Project Management in the Pharma Industry Based on PM SBT A6V10084371 Hq En

Project Managementin 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.

3


in the Pharma Industry.

PM@SBT Pharma – Sales

Pro

ject

Acq

uis

itio

n

Acq

uis

itio

n-P

has

e

Pre-

Aq

uis

itio

n

Acq

uis

itio

n-P

has

e

Qualify Lead Source

Select Leads

Perform Go/ No GoDecision

Identify Opportunities

Analyze Opportunities

Cover the Buying Center

Perform Bid/ No BidDecision

Communicate Bid/ NoBid Decision to customer

and HQ

Stop

Project Risk Ass.(LOA)

PM020-1

PM 010Acquisition Go/No Go

Decision

Sales SupportEngineering

Customer (RFQ)

Guideline 2140Calculation Scheme

Risk Assessment of the Project

Project managementassessment PMA

Project > 750 000 €

PM 020Bid/No Bid decision

(Quality Gate)

Calculation SchemePM010-2

Sales FunnelTool

PM010-1

Pharma BuyingCenter

PM020-3

Lifecycle ProfitabilityTool (LOA)PM020-5

Bid/No Bid Tool(LOA)

PM020-2

Account PlanPM020-4

Management ControlGuideline 2110;

2120; 2130; 3600

Project Risk ReviewReport (LOA)

PM021-1

Classification ProjectPM020-7

Inform HQ & localPharma Manager

ContractingSales

Manager

Sales Support

ContractingSales Manager

Sales RepresenterProject Controller

Sales Representer


Sales Representer

Sales Representer

Project > 20'000 EUR

Integration of HQ

National project

Involve CoC Pharma forsupport and assistance

International project/more divisions

involved

Involve Pharma Managerfor review

Local Pharma Manager


Sales Representer





Sales Representer

Checklist Handoversales Back office

PM020-8


BlockschemataPM020-6

Sales RepresenterProject Manager

LocalPharma Manager

ContractingSales Manager



COC Pharma HQ


ReviewPerformingFunctionReporting OutputProcess

Sales Version 2.9

Aquisition-Phase Offering-Phase

Pre-Aquisition

PM010 PM020

Bid-PreparationProject-Aquisition Contract-Negotiation Project-Handover

PM050 PM070 PM080

4


Bid

Pre

par

atio

n

Off

erin

g-P

has

eO

ffer

ing

-Ph

ase

Co

ntr

act

Neg

ota

tio

n

Outline Sales Offering

Additional dataneeded?

no

Produce Bid

Review Bid

Bid complete/correct?

Submit bid

no

Prepare NegotationStrategy

Strategic Selling Pharma

Negotiate Bid

Generate Final Conctract

Obtain Agreement OnContract

Customeracceptance?

Changes inContract?

Analyze Win/Loss& inform HQ

yes

no

Subcontract Proc.Sales Support Eng.

yes

PM 050Bid Approval

PM 070Project win/lost

Bid Preparation

yes

High riskstep

Get URS

Impact Analysis

Support CoCPharma

Risk Assessment

Inform Pharma Manageror HQ for review and

approval

Project > 20'000 EUR

approval


Management ControlGuideline Appendix 3

Contract reviewchecklist 2110

Strategic AnalysisBlue sheet PM070-1

Checklist HandoverRequirements

PM020-9

Sales RepresenterCustomer

Project Manager

CustomerLocal Pharma /

Validation Manager

Sales Representer Local Pharma /Validation Manager

CoC Pharma HQ

Sales Representer Local Pharma Manager

Sales Representer Local Pharma Manager

Local Pharma ManagerProject Controller

Sales Representer Contracting Manager

Sales Representer Project Controller

Local Pharma ManagerCoC Pharma HQ

Sales RepresenterProject Manager

Local Pharma /Validation Manager

Sales Representer


Stop

Stop

no

Involving Project /Validation Manager

yes

no approval

URSVA050-1 (draft)

Milestone PlanningPM050-1

Checklist URSVA050-3

Checklist 21 CFRPart 11

VA050-6

SBT SoftwareApplication in

regulated industryVA050-7

Checklist Val.Documents

VA050-3

Checklist ImpactAnalysisVA050-4

Validationcalculation tool

VA050-5


Gather Data for Offer

Sale

sEx

ecu

tio

nSe

rvic

e

5


Pro

ject

Han

do

ver

Off

erin

g P

has

eCompile Handover

Documents

Verify Handover Documents & Address

Changes out of Negotiaton

Conduct HandoverMeeting/Submit

Handover Checklist

Documents o.k.?

