Project Management

in the Pharma Industry

based on PM@SBT
Building Technologies s
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Project Management in the
Pharma Industry based on PM@SBT
The pharmaceutical industry is one of
the most regulated industries in the
world. The main purpose of this regula-
tion is to protect the public health. There
are special procedures (GMP or GxP) for
all processes, which could have an
impact on the drug quality. Often the
building infrastructure also has an
impact on the drug quality, e.g. the air
treated in a HVAC system, the flow of
people controlled with an access control
system or through an environmental
monitoring system, which provides the
information if a drug can be released or
not. The plants in the pharmaceutical
industry usually are running 7/24. So
each shut down e.g. from a HVAC system
not only causes a business harm worth
up to millions, it can also result in a
down time of a week or more. Due to
these reasons the pharmaceutical indus-
try requires a special way of project exe-
cution and operation of the sites.
Siemens has established an excellent
project management procedure with
PM@Siemens and the application
PM@SBT. This document provides you
with an overview, how to apply PM@SBT
for Pharma projects, where the special
issues are and where should be taken
care during the execution of projects
Successful project management relies on
adherence to certain basic principles.
Clearly defined project workflows
(phase model and milestones) as well
as the specification of clear and unam-
biguous responsibilities for the various
project phases and tasks (roles) of the
project together with comprehensible
targets for all of those involved are the
key factors for success.
Project management thus involves lea-
dership tasks, organization, techniques
and means for performing the project
flow in such a way that the cost, dead-
line and functionality targets can all be
met satisfactorily.
These PM guidelines aim to define and
implement a consistent, high standard
of project management and qualification
in all sections (national and regional
companies).
This process is supported significantly
with the electronic validation tool EVT,
provided from the Center of Competence
Pharma. It applies equally to large and
complex projects as well as for small and
straightforward projects.
To reduce the project risks for our custo-
mers and for us, the Center of Compe-
tence Pharma has established a certifi-
cation process for the local GxP project
execution. Based on a comprehensive
assessment we support the local organi-
zations to establish the proper processes,
to acquire the required knowledge and
to pass the audit successfully.
By applying PM@SBT for Pharma, con-
sistent processes can be optimized and
risks minimized; efficiency, quality and
planning security are all increased simul-
taneously.
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in the Pharma Industry.
PM@SBT Pharma Sales
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P
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Qualify Lead Source
Select Leads
Perform Go/ No Go
Decision
Identify Opportunities
Analyze Opportunities
Cover the Buying Center
Perform Bid/ No Bid
Decision
Communicate Bid/ No
Bid Decision to customer
and HQ
Stop
Project Risk Ass.
(LOA)
PM020-1
PM010
Acquisition Go/No Go
Decision
Sales Support
Engineering
Customer (RFQ)
Guideline 2140
Calculation Scheme
Risk Assessment of
the Project
Project management
assessment PMA
Project > 750 000
PM020
Bid/No Bid decision
(Quality Gate)
Calculation Scheme
PM010-2
Sales Funnel
Tool
PM010-1
Pharma Buying
Center
PM020-3
Lifecycle Profitability
Tool (LOA)
PM020-5
Bid/No Bid Tool
(LOA)
PM020-2
Account Plan
PM020-4
Management Control
Guideline 2110;
2120; 2130; 3600
Project Risk Review
Report (LOA)
PM021-1
Classification Project
PM020-7
Inform HQ & local
Pharma Manager
Contracting
Sales
Manager
Sales Support
Contracting
Sales Manager
Sales Representer
Project Controller
Sales Representer
Sales Representer
Project Controller
Sales Representer
Sales Representer
Project > 20'000 EUR
Integration of HQ
National project
Involve CoC Pharma for
support and assistance
International project/
more divisions
involved
Involve Pharma Manager
for review
Local
Pharma Manager
Local
Pharma Manager
Sales Representer
Local
Pharma Manager
Local
Pharma Manager
Local
Pharma Manager
Local
Pharma Manager
Sales Representer
Checklist Handover
sales Back office
PM020-8
Local
Pharma Manager
Blockschemata
PM020-6
Sales Representer
Project Manager
Local
Pharma Manager
Contracting
Sales Manager
Local
Pharma Manager
Local
Pharma Manager
COC Pharma HQ
Local
Pharma Manager
Review
Performing
Function
Reporting Output Process
Sales Version 2.9
Aquisition-Phase Offering-Phase
Pre-Aquisition
PM010 PM020
Bid-Preparation Project-Aquisition Contract-Negotiation Project-Handover
PM050 PM070 PM080
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B
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Outline Sales Offering
Additional data
needed?
no
Produce Bid
Review Bid
Bid complete/
correct?
