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

Project Management in the Pharma Industry based on PM@SBT

Building Technologies

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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 regulation 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 industry requires a special way of project execution 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 in the Pharma Industry.

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 unambiguous 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 leadership tasks, organization, techniques and means for performing the project flow in such a way that the cost, deadline and functionality targets can all be met satisfactorily.

To reduce the project risks for our customers and for us, the Center of Competence Pharma has established a certification process for the local GxP project execution. Based on a comprehensive assessment we support the local organizations to establish the proper processes, to acquire the required knowledge and to pass the audit successfully. By applying PM@SBT for Pharma, consistent processes can be optimized and risks minimized; efficiency, quality and planning security are all increased simultaneously.

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.

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PM@SBT Pharma – Sales Sales

Version 2.9

Aquisition-Phase Pre-Aquisition

Offering-Phase

Project-Aquisition

Bid-Preparation

PM020

PM010

Process

Contract-Negotiation

PM050

Reporting Output

Acquisition-Phase Pre-Aquisition

Qualify Lead Source

Project-Handover

PM070

PM080

Performing Function

Review

Contracting Sales Manager

Local Pharma Manager

Select Leads

Sales Funnel Tool PM010-1

Sales Support

Local Pharma Manager

Inform HQ & local Pharma Manager

Calculation Scheme PM010-2

Contracting Sales Manager

Local Pharma Manager

Guideline 2140 Calculation Scheme

Sales Representer Project Controller

Local Pharma Manager

Management Control Guideline 2110; 2120; 2130; 3600

Sales Representer

Local Pharma Manager

Project Risk Ass. (LOA) PM020-1

Sales Representer Project Controller

Local Pharma Manager

Sales Representer

Local Pharma Manager

Perform Go/ No Go Decision

Stop

PM 010 Acquisition Go/No Go Decision

Identify Opportunities

Project > 20'000 EUR

Analyze Opportunities

Project management assessment PMA Project > 750 000 €

Risk Assessment of the Project

Customer (RFQ)

Project Risk Review Report (LOA) PM021-1

Classification Project PM020-7

Pharma Buying Center PM020-3

Cover the Buying Center

Integration of HQ

International project/ more divisions involved

National project

Involve Pharma Manager for review

Involve CoC Pharma for support and assistance

Sales Representer

Contracting Sales Manager Local Pharma Manager

Account Plan PM020-4

Lifecycle Profitability Tool (LOA) PM020-5

Local Pharma Manager Sales Representer

COC Pharma HQ

Bid/No Bid Tool (LOA) PM020-2

Acquisition-Phase Project Acquisition

Perform Bid/ No Bid Decision

Communicate Bid/ No Bid Decision to customer and HQ

PM 020 Bid/No Bid decision (Quality Gate)

Sales Support Engineering

Sales Representer

Local Pharma Manager

Sales Representer Project Manager

Local Pharma Manager

Blockschemata PM020-6

Checklist Handover sales Back office PM020-8

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Reporting Output

Process

Performing Function

Review

Sales Representer Customer Project Manager

Customer Local Pharma / Validation Manager

Sales Representer

Local Pharma / Validation Manager CoC Pharma HQ

Checklist Handover Requirements PM020-9

Gather Data for Offer

Get URS Subcontract Proc. Sales Support Eng.

URS VA050-1 (draft)

Checklist URS VA050-3 Impact Analysis Checklist Val. Documents VA050-3

Support CoC Pharma Risk Assessment

Checklist Impact Analysis VA050-4

Involving Project / Validation Manager

yes

Additional data needed?

