after publishing, assuring all departments with confidence in the submission. After
the initial export, the submission always contains the most current approved documents. When publishing is
complete, the submission becomes a locked, read-only document in a repository controlled by the Submissions
Locker. MasterControl allows the publishing team to focus on publishingnot chasing down documents
resulting in faster submission times.
The Submissions Export Utility copies submission documents and folder structure to the Submissions Locker
and maintains an index of the documents. As documents are approved in MasterControl, they are automatically
copied to the Submissions Locker. If a document is revised at the last minute, the updated approved version is
immediately exported to the Locker. Not only does the Submissions Gateway have the capability to export to the
Submissions Locker but it can export to a file share as well. In addition, updates to the Submissions Locker can
be set according to a user-defined schedule and attachments may be included when documents are exported.
Users may choose to export all documents or only those that have been approved.
FDA Submission Templates: MasterControl provides appropriate templates (i.e., NDA, BLA, CTD, IND) to
facilitate the dossier-creation process. Users are given the capability to manage, view, create, delete, and
preview submissions templates. The Manage Submissions Template Right grants users access to the submission
templates, which are in XML format. Templates created by a useras well as MasterControls pre-existing
templatesappear in the Submission Templates drop-down list of the Gateway tab of an Organizer where they
are available for use.
Automated PDF File Generation: To make an electronic submission to the FDA, the agency requires that
electronic files of regulatory information be submitted in PDF format. MasterControl offers automated PDF
conversion of documents, including TOC level bookmarks, streamlining the process by not having to manually
generate or edit the PDF files. Submissions are made easier since the amount of manual effort involved is
reduced.
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Electronic Sign-offs: Signature manifestation (name, date, time, and meaning of electronic signature) can be
appended automatically to each document as required by 21 CFR Part 11. The e-signature can be configured
to include a users title and the route step name in the manifest to distinguish the different kinds of approval a
document receives (i.e., format approval made by a document control specialist vs. procedure approval made by
the medical director).
Signature Manifest Option: The Include Signature Manifest function allows users to include or exclude the
signature manifest on documents that will be exported using the Submissions Gateway, providing a more efficient
means of removing unneeded pages from documents when signature manifests are not required.
Export File Names: The Export File Naming Convention gives users the ability to select a naming format via the
Submissions Gateway. Users can choose one of several configurations of title, document number, and revision.
Part 11-Compliant Features: In addition to e-signature, MasterControl provides other capabilities that fully
satisfy FDAs 21 CFR Part 11 requirements, such as a time-stamped audit trail that can be linked to the approval
process. Security features include dual passwords for document approval; password expiration, encryption, and
certification; and account lockout to stop unauthorized users from gaining system access.
Continuous Validation: MasterControl offers a continuous validation approach that dramatically cuts the time,
pain, and cost involved in validation. MasterControls continuum of innovative products and services, including
MasterControl Transfer OQ, insure companies go-live faster and more cost effectively.
Web-based Platform: MasterControls platform is Web-based so it can connect employees, consultants, and
others involved in submissions regardless of location.
project implementation and helps companies realize software ROI more rapidly. The team conducts training at
MasterControls state-of-the-art Training Center in Salt Lake City or on-site at the customers facilities.
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MasterControl Submissions Locker

The move toward all-electronic submissions and the stringent FDA submission requirements pushes life sciences
companies to adopt a disciplined approach toward the authoring and review of submissions documents. Companies
that do not begin to create and publish submissions-ready documents in the early stages of the clinical study process
will unquestionably face delays in the submissions process and possibly suffer adverse effects from delayed approval
and potentially lose profits as products take longer to get to market.

MasterControl Inc.s Submissions Locker is an indispensable tool that can be utilized throughout a submissions
lifecycle. The Submissions Locker provides a secure environment that is accessible to any publishing tool preferred
by the user. The Submissions Locker works in tandem with MasterControls enhanced Submissions Gateway to
help users better prepare and control electronic submissions to regulatory agencies by supporting a full lifecycle for
creating submissions.
The following are some examples of how MasterControls Submissions Locker addresses common challenges faced
by companies preparing regulatory submissions.

Disconnected System: Publishing solution does Connected System: MasterControl allows all publishing
not interface with document management system. tools to access the Submissions Locker just as they would
Development of custom connectors takes time and any ordinary file share. The Submissions Locker is secure
resources. and always up to date with the most current documents.
Unsecured System: Disconnect between publishing Secure System: The Submissions Locker provides a
solution and document management system can lead secure, Web-based location where submission document
to inadvertent, uncontrolled sharing of submission access can be easily controlled. After authentication,
document files. The result is wasted company MasterControl allows the publishing tool of choice to
time and manpower, diminished confidence in the access the Submissions Locker as a standard file share.
submissions content, and the potential for document All access is controlled exclusively by MasterControl login
integrity to be compromised. parameters.
Lack of Revision Control: Documents are revised Automatic Revision Control: As documents are
and approved at different times, sometimes at the last approved in MasterControl, they are automatically copied
minute, which may require users to perform a manual to the Submissions Locker. If a document is revised at the
export. last minute, the updated approved version is immediately
exported to the Submissions Locker.
Inefficient Processes: To attempt to control Efficient Processes: MasterControl electronically controls