Submit bid
no
Prepare Negotation
Strategy
Strategic Selling Pharma
Negotiate Bid
Generate Final Conctract
Obtain Agreement On
Contract
Customer
acceptance?
Changes in
Contract?
Analyze Win/Loss
& inform HQ
yes
no
Subcontract Proc.
Sales Support Eng.
yes
PM050
Bid Approval
PM070
Project win/lost
Bid Preparation
yes
High risk
step
Get URS
Impact Analysis
Support CoC
Pharma
Risk Assessment
Inform Pharma Manager
or HQ for review and
approval
Project > 20'000 EUR
approval
Sales Representer
Project Controller
Management Control
Guideline Appendix 3
Contract review
checklist 2110
Strategic Analysis
Blue sheet PM070-1
Checklist Handover
Requirements
PM020-9
Sales Representer
Customer
Project Manager
Customer
Local Pharma /
Validation Manager
Sales Representer Local Pharma /
Validation Manager
CoC Pharma HQ
Sales Representer Local
Pharma Manager
Sales Representer Local
Pharma Manager
Local
Pharma Manager
Project Controller
Sales Representer Contracting
Manager
Sales Representer Project Controller
Local
Pharma Manager
CoC Pharma HQ
Sales Representer
Project Manager
Local Pharma /
Validation Manager
Sales Representer
Local
Pharma Manager
Stop
Stop
no
Involving Project /
Validation Manager
yes
no approval
URS
VA050-1 (draft)
Milestone Planning
PM050-1
Checklist URS
VA050-3
Checklist 21 CFR
Part 11
VA050-6
SBT Software
Application in
regulated industry
VA050-7
Checklist Val.
Documents
VA050-3
Checklist Impact
Analysis
VA050-4
Validation
calculation tool
VA050-5
Review
Performing
Function
Reporting Output Process
Gather Data for Offer
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P
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Compile Handover
Documents
Verify Handover
Documents & Address
Changes out of Negotiaton
Conduct Handover
Meeting/Submit
Handover Checklist
Documents o.k.?
Handover
to PEx
accepted?
yes
no
no
PM080
Start Project
handover to PEx
checklist
PM080-1
Sales Representer
Project Manager Project Manager
Project
Manager
Sales Representer
Review
Performing
Function
Reporting Output Process
Process Step
PM@SBT
Pharma specific
Step
Software
Category 5 Decision point
Project Milestone
Quality Gate
Ongoing Subprocess
Original Document
of PM@SBT
Pharma specific
Document
yes
User Requirement Specification (URS)
This describes what the equipment or
system is supposed to do, and as such is
normally written by the pharmaceutical
manufacturer. This links to performance
qualification, which tests these user
requirements.
Any project within the pharmaceutical
industry that requires Validation, should
have an available URS, User Requirement
Specification. The URS is a prerequisite
for Validation, and must include details
of the scope of the Validation and is
required to qualify the project and pro-
vide an accurate quotation. In the event
that the customer does not have the
capacity or skills to produce a URS, Sie-
mens can assist in the production of a
URS, or even produce a URS on behalf of
the customer.
Impact Analysis
The scope of the impact assessment is
to evaluate the impact of a system on
product quality. Those systems having
a direct impact on product quality are
subject to qualification practices in addi-
tion to Good Engineering Practice (GEP).
Indirect impact or no impact systems are
designed, installed and commissioned
according to GEP only. This allows
appropriate effort and focus to be con-
centrated on the quality impact systems.
Siemens provides a service to support
the impact analysis for the customer.
Bid Preparation
Risk Assessment
The Risk Assessment will be used to
assess systems (these can be a building
management system, a HVAC, a project
risk, etc.) which due to a failure can lead
to a risk that can have an impact on pro-
duct quality or data integrity.
It will provide a base for decision that
determines the amount of measures and
tests during the validation process to
beware or minimize potential risks.
Siemens provides a service to support
the risk assessment for the customer.
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Enter Order/Establish
PM Goals
Early Material
Requirements?
