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MWDUG August 30, 2006

MWDUG August 30, 2006. Integrating Document Management & Submissions Management. Table of Contents. Introduction Scenario / History Approach Solution Outcome Part II Future Conclusion. Introduction.

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MWDUG August 30, 2006

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  1. MWDUG August 30, 2006 Integrating Document Management & Submissions Management

  2. Table of Contents • Introduction • Scenario / History • Approach • Solution • Outcome • Part II • Future • Conclusion

  3. 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:

  4. Scenario / History Systems pre 2005: Electronic Submissions Local File Share (authored documents) Local File Share (electronically processed documents) Hard Copy Output

  5. Scenario / History • Systems pre 2005: • Software development in a development environment & validation in the production environment (no QA and/or Validation Environment) • Not 21 Code of Federal Regulations (CFR) compliant • No Electronic Signatures • No Version Control • No SOPs describing the document management process • No defined workflows • No defined document lifecycle

  6. Scenario / History 2005

  7. Scenario / History

  8. Scenario / History • January 2005 Departmental initiative to upgrade/implement electronic systems: • Implementation of an electronic submissions management system (software = docuBridge) • Implementation of a structured product labeling (SPL) system (software = i4i Alice) • Implementation of an electronic document management system (software = Documentum)

  9. Scenario / History • December 2005: • 1. Implementation of an electronic submissions management system (docuBridge 3.6 SP2) • 2. Implementation of a structured product labeling (SPL) system (i4i Alice) • 3. Implementation of an electronic document management system (Documentum)

  10. DocuBridge Scenario / History December 2005: Paper Format (IND, Annual Reports) Paper Format Local File Share Local File Share Electronic Format (eCTD, eIND, eNDA, etc.) Electronic Format

  11. Approach • User Requirements for the Documentum System • User Friendly • Bulk Import • Bulk Assignment of document attributes upon import • 21 CFR Part 11 Compliant • Maintain internal hyperlinks when documents are rendered to PDF • Provide a repository for archival of regulatory submissions • Interface with the docuBridge submissions management software • Minimize customizations for the first release • And have it all done in 4 months…

  12. Approach • Hardware / Software • Our approach was to use out-of-box options as possible to minimize re-work and revalidation when we upgrade in the future. • Out-of-the-box options were left enabled in most cases to allow for system flexibility and process improvement. • Use configurations rather than customizations in order to minimize development time and potential rework in future releases and upgrades. • ADTS was selected to allow for hyperlinks to render correctly in the system. We wanted to minimize rework in this area and used this technology to create and maintain hyperlinks automatically rather than manually. • Due to the inexperience of using a document management system in our area, this approach was effective since user requirements / expectations were reasonable.

  13. Approach • Hardware / Software • WebTop (5.3 SP2) • Apache Tomcat J2EE (5.0.28) • Oracle 10g • Solaris 10i • Red Hat Linux ES 4 • Microsoft Windows 2003 Server • Adobe Acrobat 6.0 • Advanced Documentum Transformation Services (5.3 SP2) • PDF Annotation Services (5.3 SP2) • Documentum Administrator (5.3 SP2) • Content Server Full Text Indexing (5.3 SP2) • docuBridge 3.6 SP2

  14. Approach • Hardware / Software • Develop a controlled code promotion and testing strategy – including development, QA and production environments and code promotion strategy. Production QA Development Check In / Promotion Criteria (Complete Validation Test & Sign of Validation Summary Report) Check In / Promotion Criteria (Complete Unit Test & Code Review)

  15. Approach • Project Team • Assemble a focused project team including subject matter experts from Regulatory Affairs and Medical Writing, full time QA resource and dedicated IT Manager and resources. • Define the business process • Create user requirements • Create functional requirements • Build design and define configurations • Build out IT infrastructure to support the system • Develop training and roll-out plan • Manage project scope

  16. Approach • Project Team • Assemble a focused project team including subject matter experts from Regulatory Affairs and Medical Writing, full time QA resource and dedicated IT Manager and resources. • Define the business process • Create user requirements • Create functional requirements • Build design and define configurations • Build out IT infrastructure to support the system • Develop training and roll-out plan • Manage project scope Project Team: 1 System Owner 1 Technical Project Manager 1 Business Analyst 1 QA Resource 1 IT Analyst 3 Consultants

  17. DocuBridge ADMS Approach Target System at the conclusion of the project 1 2 Paper Format Electronic Format

  18. ADMS Solution ADMS: • ADMS Working • Creation / Import • Workflows • Electronic signatures • docuBridge Connection • ADMS Archive • Archive submissions & correspondence • Limited access