Handoverto PEx

accepted?

yes

no

no

PM 080Start Project

handover to PExchecklistPM080-1

Sales Representer

Project Manager Project Manager

ProjectManager

Sales Representer


Process StepPM@SBT

Pharma specificStep

SoftwareCategory 5 Decision point

Project Milestone

Quality Gate

Ongoing SubprocessOriginal Document

of PM@SBTPharma 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 AnalysisThe 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 AssessmentThe 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.

6


Enter Order/EstablishPM Goals

Early MaterialRequirements?

Initiate / Set up Project

Obtain Deliverables fromEnabling Processes

no

Effect of Offer

Release Work Packages(Design)

Audit Suppliers &Audit of customer

Audit Report SuppliersVA100-2

Master Validation Plan(customer)

VA100-1

PSQPVA100-4

Validation GuidelineCM1 10820

Work PackagePM100-6

PM 100Entry Order Clarified

(Quality Gate)

Finance

Monitoring & Controlling

Training- GxP compliant

Risk Assessmentof the Projct

Logisticsyes

RevisionRisk Assessment

Kick off meetingwith the customer

Refine URS

Minutes of themeetingPM100-5

Audit ReportSiemensVA100-3

ContractingExecutionManager

Project ManagerProject Controller

Project Manager

Project Manager

Pharma SpecialistProject Manager

CoC Pharma

Target agreementPM100-1

Project SchedulePM100-2

Issue listPM100-3

Time schedulePM101-4

Define Project Organization &Responsibility Matrix- check education status- perform required education

Create Project & Quality Plan“Define” Work Packages




Customer

Project Manager Local Pharma /Validation Manager

Project ManagerPharma Specialist



Project/ValidationManager

Material RequirementsResourcing Planning

EngineeringSubcontract Procurement

ProjectChange Management

Claim Management”Contract Management”

Pro

ject

Op

enin

g

Exec

uti

on

-Ph

ase

yes


Installation Commissioning Acceptance Warranty

PM650PM600PM590PM550 PM580 PM700

PM670

Execution Version 2.9

Execution-Phase

Project-Opening Dispatch

PM100

Detail Planning Purchasing Manufacture

PM300PM200 PM400

no

Execution-Phase Operating-Phase

PM570

PM@SBT Pharma – Execution

Sale

sEx

ecu

tio

nSe

rvic

e

7


Obtain Approval

Perform Design Review

Release Work Packages(Technical Execution)

Ready to submitto customer?

ContractManagementyes

no approval

no

Code ReviewVA300-1

PM 200Approval of detailed

planning

Factory acceptance Test(FAT)

Functional Spec.VA200-1

HW TestSpecification

VA202-3

Factory AcceptanceTest Specification

VA200-7

Site AcceptanceTest Specification

VA200-8

Traceability matrixVA200-2

DQVA200-9

Work PackageVA200-2

HW DesignSpec.

VA200-3

HWCLVA201-3

SW DesignSpec.

VA200-4

SWCLVA201-4

SW ModuleDesign

SpecificationVA200-5

SW ModuleTest

SpecificationVA201-5

SW ModuleIntegrationTest Spec.VA200-6

SystemIntegrationTest Spec.VA201-6


Customer



Customer



Customer




Customer

SW TestSpecification

VA202-4


Customer


Customer

Project Manager

Project Manager


Customer

Project Manager Project /Validation Manager



Field ServiceEngineer

Project Manager

Service Engineer

Service Engineer

Project /Validation Manager

Project Manager Customer

Exec

uti

on

-Ph

ase

Exec

uti

on

-Ph

ase

Create FunctionalSpecification

Create Acceptance Test Specification

(FAT, SAT)

