EntErprisE ContEnt ManagEMEnt on thE MiCrosoft platforM

Count on CSC for an innovative approach to enterprise

content management and collaboration solutions fashioned

by unparalleled industry experience. Our experience enables

us to expertly pair technology and industry best practices

with regulated content management in solutions that

champion business performance. Our team of experts are

dedicated and experienced to help you realize your specific

goals throughout the life of our engagement.

An Experienced and Dedicated Content Management Team

CSC’s Content Management team has the depth and breadth

of experience to meet the unique needs and challenges that

face each of our clients. Our highly qualified team will:

• Anticipate and proactively address issues with transparency

• Use their intimate process, system and industry knowledge

to provide the best possible solution to meet the needs of

your diverse users

• Leverage our Gold partnership with Microsoft to ensure an

optimal configuration of FirstPoint in your organization

• Utilize CSC’s world sourcing delivery model to help

companies reduce cost and improve quality through a

combination of on-site, off-site and offshore resources

FirstPoint is a user-friendly, enterprise-

class application that utilizes familiar

Microsoft Office tools such as Word,

Outlook, and Excel. Leveraging Microsoft

Office SharePoint® Server (MOSS)

2007, FirstPoint exemplifies CSC’s

software innovations and industry-

leading best practices over the last

two decades. FirstPoint enables access

to any existing ECM investments and

enhances productivity by improving

the overall user experience as well as

the management of the underlying

infrastructure.

FirstPoint’s rules based, configurable

workflow engine can facilitate

collaborative processes across a myriad

of functions often overlooked in ECM

deployments. Value is realized through

extensive automation of what were once

time consuming and counterproductive

practices. FirstPoint delivers a superior

user friendly product to manage all

documents — from non-regulated to

highly regulated content.

FirstPoint provides industry standard,

out-of-the-box document inventory

models to manage content such as

Research & Development, Quality &

Manufacturing, Clinical Trial Management,

and more. FirstPoint’s content

models provide companies with the

ideal framework for the creation and

importation of related documents that

fully comply with the latest industry

guidance and compliance. FirstPoint can

be easily configured for any functional

area within your organization.

firstpoint™ EntErprisE ContEnt ManagEMEnt (ECM)

ovErviEw

KEy DiffErEnTiATors:

simple. Users are empowered with full

document management functionality

from within their familiar Microsoft Office

applications including Word, Outlook,

and SharePoint®. There’s no need

to access multiple applications to be

engaged in workflows, search, view, and

change documents. FirstPoint automates

many of what were once cumbersome

processes in the author, review, and

approval process.

intelligent. Upon logging in, FirstPoint

is personalized according to your role

and level of authority providing access

to only those documents and application

features necessary to perform your job.

A powerful business rules engine promotes

streamlined workflows and is highly

configurable to accommodate your

organization’s specific business needs.

sophisticated. Administrators can

monitor workflow progress as needed

and quickly identify bottlenecks.

FirstPoint comes with predefined reports

exportable to PDF, Excel, CSV, and HTML

formats, and further configuration can be

done for a variety of report views. A bulk

utility tool easily moves content from

legacy systems, disparate file stores and

desktops in one batch.

Cost Effective. Improved user adoption

increases ROI and a simplified Microsoft

technology stack eliminates the need for

lengthy deployments, costly customiza-

tions, and expensive ongoing administra-

tion. Further savings are realized through

seamless integration to existing invest-

ments and other enterprise business

areas. CSC can also host FirstPoint at its

state-of-the-art data center.

Compliant. FDA 21 CFR Part 11 is assured

across the document life cycle with audit

trails, electronic approval, document life

cycle based security, and validation.

Collaborative. FirstPoint supports true

document collaboration in a controlled

environment.

R&D/Non-Clinical

R&D/Clinical

RegulatoryAffairs

Quality &Manufacturing

Marketing& Sales

Operations

Enterprise Search — Metadata, Text, People

Business Process Management — Corporate Governance

Cross Functional Teams — External Partner Collaboration

Integrated Enterprise Libraries - Uncontrolled/Controlled

say good-byE to rigid CoMpliCatEd softwarE

say hEllo to firstpoint

FirstPoint champions end user performance because regardless which Office version

your organization uses, FirstPoint is seamlessly integrated with Microsoft. Now users can

save time by focusing on their task at hand, and not on going back and forth in various

applications.

firstpoint is whErE your usErs work EvEryday —

MiCrosoft offiCE

in Microsoft office 2007 firstpoint is a ribbon

in Microsoft office 2003 firstpoint is a drop down menu

firstpoint functionality is also available from the standard Microsoft sharepoint interface. users can upload documents and properties as well as participate in workflows.

how doEs firstpoint addrEss ECM ChallEngEs in lifE sCiEnCEs?

ECM ChAllEngE firsTPoinT fEATurE/uTiliTy

BEnEfiT

Multiple siloed content repositories Integrated Enterprise Libraries

All enterprise content is centralized.

Labor intensive data entry

Data entry inconsistencies affect search and retrieval

Guided Paths™ Auto population of metadata throughout the life cycle of the document eliminates data inconsistency, improves search & retrieval and reduces data entry time.

Inefficient business processes dictated by technology

Flexible rules driven workflow

Easily configured to meet specific business process needs from ad hoc to predetermined automated workflow.

Delays due to multiple authors collaborating on documents

Real time Collaborative Review

Multiple users may edit documents with track changes at the same time, while security, versioning and audit trail are supported.

Effectively managing product complaints and Corrective And Preventive Actions (CAPA)

Electronic Forms Microsoft’s InfoPath technology is leveraged to create and manage electronic forms, which can be created, routed, and approved.