file sharing between disconnected systems, IT and tracks access share rights, making the publishing
departments must constantly respond to requests to process more efficient and reducing the imposition on IT
alter share permissions during the publishing process, departments. The submission is secured by MasterControl
wasting personnel time and jeopardizing file share throughout the publishing process.
control.
Early Stage Organization: The Submissions Locker works hand-in-hand with the MasterControl Submissions
Gateway to permit pre-publishing organization and control of submissions documents. The two solutions
working together streamline the document assembly and organization process starting at the beginning of the
submissions cycle by insuring that documents are always up to date and maintained in a secure, centralized
repository.
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Uniformity: The Submissions Locker allows users to maintain documents in the same format in which
submissions are sent to the FDA.
Version Control: MasterControls Submissions Locker ensures that users are always working with the most
current document versions. All submissions are assigned unique numbers and associated with applicable parent-
child relationships.
Security and Authorization: The Submissions Locker provides regulated companies with a secure location
where submission document access can be readily controlled. Once it has been authenticated, MasterControl
allows the users publishing tool of choice to access the Submissions Locker just as it would any ordinary file
share. Rights to access the folders are controlled automatically by MasterControl.
Revision Control: Approved versions of updated documents are automatically exported to the Submissions
Locker. MasterControl insures that all revisions are linked to affiliated submission serial numbers.
Submission Assurance: The Submissions Locker, working in conjunction with MasterControls Submissions
Gateway, controls submissions before, during and after publishing, which ensures that all departments involved
can have increased confidence in regulatory submissions.
Reduced IT Pains: Since file sharing rights are controlled automatically by MasterControl, IT departments wont
have the hassle of constantly modifying access permissions throughout the submissions cycle.
No Custom Connectors Required: MasterControls Submissions Locker is publishing tool agnostic and can
work with any publishing system preferred by the user, present and future.
Centralized and Secure System: With MasterControl, all essential submissions documentation can be imported
into and maintained by a central, controlled repository. After being authenticated by MasterControl, the users
publishing tool of choice is able to access the Submissions Lockers secure environment.
Interoperability: The Submissions Locker and the enhanced Submissions Gateway function seamlessly with
MasterControls PDF Publishing solution to preserve record format, authenticity and integrity by providing PDF
features (bookmarks, table of contents, etc.) that are crucial to streamlined submission processes and regulatory
compliance. MasterControls configurable settings allow users to match regulatory agency requirements.
MasterControl alleviates the negative consequences frequently associated with uncontrolled documents by
enabling the self destruction of electronic copies, stamping expiration times on printed copies, and embedding a
list of all signatures to each document.
Compliance: MasterControls Submissions Locker is designed to meet the requirements for appropriate
document control according to GxP industry standards and regulatory guidelines, including compliance with the
FDAs 21 CFR Part 11.
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Integrations and Connectors
MasterControl Integrations
and Connectors
API Toolkit
Document Connections
Kofax Connector
MS Word Integration
Outlook E-mail Integration
PDMWorks Connector
Pro/Intralink Connector
QAAD API Suite
SharePoint Connector
WindChill Connector
MasterControl API Toolkit

Companies automate business operations by deploying a variety of software applications, such as enterprise
resource planning (ERP), customer resource management (CRM), manufacturing execution systems (MES), and
product data management (PDM) applications. FDA-regulated and ISO-certified companies also need quality
management software to ensure quality and compliance. There are many connection points between these various
applications and their corresponding business operations.

MasterControl API Toolkit allows companies to integrate MasterControls robust quality management solutions with
other enterprise applications to optimize operations. The toolkit enables the exchange of files and data between
MasterControl and other software applications.
continuous validation approach dramatically cuts the time, pain, and cost involved in validation, making it easier
to re-validate future upgrades. MasterControls continuum of products and services address different levels of
validation needs based on individual risk assessment. They include innovative products and services such as
MasterControl Transfer OQ.
Here is how MasterControl addresses the key challenges faced by companies using different enterprise applications:

Disconnected: Enterprise applications that are Connected: With MasterControl API Toolkit, existing
disconnected are inherently inefficient because they enterprise applications can be integrated with
require extra effort on the part of users to get the most MasterControl solutions to achieve more powerful
out of these systems. functionality and also enhance efficiency.
Prone to Mistakes: Different enterprise applications Helps Avoid Mistakes: By automating basic interactions
that dont operate together require interactions by necessary for different applications to complement each
users, such as sending data from one application to other, MasterControl helps users avoid common mistakes.
another, or creating a new document in one system
based on data from another system. The more
interactions, the more chances for making mistakes.
High Cost: A company might have invested a Keep Costs Down: The MasterControl API Toolkit helps
substantial amount on a certain system before companies leverage their existing systems and keep
realizing its other needs, that cannot be met by the costs down by allowing them to integrate MasterControl
system. To switch systems entirely would mean a loss quality applications with existing systems. Companies
on the initial investment and additional cost for buying will be able to take advantage of MasterControls training,
new software. CAPA, change control, customer complaints, audit,
nonconformance, and other solutions to complement their
existing systems.
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Features: MasterControl API Toolkit enables integration of MasterControl applications with ERP, CRM, and other
enterprise systems based on the following summarized features:
Receiving Data: Other systems can initiate actions in MasterControl, including:
Log in and log out;

Push data into and pull data from MasterControl;
Create a new InfoCard (the MasterControl tool that summarizes information about every document and
serves as a placeholder for the document in the database);
Retrieve InfoCard data from MasterControl;
Check in and check out an InfoCard for easy tracking of multiple revisions;
Edit an InfoCard;
Provide an external link to the main file; and
Upload a new main file and/or attachments.
Sending Data: When actions that affect other processes managed by other systems are initiated in
MasterControl, it will trigger notification to the other systems. For example, an engineering change order that
has been approved in MasterControl will trigger notification to the enterprise resource planning (ERP) system
that maintains the bill of material to ensure that the BOM is updated. The system administrator will be able to
configure the type of data that can be made available through a route trigger. He or she can choose whether
the data should be made available via comma separate value (CSV) file or Web service. There are two types of
triggers:
Document-based trigger Metadata from the documents InfoCard will be automatically made available
to the affected system; and
Form-based trigger Metadata from the documents InfoCard plus form metadata will be made available.
Web Service: These features are provided using a Web Services model, which allow loosely coupled
applications to be created by combining MasterControl components with interfaces to ERP, CRM, or other types
of enterprise applications.
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MasterControl Document Connections

Most companies in FDA and ISO environments rely heavily on electronic repositories to store, manage, and control
SOPs, engineering drawings, forms, work instructions, and other documents necessary for compliance. They might
have invested substantial amounts in document management technology before realizing their other needs, such as
training control and handling of corrective/preventive action (CAPA), which cannot be managed by repositories
even very expensive ones.

