CDMS – Implementing Documentum Compliance Manager 5.2.5

1. CDMS – ImplementingDocumentum Compliance Manager 5.2.5 American Pharmaceutical PartnersAugust 30, 2005

2. Agenda • Company Background • Project Overview • Current State • DocControl Manager 1.4.3 • Challenges and Lessons Learned • Future Release • Documentum Compliance Manager (DCM) 5.2.5 • Objectives, Approaches and Challenges • Questions

3. Who We Are… American Pharmaceutical Partners (APP) is a specialty pharmaceutical company that fulfills an important need in the medical community as a provider of a broad portfolio of injectable pharmaceutical products, including difficult to manufacture, urgently needed medical products.

4. Areas of Focus • Generic Injectables • Portfolio of more than 150 products • Focus on therapeutic areas of anti-infective, oncology and critical care • Ampicillin, Vancomycin, Cefoxitin • CARBOplatin, CISplatin, Ifosfamide • Industry leading 39 product approvals between 2001 and 2004 • Leading generic anti-infective portfolio in the industry

5. Areas of Focus • Proprietary Drugs • Abraxis Oncology Division (www.abraxisoncology.com) • Focus on protein-bound particle chemotherapeutics • Approval of Abraxane in 2005 • Next-generation taxane for treatment of breast cancer under specific indications (www.abraxane.com). • Working to expand indications in breast, lung, ovarian, head and neck, and melanoma cancers.

6. Company Background • Headquartered in Schaumburg, Illinois • Approximately 1,000 full time employees • Additional Locations in U.S., Canada and Europe • www.appdrugs.com • Completed IPO in 2001 • Trades on NASDAQ under APPX • Fundamentals • Over 400M in revenue and 50M in earnings for prior FY • >20% 5-Year annual revenue growth rate • Outlook • ~50 products in various stages of development • 4 new generic product approvals this year as of July, 2005

7. Project Overview

8. What is CDMS? • Controlled Document Management System (CDMS) • System used to manage manufacturing and operations related documentation in a controlled environment to meet quality requirements. • Change Notices • Standard Operating Procedures (SOP) • Policies • Protocols • Specifications • Test Methods • Utilizes Documentum DocControl Manager 1.4.3 and associated products. • Implemented in 2003 • First turnkey computer system for managing controlled documents at APP • Prior to system relied on combination of paper-based processes, user knowledge and some additional tracking methods (e.g., spreadsheets). • System Statistics • ~500 users across 5 sites • >6000 controlled documents

9. Project Scope • Upgrade Documentum Environment • Move to 5.2.5 version of server • Put HW/SW in place to support current Documentum products • Upgrade CDMS • Move to supported client platform • Documentum Compliance Manager 5.2.5 • Address high priority functionality requests

10. Project Timeline April May June July August September Analysis Design and Develop Testing Roll Out

11. Current State

12. DocControl Manager 1.4.3 • Product built on top of 4i core technology • WorkSpace/RightSite client • eContentServer • Content Authentication Services (CAS) • 3rd Party Components (PDFAqua) • Enhances core DCTM 4i functionality with a framework to manage controlled documents • Enhanced lifecycle functionality to facility change of controlled documents (draft, approved, implemented…) • Increased auditing capabilities • Watermarking • Make sure change occurs in a consistent and controlled manner • How does it do this? • Additional document types created in the docbase (e.g., document profiles) • WorkSpace/Intranet Client customizations (e.g., new dialogs, docbasic procedures) • Methods/Jobs (e.g., periodic review logic)

13. APP Implementation Approach • Only using WorkSpace Client • Users access through Citrix • Try to limit customization where possible • Limited Support Resources • Some are inevitable… • WorkSpace Dialog Modifications (add attributes) • Modify DocControl Manager procedures to support business rules (e.g., notification rules) • Some “custom” additions • New menu items calling new procedures • Reports

14. High Level Solution Architecture

15. Business Challenges • Getting people to work electronically • Everything’s New –how computer-literate is the user base? • Actually “enforces” standard processes – not always an easy thing for users to accept • Need adequate training and need users to follow SOPs • “This is so different than the way we used to do it..” • Document Standardization • DCM enforces use of templates • Need to convert existing documents • How should this be done? • Easy to underestimate time/cost • Electronic Routing • Who should be reviewing and approving specific documents? • Users need to manage their inbox appropriately

16. Technical Challenges • Number 1 Complaint: Performance • “It takes too long to do anything” • Citrix Deployment did not help • Many seconds just to login to Citrix • WorkSpace on Citrix is an unknown • Number of Moving Parts – WorkSpace, Server Methods/Jobs, PDFAqua • WorkSpace + DCM 1.4.3 still allows users to access a lot of functionality • Using ad-hoc routers, Move/Copy, etc. • Lot of support time spent backing out “user mistakes” • What do I need to do when business requests something outside the DCM framework? • Example – Suspend Approved Document • Customization

17. Business Lessons Learned • Need commitment to work electronically and learn the system… • Sponsorship/Champion • Adequate training and training materials • Willingness to adapt and learn • …but also need a system that is easy to use • Minimize opportunities for user error • Simplify the interface • Think about the process for managing documents • Does duplicating the paper-process make sense? • Does the product push to certain way of doing things – will it work for us? • Never let our documents enter a state of non-standardization again.

