PRESENTATION SOLUTIONS PHARMA MICROSOFT – CSC. OFFRE PHARMA MICROSOFT – CSC Founded in 1959 92,000 employees in 92 countries Global, end-to-end capabilities

PRESENTATION SOLUTIONS PHARMA

MICROSOFT – CSC

OFFRE PHARMA MICROSOFT – CSC

Founded in 1959

92,000 employees in 92 countries

Global, end-to-end capabilities in consulting, IT and business process outsourcing, and systems integration

$16.7 B in revenue Fiscal year ended march 31th, 2009

Serving 15 industries on six continents

CSC HAS A STRONG REPUTATION FOR PERFORMANCE,

TECHNICAL DEPTH, AND CUSTOMER FOCUS

CSC is a Global Leader in IT and Business Services

CSC Overview


ChinaColombiaCzech RepublicDenmarkEcuadorFinlandFranceGermanyHong KongIndia

New ZealandNicaraguaNorwayPeru PhilippinesPoland PortugalRepublic of KoreaRussia Singapore

Diego Garcia, UKEgyptGreeceGuam, U.S.GuatemalaHonduras IcelandIraq

NamibiaPakistan PanamaPapua New GuineaPuerto RicoQatarRomaniaSaudi ArabiaSri Lanka

IndonesiaIrelandItalyJapanLuxembourgMacau MalaysiaMexicoNetherlands Netherlands Antilles

IsraelJamaicaJordanKosovo KuwaitLiberiaLithuania MaltaMorocco

Our operations span the globe

49 Countries with Permanent CSC Locations

43 Countries Where CSC Serves Clients

ArgentinaAustraliaAustriaBarbadosBelgiumBermudaBrazilBritish V.I.CanadaChile

AfghanistanBahrainBosniaBotswanaBruneiCosta RicaCroatiaCyprus Democratic Republic of Congo (DRC)

SlovakiaSouth AfricaSpainSwedenSwitzerlandTaiwan (ROC)ThailandUnited KingdomUnited States

SwazilandTrinidadTurkeyUkraineUruguayVenezuelaVietnamYemen

CSC Overview


Healthcare & Life Sciences are one of CSC’s 6 main industry verticals, and form an important part of our Global Revenues

Chemical,Energy &

NaturalResources

$1.0B

Healthcare & Life Sciences

$1.2B

Technology/ Consumer

$2.4B

Manufacturing/Aerospace &

Defense

$2.6B

Financial Services

$2.8B

Public Sector

$6.7B

*CSC: $16.7 B (USD) in revenue, 12 months ended march 31 , 2009

CSC Overview


• Surveys & benchmarking for Pharma & appropriate horizontals

• Dedicated IP & Solutions for Pharma

• Over 5 500 professionals supporting the Healthcare & Life Sciences Sector

• We partner with the Market Leading Business & technology solutions providors

• World sourcing & infrastructure

• CSC’s Proven Catalyst Methodology for Project & Programme Management

• Driving revenue in a increasingly complex environment

• Business & IT performance improvement

• Pricing management

• Internationalisation, Merger and Acquisition

• Marketing strategy and Patients intelligence

• R&D productivity & Speed to Market

• Providing improvements in quality and safety

• Compliance with all required Standards & Regulations

CLIENTCHALLENGES

HEALTHCARE & LIFE SCIENCES BUSINESS

SOLUTIONSOUR EXPERTISE

CSC helps Healthcare & Life Sciences businesses around the World realise business value by providing transformational solutions that are supported by

CSC’s industry, process and technical expertise

CLIENT & SECTOR KNOWLEDGE

BUSINESS PROCESS EXPERTISE

BUSINESS & TECHNICAL SOLUTIONS

PROGRAMME & CHANGE MANAGEMENT

CSC Healthcare & Life Sciences

Overview


From FirstDoc to FirstPoint

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SOLUTIONS PHARMA CSC – FirstPoint – Genealogy

7


CSC’s FirstPoint Compliance Platform

SECURE COLLABORATION

Regulatory Affiliates CROs Investigators

CMOs Supply Chain

Go-to-Market Partners

BUSINESS MODULES

Research & Development

Clinical/ eTMF

Quality & Manufacturing

CONTENT MANAGEMENT

Microsoft SharePoint

FIRSTPOINT COMPLIANCE

PLATFORM

Metadata Automation

Authoring Templates

Document Auto Numbering

Document Auto Naming

Change Requests

Watermarking

Advanced Workflow Engine

Intuitive Workflow UI

Auto Periodic Review

Electronic Forms

Audit Trail

Advanced Security

Advanced Document Lifecycle

PDF Renditions

Metrics & Reporting

Configurable E-mail Notices

Administrative Utilities

Electronic SignatureED

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• Web based application• Office integration• Simple, validated document creation

