Bayer Healthcare Pharmaceuticals in Research and Development. Oliver Mende, MBA, PMP

Transcription

1 Bayer Healthcare Pharmaceuticals in Research and Development Oliver Mende, MBA, PMP

2 Agenda Project Overview GxP meets Collaboration Page 2 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

3 Project Motivation From Here Research & Development edms 5.3 SP2 Page 3 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

4 To There Research & Development edms 5.3 SP2 CSC FirstDoc V Documentum 6.5 SP3 Page 4 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

5 ShareDoc Project: Business Drivers Uniform edms across R&D Consolidate system landscape System with best practice functions (R&D, TMF) Reduced costs (business, IT) TMF Trial Master File R&D Research & Development Ensure compliance with less effort Single source of reference (efficient & reliable document retrievals) Reduced process complexity increased efficiency Fast global access to documents (e.g. for submissions, audits etc.) Evolving need for collaboration Internal (simultaneous co-authoring to speed up document processes) External (specific and controlled shared document access, flexible) Page 5 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

6 ShareDoc: The R&D edms For BHC Usage of CSC FirstDoc modules R&D, TMF Validated system GxP relevant Highly standardized inventory structure (purely property driven) Typical edms features (version control, workflows, lifecycles, controlled access) Collaboration support Usage of CSC FirstDoc CRX (SharePoint based) Internal: enable efficient simultaneous co-authoring on one document External: enable controlled joined access for external users Two user interfaces : CSC FirstDoc Webtop - Full range of edms options - Power Users R&D Research & Development TMF Trial Master File SPX SharePoint Experience CRX - Collaborative Review Xperience GxP - Good Practice Quality guidelines SharePoint (SPX) - Can be streamlined to specific needs - Special views for users - Direct access to Content Server Page 6 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

7 Key Challenges Business Challenges Stakeholder to accept standardization in edms processes Manage expectations of navigators (MS Windows Explorer users) versus searchers Properties / Master Data: consolidation and mapping to new data model IT Challenges Migration: conflicts with ongoing business (e.g. key submissions) Full collaboration support and internal IT regulations Page 7 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

8 Project Management Aspects Key success factors Compact project team with members from Business functions, IT functions and CSC Good cooperation between CSC and IT functions during implementation and configuration phase Intense global Stakeholder involvement from the very beginning (feasibility, vendor selection, concepts, configuration, testing) Clear project definition endorsed and monitored by Management High level project plan Q2 / 2010 Q3 / 2010 Q4 / 2010 Q1 / 2011 Q2 / 2011 Q3 / 2011 Q4 / 2011 Q1 / 2012 Q2 / 2012 Prep. Approval Kick Off Concepts, Config, User Testing Vali Validated System Migration Migration Validation Roll Out Go-Live Retirement Page 8 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

9 Advantages of Best Practice Approach Predefined Document types for pharmaceutical documents with predefined properties (e.g. studies, submissions, ) Reduction of development timelines Standard retrieval using searches or navigation Predefined workflows Page 9 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

10 GxP Meets Collaboration CSC FirstDoc is a controlled repository for GxP regulated systems Based on EMC² Documentum Strict security, document lifecycle, workflows, Audit trail Highly scalable, distributed environment Validated SharePoint is the state-of-the-art collaboration platform Standard look & feel Good integration into Office and Outlook Single-Sign-On ShareDoc uses the best of both worlds! Page 10 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

11 Standard user interface Documents are stored in a controlled environment Working copy is checked out to user s PC Classic Webtop and SharePoint (SPX) user interfaces Controlled Environment Uncontrolled Environment Page 11 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

12 Webtop and SharePoint (SPX) CSC FirstDoc Webtop Inbox for Approvers SharePoint (SPX) Documentum Content Server Page 12 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

13 Co-authoring with SharePoint (CRX) Document is checked-out into a SharePoint workspace Authors can work on the document simultaneously Non-system users can participate Result of collaboration is returned back into controlled environment on behalf of the coordinator Controlled Environment Collaborative Environment Page 13 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

14 ShareDoc Architectural Overview Page 14 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

15 Extensible Platform EMC² Webtop CSC SPX SharePoint Experience CSC CRX Collaborative Experience TMF R&D Q&M M&S Trial Master File Research & Development Quality & Manufacturing Marketing & Sales CSC FirstDoc Enterprise Layer EMC² Documentum Microsoft SharePoint *The trademarks mentioned in this presentation are registered trademarks of their respective owners and are used here solely for the purpose of specifying quality and purpose. Page 15 Bayer Healthcare Pharmaceuticals in Research and Development November 1, 2011

16 Thank You! Oliver Mende, MBA, PMP Bayer Healthcare Pharmaceuticals