Difficulty storing and retrieving documents

Automatic Document Storage

Takes burden of storage off of end user. Recognition of document type enables automatic storage in a repository at a predetermined fully configurable location.

The need for readily available PDF Renditions

PDF Renditions AdLib’s Express Server™ is leveraged and PDF Renditions can be created on demand by the end user or automatically as part of the workflow process.

No ability to provide form and layout of watermarking overlay

Watermarking The ability to apply rendition template profiles that provides options for variations in size, positions, opaqueness, and orientation to fit specific business needs.

Risking non-compliance

Meeting rigorous and dynamic regulatory demands

21 CFR Part 11 Compliance/ e-Signatures

Full compliance with FDA regulations on electronic records and electronic signatures. Enhanced features ensure security, user authentication, and auditing.

More holistic management of the document lifecycle such as Identifying bottlenecks or improving decision making

Metrics & Reporting Predefined models and reports as well as a configurable tool for personalized data models and reports.

External Partner Collaboration FirstPoint Portal Secure document exchange that minimizes the need for email and collaborative processes that can be automated.

Collaboration is more efficient In house and across the firewall.

Ensuring the system is validated before implementation

Validation Package (Optional)

Based on years of experience, CSC provides the essential Validation components to support validation in your unique environment.

Moving content from legacy systems, disparate files stores or desktops

Bulk Import Utility Tool Easily deployed tool that can be fine tuned to only those users that have the need and authority.

a ClosEr look at firstpoint’s

robust funCtionality

rEAl TiME CollABorATion

firstpoint supports true document collaboration in a controlled environ-ment. documents sent on a collabo-ration workflow are automatically copied to a temporary sharepoint workspace where named users are invited to make their changes.

CAPA AnD ChAngE rEquEsTs

firstpoint leverages Microsoft’s infopath technology to create and manage smart forms™ or electronic forms that can be created, routed, and approved like any other content type. Common uses for electronic forms range from Change requests notices to Capa compliance.

guiDED PAThsTM

documents can be easily located by minimizing the need for end users to enter property information for docu-ments created or imported. CsC’s guided paths™ technology intelli-gently guides the user through classi-fications that allow the automatic assignment of properties to be applied to a given document. addi-tionally, through the use of managed data dictionaries for most property fields, this functionality virtually elimi-nates the possibility of users entering incorrect data or misspelling values and thereby enforcing data integrity.

firsTPoinT’s EAsE of ADMinisTrATion

rEPorTing AnD METriCs

firstpoint’s reporting & Metrics feature enables administrators immediate insight into document cycle times. Quick identification of bottlenecks helps foster proactive decision making.

BulK iMPorT uTiliTy Tool

firstpoint’s bulk import utility tool imports multiple documents into firstpoint within a single batch. in addition to the documents themselves, the bulk import utility can apply property values for documents en masse.

ConfigurATion MAnAgEMEnT uTiliTy

why should users have all the fun? firstpoint provides an intuitive admin-istration site to manage your installa-tion including: configure guided paths and storage path locations for various content types, define document auto-numbering rules, design watermarking overlay templates, setup, setup elec-tronic signatures and authentication mechanisms, as well as define user and group security.

firstPoint Portal landing Page

All major FirstPoint functionality is now

accessible on a portal home page, which

includes Smart Views, The portal consists

of Web Parts for major functions such

as Tasks and Create New Document.

The portal can be used as a default

home page or in conjunction with other

applications such as a Clinical Portal.

smart Views

FirstPoint currently has two ways

in which views are customized per

user or group. Security settings limit

what documents a particular user

sees, including search. SharePoint

configuration allows views to be

configured to display documents based

on various properties and filters.

In Smart Views administrators can

create various folder views based on

any combination of metadata. Smart

Views build automatically and provide

the capability to assign users to specific

views so that they will only see the set of

documents for their role.

firstpoint portal and sMart viEws™

firstPoint will also be available as a

hosted solution

CSC can host and maintain FirstPoint at

its state-of-the-art data center. We offer

a full range of data center management

services to support FirstPoint, including

hosting capabilities, continuous systems

performance monitoring, security, and

maintenance. CSC employs service-

oriented architecture (SOA) techniques

and depending on your company’s

needs, can integrate multiple new

applications with core systems. ECM is

delivered via a secure VPN, protected

by firewalls on both the CSC and client

sides. reducing the initial investment

required to implement ECM functionality

while providing smaller companies with

the flexibility to scale functionality

as needed.

To learn more about the most robust

ECM solution for Life Sciences on

the Microsoft Platform contact us at

lifesciencesinfo@csc.com or call us at

866.287.3792.

CsC life sciences

575 E. Swedesford Road

Wayne, PA 19087

+1.610.989.7000

1.866.287.3792

lifesciencesinfo@csc.com

CsC life sciences – Europe

Unit 20 St Asaph Business Park

St. Asaph, Denbighshire LL1 70lJ

+44 1 74 558 2600

worldwide CsC headquarters

The Americas

3170 Fairview Park Drive

Falls Church, Virginia 22042

United States

+1.703.876.1000

www.csc.com

© 2008 Computer Sciences Corporation.

About CsC

The mission of CSC is to be a global leader in providing technology enabled business solutions and services.

With the broadest range of capabilities, CSC offers clients the solutions they need to manage complexity, focus on core businesses, collaborate with partners and clients, and improve operations.

CSC makes a special point of understanding its clients and provides experts with real-world experience to work with them. CSC is vendor-independent, delivering solutions that best meet each client’s unique requirements.

For more than 45 years, clients in industries and governments worldwide have trusted CSC with their business process and information systems outsourcing, systems integration and consulting needs.

The company trades on the New York Stock Exchange under the symbol “CSC.”