1 cdms – implementing documentum compliance manager 5.2.5 american pharmaceutical partners august...

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


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.


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


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.


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

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Project Overview


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


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


Project Timeline

April May June July August September

Analysis

Design and Develop

Testing

Roll Out

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Current State


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)


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


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

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Client PCSchaumburg

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Client PCNew York

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Client PCMelrose Park

Schaumburg Data Center


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


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


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.


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


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

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Future State


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)


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)


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

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Client PCSchaumburg

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Client PCNew York

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Client PCMelrose Park

Schaumburg Data Center


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


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


Example WDK Configuration - Before


Example WDK Configuration - After


Example WDK Extension - Before

My Approvals Screen


Example WDK Extension - After


Example WDK Extension


Example WDK Custom Component


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?


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


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.


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


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?


Questions

Paul [email protected]

Jonathan [email protected] ext. 262

1 cdms – implementing documentum compliance manager 5.2.5 american pharmaceutical partners august...

Documents

controlled environment

medical products

sites6000 controlled

system statistics

associated products

turnkey computer system

specific indications

medical community