Initiate / Set up Project
Obtain Deliverables from
Enabling Processes
no
Effect of Offer
Release Work Packages
(Design)
Audit Suppliers &
Audit of customer
Audit Report Suppliers
VA100-2
Master Validation Plan
(customer)
VA100-1
PSQP
VA100-4
Validation Guideline
CM1 10820
Work Package
PM100-6
PM100
Entry Order Clarified
(Quality Gate)
Finance
Monitoring
& Controlling
Training
- GxP compliant
Risk Assessment
of the Projct
Logistics yes
Revision
Risk Assessment
Kick off meeting
with the customer
Refine URS
Minutes of the
meeting
PM100-5
Audit Report
Siemens
VA100-3
Contracting
Execution
Manager
Project Manager
Project Controller
Project Manager
Project Manager
Pharma Specialist
Project Manager
CoC Pharma
Target agreement
PM100-1
Project Schedule
PM100-2
Issue list
PM100-3
Time schedule
PM101-4
Define Project Organization &
Responsibility Matrix
- check education status
- perform required education
Create Project & Quality Plan
Define Work Packages
Local
Pharma Manager
Local
Pharma Manager
Local Pharma /
Validation Manager
Customer
Project Manager Local Pharma /
Validation Manager
Project Manager
Pharma Specialist
Local Pharma /
Validation Manager
Project Manager Local Pharma /
Validation Manager
Project/Validation
Manager
Material Requirements
Resourcing Planning
Engineering
Subcontract Procurement
Project
Change Management
Claim Management
Contract Management
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yes
Review
Performing
Function
Reporting Output Process
Installation Commissioning Acceptance Warranty
PM650 PM600 PM590
PM550 PM580
PM700
PM670
Execution
Version 2.9
Execution-Phase
Project-Opening Dispatch
PM100
Detail Planning Purchasing Manufacture
PM300 PM200 PM400
no
Execution-Phase Operating-Phase
PM570
PM@SBT Pharma Execution
S
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Obtain Approval
Perform Design Review
Release Work Packages
(Technical Execution)
Ready to submit
to customer?
Contract
Management
yes
no approval
no
Code Review
VA300-1
PM200
Approval of detailed
planning
Factory acceptance Test
(FAT)
Functional Spec.
VA200-1
HW Test
Specification
VA202-3
Factory Acceptance
Test Specification
VA200-7
Site Acceptance
Test Specification
VA200-8
Traceability matrix
VA200-2
DQ
VA200-9
Work Package
VA200-2
HW Design
Spec.
VA200-3
HWCL
VA201-3
SW Design
Spec.
VA200-4
SWCL
VA201-4
SW Module
Design
Specification
VA200-5
SW Module
Test
Specification
VA201-5
SW Module
Integration
Test Spec.
VA200-6
System
Integration
Test Spec.
VA201-6
Project Manager Local Pharma /
Validation Manager
Customer
Project Manager
Pharma Specialist
Local Pharma /
Validation Manager
Customer
Project Manager
Pharma Specialist
Local Pharma /
Validation Manager
Customer
Project Manager
Pharma Specialist
Project Manager
Pharma Specialist
Local Pharma /
Validation Manager
Customer
SW Test
Specification
VA202-4
Project Manager Local Pharma /
Validation Manager
Customer
Project Manager Local Pharma /
Validation Manager
Customer
Project Manager
Project Manager
Local Pharma /
Validation Manager
Customer
Project Manager Project /
Validation Manager
Project Manager Project /
Validation Manager
Project Manager Project /
Validation Manager
Field Service
Engineer
Project Manager
Service Engineer
Service Engineer
Project /
Validation Manager
Project Manager Customer
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Create Functional
Specification
Create Acceptance
Test Specification
(FAT, SAT)
Create
Hardware
Design
Specification
Hardware
Test
Specification
Create
Software
Design
Specification
SW Test
Specification
Establish & maintain
traceability matrix
Software
Module
Design
Specification
Software
Module Test
Specification
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P
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M
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Test HW/
Peripherals
Test SW
modules
Test SW
Modul /
System
Integration
Test
integrated
SW code
Purchasing &
Manufacture
Build/
assemble
HW/
Peripherals
Code SW
modules
Perform SW
code reviews
SW Module
Test Report
VA300-4
Signature List
VA300-11
Training List
VA300-10
Deviation List
VA300-9
SW Module Integration
Test Report
VA300-5
SW Integration
Test Report
VA300-6
Test integrated SW
code Report
VA300-8
Factory Test Report
(FAT)
VA300-3
HW Test Report
VA300-7
Review
Performing
Function
Reporting Output Process
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Initiate Completed Work
Review
Review Completed Work
with Customer
Generate Punch List
Punch list items?
