Transcript GDMS Program Direction

Global Document
Management System
Midwest Documentum Users Group
February 26, 2004
This information is proprietary and confidential
GDMS Program Background:
History
2003
The Global Documentation Program (GDP)
Strategic Plan Update was approved
Q1
Q2 Q3 Q4
GDMS Phase I certified and launched (9/26)
This information is proprietary and confidential
1
GDMS Program Background:
Quality Initiative
Global Quality System
Part 11
Complaint
SQA
e-Sub
Validation
Training
Global Documentation Program
Global Documentation
Management System
This information is proprietary and confidential
Data and
Document Standards
2
GQMS
8 Abbott
Quality
Initiatives
GDMS Program Structure
GDMS
e-Sub
This information is proprietary and confidential
VMS
3
QMD
GDMS Program Vision:
Organizational Scope
GPRD
Medical Products
Corporate
Pharma Products
GPO
Pharma
Discovery
API
Finished
Goods
Humira
Expansion
Quality
CRQS
F&A
Molecular
Diagnostics
ADD
Pharma
Dev.
Global
Eng.
IT
Controller
Human
Resources
Human
Resources
Legal
Medisense
RPD
Dev.
Mgmt
Mfg
Opt.
Global
Supply
Global Mfg
Strategy
Public
Affairs
Spinal
Concepts
Vascular
Devices
Animal
Health
This information is proprietary and confidential
4
GDMS Program Vision:
Functional Scope
Abbott Product Life Cycle
Discovery
Pre-clinical
Clinical
Mfg
Sales
& Mktg
Service
Examples of
Information Supported
Product Life Cycle Aligned
• Lab Test
Results
• Regulatory
• Clinical
• Product Specs
• Lab Test
Results
• Non-clinical
• Material Specs
• Regulatory
• Packaging
• Quality
• Drawings
• Labels
• Testing
• Tox Info
• Promotional
Materials
• Customer
Letters
• Product
Training
Materials
• Technical
Service
Bulletins
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
5
GDMS Program Vision:
Design Criteria and Architecture
Highly Tailorable
to Business Need
Single Point
of Access
Core
Functionality
Business- focused Tailoring / Configuring
Discovery
Pre-Clinical
Search &
Retrieval
Security
Rendering
Audit
Trail
Electronic
Review &
Approval
Clinical
Manufacturing
Content
Change
Management
Request
Document Management
System
Integration
Header /
Footer
Impact
Analysis
Sales & Mktg
Publishing
Watermarking
Reporting
Common / Shared Software
Common Database
Common / Shared Servers and Storage
Documentum
Partnership
This information is proprietary and confidential
Scalable
6
Common SOPs
Common Training
Common Web Interface
Part 11
Compliant
GDMS Phase I:
Architecture
Business-focused Tailoring / Configuring
QMD Quality
Search &
Retrieval
Security
Rendering
Audit
Trail
VMS
Electronic
Review /
Approval
e-Sub
Content
Change
Management
Request
Document Management
Common / Shared Software
Common Database
Common / Shared Servers and Storage
Infrastructure
This information is proprietary and confidential
7
GDMS Core
Publishing
Common SOPs
Common Training
Common Web Interface
GDMS Phase I:
Organizational Scope
GPRD
Medical Products
Corporate
Pharma Products
GPO
Pharma
Discovery
API
Finished
Goods
Humira
Expansion
Quality
CRQS
F&A
Vysis
ADD
Pharma
Dev.
Global
Eng.
IT
Controller
Human
Resources
Human
Resources
Legal
Vascular
Devices
RPD
Dev.
Mgmt
Mfg
Opt.
Global
Supply
Global Mfg
Strategy
Public
Affairs
Spinal
Concepts
Medisense
Animal
Health
GDMS Phase I Planned Deployment and
Supporting At Least 1 Business Information Need
This information is proprietary and confidential
1 or More Business Functions
Have Requested GDMS Information
8
GDMS Phase I:
Functional Scope
Abbott Product Life Cycle
Discovery
Pre-clinical
Clinical
Mfg
Examples of
Information Supported
Product Life Cycle Aligned
• Regulatory
• Clinical
• Product Specs
• Non-clinical
• Material Specs
• Regulatory
• Packaging
• Quality
• Drawings
• Testing
Abbott-wide
• Validation
• Forms
• Policies
• Reports
• Procedures
• Network Diagrams
• Templates
• Safety
• Training
• Information Technology
This information is proprietary and confidential
9
Sales
& Mktg
Service
GDMS Phase II:
Priorities Based upon QMD Needs
25
0
20
2
15
7
Avg. Rank
of 22
Requirements 12
10
175
This information is proprietary and confidential
10
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GDMS Phase III+:
Future Priorities
148
10
12
12
10
Avg. Rank
14
8
of 22
Requirements 16
6
18
4
20
2
22
0
This information is proprietary and confidential
11
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
12
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
13
Hardware
•1 Documentum Docbase
•2 Web Servers
•8 Citrix Servers
•8 Core Dossier Generators
This information is proprietary and confidential
14
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
15
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
24
Validation
Analysts
Validation Lead
Integration
Lead
Validation
Analyst
(support team)
Tester
Development Team
13
Developers
This information is proprietary and confidential
Technical Team
Manager
Technical
Lead
System
Architect
3 Technical
Leads
Developer
16
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
17
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
18
Property Page Configurations
Update vs. Read-only
Required Fields
OrderLabels
of
Property
Properties
This information is proprietary and confidential
19
Search Screen
This information is proprietary and confidential
20
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
21
Library Services
Library
Module F
Module A
Module C
Module E
Module B
Module D
Module H
Module G
By building this, the result is that you can pick and
Module H of services
Module A to formulate
Module G new
chooseModule
any Ccombination
XML
business rules.
This information is proprietary and confidential
22
Library Services Example
When the final approver approves the document, a set of library
services are called
XML Configuration
Delete
Minor
Versions
This information is proprietary and confidential
Generate
Major
Version
Promote to
Approved
23
Change
Document
security
Questions?
This information is proprietary and confidential