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

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Presentation on theme: "This information is proprietary and confidential Global Document Management System Midwest Documentum Users Group February 26, 2004."— Presentation transcript:

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

2 1 This information is proprietary and confidential GDMS Program Background: History Q1Q2Q3Q4 The Global Documentation Program (GDP) Strategic Plan Update was approved GDMS Phase I certified and launched (9/26) 2003

3 2 This information is proprietary and confidential GDMS Program Background: Quality Initiative Global Quality System Global Documentation Program 8 Abbott Quality Initiatives ValidationTrainingGQMSPart 11Complaint SQA Data and Document Standards e-Sub Global Documentation Management System

4 3 This information is proprietary and confidential GDMS Program Structure GDMS e-SubVMSQMD

5 4 This information is proprietary and confidential GDMS Program Vision: Organizational Scope Pharma Products Corporate Medical Products GPRDGPO Human Resources Legal CRQSF&AADD MedisenseRPD Spinal Concepts Vascular Devices Animal Health Molecular Diagnostics Finished Goods Humira Expansion Quality Global Eng. ITController API Mfg Opt. Global Supply Global Mfg Strategy Human Resources Public Affairs Pharma Dev. Dev. Mgmt Pharma Discovery

6 5 This information is proprietary and confidential GDMS Program Vision: Functional Scope Service Customer Letters Technical Service Bulletins Sales & Mktg Promotional Materials Product Training Materials Mfg Product Specs Material Specs Packaging Drawings Testing Clinical Non-clinical Regulatory Quality Labels Pre-clinical Regulatory Lab Test Results Tox Info Discovery Lab Test Results 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 Examples of Information Supported Product Life Cycle Aligned Abbott-wide

7 6 This information is proprietary and confidential Common Web Interface Single Point of Access Business-focused Tailoring / Configuring Highly Tailorable to Business Need GDMS Program Vision: Design Criteria and Architecture Common Training Common / Shared Servers and Storage Common Database Common / Shared Software Scalable Part 11 Compliant Documentum Partnership Common SOPs DiscoveryPre-Clinical ManufacturingSales &Mktg Document Management Content Management Search & Retrieval Change Request Electronic Approval SecurityPublishing Audit Trail Impact Analysis Header / Footer Reporting System Integration RenderingWatermarking Review & Core Functionality

8 7 This information is proprietary and confidential GDMS Phase I: Architecture Common / Shared Servers and Storage Common Database Common / Shared Software Common Web Interface Common TrainingCommon SOPs Infrastructure GDMS Core Document Management Content Management Search & Retrieval Change Request Electronic Review / Approval SecurityPublishing Audit Trail Rendering Business-focused Tailoring / Configuring QMD QualityVMSe-Sub GDMS System Certified 9/26/03

9 8 This information is proprietary and confidential GDMS Phase I: O rganizational Scope Pharma Products Corporate Medical Products GPRDGPO Human Resources Legal CRQSF&AADD Vascular Devices RPD Spinal Concepts Medisense Animal Health Vysis Finished Goods Humira Expansion Quality Global Eng. ITController API Mfg Opt. Global Supply Global Mfg Strategy Human Resources Public Affairs Pharma Dev. Dev. Mgmt Pharma Discovery GDMS Phase I Planned Deployment and Supporting At Least 1 Business Information Need 1 or More Business Functions Have Requested GDMS Information

10 9 This information is proprietary and confidential Service Sales & Mktg Mfg Clinical Pre-clinical GDMS Phase I: Functional Scope Discovery RegulatoryClinical 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 Examples of Information Supported Product Life Cycle Aligned Abbott-wide

11 10 This information is proprietary and confidential GDMS Phase II: Priorities Based upon QMD Needs Avg. Rank of 22 Requirements

12 11 This information is proprietary and confidential GDMS Phase III+: Future Priorities Avg. Rank of 22 Requirements

13 12 This information is proprietary and confidential 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

14 13 This information is proprietary and confidential 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 14 This information is proprietary and confidential Hardware 1 Documentum Docbase 2 Web Servers 8 Citrix Servers 8 Core Dossier Generators

16 15 This information is proprietary and confidential 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 16 This information is proprietary and confidential 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

18 17 This information is proprietary and confidential 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 18 This information is proprietary and confidential 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 19 This information is proprietary and confidential Property Page Configurations Order of Properties Update vs. Read-only Required Fields Property Labels

21 20 This information is proprietary and confidential Search Screen

22 21 This information is proprietary and confidential 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

23 22 This information is proprietary and confidential Library Module A Library Services Module B Module C Module D Module E Module F Module G Module H Module AModule HModule GModule C XML By building this, the result is that you can pick and choose any combination of services to formulate new business rules.

24 23 This information is proprietary and confidential 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

25 This information is proprietary and confidential Questions?


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