Obtain Customer
Acceptance
Submit Certificate to
Finance Department
Project 100%
complete?
yes
no
no
Monitoring
& Controlling
Finance
Dispatch
Erection/Installation
Punch list
PM650-1
Project Closure
Checklist
PM650-2
Request acceptance
Review
PM650-3
Supplier Evaluation
Assessment
PM650-4
Final Validation
Report
(Customer)
Acceptance
Test Protocol
PM650-5
Acceptance
Certification
PM650-6
Transmittal
Confirmation
PM650-7
PM400
Material & Resources at
Site
PM300
Dispatch approval
PM550
Erection Completed
PM600
Release to Acceptance
PM580 IQ released
PM570
Mechanical Completion
PM590 OQ released
Configuration
Management Plan
VA550-1
Check Sheet to
comply with the
requirements
PM550-1
Install SW
Install HW/
Periperhals
Calibration
Calibration
Documentation
VA550-2
Prepare Validation
Report
Project Manager
Pharma Specialist
Local Pharma /
Validation Manager
Customer
Project Manager
Project Manager
Field Service
Engineer
Project Manager
Field Service
Engineer
Project Manager
Pharma Specialist Project Manager
Field Service
Engineer
Field Service
Engineer
Project /
Validation Manager
Field Service
Engineer
Project /
Validation Manager
Field Service
Engineer
Project /
Validation Manager
Project Manager Local
Pharma Manager
Project Manager
Project Manager
Customer
Local
Pharma Manager
Project Manager
Project Manager
Local
Pharma Manager
Training
- GxP compliant
Change Control
Training of Operator
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P
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OQ Specification
VA550-4
IQ Specification
VA550-3
Perform System
Acceptance Testing
(SAT)
Test
HW/SW Peripherals
(IQ)
HW/SW Peripherals
OQ
Commissioning
IQ-Test
Plan / protocol
VA580-1
IQ-Report
VA580-2
OQ-Plan /
protocol
VA590-1
OQ-Report
VA590-2
Test
SAT Report
VA590-1
PM650
Customer Acceptance
Review
Performing
Function
Reporting Output Process
S
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Monitoring
& Controlling
Compile Handover to
Service File
Conduct Site Visit
Handover to Service
Open Warranty Account Service Execution
PM670
PEx Handover Accepted
Meeting Customer
(Lessons Learned)
- Punch list closed
- handover service
checklist
PM670-1
Demobilize Project Site
PM700
End of Warranty
Close Warranty Account
warranty closure
communication
Project Manager
Project Manager
Project Manager
Project Manager
Project Controller
Project Controller
Local
Pharma Manager Project Manager
Customer
W
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O
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P
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Service Lead
Generation
Qualifying
& Verification
yes
Review
Performing
Function
Reporting Output Process
Process Step
PM@SBT
Pharma specific
Step
Software
Category 5 Decision point
Project Milestone
Quality Gate
Ongoing Subprocess
Original Document
of PM@SBT
Pharma specific
Document
Audit
An activity to determine through investi-
gation the adequacy of, and adherence
to, established procedures, instructions,
specifications, codes, and standards or
other applicable contractual and licen-
sing requirements, and the effectiveness
of implementation of a vendor.
As an offer to our customers, Siemens
can provide the customer access to an
audit report of our development in Zug
made by external auditors.
Project Specific Quality Plan (PSQP)
Document specifying which procedures
and associated resources shall be applied
by whom and when to a specific project,
product, process or contract.
This Project Specific Quality Plan PSQP)
defines how Siemens Building Technolo-
gies will fulfil both Siemens and custo-
mer quality requirements of the project
as they relate to the design, supply,
installation, and commissioning of the
Building Management System (BMS) for
the customer plant. The PSQP defines
the activities to be performed, their
timing, which will perform them, the
control mechanisms to be used, and the
deliverable items.
Project Opening
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Detail Planning
Hardware Design Specification (HDS)
The Hardware Design Specification is to
specify and document the choice of con-
trol and electric components. The Hard-
ware Design Specification concerns design
and construction which requires particular
attention, including the choice of:
Servers and hardware configuration of
these
Clients and hardware configuration of
these
Network components
Printers and monitors
External storage medias
Controllers, I/Os, and sensors
Uninterruptible power supply
The HDS, Hardware Design Specification,
should be completed and signed off by
the customer during this step.