  19. ADMS Solution ADMS: The folder structure for the working cabinet resembles the CTD submission structure. This enables the submissions personnel entering the documents to place the documents in the same location as they will appear in the submission. The folder structure for the archive cabinet will be build by the submissions personnel as submissions are made to the regulatory authorities. • ADMS Working • Creation / Import • Workflows • Electronic signatures • docuBridge Connection • ADMS Archive • Archive submissions & correspondence • Limited access

  20. Solution

  21. Solution

  22. Solution • ADMS: • Major Configuration Items: • Document Types • Document Attributes • Document Lifecycle • Workflows

  23. Solution • ADMS: • Major Configuration Items: • Document Types • Created 20 document types for the working cabinet • Created 1 document type for the archive cabinet • Document Attributes • Document Lifecycle • Workflows

  24. Solution • ADMS: • Major Configuration Items: • Document Types • Document Attributes • Created corresponding attributes for each document type. • The astellas_doc type held common attributes • Subsequent document_types held specific attributes • Document Lifecycle • Workflows

  25. Solution • ADMS: • Major Configuration Items: • Document Types • Document Attributes • Document Lifecycle • Defined a document lifecycle for all documents in ADMS • Workflows

  26. Solution • ADMS: • Major Configuration Items: • Document Types • Document Attributes • Document Lifecycle • Workflows • Three Workflows for ADMS documents • Route for Review w/ PDF annotations • Route for Submissions Ready w/ eSig • Route for Submissions Ready w/o eSig

  27. Solution • ADMS – docuBridge connector: Connector functionality: • Automatically move submissions ready documents from ADMS to docuBridge • Automatically move document attributes from ADMS to docuBridge • Allow for users to manually select documents to move to docuBridge

  28. Solution • ADMS – docuBridge connector: Connector functionality: • Automatically move submissions ready documents from ADMS to docuBridge • When a document is promoted to the “Submissions Ready” lifecycle state, the document is moved to docuBridge • Automatically move document attributes from ADMS to docuBridge • Allow for users to manually select documents to move to docuBridge

  29. Solution • ADMS – docuBridge connector: Connector functionality: • Automatically move submissions ready documents from ADMS to docuBridge • Automatically move document attributes from ADMS to docuBridge • When a document is moved to docuBridge, its attributes are also moved into docuBridge • Allow for users to manually select documents to move to docuBridge

  30. Solution • ADMS – docuBridge connector: Connector functionality: • Automatically move submissions ready documents from ADMS to docuBridge • Automatically move document attributes from ADMS to docuBridge • Allow for users to manually select documents to move to docuBridge • Provide a manual interface to move Draft documents from ADMS to docuBridge

  31. Solution

  32. DocuBridge Doc A Attribute A Attribute B Attribute C Solution ADMS – docuBridge connector: ADMS Lifecycle Paper Format Electronic Format

  33. DocuBridge Doc A Attribute A Attribute B Attribute C Solution ADMS – docuBridge connector: ADMS Lifecycle Paper Format Electronic Format

  34. Part II • ADMS v.1.2 • Update the ADMS and docuBridge document types and attributes to be consistent • Validate docuBridge against Adobe 6.0 and 7.0

  35. Part II • ADMS v.1.2 • Update the ADMS and docuBridge document types and attributes to be consistent • The first phase solely focused on developing the ADMS document types and attributes. This phase requires the document types and attributes to be synchronized between systems. • Addition of document types and properties to both systems to ensure data consistency. • Validate docuBridge against Adobe 6.0 and 7.0

  36. Part II • ADMS v.1.2 • Update the ADMS and docuBridge document types and attributes to be consistent • Validate docuBridge against Adobe 6.x and 7.x • Our corporate standard for Adobe will change to 7.x in August. We validated Adobe 6.x to include users of the SPL application that will not upgrade. We were validated against Adobe 5.x, 6.x and 7.x.

  37. Future • ADMS • Creating an interface for the management of Standard Operating Procedures (SOPs) within ADMS • Creating an interface for Validation documents within ADMS • Integration with the SPL system • Integration/replacement of the global document exchange into ADMS • Integration with the global document management system

  38. Future

  39. Conclusion • ADMS • Implementing a system in 4 months takes a dedicated team and strict management of scope. • Good requirements (both User and Functional) are the basis to managing scope. • Build an IT infrastructure for developing and promoting code for a validated application. • Using primarily out-of-the-box functionality allowed for a fast, flexible and cost-effective solution for our user base. • The new system enhanced the current business process and reduced manual steps (ADMS – docuBridge integration).

  40. Questions ?

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