Validation calculation tool VA050-5

no

Local Pharma Manager

Service

Checklist 21 CFR Part 11 VA050-6

Outline Sales Offering

Sales Representer Produce Bid

SBT Software Application in regulated industry VA050-7

Review Bid

Sales Representer Project Manager

Local Pharma / Validation Manager

Milestone Planning PM050-1 no

Bid complete/ correct?

no approval

Project > 20'000 EUR

Inform Pharma Manager or HQ for review and approval

Offering-Phase Bid Preparation

Execution

Stop

Local Pharma Manager CoC Pharma HQ

yes approval PM 050 Bid Approval

Sales Representer

Local Pharma Manager

Sales Representer

Project Controller

Sales Representer Project Controller

Local Pharma Manager Project Controller

Sales Representer

Contracting Manager

Sales Representer

Local Pharma Manager

Sales

Submit bid

Prepare Negotation Strategy Strategic Selling Pharma

Negotiate Bid

Customer acceptance?

High risk step

yes

yes

no

Bid Preparation

Stop

Management Control Guideline Appendix 3 Contract review checklist 2110

Generate Final Conctract

Offering-Phase Contract Negotation

Obtain Agreement On Contract

Changes in Contract?

PM 070 Project win/lost

Analyze Win/Loss & inform HQ no

Strategic Analysis Blue sheet PM070-1

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Performing Function

Reporting Output

Process

Compile Handover Documents

Review

Sales Representer

Verify Handover Documents & Address Changes out of Negotiaton

Project Manager

Project Manager

no

Documents o.k.? no

yes

Offering Phase Project Handover

Sales Representer

Process Step PM@SBT

Conduct Handover Meeting/Submit Handover Checklist

Project Manager

handover to PEx checklist PM080-1

Handover to PEx accepted?

yes

PM 080 Start Project

Pharma specific Step

Pharma specific Document

Software Category 5

Original Document of PM@SBT

Project Milestone

Ongoing Subprocess

Decision point Quality Gate

Bid Preparation 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 provide an accurate quotation. In the event that the customer does not have the capacity or skills to produce a URS, Siemens 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 addition 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 concentrated on the quality impact systems. Siemens provides a service to support the impact analysis for the customer.

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 product 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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PM@SBT Pharma – Execution Execution

Version 2.9

Execution-Phase Detail Planning

PM100

Purchasing Manufacture

Dispatch

PM300

PM200

PM400

Execution-Phase

Operating-Phase

Commissioning

PM550 PM580

Acceptance

PM650

PM590 PM600

PM700

PM670

PM570 Reporting Output

Process

Target agreement PM100-1

Enter Order/Establish PM Goals

Issue list PM100-3

Initiate / Set up Project Monitoring & Controlling

Contracting Execution Manager

Local Pharma Manager

Project Manager Project Controller

Local Pharma Manager

Audit Report Suppliers VA100-2

Audit Report Siemens VA100-3

Risk Assessment of the Projct

yes

Review

Master Validation Plan (customer) VA100-1

Training - GxP compliant

Audit Suppliers & Audit of customer

Performing Function

Project Schedule PM100-2

Finance

Early Material Requirements?

Warranty

Service

Installation

Execution

Project-Opening

Project/Validation Manager

CoC Pharma

Logistics

Obtain Deliverables from Enabling Processes

Sales

no

Project Manager

Material Requirements Resourcing Planning Engineering Subcontract Procurement

Project Change Management Minutes of the meeting PM100-5

Claim Management ”Contract Management” Kick off meeting with the customer

Refine URS

Project Manager

Validation Guideline CM1 10820

Pharma Specialist Project Manager

Revision Risk Assessment

Local Pharma / Validation Manager Customer

yes

Effect of Offer

no

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Project Opening

Execution-Phase

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

Create Project & Quality Plan “Define” Work Packages

PSQP VA100-4

Project Manager

Local Pharma / Validation Manager

Project Manager Pharma Specialist

Local Pharma / Validation Manager

Project Manager

Local Pharma / Validation Manager

Time schedule PM101-4 Release Work Packages (Design) PM 100 Entry Order Clarified (Quality Gate)

Work Package PM100-6

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Reporting Output

Process

Functional Spec. VA200-1

Create Functional Specification

HW Design Spec. VA200-3

Create Hardware Hardware Test Design Specification Specification

HW Test Specification VA202-3

Create Software SW Test Design Specification Specification

no

SW Design Spec. VA200-4

Software Software Module Module Test Design Specification Specification

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

Local Pharma / Validation Manager Customer

Project Manager

Local Pharma / Validation Manager Customer

Project Manager

Customer

SWCL VA201-4

SW Module SW Module Design Test Specification Specification VA200-5 VA201-5

Establish & maintain traceability matrix

SW Module Integration Test Spec. VA200-6

no approval

Contract Management

yes

Review

SW Test Specification VA202-4

Create Acceptance Test Specification (FAT, SAT)

Ready to submit to customer?