Hardware Configuration List (HWCL)
The purpose of the Hardware Configura-
tion List is to have a detailed document
of: The firmware versions, internal hard-
ware settings through jumpers and swit-
ches, used network IP addresses, serial
numbers and computer hardware confi-
gurations; i.e. for the components that
are assigned with a configuration item
index number (CI) in the main configura-
tion drawing in the document.
This Hardware Configuration List is an
appendix to the hardware design specifi-
cation, but can also be used separately
to make future hardware baselines.
Software Design Specification (SDS)
The SDS describes how the software will
be configured to achieve what the BMS is
designed to do and provides a list of
design objectives, as well as identifying
system limitations, as detailed in the URS
document and in sufficient detail to
avoid any ambiguities.
The SDS, Software Design Specification,
should be completed and signed off by
the customer during this step.
Software List (SWL)
This SWL will list the software for Siemens
BMS Pharma system.
This software list is an appendix to the
software design specification.
Test Plan / Protocol
A document describing the scope,
approach, resources, and schedule of
intended test activities. It identifies test
items, features to be tested, testing
tasks, who will do each task, and any
risks requiring contingency planning.
Test Protocol
Detailed instructions for the set-up,
execution, and evaluation of results for a
given test case.
After execution of the tests the test plan
will be our protocol.
Design Qualification (DQ)
Design Qualification, formal and syste-
matic verification that the requirements
defined during specification are comple-
tely covered by subsequent specification
or implementation.
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Qualification
Installation Qualification (IQ)
This is a documented verification that all
key aspects of hardware installation
adhere to appropriate codes and appro-
ved design intentions and that the
recommendations of the manufacturer
have been suitably considered.
IQ Protocols should include
Documentation introduction, objec-
tive, signature record, abbreviation
and definitions, documentation
checks, conclusions and approvals.
Hardware drawing information,
major hardware components, loca-
tions, pre-start hardware checks.
Software software version numbers,
service pack number. Pre-start applica-
tion software checks.
Installation procedures installing the
software on the target hardware plat-
form.
Calibration schedules, certificates.
Operational Qualification (OQ)
This is a documented verification that
the equipment-related system or sub-
system performs as intended throughout
representative or anticipated operating
ranges.
OQ Protocols should include
Documentation introduction, objec-
tive, signature record, abbreviation
and definitions, documentation
checks, conclusions and approvals.
Hardware digital input/output tests,
analogue input/output tests.
Software system security tests, com-
puter functionality tests, operator con-
trol tests, invalid input tests.
Systems control system sequence
tests, control system alarm tests.
General stress/recovery tests, source
code audit, software version tests.
Flow measurement devices
Temperature/humidity devices
Alarms and alarm messages
etc.
Purchasing Manufacture
Factory Acceptance Test (FAT)
The Factory Acceptance Test (FAT) is exe-
cuted after completion of system imple-
mentation at the system suppliers site.
At the end of the FAT the client should
agree to the delivery of the system. An
additional advantage of an extensive FAT
is to detect possible faults in software
programming early and to be able to cor-
rect them prior to the installation of the
system at the clients site, so that the
commissioning can be executed quickly.
As far as possible the FAT should be exe-
cuted with the original system equipment
and can be supported with the help of
simulated processes and test programs.
Installation
Change Control
A formal system by which qualified
representatives of appropriate disciplines
review proposed or actual changes that
might affect a validated status. The pur-
pose is to determine the need for action
which would ensure and document that
the system is maintained in a validated
state.
Commissioning
Site Acceptance Tests (SAT)
The Site Acceptance Test (SAT) demon-
strates that the system is working in its
operational environment and interfaces
with instruments and equipment. The
SAT normally constitutes a repeat of ele-
ments of the FAT in the users operating
environment plus those tests made pos-
sible with all process, field instruments,
interfaces and service connections esta-
blished. The SAT may be combined with
equipment and plant commissioning,
and this will provide a basis for OQ.
Note:
Siemens Building Automation is normally
not directly involved in PQ.
IQ/OQ Report:
After the tests of all test phases are exe-
cuted according to their specification
and the single test results are evaluated
and no major deviations are left, the end
of the qualification phases has to be
documented. The Qualification Report is
created by the client/system supplier. It
summarizes the test results of all test
phases,
e.g. FAT, SAT, IQ, OQ.
