This information is proprietary and confidential Global Document Management System Midwest Documentum Users Group February 26, 2004

This information is proprietary and confidential

Global Document Management System

Midwest Documentum Users GroupFebruary 26, 2004

2This information is proprietary and confidential

GDMS Program Background:History

Q1 Q2 Q3 Q4

The Global Documentation Program (GDP) Strategic Plan Update was approved

GDMS Phase I certified and launched (9/26)

2003


GDMS Program Background:Quality Initiative

Global Quality System

Global Documentation Program

8 Abbott Quality

InitiativesValidation Training GQMSPart 11 Complaint SQA

Data andDocument Standards

e-Sub

Global DocumentationManagement System


GDMS Program Structure

GDMS

e-Sub VMS QMD


GDMS Program Vision: Organizational Scope

Pharma Products Corporate Medical Products

GPRD GPO

HumanResources

Legal

CRQS F&A ADD

Medisense RPD

SpinalConcepts

VascularDevices

AnimalHealth

MolecularDiagnostics

FinishedGoods

HumiraExpansion

Quality

GlobalEng.

IT Controller

API

MfgOpt.

GlobalSupply

Global MfgStrategy

HumanResources

PublicAffairs

PharmaDev.

Dev.Mgmt

PharmaDiscovery


GDMS Program Vision: Functional Scope

Service

• CustomerLetters

• Technical ServiceBulletins

Sales& Mktg

• PromotionalMaterials

• ProductTrainingMaterials

Mfg

• Product Specs

• Material Specs

• Packaging

• Drawings

• Testing

Clinical

• Clinical

• Non-clinical

• Regulatory

• Quality

• Labels

Pre-clinical

• Regulatory

• Lab TestResults

• Tox Info

Discovery

• Lab TestResults

• Validation

• Policies

• Procedures

• Templates

• Training

• Forms

• Reports

• Network Diagrams

• Safety

• Information Technology

• Contracts / Agreements

• Management Reviews

• Change Requests

• Software Dev. Life Cycle

• Organization Charts

• Reference Manuals

• Purchase Orders

• Vendor Manuals

• Audit Information

• Job Descriptions

Abbott Product Life Cycle

Exa

mpl

es o

f In

form

atio

n S

uppo

rted

Product Life Cycle Aligned

Abbott-wide


Common Web Interface

Single Pointof Access

Business- focused Tailoring / Configuring

Highly Tailorableto Business Need

GDMS Program Vision:Design Criteria and Architecture

Co

mm

on

Tra

inin

g

Common / Shared Servers and Storage

Common Database

Common / Shared Software

Scalable

Part 11 Compliant

DocumentumPartnership

Co

mm

on

SO

Ps

Discovery Pre-Clinical Clinical Manufacturing Sales & Mktg

Document Management

ContentManagement

Search &Retrieval

ChangeRequest

Electronic

Approval

Security Publishing

AuditTrail

ImpactAnalysis

Header /Footer Reporting

SystemIntegration

Rendering Watermarking

Review &CoreFunctionality


GDMS Phase I: Architecture

Common / Shared Servers and Storage

Common Database

Common / Shared Software

Common Web Interface

Co

mm

on

Tra

inin

g

Co

mm

on

SO

Ps

Infrastructure GDMS Core

Document Management

ContentManagement

Search &Retrieval

ChangeRequest

ElectronicReview /Approval

Security Publishing

AuditTrail

Rendering

Business-focused Tailoring / Configuring

QMD Quality VMS e-Sub

GDMS Sy

stem

Certifi

ed

9/26

/03


GDMS Phase I:Organizational Scope

Pharma Products Corporate Medical Products

GPRD GPO

HumanResources

Legal

CRQS F&A ADD

VascularDevices

RPD

SpinalConcepts

Medisense

AnimalHealth

VysisFinishedGoods

HumiraExpansion

Quality

GlobalEng.

IT Controller

API

MfgOpt.

GlobalSupply

Global MfgStrategy

HumanResources

PublicAffairs

PharmaDev.

