Project Management in the Pharma Industry based on PM@SBT Building Technologies 41557_PMS_Brochure_en2.indd 1 s 30.10.
41557_PMS_Brochure_en2.indd 2 30.10.
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.
PM@SBT Pharma – Sales Sales Version 2.
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.
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.
PM@SBT Pharma – Execution Execution Version 2.
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.
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 Proj
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
Detail Planning Hardware Design Specification (HDS) The Hardware Design Specification is to specify and document the choice of control and electric components.
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.
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.
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.
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.
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.