MasterControl Document Connections allows companies to integrate their existing electronic repositories ECM,
PLM, or other types with MasterControl Training, MasterControl CAPA, MasterControl Forms, and other
cutting-edge MasterControl applications. By using this module, integration of MasterControl solutions with external
repositories can be made easily and immediately, without custom coding.
Transfer OQ.
Here is how MasterControl addresses common challenges in managing electronic repositories that are not connected
to quality processes:

Disconnected: Electronic repositories that function Connected: Connecting electronic repositories with
separately from quality processes (CAPA, training quality processes fosters efficiency and also ensures
control, etc.) are likely to cause some inefficiency. that quality issues are handled in a timely manner. This
Disconnected processes also increase the likelihood connectivity allows a holistic and proactive approach to
of quality issues falling through the cracks. quality management.
Lacks Process-Specific Functionality: While Allows Integration with Process-Specific Applications:

electronic repositories are useful for document Through MasterControl Document Connections,
management, they dont have the ability to control companies can complement their existing repositories with
specific quality processes that are critical to regulatory MasterControls powerful, process-specific applications for
compliance. managing training, CAPA, audit, change control, customer
complaints, nonconformance, and other quality processes.
High Cost: A company that has made a significant Cost-Effective: MasterControl can integrate a repository
financial investment in an electronic repository expects with MasterControl quality management applications
to use the system for a number of years. Buying a new without the need for expensive custom coding. With this
system that renders the existing repository useless solution, an existing repository need not turn into a white
means a loss on the initial investment. elephant.
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Features: MasterControl Document Connections, a part of the MasterControl integrated quality management suite,
is an innovative solution designed to help companies leverage their existing repositories for a holistic, compliant, and
cost-effective quality management system.
A key element of this solution is the use of Surrogate InfoCards. The InfoCard is the MasterControl tool that
summarizes information about every document in the system and serves as a placeholder for the document in the
database. Every item in a repository will have a corresponding Surrogate InfoCard in MasterControl Document
Connections. Surrogate InfoCards allow communication between the repository and MasterControl Connections,
which then leads to an appropriate action in MasterControl Training, MasterControl CAPA, or other MasterControl
applications. Below are the highlights of this solution.
Document Change Triggers Action: When a revised document (e.g. SOP, work instructions, etc.) in a
repository is approved, MasterControl will trigger related tasks in the MasterControl application that has been
integrated with the repository. For example, MasterControl Training tasks can be automatically sent to affected
trainees when the document is revised in the connected repository.
Linking of Documents: A document in a repository can be linked to a MasterControl form for a streamlined
workflow. For example, a new SOP is approved and released in a repository. When a CAPA, change request,
customer complaint, or other type of form related to this particular SOP is launched in the MasterControl system,
a link can be made to the corresponding SOP. This enables the participants to have easy access to the SOP that
exists in an alternate repository.
Multiple Document Connections: Multiple connections can be made to multiple repositories. This is beneficial
for those companies that may have documents stored in multiple repositories (e.g., SOPs in one and engineering
drawings in another), but would like to trigger training when changes occur in either.
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MasterControl Kofax Connector

Tired of manually capturing paper documentation such as audit records, clinical documentation or shipping and
receiving documents for storage in your document control system? Sick of recreating legacy documents like lab
notebook quotes, applications, and resumes? MasterControl and Kofaxs Ascent Capture allows users to directly
upload scanned documentation into the MasterControl document control and management system.

MasterControl has developed an interface that links Kofax scanning technology with MasterControls electronic
document control system. The custom release script software now available from MasterControl makes it possible to
use Kofaxs Optical Character Recognition (OCR) tools to digitally capture existing documentation and then directly
upload and automatically store the scanned documents into MasterControl.
Heres how MasterControls Kofax interface addresses key challenges faced by regulated companies needing to
scan large amounts of documents:

Costly Manual Process: Outsourcing voluminous Cost-Efficient Automated Process: The MasterControl
amounts of documentation to be scanned or devoting release script in combination with Kofax software allows
excessive amounts of employee time to scanning users to automatically upload scanned documents into
documents is costly and time consuming. the MasterControl system, saving time and money.
Outsourcing can be avoided since automatic scanning and
upload can be done in-house relatively quickly.
Paperwork Backlog: Departments that daily Documentation Upkeep: MasterControls interface

receive or create a large amount of hard copy streamlines the scanning and uploading process, making
documentationan accounting departments it possible for all departments to keep up with the daily
invoices, for instancefrequently accumulate an accumulation of documents needing to be scanned.
overabundance of paperwork that needs to be
scanned.
Disjointed Processes: Most life science companies Unified Process: MasterControls release script makes
have documents located in both paper and electronic it possible for a company to consolidate its scanning
formats in a variety of separate systems. protocols and centralize electronic documentation.
Scanning Software Limitations: Scanning programs Unlimited Functionality: MasterControl permits users
and interfaces are typically lacking in functionality. to scan and upload any portion of a document. Scanned
For instance, they may not be able to digitally convert images can be converted into searchable text and there is
a document into searchable text or they may not be no limit to the number of pages that can be input into the
able to single out a particular section of a document system simultaneously.
utilizing OCR tools.
Overwhelming Volume of Paperwork: Many Manageable Documentation: MasterControl users can