18. Technical Lessons Learned • It’s all downhill if performance is a major issue • Make sure environment is adequate to support users • Performance/Load testing • If a feature is available, you can be sure someone will try to use it • Restrict/remove functionality to prevent improper use • Are there ways to back out of mistakes appropriately • Simplify the interface • Less “clutter” on the screen • Less to remember when having to perform an action • Less opportunity to do something wrong

19. Benefits Despite the Pain… • Everything is in a centralized location for the first time • Search Ability • Always find the current version • Standardized processes • Documents changed in consistent manner • Document content is standardized • Auditing • Always know what has happened to a document • Can always find out the current state of a document

20. Future State

21. DocControl Manager 5.2.5 SP1 • Product built on top of 5.x core technology • Web Interface (Webtop) • Similar core functionality • Extend lifecycles to associate state-specific info • Approval information • Promotion details • Leverage Trusted Content Services (TCS) for auditing • How does it do this? • Additional document types created in the docbase (e.g., document class) • Extension of Webtop (e.g., extended and new components) • Methods/Jobs (e.g., periodic review logic)

22. APP Implementation Objectives • Remove Citrix – allow users to access the system directly • Duplicate customizations from 1.4.3 if they have not been incorporated into the core product • Simplify the interface and the process where possible while still trying to limit customization • WDK Configuration • WDK Extension • Typed-based Business Objects (TBOs) • Other Options (e.g., Lifecycle Action Procedures)

23. High Level Solution Architecture

24. Architecture Benefits • No longer using Citrix Servers • Appropriately sized J2EE Application Server • Allows for direct access by users • Provide support for future efforts • New Oracle Server • No longer shared with multiple oracle applications – Documentum specific • Sized based on statistics from initial implementation

25. Technical Approach – Simplifying the UI • WDK configuration • XML configuration files • JSP modification • Minimal effort • Extension of Existing Components • Modify/Create New JSPs • Extend WDK Java behavior classes • Minimal to moderate effort • Create Custom WDK Components • Add new xml/jsp/component for specific business requirement • Most effort

26. Example WDK Configuration - Before

27. Example WDK Configuration - After

28. Example WDK Configuration - Before

29. Example WDK Configuration - After

30. Example WDK Configuration - Before

31. Example WDK Configuration - After

32. Example WDK Configuration - Before

33. Example WDK Configuration - After

34. Example WDK Extension - Before My Approvals Screen

35. Example WDK Extension - After

36. Example WDK Extension

37. Example WDK Custom Component

38. Example WDK Custom Component

39. Example WDK Custom Component

40. Technical Challenges • Porting customizations from WorkSpace/Docbasic to WDK/Java • Need familiarity with WDK framework, but there is also a lot of DCM specific functionality • WorkSpace was a fat-client, is there a logical port for everything? • Search Results/Reports • Love of the right-mouse click context menu • Differences in how DCM 5.2.5 works • Business Applications, Document Classes, Lifecycle Extensions, etc. • How will existing configuration be translated to 5.2.5 • Migration utility available but not used • Example - Less reliance on workflow with lifecycle state approval in 5.2.5. How will users adjust? • Reports are not as advanced – how do we add new ones?

41. Technical Challenges - Continued • Limitations encountered when core DCM Framework is at odds with business requirement • Example – Routing documents for Obsoletion with a new CN while leaving original CN relationship intact • How easy is it to extend DCM components (private member variables, etc.) – may not be able to extend what you would like to. • In some ways it was easier to do this when everything was in docbasic – need to evaluate what was done the first time. • DCM 5.2.5 is still a new product • Keep up to date with patches • Documentation also relatively new • Takes time to come up to speed with how it works

42. Technical Challenges – Data Migration • Need to move 1.4.3 documents to new 5.2.5 model • Upgrade/Migration utility available and evaluated but no plans to use • Initial releases of the tool had some issues • Began looking at alternative means to migrate data • Plan to use migration scripts to move all data, relationships, notes, etc. • Flexibility to cleanly match new 5.2.5 object model • Business has made some changes that can be easily implemented this way (cabinet name changes, acl name changes, etc). • Also allows for transformation of Acrobat 4.x notes to Acrobat 5.x annotation format.

43. Business Challenges • How much can business bend to fit into DCM best practices? • Amount of customization required will depend directly on the answer • New interface and (some) new functionality to learn • Concepts are similar, but actions and terminology have changed in some cases • Web interface is more intuitive, but it is still new • Update SOPs and training • Conduct training and recertification

44. Conclusions • Moving to 5.x platform will provide benefits to CDMS and other applications… • Increase performance and usability • Foundation to roll-out additional DCTM applications • But make sure enough time is allocated to evaluate DCM 5.2.5 – by both business and technical users • The product provides a framework based on best practices – how much your business currently operates according to those best practices? • If you need to modify the product, what options do you have and what are the costs?

45. Questions Paul Contreras PaulContreras@appdrugs.com 847-330-1244 Jonathan Paetsch jonathanp@tsgrp.com 312-372-7777 ext. 262