Global Document Management System Midwest Documentum Users Group February 26, 2004

1
Global Document Management SystemMidwest
Documentum Users GroupFebruary 26, 2004
2
GDMS Program BackgroundHistory
The Global Documentation Program (GDP) Strategic
Plan Update was approved
Q1
Q2
Q3
Q4
2003
GDMS Phase I certified and launched (9/26)
3
GDMS Program BackgroundQuality Initiative
Global Quality System
8 Abbott Quality Initiatives
Validation
Training
GQMS
Part 11
Complaint
e-Sub
SQA
Global Documentation Program
Data andDocument Standards
Global DocumentationManagement System
4
GDMS Program Structure
GDMS
e-Sub
VMS
QMD
5
GDMS Program Vision Organizational Scope
Medical Products
Corporate
Pharma Products
GPRD
GPO
CRQS
FA
ADD
MolecularDiagnostics
FinishedGoods
HumiraExpansion
Quality
API
Pharma Discovery
HumanResources
Legal
Medisense
RPD
GlobalEng.
IT
Controller
HumanResources
PharmaDev.
SpinalConcepts
VascularDevices
MfgOpt.
GlobalSupply
Global MfgStrategy
PublicAffairs
Dev.Mgmt
AnimalHealth
6
GDMS Program Vision Functional Scope
Abbott Product Life Cycle
7
GDMS Program VisionDesign Criteria and
Architecture
8
GDMS Phase I Architecture
Common Web Interface
Business-focused Tailoring / Configuring
QMD Quality
VMS
e-Sub
Common Training
Common SOPs
Document Management
ContentManagement
Search Retrieval
ChangeRequest
Security
Publishing
Rendering
ElectronicReview /Approval
AuditTrail
Common / Shared Software
Common Database
Common / Shared Servers and Storage
Infrastructure
GDMS Core
9
GDMS Phase IOrganizational Scope
Medical Products
Corporate
Pharma Products
GPRD
GPO
CRQS
FA
ADD
Vysis
FinishedGoods
HumiraExpansion
Quality
API
Pharma Discovery
HumanResources
Legal
VascularDevices
RPD
GlobalEng.
IT
Controller
HumanResources
PharmaDev.
SpinalConcepts
Medisense
MfgOpt.
GlobalSupply
Global MfgStrategy
PublicAffairs
Dev.Mgmt
AnimalHealth
GDMS Phase I Planned Deployment andSupporting At
Least 1 Business Information Need
1 or More Business FunctionsHave Requested GDMS
Information
10
GDMS Phase I Functional Scope
Abbott Product Life Cycle
Service
Sales Mktg
Mfg
Clinical
Pre-clinical
Discovery
Product Life Cycle Aligned

• Regulatory

• Clinical
• Non-clinical
• Regulatory
• Quality

• Product Specs
• Material Specs
• Packaging
• Drawings
• Testing

Examples of Information Supported
Abbott-wide

• Validation
• Policies
• Procedures
• Templates
• Training

• Forms
• Reports
• Network Diagrams
• Safety
• Information Technology

11
GDMS Phase IIPriorities Based upon QMD Needs
Avg. Rankof 22 Requirements
12
GDMS Phase IIIFuture Priorities
8
10
12
Avg. Rankof 22 Requirements
14
16
18
20
22
13
GDMS Phase IIScope

• 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

14
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

15
Hardware

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

16
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

17
Technical Team Structure
Validation Review Board
2 Project Managers
Technical Project Manager
SQA Manager
SQA Client Manager
Project Librarian
5 Business System Analysts
Business Systems Analyst
Validation Team
Integration Lead
Validation Lead
24 Validation Analysts
(support team)
Validation Analyst
Tester
Development Team
System Architect
Technical Team Manager
3 Technical Leads
Technical Lead
13 Developers
Developer
18
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

19
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.

20
Property Page Configurations
Order of Properties
Update vs.
Read-only
Required Fields
Property Labels
21
Search Screen
22
Library Services

• What is Library Services?
• A set of distinct action oriented programming
  functions.
• Each object in the library is validated (Input -gt
  Output)
• Through a configuration object, these services
  can be chained together to produce business
  logic.
• Lifecycle Activities
• Workflow Activities and Processes
• Electronic Signatures
• Auditing

23
Library Services
Library
Module F
Module A
Module C
Module H
Module E
Module B
Module D
Module G

• By building this, the result is that you can pick
  and choose any combination of services to
  formulate new business rules.

Module A
Module H
Module G
Module C
XML
24
Library Services Example
When the final approver approves the document, a
set of library services are called
XML Configuration
Change Document security
Generate Major Version
Promote to Approved
Delete Minor Versions
25
Questions?