organizations have such a tremendous amount create PDFs from any existing saved documentspaper
of documentation and legacy paperwork that or electronicand create a single secure and organized
the daunting process of scanning and securing electronic repository for all critical documentation.
documents imposes an organization-wide drain on
time and resources.
Paper Format: Early non-clinical work done by an Electronic Format: The MasterControl release script
acquired entity, contract house or academic institution makes it possible to scan, index and secure all vital
may not be provided in electronic formats. documentation.
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MasterControl Insures Compliance for Medical Device Developers: Medical device companies need to scan
data sheets created during design verification and validation testing. These sheets can number in the thousands
for a single report and are often generated in a format that is not readily viewed by standard applications. Many
of these documents can be manually populated, making scanning the only solution for getting these records in
an electronic format. MasterControls interface simplifies the handling of these documents by automating the
process. Survey data from design validation efforts and gathering of market needs are also prime candidates for
a scanning application like the MasterControl interface.
Compliance Benefits for Pharmaceutical Companies: With so many thousands of documents required for
submissions, drug developers are bound to have many documents in non-electronic formats. Case Report
Forms, for example, or non-clinical work from outside sources, early stage documentation or hand-written
clinic notes may all need to be scanned at some stage. MasterControl makes it possible to scan, index and
secure all such submissions-related documentation. Paper invoices, clinical documents and early stage paper
documentation provided by external contract resources can also be readily handled by MasterControl.
User-defined Criteria: MasterControl users determine whether an entire document or just a particular portion of
extracted data is digitized and automatically routed to the appropriate archive within the MasterControl system.
Streamlined Input and Indexing: The interface not only allows users to convert scanned images into
searchable text, it also enables them to input many pages into the system simultaneously (depending on their
Ascent Capture software settings). The release script includes an indexing feature that compiles an index of
the fields when documents are scanned, meaning that barcodes, document titles or any other types of useful
information can be incorporated into saved documentation.
Kofax Interface: MasterControls release script interfaces with the Ascent Capture software provided by Kofax,
the worlds largest information capture vendor. Ascent Capture automates information capture from scanned
papers and imported electronic documents. In conjunction with Ascent Capture, the MasterControl release script
enables the automation of business processes by collecting paper documents, forms and e-documents across an
enterprise, transforming them into retrievable information, and delivering all the digital documentation to line-of-
business applications, databases, and archives.
Simplified Scanning Process: The automated access to GxP documentation provided by the new release script
permits life science companies to easily organize, search and track documents, thereby saving time, effort and
money. The new interface also makes it possible to scan a document, strip off unwanted or irrelevant information,
and create new titles and notes. Users can also select the most suitable document format, such as PDF or
TIFF (PDF being the most efficient since it grants the ability to search for text within the document). Once in the
MasterControl document management system, documents can be routed, linked to other documents, escalated
and approved electronically.
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MasterControl MS Word Integration

What does any office worker need? A desk, a computer and, of course, Microsoft Office. The tools that make up the
MS Office suite are mandatory for businesses around the world.

Microsoft Office applications are ubiquitous and MasterControl recognizes that they can be used as windows to
additional powerful applications. With the MasterControl MS Word Integration, the MasterControl document control
solution can be easily accessed via a MasterControl addon toolbar in Word 2007. MasterControls MS Word
Integration allows users to stay in the environment where they are most comfortable and where they work on a
dailyif not hourlybasis. MasterControls integration product lets users search, access, review, and collaborate on
critical documents within MS Word.
Here are just a few examples of how MasterControl is helping Word users overcome common document
management challenges:

Context Switching: For users of both MS Word and Use Two Solutions as One: The MasterControl MS Word
MasterControl it can be frustrating to continually have Integration allows users to utilize MS Word 2007 not only
to jump from one solution to another. create documents but to control and manage documents in
Word as well. Users can search MasterControls archives,
create new InfoCards, attach documents as an InfoCards
main file, place main files in a collaboration, or simply save
InfoCards for future use.
Rogue Documents: Users may perceive the time Quick Log-in and Log-off: The seamless integration
required to log in to MasterControl as lengthy and between MasterControl and MS Word 2007 merges two
will often create and store documents haphazardly to applications into one by streamlining processes that allow
avoid logging in to MasterControl. By so doing, rogue users to avoid extra steps while ensuring the proper control
documents may be created that can result in financial over critical documents.
or regulatory disasters.
Add-on Toolbar: The MasterControl MS Word Integration product provides a MasterControl Documents add-on
toolbar that can be uploaded to MS Word 2007.
Simple Login: Users can log in to and log off the MasterControl Documents system via an icon on the add-on
toolbar.
Streamlined Search: Users can search through MasterControl documents via a search box
on the add-on toolbar.
Simplified InfoCard Creation: Users can create new InfoCards via the add-on toolbar.
Trouble-free Document Attachment: Users can attach documents as main files to their associated InfoCards
via the add-on toolbar.
Uncomplicated Editing: Main files can be edited directly from the toolbar.
Easy File Retrieval/Replacement: An InfoCard can be retrieved and the main file replaced from the toolbar.
Straightforward Revision and Collaboration: From the toolbar, users can also begin document revisions,
collaborate on documents, and submit redlined files. Lists of collaboration tasks can be readily retrieved from the
My Tasks files.
Effortless Document Copying: Documents can be copied from MasterControl and used to create templates.
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MasterControl Outlook E-mail Integration

Whether you are an executive or a manufacturing line worker, you know that a companys most valuable resource
is time. When a user has to access one applicationtypically e-mailto send or receive information about a task
and another separate application to actually perform the task, the end result is wasted time as well as the risk that
managers and executives are left out of the loop.

