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MWDUG Managing Quality Assurance Documentation at Astellas

MWDUG Managing Quality Assurance Documentation at Astellas. February 28, 2008. Introduction. Astellas Pharma US, Inc. (formerly Fujisawa in the Chicago area & Yamanouchi in the New Jersey area) is in the top 20 pharmaceutical companies in the world.

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MWDUG Managing Quality Assurance Documentation at Astellas

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  1. MWDUG Managing Quality Assurance Documentation at Astellas February 28, 2008

  2. Introduction Astellas Pharma US, Inc. (formerly Fujisawa in the Chicago area & Yamanouchi in the New Jersey area) is in the top 20 pharmaceutical companies in the world. World headquarters are in Tokyo, Japan. US headquarters are in Deerfield, IL. Marketed Products:

  3. Presentation Overview • QA & Documentum Background • New System Analysis • ADMS 2.0 Implementation • Lessons Learned • Future

  4. QA Document Managementat AstellasYesterday’s Story

  5. QA Doc Management Needs Process Issues • Forms and Work Instructions are not managed within a consistent process • Manual review process • Unclear review and approval requirements • System is not validated • No centralized location for other quality documents Limitations of the current system • Not validated • No audit trail • No repository function • Document life cycle managed manually • Configuration of the entire system in order to add other document types

  6. Project Mission To implement a validated document management system which will assist Quality Assurance in: • Maintaining documents at all document life cycles within a centralized system; • Managing change control for Astellas procedural documents (SOP, Work Instruction, Form, etc); • Publishing Documents through the intranet and providing enhanced document search capability, and • Reduce substantial amount of manual operations in the process of document creation and revision.

  7. New System Analysis

  8. Project ApproachPhase I Analysis • User Requirements (URS) • Functional Requirements (FRS) • Prototype • Hardware / Software Analysis • Implementation Cost Analysis

  9. Project ApproachPhase II Implementation • System Design • System Development • System Unit Test • System Validation • Production Deployment • Migration of Existing QA Documents

  10. ADMS 1.0 Starting Point • Infrastructure • Development, Quality, Production environments • Documentum User Licenses • Functional Components • Document Creation and Editing • Automatic PDF Rendering • Route for Review w/ Electronic Annotation • Route for Approval w/ Electronic Signature • Full Text Searching • ADMS 1.0 requirements have already been validated

  11. ADMS 2.0 New Requirements • Functional Components • Change Control • Effective & Obsolete Document Status • Document Numbering • Periodic Review • Watermarking • External Site Caching

  12. ADMS 2.0Implementation

  13. Electronic Approval versus Final Documents Electronic Workflow • APUS QA Procedural Documents Final Documents • Astellas Final Documents • Business Procedural Documents Two Paths in ADMS

  14. QA Document Lifecycle

  15. Change Control • CR form automatically created and linked when a new document or new major version of a document is created within the system

  16. Change Control • Word template used for basic CR form

  17. Documentum Relationships • Document and CRs are linked using Documentum Relationships

  18. Document Numbering • Once the document and change request are checked in, both the document and the change request are auto-numbered • <Document Type>-<Department>-<Number> (i.e. WPD-QA-001) • CR-<Number> (i.e. CR-0001)

  19. Watermarking Tool • Evaluated multiple solutions • PDFaqua • Custom Solution utilizing 3rd party PDF libraries • PDFaqua Selected • Integrates directly with Documentum to provide configurable watermarking overlays • Scalability: Allows for future additions of new departments, document types, and watermark layouts • Support: Support provided by Liquent • Astellas IT Standards: More out-of-box, Less customization

  20. Document Watermarks • Documents headers dynamically applied to Documents and Change Request forms when the PDF is viewed within the system

  21. Document Watermarks • Watermarks dynamically applied according to document state

  22. Document Watermarks • “For Training Only” Watermark dynamically applied to documents Approved but not yet Effective

  23. Electronic Review • Documentum Annotation Services

  24. Electronic Workflow • Electronic Signatures are used in ADMS to replace handwritten signatures

  25. How does a document become Effective? • When a document is Approved, the system calculates the Effective Date by adding the Training Period to the Approved Date Effective Date = Approved Date + Training Period • When the Effective Date for a document is reached, the system promotes the document to the Effective lifecycle state and publishes to the external interface

  26. External Interface • User friendly interface that provides search and retrieve functionality for documents outside of Documentum • Initial scope: SOPs, Forms, and Working Practice Documents • Documents cached outside of Documentum for quick access • Links directly to Documentum • Approved (Training) and Effective documents added/removed automatically by Documentum • Document content and properties are exported • Accessed via Company Intranet Site

  27. Search Screen • Search by Document Property or Key Word

  28. Search Results

  29. Viewing a Document • Documents are displayed with PDFaqua Watermarks

  30. Periodic Review • System initiates periodic review workflow periodic review date of a document is approaching

  31. Document Migration • Documents were manually migrated from existing system into Documentum • Approximately 300 documents • Documents were reviewed, re-formatted and revised if necessary as part of the migration process

  32. Lessons Learned

  33. Lessons Learned • Using Out-of-box system components allowed features such as PDF rendering, Watermarking, Full Text Searching were easily expanded to include new scope of documents. • Documentum trained personnel required to adequately support system • Efficiencies were gained by having project team members already familiar with Documentum technology and implementation (IT management, QA Validation, IT Developers, System Users)

  34. Lessons Learned • Timeline was delayed several times due to critical issues. Clear definition and understanding of validation process is necessary to work through issues quickly • DMCL performance on LINUX Content Server • Full Text Server issues once large number of documents are indexed

  35. Looking Aheadwith Documentum

  36. Upcoming Initiatives • Integration with Training • Electronic Review and Approval of Promotional Material Packages • Integration with the global document management system

  37. Questions?

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