DCN Project EngagementWorldwide Sales Meeting

January 11-15, 1999San Francisco, Ca.

Solution Engagement Presentation TemplateOverview

• Project Description• Key Activities and Deliverables• Major Challenges• Lessons Learned

Project Description

• Project Description – GSMS – MQAQC

• Client Profile (e.g. title, organizational entity, etc.)

• Business Issues Addressed• Our Proposed Solution

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

The Framework

GSMS

TRO

LL

CLI

NA

R

PRE-

CLI

NIC

AL

&R

ESEA

RC

H

MQAQC

ENTERPRISE STUDY : TROLL; CLINAR; MQAQC; GSMSAPR - JUN ‘97

DEFINED METHODOLOGY, TOOLS, INFRASTRUCTURE, WORKING RELATIONSHIP, & BEST PRACTICES FOR CHIRONFEB - JUN ‘98

The Framework

ENTERPRISE STUDY:

GSMS

TRO

LL

CLI

NA

RPR

E-C

LIN

ICA

L &

RES

EAR

CH

ENHANCED PLANFOR GSMS

IMPLEMENTATION PLANFOR GSMS

MQAQC

ENHANCED PLANFOR MQAQC

IMPLEMENTATION PLANFOR MQAQC

DEFINED METHODOLOGY, TOOLS, INFRASTRUCTURE, WORKING RELATIONSHIP, & BEST PRACTICES FOR CHIRON

TROLL; CLINAR; MQAQC; GSMSAPR - JUN ‘97

FEB - JUN ‘98

AUG‘98

SEP ‘98

Regulatory Submissions Systems & Knowledge Chain Management

KN

OW

LED

GE

KN

OW

LED

GE

RegulatorySubmission

SystemPhase IClinical Study

Phase IIClinical Study

SubmissionTracking

Phase IIIClinicalStudy

Research

New Drug Process

RegulatoryApproval

ClinicalPhase I

ClinicalPhase II

ClinicalPhase IIIPre-Clinical

PRO

CES

SPR

OC

ESS

• 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

Documentum RSS FrameworkK

now

ledg

eK

now

ledg

e

RegulatorySubmission

SystemPhase IClinical Study

Phase IIClinical Study

SubmissionTracking

Phase IIIClinicalStudy

Research

DocumentumDocumentum

CoreDossier/XDAPublishing

DocumentProfiling

DMSAssemblevia VDM

PIPER• Workflow• GUI• Enterprise Structure

• Bus. Model

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

WorkflowUser Requirements & Design Docs.

===>>> Development UnitTesting

===>>> ===>>>

DocumentRepository

User Requirements & Design Docs.

===>>> DevelopmentUnitTesting ===>>>

Publishing Vendor SelectionDesign Docs.Installation & Configuration ===>>> UnitTesting

ValidationTest Cases Validation

Testing ===>>> ===>>> ===>>>Master Test Plan ===>>>

Infra-structure

Infrastructure Plan & PurchasesInstallation & ConfigurationIntegration & Customization Performance Tuning

===>>> ===>>> ===>>> ===>>> ===>>> ===>>> ===>>> ===>>>

Training Training Plan Training ===>>> ===>>> ===>>> ===>>>

Back FileConversion

Service Bureau SelectionDocument Preparation Document Scanning ===>>> ===>>> ===>>> ===>>> ===>>>

Deployment Deployment Plan Pilot Deployment ===>>> ===>>> ===>>> ===>>> ===>>> ===>>> ===>>>

Documentum Manufacturing Framework

Idea

s Id

eas Knowledge

Chain ProductDevelopment

Planningand Infra-structure

ServiceMarketingand Sales

Research

Manufacturing SalesPurchasing Production DistributionProductionPlanning

Raw

Mat

eria

lsR

aw M

ater

ials

• Production PlansProduction Plans• Production ReportsProduction Reports• Recipes & FormulationsRecipes & Formulations• Material SpecificationsMaterial Specifications

• Standard Operating Standard Operating ProceduresProcedures

• Quality Test ProtocolsQuality Test Protocols• Design DrawingsDesign Drawings

• Sales ProposalsSales Proposals• Sales OrdersSales Orders• Product InfoProduct Info• Financial ReportsFinancial Reports

Master Batch Records

Batch ProductionRecord - Printed

Distribute andControl BPR

Batch Release,Scan & Archive

SAP

Start

Order or Batch NumberManagement - GOLD

Mater Batch Record

ArchiveLinkArchiveLink

Classify, File,Classify, File,Secure, Index,Secure, Index,Render & RouteRender & Route

SAP R/3 Print ListsSAP R/3 Print Lists

Replicate Reports Replicate Reports for Viewing at for Viewing at

Other SitesOther Sites

SAP & Documentum Link

Search and View Search and View withwith

R/3 Print List ViewerR/3 Print List Viewer

Search and View Search and View withwith

Web BrowserWeb Browser

Project Status

MQAQC Imple-

mentation

Plan

Back FileConversion

Identify service vendorScannin

g Scanning ===>>> ===>>>

EnterpriseStudy

StartedEnterprise

Study.

SubmittedEnterprise

Study.

TROLL Design Go Live!Develop-

ment.Test &Train

CLINAR Design Go Live!Develop-

ment.Test &Train ===>>>

GSMS Imple-

mentation

Plan

===>>> ===>>> ===>>> ===>>> ===>>>MethodologyTools, Infra,

Best Practice

Defined Methodology, Tools, Infrastructure, Working relationship and Best Practices

Apr’97 June’97 Mar ‘98 April ‘98 May 98 June 98 Feb ‘98 1999 Nov ‘98 1999 1999 1999

Apr’97 June’97 Mar ‘98 April ‘98 May 98 June 98 Feb ‘98 1999 Nov ‘98 1999 1999 1999

Design

Design

Go Live!

Go Live!

Develop-ment.

Develop-ment.

Validate& Train

Validate& Train

Rqm’ts&

Scope

Rqm’ts&

Scope

Centralized DMS Library

Centralized Library :• Central Docbase• Corp. Knowledge• Division Standards• Project Templates• Validation Documents

ApplicationFramework

Submission Batch Record

Chiron Intranet & LAN/WAN

Research

TROLL

SubmissionApplication

CLINAR

Manufacturing

Specifications

ControlledDocuments

Reference

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)

Major Challenges

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

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.)