ATTENTION AUDIO Options

Option 1: Voice Streaming Audio Broadcast

Option 2: Teleconference (Dial In)

No need to dial in on a telephone

Questions can be asked in the WebEx Q&A panel
Details

Requires telephone to dial in

Questions can be asked over the phone or in the
WebEx Chat
Details
Conference ID: 41912059
Password: logistics
International dial in: 706-501-7826
US Free call: 1 877-368-7516
List with national toll free numbers is available
in Doc ID: 1148600.1
View anytime during the conference using
Communicate > Teleconference > Join
Teleconference from your WebEx menu

Current Webcast: Solving Issues with the Work In

Process (WIP) Job Diagnostics Sep 16th 2015

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Upcoming Advisor Webcast Schedule

Check out Note ID : 740966.1
Select your Product Area
Scan through the list of Current Topics
Register for the session of your interest

Next Webcast: - Pull Replenishment - Setup

and Troubleshooting Nov 4th 2015

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Safe Harbor Statement

The following is intended to outline our general product direction. It is intended for
information purposes only, and may not be incorporated into any contract. It is not a
commitment to deliver any material, code, or functionality, and should not be relied upon
in making purchasing decisions. The development, release, and timing of any features or
functionality described for Oracles products remains at the sole discretion of Oracle.

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Oracle Advisor Webcast

Introduction to Oracle Pedigree and
Serialization Manager (OPSM)
Daniel Newman
Warren Schubert
October 21, 2015

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Objectives
Highlight OPSM Module
Short Demos,

- Weblogic, Dashboard, Generating Serials

Document Available Resources

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Agenda
1

Introduction and History about OPSM

Demos Setup, Generating Serials

New Features in Release 2

Resources available (Training, Troubleshooting)

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Introduction
Oracle Pedigree and Serialization Manager (OPSM)

OPSM is an integrated, mass-serialization and pedigree application

Industry is emerging, based upon requirements:
Federal mandates
Many countries around the world (Brazil, Turkey, Italy, India, China)

Counterfeit drugs while far from the only issue, is immense problem
Solution is more detailed tracking and tracing of products throughout the
Supply Chain

OPSM was developed from ground up for pharmaceutical industry

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Introduction
Oracle Pedigree and Serialization Manager (OPSM)

Current State of Legislation in U.S.

California pedigree law has been superseded by the Drug Supply Chain Security Act
(DSCSA)
The Drug Quality & Security Act of 2013
Overview and Implications (complete presentation is available upon request)

There are several other legislations worldwide that OPSM is able to handle, but we
are not necessarily tailoring OPSM so that we meet them all "out of the box"

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Timeline & Requirements by Supply Chain Trading Partner

Manufacturers
January 1, 2015

Be licensed
Provide downstream
Transaction information by lot
Verify product by lot
Respond to external
verification requests within
24-48 hours*
Do business with Authorized
Trading Partners ONLY

November 27,
2017

November 27,
2023

Affix SNI, Lot # & Lot

Expiration to packages and
homogeneous cases
Implement verification
systems at package level via
SNI (internal and external)
Send transaction data
electronically
Follow new returns
requirements

All segments of the supply

chain using serial numbers
Serial numbers and
transaction data stored in a
secure electronic manner
Transaction history no longer
passed (accessible via
above)

* Although this would be a business process, the system should provide

a way to verify the information requested.
Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Timeline & Requirements by Supply Chain Trading Partner

Wholesale Distributors
January 1, 2015

Be licensed
Cannot accept
product ownership
without Transaction
data
Provide downstream
Transaction
information by lot
Verify suspect product
by lot (internal and
external)*

November 27,
2017

November 27,
2019

Be able to receive
electronic transaction
data from
manufacturers

Verify suspect
product at package
level via SNI
Only handle products
with DSCSA product
identifiers
Follow new returns
requirements

November 27,
2023

All segments of the

supply chain using
serial numbers
Serial numbers and
transaction data
stored in a secure
electronic manner
Transaction history
no longer passed
(accessible via
above)

* Although this would be a business process, the system should provide

a way to verify the information requested.
Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Introduction
Current Development Priorities

OPSM Integration
Conformance to global regulations and standards
Track Product Movement through Supply Chain
Track Location graphically on a map
Provide secure portal to inquire on Products current location

Product Authentication
Initiate Automated Messages about suspected Counterfeit items
Consumer can request to authenticate product via secure portal (consumer)
Manufacturer can view Location of Authentication Request

Customer-driven enhancements
Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

12

Introduction
Oracle Pedigree and Serialization Manager (OPSM)

Advice from OPSM Development:

The toughest part of OPSM is the Installation and Setup.

The OPSM development group has published a complete guide for

installation and setup to aid in being successful as quickly as possible.
Following these guidelines will greatly reduce the amount of setup issues.