MasterControl Inc. has designed an e-mail integration that allows everyday and everymonth users alike to
access MasterControl tasks from any HTML e-mail client, including Microsoft Outlook. The interface facilitates
vastly improved efficiency by providing quick connections via a familiar tool used by all employees every day. With
MasterControl keeping them connected, even infrequent users can participate in the process.
Here are just a few ways MasterControl is helping e-mail users overcome common obstacles:

Inefficient Systems: More than anyone else in a Efficient System: The MasterControl Outlook
company, executives are pressed for time. integration allows executives and managers to efficiently
Inefficiencies frequently encountered by executives complete critical approvals using the same application
such as delayed approval on critical documents, they are already working with all day, every day: their
time-consuming change implementation, and similar e-mail. MasterControl allows these users to complete
adverse processescan cripple any company. most tasks entirely from the e-mail, making tasks like
approvals or process data entry easy to complete.
Some more complex tasks have links directly to the task
in MasterControl, making them easy to complete and
simplifying navigation through the system to find the
tasks.
Disconnected Systems: When separate systems Connected System: With MasterControls Outlook
are in use employees waste time jumping back and e-mail integration, employees can use a familiar
forth between the e-mail system that informs them interface to perform common tasks. MasterControl is
about tasks and the applications in which the tasks integrated into corporate environments where e-mail
are carried out. is a vital aspect of daily activities. Many tasks (such as
viewing forms/documents, approving forms/documents,
or rejecting/signing off) can be completed directly from
an e-mail message.
Difficult User Training Management: Employees Up-to-speed Users: The Outlook integration is so easy
must complete critical training prior to working on a to use that employees can start producing before they
manufacturing line. Most training systems require are even trained on MasterControls full capabilities.
companies to devote an overwhelming amount of Task lists can be set to appear as messages in users
man-hours and resources to routing documents/ inboxes. With the MasterControl interface, users can
forms, signing off training tasks, obtaining approval even reset passwords directly from their e-mail.
and signatures, meeting to discuss changes, and
searching for and retrieving documents.
Universal E-mail Clients: MasterControls integration product works with any HTML e-mail client, including
Outlook, Google Gmail, MSN Hotmail, etc.
Easy to Use: The familiar, modern interface is intuitive and user friendly.
Quick Connection: The MasterControl Outlook E-mail Integration allows immediate access to even casual or
novice MasterControl users.
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Rich HTML E-mail: MasterControl has designed a more enticing e-mail connection that allows everyday users
to perform a variety of MasterControl actions from within their e-mail interface with a single click.
Transparent Interaction: Users enterprise-wide can perform everyday tasks in a familiar interface without
needing an extensive knowledge of MasterControl. The integration allows them to work with their same Outlook
e-mail interface while still being able take advantage of MasterControls robust functionalities.
Improved Training Task Access: Users can conduct a variety of training activities directly from their e-mail,
such as viewing training tasks and related information, accessing documents associated with particular courses,
and signing off on training tasks. Training course materials can be viewed and simple training tasks can be
signed off with a single click.
Direct Link to Forms: MasterControl has designed a more enticing e-mail connection that allows everyday users
to perform a variety of MasterControl actions from within their e-mail interface with a single click.
Web-based System: MasterControl connects different departments with each other and with data and
processes, all under a secure and centralized Web-based system that is integrated with users e-mail. This
connectivity helps promote quality throughout the enterprise by allowing management to continuously monitor
and proactively improve quality processes. MasterControl helps companies meet key regulatory standards and
requirements, while simultaneously increasing efficiency and keeping compliance costs down.
Assured Compliance: For companies doing business in regulatory environments, MasterControl ensures that
its solutions are fully compliant with regulatory requirements such as the FDAs 21 CFR Part 11. MasterControl
provides time-stamped audit trails, reporting, and electronic signature capabilities. Security features include dual
passwords for document approval as well as password expiration, encryption, and certification.
Page 155
MasterControl PDMWorks Connector

Streamline 3D CAD File Collaborations and Workflows with MasterControl
industries are often forced to manage these types of product data according to strict regulatory requirements while
juggling multiple data filesoften in different file formatslocated in separate systems.
How Can MasterControl PDM Software Help You?

MasterControls PDM Connector for SolidWorks PDMWorks solution is easy to use and allows collaboration and
redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays in sync with
native files in the PDMWorks solution.
Here are some examples of how MasterControls PDMWorks integration system facilitates the handling of
complex CAD files and, in so doing, helps companies in regulated environments overcome common product data
management challenges.

Complex Process: CAD file relationships are Simplified Process: MasterControls PDMWorks
intrinsically complicated and can be disrupted by Connector provides users with straightforward means of
introducing inadequate maintenance and control applying document control to CAD data without forcing
systems. designers into a non-native application for managing their
CAD files. CAD files are maintained by the native PDM
solution while MasterControl creates PDF copies for official
document control purposes such as routing, approval and
production.
Manual Process: Manually revising, publishing, Automated Process: MasterControl InfoCards are
and routing drawings is time consuming and wastes created for each new and revised drawing at a user-
resources throughout the enterprise. defined state in the PDMWorks solution, automating the
publishing process and allowing drawings to be routed for
collaboration and approval.
Inefficient System: Manual systems have inherently Efficient System: MasterControl manages and tracks the
complex structures, which can lead to limited or no creation, change and archiving of all information relating to
workflow capability for routing and approving crucial a product. The automated routing and approval provided
CAD product data. by MasterControl PDM connector improves workflow
functionality and allows effective, seamless handling of
CAD files.
Disconnected System: Product information is Connected System: When the link between MasterControl
scattered throughout several different systems and is and the PDMWorks solution is initialized, the system
often out of sync with data in the PDM solution. automatically processes packets of files until there are no
more files requiring synchronization. The MasterControl
system can also be manually synchronized and still identify
and rectify any gaps that may exist.
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Collaboration: The MasterControl PDMWorks connector fosters an effective communication environment by

