1. DCN Project Engagement
Worldwide Sales Meeting
January 11-15, 1999
San Francisco, Ca.

2. Solution Engagement
Presentation Template
Overview
• Project Description
• Key Activities and Deliverables
• Major Challenges
• Lessons Learned

3. Project Description
• Project Description
– GSMS
– MQAQC
• Client Profile (e.g. title, organizational entity, etc.)
• Business Issues Addressed
• Our Proposed Solution

4. What is Regulatory
Submissions?
• Regulatory Submissions are:
– Information submitted by
Pharmaceutical Companies
to regulatory agencies, e.g.,
FDA, EMEA, HPB
– Typical Documents
• INDs
• Annual Reports
• NDAs (~1Million pages)
• MAAs
• BLA
• Other related documents

5. The Framework
GSMS
TROLLTROLL
CLINARCLINAR
PRE-CLINICAL&
RESEARCH
PRE-CLINICAL&
RESEARCH
MQAQC
ENTERPRISE STUDY : TROLL; CLINAR; MQAQC; GSMSAPR - JUN ‘97
DEFINED METHODOLOGY, TOOLS, INFRASTRUCTURE,
WORKING RELATIONSHIP, & BEST PRACTICES FOR CHIRON
FEB - JUN ‘98

6. The Framework
ENTERPRISE STUDY:ENTERPRISE STUDY:
GSMS
TROLLTROLL
CLINARCLINAR
PRE-CLINICAL&
RESEARCH
PRE-CLINICAL&
RESEARCH
ENHANCED PLAN
FOR GSMS
IMPLEMENTATION PLAN
FOR GSMS
MQAQC
ENHANCED PLAN
FOR MQAQC
IMPLEMENTATION PLAN
FOR MQAQC
DEFINED METHODOLOGY, TOOLS, INFRASTRUCTURE,
WORKING RELATIONSHIP, & BEST PRACTICES FOR CHIRON
TROLL; CLINAR; MQAQC; GSMSAPR - JUN ‘97
FEB - JUN ‘98
AUG‘98
SEP ‘98

7. Regulatory Submissions Systems &
Knowledge Chain Management
KNOWLEDGEKNOWLEDGE
Regulatory
Submission
System
Phase I
Clinical
Study
Phase II
Clinical
Study
Submission
Tracking
Phase III
Clinical
Study
Research
New Drug
Process
Regulatory
Approval
Clinical
Phase I
Clinical
Phase II
Clinical
Phase III
Pre-Clinical
PROCESSPROCESS
• NotebooksNotebooks
• Research notesResearch notes
• IND & BLAIND & BLA
• Site ProtocolSite Protocol
• Project ManagementProject Management
• CRFsCRFs
• SAS outputSAS output
• Adverse EventsAdverse Events
• Safety ReportsSafety Reports
• Status & Annual ReportsStatus & Annual Reports
• Annual ReportsAnnual Reports
• NDA & NDSNDA & NDS
• MAAMAA
• CorrespondencesCorrespondences
• Other related docsOther related docs

8. Documentum RSS FrameworkKnowledgeKnowledge
Regulatory
Submission
System
Phase I
Clinical
Study
Phase II
Clinical
Study
Submission
Tracking
Phase III
Clinical
Study
Research
DocumentumDocumentum
CoreDossier/XDA
Publishing
Document
Profiling
DMSAssemble
via VDM
PIPER
• Workflow
• GUI
• Enterprise
Structure
• Bus. Model

9. RSS Framework Project
Plan
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12
Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12
Workflow
User Requirements & Design Docs.
===>>> Development Unit
Testing
===>>> ===>>>
Document
Repository
User Requirements & Design Docs.
===>>> Development
Unit
Testing
===>>>
Publishing
Vendor SelectionDesign Docs.Installation & Configuration
===>>>
Unit
Testing
Validation
Test Cases Validation
Testing
===>>> ===>>> ===>>>
Master Test Plan
===>>>
Infra-
structure
Infrastructure Plan & Purchases
Installation & ConfigurationIntegration & Customization Performance Tuning
===>>> ===>>> ===>>> ===>>> ===>>> ===>>> ===>>> ===>>>
Training Training Plan Training ===>>> ===>>> ===>>> ===>>>
Back File
Conversion
Service Bureau Selection
Document Preparation Document Scanning
===>>> ===>>> ===>>> ===>>>===>>>
Deployment
Deployment Plan Pilot Deployment
===>>> ===>>>===>>> ===>>> ===>>> ===>>>===>>>