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

13

Demonstration
Demo OPSM Access
(WebLogic, OPSM, Bug Template)

Demo Generating Serials from the front end

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

OPSM
New Features, Troubleshooting and
Other Resources

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Location Security
Description

Previous versions of OPSM had functional security to restrict access to

information at the form or process level. For example, a user could be
given functional access to a setup form such as Maintain Products, and
access could be limited to whether they could Add, Update and/or Delete
Product information. This new feature adds location security to restrict
access to certain data based on the user's location security access in
addition to their functional role.

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

16

Location Security
Description

In order to introduce this new feature, changes had to be made to existing

functionality:
A location and / or location group will have to be associated to users to
accommodate the assignment of location security privileges.
Weve provided a way for administrators to group users so that an association
between these users and locations or location groups can be established quickly and
easily. In this way, if a user leaves the company, the user can be removed from the
group, but no other location security setup need be affected.

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

17

Location Security
Benefits

Having the ability to restrict access to data based on location assignments

will allow companies to use OPSM as a central repository for all processing
without exposing data to users who do not need visibility into that data.
This feature will also prevent accidental tampering with data which is not
authorized.

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

18

Other new features in OPSM r2

Web Services Improvements
Generation of serials by GTIN
Lots Web Services includes User Defined fields
Serials Web Services includes User Defined fields

Transactions Web Services includes User Defined fields

Additional Transaction types for Serial Destination Rules

Commission Serials
Decommission Serials
Edit Serials
Reserve Serials
.more..

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

19

Resources are available to support OPSM Implementations

Support and Troubleshooting Notes
Functional and Technical

Patching Strategy Papers

Supportability

Oracle Support has access to a Demo system

Many Whitepapers are available
Modifying existing Pedigree templates
Serial Generation Process
Transactions Backend Processing

Many other external and internal resources

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

20

Useful Notes
Oracle Pedigree and Serialization Manager (OPSM)
Note 1542501.1 - Oracle Pedigree & Serialization Manager (OPSM) Training Information
Note 1309862.1 - OPSM - Oracle Pedigree And Serialization Manager (And Fusion) - Terminology, Troubleshooting
Note 339163.1 - INTERNAL ONLY - Most Common PCW, OPSM, and RDBMS Bugs

Note 1634378.1 - Better Search Results From Functional User Perspective For OPSM Audit Trail Functionality
Note 1305637.1 - Oracle Pedigree and Serialization Manager: Creating Your Own Pedigree
Note 1969479.1 - Oracle Pedigree and Serialization Manager Release Notes for Release 2.0.0.0.0
Note 1988806.1 - Oracle Pedigree and Serialization Manager Process Guide, Installation Guide, and Security
Guide for Release 2.0.0.0.0

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Summary
What we covered today
OPSM Introduction

Demos

OPSM Access
Generating Serials

Resources available!

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

 To ask a question on the phone

line, select *1 on your phone.

Q&A

To ask a question online, use the

Chat area at the top.
Your question will be read aloud in
the order received.
Question can also be asked on the
My Oracle Support Communities

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

23

Top Articles and Community Links

Document for this Webcast [ID 1542501.1 ].
Logistics Advisor Webcast Calendar/Archive [ID
1455888.1]
Oracle Advisor Webcast Schedule [ID 740966.1]
Continue the Discussion on the Logistics
Community
https://community.oracle.com/thread/
3808745
Webcast Survey After Todays Session.
What advisor webcast topics do YOU want to
see presented?
Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

24

 To ask a question on the phone

line, select *1 on your phone.

Q&A

To ask a question online, use the

Chat area at the top.
Your question will be read aloud in
the order received.
Question can also be asked on the
My Oracle Support Communities

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

25

THANK YOU
Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

26

Learn More
Available References and Resources to Get Proactive
My Oracle Support Essentials Webcast Series
https://support. oracle.com | Doc ID: 553747.1

My Oracle Support Blog

https://blogs.oracle.com/supportportal/
Get Proactive in My Oracle Support
https://support. oracle.com | Doc ID: 432.1
Ask the Get Proactive Team
get-proactive_ww@oracle.com
Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Where Can I Get The Slides From This Session?

1. PDF link from Doc ID 740966.1 (within 48 hours)

2. Logistics Community >Content Tab > Documents (within 24 hours)

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Oracle Advisor Webcast Program

Locating Current Schedule & Archived Recordings
From Note ID : 740966.1 drill
down to your area of interest
Select your Product Area
Oracle E-Business Suite Manufacturing

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Oracle Advisor Webcast Program

Locating Current Schedule & Archived Recordings

Note:
Click column headings to sort
Hover on Webcast Title for more
information
Recordings available within 48
hours

Advisor Webcast Questions on a

webcast or ask questions via the
Questions? link

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

Copyright 2015 Oracle and/or its affiliates. All rights reserved. |

31