Global Document

Management System
Midwest Documentum Users
Group
February 26, 2004

This information is proprietary and confidential

 GDMS Program Background:
History

The Global Documentation Program

(GDP)
Strategic Plan Update was approved
2003

Q1 Q2 Q3 Q4

GDMS Phase I certified and launched (9/26)

This information is proprietary and confidential

2
 GDMS Program Background:
Quality Initiative

Global Quality System

8 Abbott
Part 11 Complaint SQA e-Sub Validation Training GQMS Quality
Initiatives

Global Documentation Program

Global Documentation Data and

Management System Document Standards

This information is proprietary and confidential

3
 GDMS Program Structure

GDMS

e-Sub VMS QMD

This information is proprietary and confidential
4
 GDMS Program Vision:
Organizational Scope

Pharma Products Corporate Medical Products

GPRD GPO

Pharma Finished Humira Molecular

API Quality CRQS F&A ADD
Discovery Goods Expansion Diagnostics

Pharma Global Human Human

IT Controller Legal Medisense RPD
Dev. Eng. Resources Resources

Dev. Mfg Global Global Mfg Public Spinal Vascular

Mgmt Opt. Supply Strategy Affairs Concepts Devices

Animal
Health

This information is proprietary and confidential

5
 GDMS Program Vision:
Functional Scope
Abbott Product Life Cycle
Sales
Discovery Pre-clinical Clinical Mfg Service
& Mktg

Product Life Cycle Aligned

• Lab Test • Regulatory • Clinical • Product Specs • Promotional • Customer

Information Supported

Results Materials Letters

• Lab Test • Non-clinical • Material Specs
Results • Product • Technical
• Regulatory • Packaging
Examples of

Training Service
• Tox Info
• Quality • Drawings Materials Bulletins
• Labels • Testing

Abbott-wide
• Validation • Forms • Contracts / Agreements • Reference Manuals
• Policies • Reports • Management Reviews • Purchase Orders
• Procedures • Network Diagrams • Change Requests • Vendor Manuals
• Templates • Safety • Software Dev. Life Cycle • Audit Information
• Training • Information Technology • Organization Charts • Job Descriptions

This information is proprietary and confidential

6
 GDMS Program Vision:
Design Criteria and Architecture
Highly Tailorable Single Point
to Business Need of Access

Common Web Interface

Business- focused Tailoring / Configuring

Common Training

Common SOPs
Discovery Pre-Clinical Clinical Manufacturing Sales & Mktg

Search & Content Change

Security Retrieval Management Request Publishing Part 11
Rendering
Electronic
Document Management Watermarking Compliant
Audit System Header / Impact
Core Trail
Review &
Approval Integration Footer Analysis Reporting

Functionality
Common / Shared Software

Common Database

Common / Shared Servers and Storage

Documentum
Partnership Scalable

This information is proprietary and confidential

7
 GDMS Phase I:
Architecture
Common Web Interface

Business-focused Tailoring / Configuring

Common Training

Common SOPs
QMD Quality VMS e-Sub

Search & Content Change

Security Retrieval Management Request Publishing

e m
Rendering
Audit
Electronic
Document Management
st
Sy ied
Review /
Trail Approval

S tif 3
Common / Shared Software
M r /0
D e
Common Database G C /26
Common / Shared Servers and Storage
9
Infrastructure GDMS Core

This information is proprietary and confidential

8
 GDMS Phase I:
Organizational Scope

Pharma Products Corporate Medical Products

GPRD GPO

Pharma Finished Humira

API Quality CRQS F&A Vysis ADD
Discovery Goods Expansion

Pharma Global Human Human Vascular

IT Controller Legal RPD
Dev. Eng. Resources Resources Devices

Dev. Mfg Global Global Mfg Public Spinal

Medisense
Mgmt Opt. Supply Strategy Affairs Concepts

Animal
Health
GDMS Phase I Planned Deployment and 1 or More Business Functions
Supporting At Least 1 Business Information Need Have Requested GDMS Information