Dev.Mgmt

PharmaDiscovery

GDMS Phase I Planned Deployment andSupporting At Least 1 Business Information Need

1 or More Business FunctionsHave Requested GDMS Information


ServiceSales

& Mktg Mfg Clinical Pre-clinical

GDMS Phase I: Functional Scope

Discovery

• Regulatory • Clinical

• Non-clinical

• Regulatory

• Quality

• Product Specs

• Material Specs

• Packaging

• Drawings

• Testing

• Validation

• Policies

• Procedures

• Templates

• Training

• Forms

• Reports

• Network Diagrams

• Safety

• Information Technology

Abbott Product Life Cycle

Exa

mpl

es o

f In

form

atio

n S

uppo

rted

Product Life Cycle Aligned

Abbott-wide


0

5

10

15

20

250

22

17

12

7

2

GDMS Phase II:Priorities Based upon QMD Needs

Avg. Rankof 22

Requirements


0

2

4

6

8

10

12

14

Man

age F

orm

s

Docum

ent A

ssoic

ation

s

Effect

of N

ew Pro

perti

es

Lock

ed D

ocum

ents

Perio

dic R

evie

w

Templ

ate

Verific

ation

Confid

entia

l Doc

umen

ts

Wate

rmar

king

Subsc

riptio

ns

Publis

hing

Produ

ct In

dex

Form

Prin

ting

Accou

ntab

ility

High

Volum

e Sca

nnin

g

Pendin

g Docu

men

t Rele

ase

Mul

it-La

nguag

e

16

22

18

20

14

12

10

8

GDMS Phase III+:Future Priorities

Avg. Rankof 22

Requirements


GDMS Phase II:ScopeHeaders and Footers – headers and footers automatically

applied to a document

Enhanced route, review and approval – ability to route a change package for approval and generate an electronic differences document

Distribution – automatic message for document promotions or changes

Update to properties – ability to update selected properties after document approval

Reporting – metrics

Impact analysis – saved searches

Multi-site effectivity – site-specific implementation dates for corporate/division documents


GDMS Program Benefits

Avoid Part 11 remediation costs on 50 – 200+ systems

One system, one look for all – common system procedures, training, user guide

Easily tailored to support changing business needs (configurability)

Phased approach aligned with business priorities

There is an end point - Abbott-wide availability


Hardware

•1 Documentum Docbase•2 Web Servers•8 Citrix Servers•8 Core Dossier Generators


Layered SoftwareDocumentum WebTop 5.1 WDK 5.1 (Customized)Oracle 9.2BEA WebLogic Application Server v7.0Liquent CoreDossier v5.5InfoData AnnodocCitrix Server

•Adobe Acrobat v5.05•Internet Explorer v5.5•Visio Professional 2000 •MS Office 2000 Standard


Validation Review Board

Technical Project Manager

SQA Manager

SQA Client Manager

Project Librarian

Business Systems Analyst

System Architect

Integration Lead

Technical Team Manager

(support team)

Technical Lead

Developer

Validation Lead

Validation Analyst

Development Team

Validation Team

Tester

Technical Team Structure

24 Validation Analysts

13 Developers

3 Technical Leads

5 Business System Analysts

2 Project Managers


Documentum Data Model

Client Data•Extension of a Documentum Document Object

(dm_document) Global Inheritance (Abbott Layer) Family Layer (eSubs, VMS and QMD) Category Layer

• eSubs – 4 • VMS – 1• QMD – 12

Document Type Layer• eSubs – 28 • VMS – 18• QMD - 46

System Data (used to support the client model)•Extension of Documentum Folder Object•Extension of Documentum Configuration Object


WebTop Customizations

Replaced the WebTop property presentation with a custom configuration and presentation service. •Use of Documentum managed XML configuration files which

control property and state filters. •Used to control document creation location•Security around who can process the data (app context)•Completely replaced the search component.

These are all items that can be managed by the Documentum product within the Documentum product. •Dynamically retrieve the XML configuration files from the

Docbase.•Qualified the Documentum product (Developer Studio,

Workflow Manager) for use as configuration engines.


Property Page Configurations

Order of Properties

Update vs. Read-only

Required Fields

Property Labels


Search Screen


Library ServicesWhat is Library Services?A set of distinct action oriented programming

functions.Each object in the library is validated (Input ->

Output)Through a configuration object, these services

can be chained together to produce business logic. •Lifecycle Activities•Workflow Activities and Processes•Electronic Signatures•Auditing


LibraryModule A

Library Services

Module B

Module C

Module D

Module E

Module F

Module G

Module H

Module AModule H Module GModule CXMLBy building this, the result is that you can pick

and choose any combination of services to formulate new business rules.


XML Configuration

Library Services Example

When the final approver approves the document, a set of library services are called

Change Document security

Generate Major

Version

Promote to Approved

Delete Minor Versions

This information is proprietary and confidential

Questions?

Documents

This information is proprietary and confidential Global Document Management System Midwest Documentum Users Group February 26, 2004