HWCL VA201-3

Performing Function

System Integration Test Spec. VA201-6

Factory Acceptance Test Specification VA200-7

Site Acceptance Test Specification VA200-8

Obtain Approval

Traceability matrix VA200-2

Detailled Planning

Execution-Phase

Project Manager Pharma Specialist

Perform Design Review

DQ VA200-9

Release Work Packages (Technical Execution)

Work Package VA200-2

Project Manager

Deviation List VA300-9

Training List VA300-10 Code SW modules

Build/ assemble HW/ Peripherals

SW Module Test Report VA300-4 Test SW modules

Test HW/ Peripherals

Test SW Modul / System Integration

Test integrated SW code

Project Manager Pharma Specialist

Local Pharma / Validation Manager Customer

Project Manager

Project / Validation Manager

Project Manager

Project / Validation Manager

Service Engineer

Project / Validation Manager

Project Manager

Project / Validation Manager

Signature List VA300-11

Code Review VA300-1

Perform SW code reviews

Purchasing Manufacture

Local Pharma / Validation Manager Customer

PM 200 Approval of detailed planning

Purchasing & Manufacture

Execution-Phase

Project Manager

SW Module Integration Test Report VA300-5

SW Integration Test Report VA300-6

HW Test Report VA300-7 Service Engineer Test integrated SW code Report VA300-8

Factory acceptance Test (FAT)

Factory Test Report (FAT) VA300-3

Field Service Engineer

Project Manager

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Reporting Output

IQ – Specification VA550-3

Install HW/ Periperhals

Install SW

Project Manager Pharma Specialist

Local Pharma / Validation Manager Customer

OQ – Specification VA550-4

Erection/Installation

Installation

Review

Project Manager

Dispatch

PM 400 Material & Resources at Site

Commissioning

Performing Function

Calibration

PM 550 Erection Completed

Configuration Management Plan VA550-1

Project Manager

Check Sheet to comply with the requirements PM550-1

Field Service Engineer

Project Manager

Calibration Documentation VA550-2

Field Service Engineer

Project Manager

Commissioning

Service

Dispatch

Process PM 300 Dispatch approval

Field Service Engineer Test SAT Report VA590-1

Perform System Acceptance Testing (SAT)

Field Service Engineer

Project / Validation Manager

Pharma Specialist

Project Manager

Field Service Engineer

Project / Validation Manager

Field Service Engineer

Project / Validation Manager

Project Manager

Local Pharma Manager

Project Manager

Local Pharma Manager

PM 570

Test HW/SW Peripherals (IQ)

IQ-Test Plan / protocol VA580-1

IQ-Report VA580-2

Change Control

OQ-Plan / protocol VA590-1

HW/SW Peripherals OQ

OQ-Report VA590-2

PM 590 OQ released

Training of Operator PM 600 Release to Acceptance

Initiate Completed Work Review

Sales

Execution-Phase Qualification

PM 580 IQ released

Training - GxP compliant

Execution

Mechanical Completion

Punch list PM650-1 Review Completed Work with Customer

Project Closure Checklist PM650-2

Request acceptance Review PM650-3

Punch list items?

yes

Supplier Evaluation Assessment PM650-4

Generate Punch List no

Project Manager Monitoring & Controlling Prepare Validation Report

Final Validation Report (Customer)

Customer

Obtain Customer Acceptance

Acceptance Test Protocol PM650-5

Project Manager

Execution Phase Acceptance

PM 650 Customer Acceptance

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Submit Certificate to Finance Department

Local Pharma Manager

Acceptance Certification PM650-6 Finance

Project Manager Transmittal Confirmation PM650-7

no

Project 100% complete?

