CDMS

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
• gt20 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
• gt6000 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
• Everythings 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

• Its 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_at_appdrugs.com
• 847-330-1244
• Jonathan Paetsch
• jonathanp_at_tsgrp.com
• 312-372-7777 ext. 262