allowing users to collaborate on engineering drawings using nothing more than Adobe Reader. Users across
an organization can redline and collaborate on drawings, even those users who lack intimate knowledge of the
CAD package. When collaboration introduces new changes, collaboration leaders can make the necessary
modifications using the native CAD application. MasterControl then automatically publishes a new PDF file
reflecting the changes made.
Notification: If missing metadata in the PDM system causes the transfer process to fail, MasterControl
revise drawings. The InfoCards also support custom field data that can be directly passed from the PDM solution.
released-state drawings in the PDM solution. The system publishes a PDF main file for each new drawing using
the metadata from the PDMWorks solution. Similarly, revised drawings trigger revisions in MasterControl which
pushes the metadata from the PDM solution to updated MasterControl InfoCards.
Integration: MasterControls PDM connector works seamlessly with MasterControl BOM to provide a unified
organizational structure throughout the design and manufacturing processes.
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MasterControl Pro/Intralink Connector

Streamline 3D CAD File Collaborations and Workflows with MasterControl
multiple data files that are located in separate systems and are often in different file formats.

MasterControls PDM Connector for PTCs Pro/Intralink solution is easy to use and allows collaboration and
redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays in sync with
native files in the Pro/Intralink PDM solution.
Here are some examples of how MasterControls PDM integration system with the PTC Pro/Intralink solution
facilitates and simplifies the handling of complex CAD files and, in so doing, helps companies in regulated
environments overcome common product data management challenges.

Complex Process: CAD file relationships are Simplified Process: The MasterControl PDM Connector
intrinsically complicated and can be disrupted by for Pro/Intralink provides users with straightforward
introducing inadequate maintenance and control means of applying document control to CAD data
systems. without forcing designers into a non-native application
for managing their CAD files. CAD files are maintained
by the native PDM solution, while MasterControl creates
PDF copies for official document control purposes such as
routing, approval, and production.
and routing drawings is time consuming and wastes created for each new and revised drawing at a user-
resources throughout the enterprise. defined state in the Pro/Intralink solution, automating the
Inefficient System: Manual systems have inherently Efficient System: MasterControl manages and tracks
complex structures, which can lead to limited or no the creation, change, and archiving of all information
workflow capability for routing and approving crucial relating to a product. The automated routing and approval
CAD product data. processes provided by the MasterControl PDM Connector
for Pro/Intralink improves workflow functionality and allows
effective, seamless handling of CAD files.
scattered throughout several different systems and is MasterControl and the Pro/Intralink solution is
often out of sync with data in the PDM solution. initialized, the system automatically processes
packets of files until there are no more files requiring
synchronization. The MasterControl system can also
be manually synchronized with Pro/Intralink and
still identify and rectify any gaps that may exist.
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Collaboration: The MasterControl PDM connector for Pro/Intralink fosters an effective communication
environment by allowing users to collaborate on engineering drawings using nothing more than Adobe Reader.
Users across an organization can redline and collaborate on drawings, even those users who lack intimate
knowledge of the CAD package. When collaboration introduces new changes, collaboration leaders can make
the necessary modifications using the native CAD application. MasterControl then automatically publishes a new
PDF file reflecting the changes made.
Notification: If missing metadata in the Pro/Intralink system causes the transfer process to fail, MasterControl
revise drawings. The InfoCards also support custom field data that can be directly passed from Pro/Intralink.
released-state drawings in Pro/Intralink. The system publishes a PDF main file for each new drawing using the
metadata from Pro/Intralink. Similarly, revised drawings trigger revisions in MasterControl which pushes the
metadata from the PDM solution to updated MasterControl InfoCards.
Integration: MasterControls Connector for Pro/Intralink works seamlessly with MasterControl BOM to
provide a unified organizational structure throughout the design and manufacturing processes.
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MasterControl QAAD API Suite

The MasterControl QAAD API Suite enables authorized users to access the QAAD database programmatically
through a validated interface. This eliminates the need to enter client database records individually via the
applications user interface.
How can the MasterControl QAAD API Suite Help You?

The fully validated QAAD API Suite saves you time and ensures that your QAAD database is always up-to-date.

Disconnected: Manually entering data into any Connected: With the QAAD API suite, you can write a
database system can be a time consuming and program that will take data exported in XML from your
laborious task. Having to re-enter data already current system and import it into the QAAD database
present in another system can be particularly through a set of easy-to-use API functions.
frustrating.
Inefficient: When running multiple databases that Efficient: MasterControl InfoCards are created for each
contain copies of the same information, maintaining new and revised drawing at a user-defined state in the
each one manually to ensure data consistency can be Pro/Intralink solution, automating the publishing process
a logistical nightmare. and allowing drawings to be routed for collaboration and
approval.
Requires Manual Validation: Manually re-entering Eliminates Need for Manual Validation: The use of
data can lead to unintentional variations in the data industry standard XML allows for great flexibility when
due to typing errors, etc. The need to manually interfacing different systems. Using the QAAD APIs to
validate data and correct mistakes every time the data import and export data programmatically ensures that all
is modified is a waste of valuable human resources. of the business rule validation present when using the user
interface is retained, thereby avoiding the need for manual
validation.
Requires Manual Validation: Manually re-entering Eliminates Need for Manual Validation: The use of
data can lead to unintentional variations in the data industry standard XML allows for great flexibility when
due to typing errors, etc. The need to manually interfacing different systems. Using the QAAD APIs to
validate data and correct mistakes every time the data import and export data programmatically ensures that all
is modified is a waste of valuable human resources. of the business rule validation present when using the user
interface is retained, thereby avoiding the need for manual
validation.
API Suite Commands: The QAAD API Suite consists currently of 70 API commands, which can be called from any
application that supports web services.
Summary of Benefits: The MasterControl QAAD API Suite:
Saves time and money by eliminating the need to enter database records manually.
Ensures database synchronicity.
Uses XML to transfer information to/from APIs.
Provides a comprehensive audit trail.
Is user-configurable and fully validated.
Optional programming services are available.
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MasterControl SharePoint Connector