Create Hardware

DesignSpecification

HardwareTest

Specification

Create SoftwareDesign

Specification

SW TestSpecification

Establish & maintaintraceability matrix

SoftwareModuleDesign

Specification

SoftwareModule TestSpecification

Det

aille

d P

lan

nin

gPu

rch

asin

g M

anu

fact

ure

Test HW/Peripherals

Test SWmodules

Test SWModul /System

Integration

Test integratedSW code

Purchasing &Manufacture

Build/assemble

HW/Peripherals

Code SWmodules

Perform SWcode reviews

SW Module Test Report

VA300-4

Signature ListVA300-11

Training ListVA300-10

Deviation ListVA300-9

SW Module IntegrationTest ReportVA300-5

SW IntegrationTest ReportVA300-6

Test integrated SWcode Report

VA300-8

Factory Test Report(FAT)

VA300-3

HW Test ReportVA300-7


8


Initiate Completed WorkReview

Review Completed Workwith Customer

Generate Punch List

Punch list items?

Obtain CustomerAcceptance

Submit Certificate toFinance Department

Project 100%complete?

yes

no

no


Finance

Dispatch

Erection/Installation

Punch listPM650-1

Project ClosureChecklistPM650-2

Request acceptanceReview

PM650-3

Supplier EvaluationAssessment

PM650-4

Final ValidationReport

(Customer)

AcceptanceTest Protocol

PM650-5

AcceptanceCertification

PM650-6

TransmittalConfirmation

PM650-7

PM 400Material & Resources at

Site

PM 300Dispatch approval

PM 550Erection Completed

PM 600Release to Acceptance

PM 580 IQ released

PM 570

Mechanical Completion

PM 590 OQ released

ConfigurationManagement Plan

VA550-1

Check Sheet tocomply with the

requirementsPM550-1

Install SW Install HW/Periperhals

Calibration

CalibrationDocumentation

VA550-2

Prepare ValidationReport



Customer

Project Manager

Project Manager


Project Manager


Project Manager

Pharma Specialist Project Manager








Project Manager LocalPharma Manager

Project Manager

Project Manager

Customer

LocalPharma Manager

Project Manager

Project Manager

LocalPharma Manager

Training- GxP compliant

Change Control

Training of Operator

Exec

uti

on

-Ph

ase

Dis

pat

chIn

stal

lati

on

Co

mm

issi

on

ing

Qu

alif

icat

ion

Acc

epta

nce

Exec

uti

on

Ph

ase

OQ – SpecificationVA550-4

IQ – SpecificationVA550-3

Perform SystemAcceptance Testing

(SAT)

TestHW/SW Peripherals

(IQ)

HW/SW PeripheralsOQ

Commissioning

IQ-Test Plan / protocol

VA580-1

IQ-ReportVA580-2

OQ-Plan /protocolVA590-1

OQ-ReportVA590-2

TestSAT ReportVA590-1

PM 650Customer Acceptance


Sale

sEx

ecu

tio

nSe

rvic

e

9



Compile Handover toService File

Conduct Site Visit

Handover to Service

Open Warranty Account Service Execution

PM 670PEx Handover Accepted

Meeting Customer(Lessons Learned)

- Punch list closed- handover service

checklistPM670-1

Demobilize Project Site

PM 700End of Warranty

Close Warranty Accountwarranty closurecommunication

Project Manager

Project Manager

Project Manager

Project Manager

Project Controller

Project Controller

LocalPharma ManagerProject Manager

Customer

War

ran

ty

Op

erat

ing

Ph

ase

Service LeadGeneration

Qualifying& Verification

yes


Process StepPM@SBT

Pharma specificStep


Project Milestone

Quality Gate



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

10


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 supplyThe 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 / ProtocolA 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 ProtocolDetailed 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.

11


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 supplier’s 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 client’s 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 ControlA 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 user’s 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 ReportWhatever 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


Assign Service SalesResource

Lead Approvalrequired?