This information is proprietary and confidential

9
 GDMS Phase I:
Functional Scope
Abbott Product Life Cycle
Sales
Discovery Pre-clinical Clinical Mfg Service
& Mktg

Product Life Cycle Aligned

• Regulatory • Clinical • Product Specs

Information Supported

• Non-clinical • Material Specs

• Regulatory • Packaging
Examples of

• Quality • Drawings
• Testing

Abbott-wide
• Validation • Forms
• Policies • Reports
• Procedures • Network Diagrams
• Templates • Safety
• Training • Information Technology

This information is proprietary and confidential

10
 GDMS Phase II:
Priorities Based upon QMD Needs
25
0

20
2

Avg. Rank 15
7
of 22
10
Requirements 12

175

220
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oo

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fe
Re

An
str
er

Ef
Pr
ad

Di

ct

it e
te

pa
He

da

i- s
Im

ult
Up

This information is proprietary and confidential

11 M
 of 22
Avg. Rank
D M
oc an
um ag
e

0
2
4
6
8
10
12
148

22
20
18
Requirements 16
14
12
10
Ef en Fo
fe tA rm
ct ss s
of oi
N ca
ew tio

This information is proprietary and confidential

Lo P ro
ns
ck pe
ed rti
D es
oc
Pe um
ri o en
Te di ts
m c
Future Priorities

pl R
C at
e
ev
ie
on
fi d Ve w
en ri f
ti a ic
at
lD io
oc n
GDMS Phase III+:

12
um
W en
at ts
er
m
Su ar
ki
bs ng
cr
ip
tio
ns
Fo P ub
rm lis
Pr hi
Pr
in o du ng
ti n ct
g In
H A de
ig cc x
h ou
Pe Vo n ta
nd lu
in m bi
g e li t
y
D S ca
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 GDMS Phase II:
Scope
 Headers 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
This information is proprietary and confidential
13
 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

This information is proprietary and confidential

14
 Hardware
•1 Documentum Docbase
•2 Web Servers
•8 Citrix Servers
•8 Core Dossier Generators

This information is proprietary and confidential

15
 Layered Software
Documentum WebTop 5.1
WDK 5.1 (Customized)
Oracle 9.2
BEA WebLogic Application Server v7.0
Liquent CoreDossier v5.5
InfoData Annodoc
Citrix Server
•Adobe Acrobat v5.05
•Internet Explorer v5.5
•Visio Professional 2000
•MS Office 2000 Standard

This information is proprietary and confidential

16
 Technical Team Structure Validation
Review Board

2 Project Managers Technical Project

Manager
SQA
Manager

Project SQA Client

Librarian Manager

5 Business System
Business Systems
Analysts Analyst

Integration
Validation Team Validation Lead
Lead

24 Validation (support team)

Validation
Analyst

Analysts Tester

Development Team Technical Team System

Manager Architect

Technical
Lead 3 Technical
13
Leads
Developers Developer

This information is proprietary and confidential

17
 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

This information is proprietary and confidential

18
 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.

This information is proprietary and confidential

19
 Property Page Configurations

Update vs. Read-only

Required Fields
OrderLabels
Property of
Properties 20
This information is proprietary and confidential
 Search Screen

This information is proprietary and confidential

21
 Library Services
What 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

This information is proprietary and confidential

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 Library Services

Library
Module A Module F
Module C

Module H
Module E
Module B

Module D
Module G

By building this, the result is that you can pick

and Module
XML chooseC any combination
Module H Module A of services
Module G to
formulate new business rules.
This information is proprietary and confidential
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 Library Services Example
When the final approver approves the document, a set of library
services are called

XML Configuration

Generate Change
Delete Minor Promote to
Major Document
Versions Approved
Version security

This information is proprietary and confidential

24
 Questions?

This information is proprietary and confidential