The Microsoft Office SharePoint Server, the server program component of the 2007 Microsoft Office system, is used
by countless organizations to facilitate collaboration, manage content, and provide access to essential information.
Since Microsoft Office is already in use almost universally, some IT departments advocate the use of SharePoint as a
free collaboration tool and document management solution. Many SharePoint users, however, find that the system
lacks sufficient document control, training, and other business process automation capabilities.
MasterControl complements the SharePoint server program to facilitate streamlined business processes and provide
incomparable document control. MasterControl offers a seamless, out-of-the-box integration with SharePoint that
capitalizes on the benefits of SharePoint while adding truly robust compliance solutions.

Here are just a few ways that MasterControl is helping SharePoint users control documents and manage business
processes with greater ease and effectiveness:

Disconnected systems: Many companies nested in Connected Systems: Rather than forcing users to
SharePoint find themselves having to use separate manage disparate solutions, MasterControl connects
software solutions for more advanced business the two robust systems so processes may be fulfilled
processes that SharePoint was not designed to within the same platform of customizable, unified
handle such as document control and personnel solutions.
training. This usually results in processes that are
overly complicated and time consuming.
Document Confusion: When documents are Document Assurance: With MasterControl, users are
managed and controlled in different systems it is guaranteed that they are working with the most current
difficult for users to determine when and if they are version of a document. Stored in MasterControls
working with the most up-to-date documents. Such secure, centralized repository, the most recent versions
challenges inevitably lead to duplicated efforts and of documents are easily accessed with a mere click of
wasted time. a mouse. Links to these documents are easily added
to the SharePoint library, making access simple for the
SharePoint user.
Difficulty Transitioning to New Process Seamless Transition to New Solutions: With

Management Solutions: In instances when MasterControls SharePoint Connector, users can
SharePoint does not offer sufficient functionality for continue to use the SharePoint interface with which they
all required business processes, new solutions may are already familiar and simply enhance its capabilities
need to be implemented. Replacing and learning new by adding unparalleled document control and other
systems can be confusing, time consuming, and a MasterControl business process functionalities.
waste of resources.
Connected Systems: Without leaving SharePoint, users are able to log in to MasterControl and locate
important documents or export a document from SharePoint into MasterControl. MasterControl InfoCards can
be checked out and edited from within SharePoint.
Easy Storage, Revision, and Approval: Document templates can be effortlessly stored, revised, and approved
within the MasterControl system and used from within SharePoint to create new documents with ease.
Dynamic Link Functionality: When templates are updated in MasterControl, the system automatically updates
relevant links to ensure that users are working with the most current version.
Enhanced Collaboration: Users can start documents from templates and collaborate in SharePoint.
Documents can be automatically routed for final review and approval in MasterControl.
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Controlled Copies: Final controlled copies of documents are securely maintained in the MasterControl system.
Links to the final controlled copies may be placed back in SharePoint, if desired, so other users may view them.
Simplified Document Copying: Documents created in MasterControl can be seamlessly copied back into
SharePoint. Document templates stored in MasterControls secure Web-based repository can be copied into
SharePoint for easy access.
Assured Compliance: For companies doing business in regulatory environments, MasterControl ensures that
its solutions are fully compliant with regulatory requirements such as the FDAs 21 CFR Part 11. MasterControl
provides time-stamped audit trails, reporting, and electronic signature capabilities. Security features include dual
passwords for document approval as well as password expiration, encryption, and certification.
Web-based System: MasterControl connects different departments with each other and with data and
processes, all under a secure and centralized Web-based system. This connectivity helps promote quality
throughout the enterprise by allowing management to continuously monitor and proactively improve quality
processes. MasterControl helps companies meet key CGMP requirements and regulatory standards, while at
the same time increasing efficiency and keeping compliance costs down.
Continuous Validation: MasterControl considers validation an integral part of software solutions for
customers subject to regulatory requirements. Our continuous validation approach dramatically cuts the time,
pain, and cost involved in validation, making it easier to re-validate future upgrades. MasterControls continuum
of products and services address different levels of validation needs based on individual risk assessment,
including innovative products and services such as MasterControl Transfer OQ.
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MasterControl WindChill Connector

Streamline 3D CAD File Collaborations with MasterControl
multiple data files that are located in separate systems and often are in different file formats.

MasterControls MasterControls PDM Connector for PTCs Windchill solution is easy to use and allows
collaboration and redlining on PDF drawings while guaranteeing that the PDF copy in the MasterControl system stays
in sync with native files in the Windchill PDM solution.
Here are some examples of how MasterControls PDM integration system with the PTC Windchill solution
facilitates and simplifies the handling of complex CAD files and, in so doing, helps companies in regulatory
environments overcome common product data management challenges.