• Services Based Architecture• Feature-Rich Workflow Engine• 21 CFR Part 11 compliance

SOLUTIONS PHARMA CSC – FirstPoint – The Solution 1/4


FirstPoint’s Quick Start to Compliance

• Content types• Site columns

• Workflow templates• Security templates

The libraries consist of predefined:

• Guided Paths (Metadata Automation)

BUSINESS MODULES

Each business module contains preconfigured libraries based on experience from over 50 implementations!

• Nonclinical• Clinical• Quality (CMC)• Regulatory

Research & Development

• Clinical• TMF Site• TMF Study

Clinical/ eTMF

• Controlled Documents

• Controlled Records• Change Requests

Quality & Manufacturing


9


Product Roadmap

2009 2010 2011Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D

SharePoint

FirstPoint V1.6.3

FirstPoint V2.1

V1.6.3 • 21 CFR Part 11 Compliant

FirstPoint V1.6.4 • R&D• TMF

•

FirstPoint V1.6.4

FirstPoint V3.0

FirstPoint V2.0

V2.0• Quality & Manufacturing

V2.1• SP2010 Compatibility• Advanced Q&M

V3.0• Office 2010• Advanced Publishing Integration• Training Management• FirstDoc to FirstPoint Migration

Utility

•

V3.1 / V3.2• CAPA• Enterprise API • "Unified desktop”• Auto-config loader

FirstPoint V3.1

FirstPoint V3.2



SharePoint 2010 – FirstPoint Areas of Focus

• Managed Metadata / Content Type Hub for centrally managed taxonomies for enterprise deployments

• Integrate Guided Paths with the Term Store as a back end

• Support Content Organizer as an optional storage path for Guided Paths

• Utilize Document Sets as “Virtual Documents”

• Records Management integration to enforce Retention Policies


Advantages


• SharePoint solution: fewer configurations, less deployment time, reduced total cost of ownership compared to custom or legacy document management systems

• The FirstPoint Compliance platform: functionality required to meet global regulatory requirements including 21 CFR Part 11, complete set of fully integrated out-of-the-box preconfigured solutions incorporated with the latest in best practices for life sciences organizations, browser based solution that seamlessly integrates with Microsoft Office applications

• Secure SharePoint portals: easy and controlled collaboration with business partners across the drug development and commercialization lifecycle

Benefits at a Glance

− Preconfigured, Best Practice Libraries− Relational Metadata − Rules Driven Workflow− Electronic Forms− PDF Renditions− Watermarking /Overlays− Electronic Signature− Preconfigured Reports− Bulk Import− Configuration Management Utility− 21 CFR Part 11 Compliance− File Auto-Naming

− File Auto-Numbering− Validation Package− Advanced Security− Change Request Forms**− Advanced Life Cycle**− Manual Status Change**− Periodic Review**− “My tasks” web part**− Configurable Email Notifications**− Out-of-Office /Delegate Task**

** New in V2.0

SOLUTIONS PHARMA CSC – FirstPoint – Advantages 1/14

13


Seamless Office Integration

MS Office 2007: Ribbon

MS Office 2003: Drop Down Menu

• Technology champions compliance in familiar applications

• Users are less inclined to take short cuts that jeopardize compliance


14


FirstPoint Eliminates Error Prone Processes and Boosts Productivity via “Guided Paths”

• FirstPoint auto populates metadata where possible

• Consistent data and reduced volume of data entry

• More valuable metadata for searching and workflow automation

Creating a document is faster, easier, and

less error prone when it’s pre-

populated with exactly what you

need!


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Personalize Your User Experience with SharePoint Web Parts


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Robust, Rules Driven Workflow

• Automated Workflow– Workflow runs automatically without any user intervention. The workflow engine will

automatically send the document(s) on a route template based on predefined business rules for content type, participants, lifecycle status, etc.