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yes

Performing Function

Reporting Output

Process

Review

Service Lead Generation

Demobilize Project Site

Qualifying & Verification

Project Manager

Compile Handover to Service File

Project Manager

Conduct Site Visit

Project Manager

Project Manager Customer

Meeting Customer (Lessons Learned)

Local Pharma Manager

- Punch list closed - handover service checklist PM670-1 Project Manager

Handover to Service

PM 670 PEx Handover Accepted

Open Warranty Account

Project Controller

Service Execution

Operating Phase Warranty

Monitoring & Controlling

Process Step PM@SBT

warranty closure communication

Close Warranty Account

Project Controller

PM 700 End of Warranty

Pharma specific Step

Pharma specific Document

Software Category 5

Original Document of PM@SBT

Project Milestone

Ongoing Subprocess

Decision point Quality Gate

Project Opening Audit An activity to determine through investigation the adequacy of, and adherence to, established procedures, instructions, specifications, codes, and standards or other applicable contractual and licensing 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 Technologies will fulfil both Siemens and customer 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.

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Detail Planning Hardware Design Specification (HDS) The Hardware Design Specification is to specify and document the choice of control and electric components. The Hardware 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 Configuration List is to have a detailed document of: The firmware versions, internal hardware settings through jumpers and switches, 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 configuration drawing in the document. This Hardware Configuration List is an appendix to the hardware design specification, 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 systematic verification that the requirements defined during specification are completely covered by subsequent specification or implementation.

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Purchasing Manufacture

Qualification

Factory Acceptance Test (FAT) The Factory Acceptance Test (FAT) is executed after completion of system implementation 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 correct 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 executed with the original system equipment and can be supported with the help of simulated processes and test programs.

Installation Qualification (IQ) This is a documented verification that all key aspects of hardware installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered.

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 purpose 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) demonstrates that the system is working in its operational environment and interfaces with instruments and equipment. The SAT normally constitutes a repeat of elements of the FAT in the user’s operating environment plus those tests made possible with all process, field instruments, interfaces and service connections established. The SAT may be combined with equipment and plant commissioning, and this will provide a basis for OQ.

IQ Protocols should include ■ Documentation – introduction, objective, signature record, abbreviation and definitions, documentation checks, conclusions and approvals. ■ Hardware – drawing information, major hardware components, locations, pre-start hardware checks. ■ Software – software version numbers, service pack number. Pre-start application software checks. ■ Installation procedures – installing the software on the target hardware platform. ■ Calibration – schedules, certificates. Operational Qualification (OQ) This is a documented verification that the equipment-related system or subsystem performs as intended throughout representative or anticipated operating ranges. OQ Protocols should include ■ Documentation – introduction, objective, signature record, abbreviation and definitions, documentation checks, conclusions and approvals. ■ Hardware – digital input/output tests, analogue input/output tests. ■ Software – system security tests, computer functionality tests, operator control 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.

Note: Siemens Building Automation is normally not directly involved in PQ. IQ/OQ Report: After the tests of all test phases are executed 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 Deviation 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 project, 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 outcome of activities defined in the validation plan.

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PM@SBT Pharma – Service Service

Version 2.9

Service-Phase Lead-Generation

Qualifying & Verification

BT410

Proposal Generation

BT420

Service Negotiation

BT430

BT440

Service-Phase Handover & Execution

Service Execution

Service Settlement

BT450

Include Lead in Service Sales Funnel (Prospect List)

Check Compain Data for Prospect / Customer

Indentify Key Customer Prospect Contacts

Service Manager

Local Pharma Manager

Service Support

Local Pharma Manager

Service Supervisor Sales Rep.

Local Pharma Manager

Service Sales Rep.

Local Pharma Manager

Service Sales Rep.

Local Pharma Manager

BT 410 Target Leads Identified

Lead Approval required?