Include Lead in ServiceSales Funnel

(Prospect List)

Check HandoverChecklist for Prospect /

Customer

Arrange Customer /Prospect

Contractor Visit

Indentify Key CustomerProspect Contacts

no no

Continue withbusiness

opportunity

Confirm Service offeringScope with customer

Check Compain Datafor Prospect / Customer

Obtain approval

Inform Customer

Inform Customerabout no go

Negotiation

SubcontractProcurement

yes

BT 420 Qualified profilereviewed & verifiedCustomer Offering

BT 410Target Leads Identified

Analyze businessopportunity & recognize

customer needsLinked with SBT capabilities

Cover the Customer/Prospect Buying Center

& Determine preliminaryscope

Scope confirmedSufficient

Data

Customer MappingPM420-1

Qualification ProfilePM420-2

Service ManagerHandover to ServicePEx checklist

PM410-1

Service SalesFunnel Tool

PM410-2

Outline Service offering&

Review/submitSBT capabilities

LocalPharma Manager

Service Support LocalPharma Manager

Service SupervisorSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

LocalPharma ManagerComplete

Qualification Profile

Serv

ice

Lead

Gen

erat

ion

Serv

ice-

Phas

e

Qu

alif

yin

g &

Ver

ific

atio

n

Serv

ice-

Phas

e

yes

Prepare customer /prospect visitor contact

(in line with segment andopportunity)

yes

no

no

yes


Handover & Execution Service Execution Service Settlement

Service Version 2.9

Lead-Generation Service NegotiationQualifying & Verification Proposal Generation

BT410 BT420

BT450

BT430 BT440

Service-Phase

Service-Phase

PM@SBT Pharma – Service

Sale

sEx

ecu

tio

nSe

rvic

e

13


Negotiation ServiceProposal Pharma

Review ServiceContract Signed by

Customer

Register ServiceContract in IT System

Analyze Win/Loss& inform HQ

On-Call

Service Planning

yes

Compile HandoverDocuments

US Service SalesFunnel Tool BAU

PM440-1

Service contractHandover checklist

PM440-2

Service handover toPEx checklist

Impact AnalysisVA-450-1

Risk AssessmentVA-450-2

PART11 AuditConsulancy

URS Consulancy

AdjustmentRequired

CustomerModifications

toProposal

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

ServiceSales Rep.

Service SupportSales Rep.

Service SalesRep.

Service SalesRep.

Service SalesRep.

Service Support

Pharma ManagerProject Controller

ServiceSales Rep.

Serv

ice

Ne

go

tiat

ion

Serv

ice

-Ph

ase

Pro

po

sal G

en

era

tio

n

Serv

ice

-Ph

ase

Serv

ice

Han

do

ver

Exe

cuti

on

Serv

ice

-Ph

ase

BT 430 Proposal Submitted

to customer

BT 440Signed Contract

Qualifying &Verification

no

yes

yes

no

Send Confirmationand Copy of Contract

to customer

Verify HandoverDocuments & Address

Changes out of Negotiation

Conduct HandoverMetting / Submitt

Handover Checklist

no

Submit/PresentService Proposal

ProposalComplete

Service Settlement(in case of

existing customer)

Request for Proposalfrom existing

customer's only

Service SalesFunnel Tool

PM430-1

Service ValueProposition Card

PM430-2

CustomerRequirements

Solution MatrixPM430-3

ServiceSales Rep.

LocalPharma Manager

ServiceSales Rep.

ServiceSales Rep.

Pharma /Validation Manager

Prepare ServiceProposal

incl. Quotation

ReviewService Proposal

Receive and Checkrequest for

Service Proposal


Process StepPM@SBT

Pharma specificStep


Project Milestone

Quality Gate



Document

14


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 customer’s service needs and links them to Pharma service modules. The service salesperson relies on knowledge of our service capabilities, knowledge of the customer‘s 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 customer’s 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 program‘s modular structure allows us to offer an individual service program tailored to the customer‘s 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 customer‘s 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 ConceptThe 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


www.siemens.com/buildingtechnologies-pharma

Siemens Switzerland LtdBuilding Technologies GroupInternational HeadquartersGubelstrasse 22CH-6301 ZugTel. +41 41-724 24 24Fax +41 41-724 35 22www.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