• Manual Workflow– End user are able to intercept a template driven workflow to select the workflow

participants and/or add additional documents to the packet

– All other processes follow the predefined business rules of the workflow

• All workflow templates can be configured to “pause” at any step, so a workflow template can actually be a combination of a fully automated and semi-automated workflow



Workflow Guides Secure Collaboration That Includes Real Time Co-authoring

1. Author initiates workflow and invites contributing authors

3. Contributing authors and external business

partners can simultaneously

collaborate in a secure and controlled setting

using Word Track Changes

4. An audit trail is kept of all actions

for the updated document and the

collaboration site is deleted upon

completion of the workflow

2. A copy of the document is automatically exported to a

controlled SharePoint site


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Intuitive, Robust User Interface that Shows You Where You Are in the Workflow

• Our Advanced Workflow Engine comes with countless options to meet your specific business needs


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FirstPoint’s Metrics and Reporting Feature

• FirstPoint provides a powerful reporting tool to support basic document management reports as well as workflow processing metrics

• Predefined models and reports provide out of the box industry standard reports for quick deployment

• Configurable tool enables you to create your own data models and reports

• Metrics and Reporting• Document Information• Metadata Audit• Workflow• Workflow Management


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Workflow Task Notifications

• Fully configuration notification email templates with rich formatting for email messages


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Streamline and Automate Your Change Control Process from End to End

• Based on Microsoft’s advanced Silverlight™ technology providing an intuitive, electronic forms-based interface

• Business process is automated based on user selections within the form

• Users can manage the documents, reason for change, and reviewers all from right within the form

• Microsoft’s InfoPath forms are also fully supported


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Advanced Life Cycle Management


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Auto-Numbering/Auto-Naming

• Automatically names and numbers documents based on any metadata

• Naming and numbering rule can be assigned to properties such as Name, Title, Number, etc. and different rules can be assigned to various content types

• Uses system generated numbers, property fields, literals or a combination


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PDF Renditions

• FirstPoint supports the creation of PDF Renditions through an OEM integration with AdLib’s Express Server

• PDF Renditions can be created on demand by the end user or automatically as part of the workflow process

• The workflow template can be configured to route the native document, PDF Rendition, or both

• PDFs are stored on a separate SharePoint sub-site– FirstPoint manages all relationships between source and rendition to ensure that

they are in sync

• FirstPoint supports PDF annotations (sticky notes) as part of the workflow review process.

• PDF Watermarking is available to provide overlays to renditions at the Content Type Level


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Compliance

• Advanced Security• Easy to access and read document Audit Trail Report• Electronic Signatures Built into Workflow• FirstPoint meets global regulatory requirements such as :

– FDA

– ICH

– GcP

– GMP


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Architecture


FirstPoint Architecture

SOLUTIONS PHARMA CSC – FirstPoint – Architecture 1/3

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Product Release Schedule

2009 2010Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

J F M A M J J A S O N D J F M A M J J A S O N D

FirstPoint V1.6.4 R&D TMF

SharePoint

FirstPoint V1.6.3

FirstPoint V2.1

FirstPoint V1.6.3 Core Document

Management

FirstPoint V1.6.4

FirstPoint V3.0

FirstPoint V2.1**Advanced Q&M

SP2010

FirstPoint V3.0**Advanced R&D

FirstPoint V2.0

FirstPoint V2.0Quality and

Manufacturing

** Release date may vary depending on analysis outcome and actual release date of SP2010


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SharePoint 2010 – FirstPoint Areas of Focus

• Metadata Services• Service Architecture• Taxonomy and Content Types• Content Authoring• Document Sets• Development Environments

– Silverlight

• Workflow• User Interface

– Office, SharePoint


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Business Model


SOLUTIONS PHARMA CSC – FirstPoint – Business Model 1/2

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Partnership Business Model

Item Microsoft CSCService Delivered by CSC

Licenses Development :• Visual Studio 2008

Server :• Microsoft Office SharePoint Server 2007

Enterprise SP2 or later• Microsoft Internet Information Services (IIS)

6.0 or higher• Microsoft .NET Framework 3.5 SP1• Office 2007 (SP2) is required for crawling into

Office 2007 documents• Microsoft Internet Explorer 7.0 with latest

security updates• Microsoft SQL Server 2005 or 2008 Reporting

Services Add-in for Microsoft SharePoint Technologies

Client :• Since in V2.0, the Office client is optional, it

depends if you need/want the Office integration (2003 or 2007) and/or the Web interface)

Server :• FirstPoint 2.0

Support % of each license Third Party Maintenance


SOLUTIONS PHARMA CSC – FirstPoint – Business Model 2/2

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Partnership Business Model: Office client