Deviation List:
To each test phase one Deviation List has
to be included. It contains test points
that were not evaluated as successful, i.
e. the specified acceptance criteria were
not fulfilled.
The Deviation List is appended to the
xQ-Report. Further on in the master
exemplar (not in any copy!) of the Devia-
tion List the correction of the defects has
to be signed by the respective person
and to be approved by the client.
Acceptance
Validation Report
Whatever the scale or scope of the pro-
ject, there is always a requirement to
issue a final Validation Report which
summarizes the entire project, measures
its ultimate success, and clearly signifies
acceptance of a final solution by the user
and quality assurance.
This report should document the out-
come of activities defined in the valida-
tion plan.
12
41557_PMS_Brochure_en2.indd 12 30.10.2006 16:22:42 Uhr
Assign Service Sales
Resource
Lead Approval
required?
Include Lead in Service
Sales Funnel
(Prospect List)
Check Handover
Checklist for Prospect /
Customer
Arrange Customer /
Prospect
Contractor Visit
Indentify Key Customer
Prospect Contacts
no no
Continue with
business
opportunity
Confirm Service offering
Scope with customer
Check Compain Data
for Prospect / Customer
Obtain approval
Inform Customer
Inform Customer
about no go
Negotiation
Subcontract
Procurement
yes
BT 420 Qualified profile
reviewed & verified
Customer Offering
BT 410
Target Leads Identified
Analyze business
opportunity & recognize
customer needs
Linked with SBT capabilities
Cover the Customer/
Prospect Buying Center
& Determine preliminary
scope
Scope
confirmed
Sufficient
Data
Customer Mapping
PM420-1
Qualification Profile
PM420-2
Service Manager
Handover to Service
PEx checklist
PM410-1
Service Sales
Funnel Tool
PM410-2
Outline Service offering
&
Review/submit
SBT capabilities
Local
Pharma Manager
Service Support
Local
Pharma Manager
Service Supervisor
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Local
Pharma Manager
Complete
Qualification Profile
S
e
r
v
i
c
e

L
e
a
d

G
e
n
e
r
a
t
i
o
n
S
e
r
v
i
c
e
-
P
h
a
s
e
Q
u
a
l
i
f
y
i
n
g

&

V
e
r
i
f
i
c
a
t
i
o
n
S
e
r
v
i
c
e
-
P
h
a
s
e
yes
Prepare customer /
prospect visitor contact
(in line with segment and
opportunity)
yes
no
no
yes
Review
Performing
Function
Reporting Output Process
Handover & Execution Service Execution Service Settlement
Service
Version 2.9
Lead-Generation Service Negotiation Qualifying & Verification Proposal Generation
BT410 BT420
BT450
BT430 BT440
Service-Phase
Service-Phase
PM@SBT Pharma Service
S
a
l
e
s
E
x
e
c
u
t
i
o
n
S
e
r
v
i
c
e
13
41557_PMS_Brochure_en2.indd 13 30.10.2006 16:22:43 Uhr
Negotiation Service
Proposal Pharma
Review Service
Contract Signed by
Customer
Register Service
Contract in IT System
Analyze Win/Loss
& inform HQ
On-Call
Service Planning
yes
Compile Handover
Documents
US Service Sales
Funnel Tool BAU
PM440-1
Service contract
Handover checklist
PM440-2
Service handover to
PEx checklist
Impact Analysis
VA-450-1
Risk Assessment
VA-450-2
PART11 Audit
Consulancy
URS Consulancy
Adjustment
Required
Customer
Modifications
to
Proposal
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Service
Sales Rep.
Service Support
Sales Rep.
Service Sales
Rep.
Service Sales
Rep.
Service Sales
Rep.
Service Support
Pharma Manager
Project Controller
Service
Sales Rep.