Complex Process: CAD file relationships are Simplified Process: MasterControl PDM Connector for
intrinsically complicated and can be disrupted by Windchill provides users with a straightforward means
introducing inadequate maintenance and control of applying document control to CAD data without forcing
systems. designers into a non-native application for managing their
CAD files. CAD files are maintained by the native PDM
solution while MasterControl creates PDF copies for official
document control purposes such as routing, approval, and
production.
and routing drawings is time consuming and wastes created for each new and revised drawing in a user-
resources throughout the enterprise. defined state in the Windchill solution, automating the
Inefficient System: Manual systems have inherently Efficient System: MasterControl manages and tracks
complex structures, which can lead to limited or no the creation, change, and archiving of all information
workflow capability for routing and approving crucial relating to a product. The automated routing and approval
CAD product data. processes provided by the MasterControl PDM Connector
for Windchill improves workflow functionality and allows
effective, seamless handling of CAD files.
scattered throughout several different systems and is MasterControl and the Windchill solution is initialized,
often out of sync with data in the PDM solution. the system automatically processes packets of files until
there are no more files requiring synchronization. The
MasterControl system can also be manually synchronized
with Windchill and still identify and rectify any gaps that
may exist.
Page 163
Collaboration: The MasterControl PDM connector for Windchill fosters an effective communication
environment by allowing users to collaborate on engineering drawings using nothing more than Adobe Reader.
Users across an organization can redline and collaborate on drawings, even those users who lack intimate
knowledge of the CAD package. When collaboration introduces new changes, collaboration leaders can make
the necessary modifications using the native CAD application. MasterControl then automatically publishes a new
PDF file reflecting the changes made.
Notification: If missing metadata in the Windchill system causes the transfer process to fail, MasterControl
revise drawings. The InfoCards also support custom field data that can be directly passed from Windchill.
released-state drawings in Windchill. The system publishes a PDF main file for each new drawing using the
metadata from Windchill. Similarly, revised drawings trigger revisions in MasterControl which pushes the
metadata from the PDM solution to updated MasterControl InfoCards.
Integration: MasterControls Connector for Windchill works seamlessly with MasterControl BOM to provide
a unified organizational structure throughout the design and manufacturing processes.
Page 164
About MasterControl
MasterControl Inc. provides GxP process and document management software solutions to hundreds
of life science companies worldwide. Since 1993, MasterControl has offered automated solutions that
effectively manage document control, change control, audits, corrective/preventive actions (CAPA),
regulatory training, nonconformance disposition, customer complaints, and other GxP processes.
Based in Salt Lake City, Utah, MasterControl provides powerful solutions that incorporate industry best
practices for automating and linking every phase of a products development cycle, while also facilitating
compliance with regulatory requirements such as ISO standards, FDA regulations, and the Sarbanes-
Oxley Act (SOX). The combination of MasterControls integrated platform and a continuum of risk-based
software validation products and services reduce the total cost of ownership and enables customers to
extend their investment across the enterprise.
For more information about MasterControl, visit our website or call toll-free at (001) 800-825-9117.
Corporate Headquarters:
MasterControl Inc.
6322 S. 3000 E. Ste. 110
Salt Lake City, UT 84121
United States
Phone: (001) 800.825.9117
Fax: 801.942.7088
European Headquarters:
MasterControl Global Limited
First Floor North Wing
Matrix Building
Basing View
Basingstoke
RG21 4FF
United Kingdom
Phone: +44 (0) 1256 325 949
Fax: +44 (0) 1256 325 289
Germany Office
Mendelstrasse 11
48149 Muenster
Germany
Phone: +49 (0) 251 980 2140
Fax: +49 (0) 251 980 2149
Asian Headquarters:
MasterControl KK
Aios Akihabara 702
3-2-2 Ueno Taito-ku
Tokyo 110-0005
Japan
Phone: +81 (0) 3 6801 6147
Fax: +81 (0) 3 6801 6148
Copyright 2009, MasterControl Inc.

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MasterControl

Products and Services Guide

Toll Free: 800.825.9117

We look forward to a long and successful relationship!

2009 MasterControl Products and Services Guide

Helps and Guides

Helps and Guides

Helps and Guides

2009 MasterControl Products and Services Guide

MasterControl Customer Reference Program

Your participation in the program is renewable on a yearly basis.

Credits can be applied toward purchase of products*.

$2,000 credit for completion of a case study

Your Customer Relationship Manager (CRM)

NEW PRODUCTS PRODUCT

& SERVICES ENHANCEMENT

PROJECT GxP & BUSINESS

Touchpoints in a Customers Experience with MasterControl

Summary of How Your CRM Can Help

Send out occasional customer surveys.

Introduce you to MasterControls Customer Success program.

Visit you onsite, as needed, and continue to serve as an advisor.

Where to go for Help

Customer Website and Self-Service Portal

Customized Support Options

Highlights of the annual Masters Summit include:

Tips and tricks for using MasterControl products

Highlights of the annual Masters Summit include:

Receive extensive training on MasterControl products and services

Regional User Group Meetings

What are the Advantages of Attending?

Host a Regional User Group in Your Area?

Accessing the MasterControl Website

1. Contact MasterControl technical support either by phone (800-825-9117) or e-mail (support@mastercontrol.

What Can You Find on the MasterControl Customer Website?

User Group Meetings and the Annual Masters Summit

Product and Service Information

Getting Started In addition to the navigation at the top of each page,

Enter your user ID and password in the fields provided.

Simply point your mouse to a section title to see the listed

The Customer Discussion Community Forum is the area

User Group Meetings and the Annual Masters

Simply move the mouse over the Participate in User

The technical support area of the Customer Website

Log technical issues and receive a tracking number

MasterControl customers can also seek support guidance

(Please note that MasterControl QAAD training is currently

To recommend other MasterControl courses that you

To view information and register for upcoming

Technical support services

Webinars and Other Educational Materials

To access MasterControls extensive library of helpful

By navigating through the drop down menus of the

Note: Logging enhancement requests entails a separate

Once you have received the new login username and

Training courses currently available in the Customer Store include:

How Does it Work?

What Payment Types are Accepted?

MasterControl Best Practices for

MasterControl Best Practices Guidelines

1. Define Your Needs and Objectives

a) Make a list of training courses needed;

Processes Challenges People and Expected Priority Target