Obtain approval

yes

no

no

Service Sales Rep.

yes

Arrange Customer / Prospect Contractor Visit

Inform Customer

Service Sales Rep.

Local Pharma Manager

Service Sales Rep.

Local Pharma Manager

Service Sales Rep.

Local Pharma Manager

Inform Customer about no go

Service Sales Rep.

Local Pharma Manager

Negotiation

Service Sales Rep.

Local Pharma Manager

Subcontract Procurement

Service Sales Rep.

Local Pharma Manager

Prepare customer / prospect visitor contact (in line with segment and opportunity)

Sales

Service-Phase Service Lead Generation

Check Handover Checklist for Prospect / Customer

Service Sales Funnel Tool PM410-2

Review

Service

Handover to Service PEx checklist PM410-1

Assign Service Sales Resource

Performing Function

Execution

Reporting Output

Process

Customer Mapping PM420-1

Analyze business opportunity & recognize customer needs Linked with SBT capabilities

Qualification Profile PM420-2

Cover the Customer/ Prospect Buying Center & Determine preliminary scope

Continue with business opportunity

no

yes

Service-Phase Qualifying & Verification

Outline Service offering & Review/submit SBT capabilities

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Confirm Service offering Scope with customer

Scope confirmed Sufficient Data

no

Service Sales Rep.

yes

Complete Qualification Profile BT 420 Qualified profile reviewed & verified Customer Offering

Service Sales Rep.

Local Pharma Manager

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Reporting Output

Process Service Settlement (in case of existing customer)

Review

Service Sales Funnel Tool PM430-1 Service Sales Rep.

Request for Proposal from existing customer's only

Receive and Check request for Service Proposal

Prepare Service Proposal incl. Quotation

Service Sales Rep.

Pharma / Validation Manager

Submit/Present Service Proposal

Service Sales Rep.

Local Pharma Manager

Negotiation Service Proposal Pharma

Service Sales Rep.

Local Pharma Manager

Review Service Proposal

Service-Phase Proposal Generation

Performing Function

Service Value Proposition Card PM430-2

no

Proposal Complete Customer Requirements Solution Matrix PM430-3

yes

BT 430 Proposal Submitted to customer

Adjustment Required

yes

Qualifying & Verification

US Service Sales Funnel Tool BAU PM440-1

Service Sales Rep.

Service contract Handover checklist PM440-2

Service Sales Rep.

no

yes

Review Service Contract Signed by Customer

Pharma Manager Project Controller

BT 440 Signed Contract

Service Sales Rep.

Service Negotiation

Service-Phase Service Handover Execution

Service-Phase

Customer Modifications to Proposal

Process Step PM@SBT

no

Register Service Contract in IT System

Analyze Win/Loss & inform HQ

Service Support

Service Support Sales Rep.

Send Confirmation and Copy of Contract to customer

Compile Handover Documents

PART11 Audit Consulancy

Verify Handover Documents & Address Changes out of Negotiation

URS Consulancy

Conduct Handover Metting / Submitt Handover Checklist

Service Sales Rep.

Service Sales Rep.

On-Call

Service Planning

Service handover to PEx checklist Service Sales Rep.

Impact Analysis VA-450-1

Risk Assessment VA-450-2

Pharma specific Step

Pharma specific Document

Software Category 5

Original Document of PM@SBT

Project Milestone

Ongoing Subprocess

Decision point Quality Gate

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Service Lead Generation

Service Negotiation

The Lead Generation step in the service sales process includes activities that lead to prospecting for customers and covering their potential needs. A strategy is planned based on these needs and questions and implications are prepared for use during this phase.

The NEGOTIATION step involves obtaining 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.

Qualifying & Verification

Service Handover Execution

The QUALIFYING step of the service process 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 consultation with the customer, the Custo mer Requirement Solutions Matrix is used to quickly highlight applicable solutions to address those needs. The VERIFICATION step confirms the importance of the customer’s needs or requirements. Potential services are positioned 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

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 vironment 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 assessment, 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 maintaining 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

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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

www.siemens.com/buildingtechnologies-pharma

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