S
e
r
v
i
c
e

N
e
g
o
t
i
a
t
i
o
n
S
e
r
v
i
c
e
-
P
h
a
s
e
P
r
o
p
o
s
a
l

G
e
n
e
r
a
t
i
o
n
S
e
r
v
i
c
e
-
P
h
a
s
e
S
e
r
v
i
c
e

H
a
n
d
o
v
e
r

E
x
e
c
u
t
i
o
n
S
e
r
v
i
c
e
-
P
h
a
s
e
BT 430
Proposal Submitted
to customer
BT 440
Signed Contract
Qualifying &
Verification
no
yes
yes
no
Send Confirmation
and Copy of Contract
to customer
Verify Handover
Documents & Address
Changes out of Negotiation
Conduct Handover
Metting / Submitt
Handover Checklist
no
Submit/Present
Service Proposal
Proposal
Complete
Service Settlement
(in case of
existing customer)
Request for Proposal
from existing
customer's only
Service Sales
Funnel Tool
PM430-1
Service Value
Proposition Card
PM430-2
Customer
Requirements
Solution Matrix
PM430-3
Service
Sales Rep.
Local
Pharma Manager
Service
Sales Rep.
Service
Sales Rep.
Pharma /
Validation Manager
Prepare Service
Proposal
incl. Quotation
Review
Service Proposal
Receive and Check
request for
Service Proposal
Review
Performing
Function
Reporting Output Process
Process Step
PM@SBT
Pharma specific
Step
Software
Category 5 Decision point
Project Milestone
Quality Gate
Ongoing Subprocess
Original Document
of PM@SBT
Pharma specific
Document
14
41557_PMS_Brochure_en2.indd 14 30.10.2006 16:22:43 Uhr
Service Lead Generation
The Lead Generation step in the service
sales process includes activities that lead
to prospecting for customers and cover-
ing their potential needs. A strategy is
planned based on these needs and quest-
ions and implications are prepared for
use during this phase.
Qualifying & Verification
The QUALIFYING step of the service pro-
cess identifies the customers service
needs and links them to Pharma service
modules. The service salesperson relies
on knowledge of our service capabilities,
knowledge of the customers market
drivers and specific goals, and on sales
skills and techniques to determine the
needs of the customer.
Once needs are acknowledged in con-
sultation with the customer, the Custo -
mer Requirement Solutions Matrix is
used to quickly highlight applicable solu-
tions to address those needs.
The VERIFICATION step confirms the
importance of the customers needs or
requirements. Potential services are posi-
tioned as solutions to meet their needs
or satisfy their requirements.
Proposal Generation
In this step a proposal or a site specific
contractual agreement (Service Level
Agreement) is created to document the
scope of recommended services.
The customer-specific service concept
not only covers the services from the
Pharma Service Program but also
includes traditional Advantage
Services specially adapted to Pharma.
The programs modular structure allows
us to offer an individual service program
tailored to the customers needs:
Each module specifically offers:
Standard operating procedure (SOP)
for executing the service
Required tools and processes
Required checklists to support our
experts on-site
Expert training
Service Negotiation
The NEGOTIATION step involves obtain-
ing the approval of the customer and
conforming acceptance of the terms and
conditions identified within the service
contract. The salesperson addresses the
entire contract, including scope, price,
terms and conditions and service dates.
Service Handover
Execution
During the HANDOVER phase, the service
team clearly understands and delivers
the individual, customer specific service
concept or standard service package
identified in the service agreement.
When executing services in a critical
environment, the service staff must be
trained on how to operate in this en -
viron ment and be fully aware of the
customers change management
procedures.
A formal analysis of the possible impact
of any planned changes to a validated
system, combined with a risk assess-
ment, is required.
All changes to existing systems must be
formally approved from the customer
prior to execution.
Pharma Service Concept
The Pharma Service Concept for main-
taining a validated state is divided into
three main groups:
Compliance consultancy
(URS Consultancy, Impact Analysis,
Risk Assessment)
Business continuity (Backup Integrity,
System Integrity, Archive Test)
Validation review (Part 11 Audit,
Calibration, Baselining)
15
41557_PMS_Brochure_en2.indd 15 30.10.2006 16:22:43 Uhr
www.siemens.com/buildingtechnologies-pharma
Siemens Switzerland Ltd
Building Technologies Group
International Headquarters
Gubelstrasse 22
CH-6301 Zug
Tel. +41 41-724 24 24
Fax +41 41-724 35 22
www.siemens.com/buildingtechnologies
The information in this document contains general descriptions of technical options available,
which do not always have to be present in individual cases. The required features should therefore
be specified in each individual case at the time of closing the contract.
Subject to change Order no. 0-92004-en
Siemens Switzerland Ltd Printed in Switzerland 0,00000 Ni/Ah
41557_PMS_Brochure_en2.indd 16 30.10.2006 16:22:26 Uhr