Post on 11-Jan-2016
1
CDMS – ImplementingDocumentum Compliance Manager 5.2.5
American Pharmaceutical Partners
August 30, 2005
2Confidential – Property of APP
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
3Confidential – Property of APP
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.
4Confidential – Property of APP
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
5Confidential – Property of APP
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.
6Confidential – Property of APP
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
8Confidential – Property of APP
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
9Confidential – Property of APP
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
10Confidential – Property of APP
Project Timeline
April May June July August September
Analysis
Design and Develop
Testing
Roll Out
11
Current State
12Confidential – Property of APP
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)
13Confidential – Property of APP
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
14Confidential – Property of APP
High Level Solution Architecture
Win32Content Server 4.2.6
DCM 1.4.3.1cCAS 1.1.3
CDC PDFAqua
Win32Oracle 8.1.7
Win32Citrix Servers (4)
WorkSpace 3.2.10fDCM 1.4.3.1cAcrobat 4.0
`
Client PCSchaumburg
`
Client PCNew York
`
Client PCMelrose Park
Schaumburg Data Center
15Confidential – Property of APP
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
16Confidential – Property of APP
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
17Confidential – Property of APP
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.
18Confidential – Property of APP
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
19Confidential – Property of APP
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
21Confidential – Property of APP
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)
22Confidential – Property of APP
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)
23Confidential – Property of APP
High Level Solution Architecture
Win32Content Server 5.2.5 SP4
With TCS DCM 5.2.5 SP1PDFAqua 5.1
Win32Oracle 9i
Win32IBM WebSphere 5.x
DCM 5.2.5 SP1PDF Annotation Services 5.2.5 SP1
`
Client PCSchaumburg
`
Client PCNew York
`
Client PCMelrose Park
Schaumburg Data Center
24Confidential – Property of APP
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
25Confidential – Property of APP
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
26Confidential – Property of APP
Example WDK Configuration - Before
27Confidential – Property of APP
Example WDK Configuration - After
28Confidential – Property of APP
Example WDK Configuration - Before
29Confidential – Property of APP
Example WDK Configuration - After
30Confidential – Property of APP
Example WDK Configuration - Before
31Confidential – Property of APP
Example WDK Configuration - After
32Confidential – Property of APP
Example WDK Configuration - Before
33Confidential – Property of APP
Example WDK Configuration - After
34Confidential – Property of APP
Example WDK Extension - Before
My Approvals Screen
35Confidential – Property of APP
Example WDK Extension - After
36Confidential – Property of APP
Example WDK Extension
37Confidential – Property of APP
Example WDK Custom Component
38Confidential – Property of APP
Example WDK Custom Component
39Confidential – Property of APP
Example WDK Custom Component
40Confidential – Property of APP
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?
41Confidential – Property of APP
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
42Confidential – Property of APP
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.
43Confidential – Property of APP
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
44Confidential – Property of APP
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?
45Confidential – Property of APP
Questions
Paul ContrerasPaulContreras@appdrugs.com847-330-1244
Jonathan Paetschjonathanp@tsgrp.com312-372-7777 ext. 262