10. Documentum Manufacturing
Framework
IdeasIdeas
Knowledge
Chain
Product
Development
Planning
and Infra-
structure
ServiceMarketing
and Sales
Research
Manufacturing SalesPurchasing Production Distribution
Production
Planning
RawMaterialsRawMaterials
• Production PlansProduction Plans
• Production ReportsProduction Reports
• Recipes & FormulationsRecipes & Formulations
• Material SpecificationsMaterial Specifications
• Standard OperatingStandard Operating
ProceduresProcedures
• Quality Test ProtocolsQuality Test Protocols
• Design DrawingsDesign Drawings
• Sales ProposalsSales Proposals
• Sales OrdersSales Orders
• Product InfoProduct Info
• Financial ReportsFinancial Reports

11. Master Batch RecordsMaster Batch Records
Batch Production
Record - Printed
Batch Production
Record - Printed
Distribute and
Control BPR
Distribute and
Control BPR
Batch Release,
Scan & Archive
Batch Release,
Scan & Archive
SAPSAP
Start
Order or Batch Number
Management - GOLD
Order or Batch Number
Management - GOLD
Mater Batch Record

12. ArchiveLinkArchiveLink
Classify, File,Classify, File,
Secure, Index,Secure, Index,
Render & RouteRender & Route
SAP R/3 Print ListsSAP R/3 Print Lists
Replicate ReportsReplicate Reports
for Viewing atfor Viewing at
Other SitesOther Sites
SAP & Documentum
Link
Search and ViewSearch and View
withwith
R/3 Print List ViewerR/3 Print List Viewer
Search and ViewSearch and View
withwith
Web BrowserWeb Browser

13. Project Status
MQAQC
Imple-
mentatio
n
Plan
Back File
Conversion
Identify service
vendorScannin
g
Scanning ===>>> ===>>>
Enterprise
Study
Started
Enterprise
Study.
Submitted
Enterprise
Study.
TROLL Design Go Live!
Develop-
ment.
Test &
Train
CLINAR Design Go Live!
Develop-
ment.
Test &
Train
===>>>
GSMS
Imple-
mentatio
n
Plan
===>>>===>>> ===>>> ===>>> ===>>>
Methodology
Tools, Infra,
Best Practice
Defined Methodology, Tools, Infrastructure,
Working relationship and Best Practices
Apr’97 June’97 Mar ‘98 April ‘98 May 98 June 98Feb ‘98 1999Nov ‘98 1999 1999 1999
Apr’97 June’97 Mar ‘98 April ‘98 May 98 June 98Feb ‘98 1999Nov ‘98 1999 1999 1999
Design
Design
Go Live!
Go Live!
Develop-
ment.
Develop-
ment.
Validate
& Train
Validate
& Train
Rqm’ts
&
Scope
Rqm’ts
&
Scope

14. Centralized DMS Library
Centralized Library :
• Central Docbase
• Corp. Knowledge
• Division Standards
• Project Templates
• Validation Documents
Application
Framework
Submission
Batch Record
Chiron Intranet
& LAN/WAN
Research
TROLL
Submission
Application
CLINAR
Manufacturing
Specifications
Controlled
Documents
Reference

15. Key Activities & Deliverables
• High Level Project Plan Overview
• Engagement Length(s) and Fees
• Consulting Resources Used (e.g. 2-4 DCTM
Consultants, X # of sub-contractors from ABC)

16. Major Challenges
• List 3-5 major challenges encountered
• How you overcame (or didn’t) the challenges

17. Lessons
Learned
• Top 3-5 lessons learned
• What would you have done differently, if
anything?
• Collateral material produced on the
project that could be re-used/re-
purposed by other consultants
(workplans, code, deliverables,
tools/techniques, etc.)