Digital Pharma & Life Sciences Conference 2011

Dienstag, 22. Februar 2011 g,Kurhaus Wiesbaden

Tuesday, February 22, 2011 Kurhaus Wiesbaden/Germany

Go Green with CSC’sGo Green with CSC s FirstPoint

DIPL.-ING. Peter BRANDSTETTER DIPL. ING. Peter BRANDSTETTER Head of Life Sciences EMEA Central Region CSC

Agenda

• CSC‘s Green Initiative • Reduce Papper and Enhance Collaboration with

FirstPoint • FirstPoint 3.0FirstPoint 3.0

CSC‘s Green Initiative CSC s Green Initiative

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Picture orText

                           

  

CSC’s Green Initiative

• M b Cli t S CMember Climate Savers Computiti ng Initiative

• CSC ranked #3 Green Outsourcer in the World, 2009

• Global Green 100 Honoree • Paper Consumption decreased by Paper Consumption decreased by

34%.

• What FirstPoint can do ? More than 99 Million Tons of – Reduce Paper

paper and paperboard were used p p p p – Enhance Collaboration to reduce Travel Enhance Collaboration to reduce Travel in the U.S. in 2005

(http://www.epa.gov/ne/green/paperuse.html) Think before you print !

Reduce Paper and EnhanceReduce Paper and Enhance Collaboration with FirstPoint

               

          

C li         

            

Gartner – Predicts 2010 – IT Pharma

R&DR&D •Clinical trials will continue to move away from paper‐based

SupplyChain •Concentration of pharmaceutical distribution Chain

Compli-ance

p continues to grow

•Penalties for noncompliance increase •Government contracting complex

Sales •Traditional role is evolving •Tremendous market changes in EuropeTremendous market changes in Europe

g

R&D - Collaboration beyond ELN

R&D Processes – IT Today

Pharma

Post Market

De ices

Clinical (I – III)

Pre-ClincalDiscovery

Excel, Word

Custom code

Devices (LIMS) eCTD

Pharma covigilanc

e

R&D Processes – IT Vision Post MarketClinical

(I – III) Pre-ClincalDiscovery

ECM and Collaboration Platform

Pharma covigilance

Custom Code, Standard SW

(Multi Site, Multi Organisation) QM Backbone

(ELN, SAP, LIMS)( , , )

Power of Choice: Software + Services

EAI LayerEAI Layer

LIMS FirstDocSAPFirstPoint (Sharepoint) MES, LIMS FirstDocSAP

Word Excel

, etc.

Quality Datawarehousey

Quality Management Cockpit

FirstPoint 3.0FirstPoint 3.0

t

TRUSTED COMPLIANCE @ WORKTRUSTED COMPLIANCE @ WORK

• Offi IOffice Integratiion • Guided Path • Advanced WorkflowsAdvanced Workflows • Electronic Forms • Compliant Spreadsheets • PDF Renditions • Controlled Printing

B t P Best Practiice Librariies• Lib – R&D, eTMF and Clinical – QM – Sales & Marketing

CSC’s FirstPoint Compliance platform extends SharePoint to fully comply with 21 CFR Part 11 and Annex 11 ensuring 21 CFR Part 11 and Annex 11 ensuring secure collaboration with a myriad of

external business partners

          

               

         

  

    

      

 

    

     

   

 

    

  

CSC’s FirstPoint Compliance Platform

SECURE COLLA‐ Regulatory CROs CMOs Go‐to‐Market BORATION Affiliates Investigators Supply Chain Partners

BUSINESS MODULES

Research & Development

Clinical/ eTMF

Quality & Manufacturing

Sales & Marketing O

N

MODULES Development eTMF Manufacturing Marketing

Metadata Automation

Advanced Workflow Engine

Advanced Document Lifecycle

ABO

RATIO

FIRSTPOINT COMPLIANCE

Authoring Templates Document Auto Numbering

Intuitive Workflow UI Auto Periodic Review Electronic Forms

PDF Renditions Metrics & Reporting Configurable E‐mail

M &

COLLA

PLATFORM Document Auto Naming Change Requests

Audit Trail Advanced Security

Notices Administrative Utilities ED

M

CONTENT MANAGEMENT

Microsoft SharePoint

                      

esear       

 

       

     

  

  

  

            

FirstPoint’s Quick Start to Compliance

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

BUSINESS R ch & Clinical/ Quality & Sales & BUSINESS MODULES

•Nonclinical •Clinical

Research & Development

•Clinical •TMF Site

Clinical/ eTMF

•Controlled Documents

Quality & Manufacturing

•Advertise‐ments and

Sales & Marketing

Clinical •Quality (CMC) •Regulatory

TMF Site •TMF Study

Documents •Change Requests

ments and Promotional Materials

•Content types •Site columns

•Workflow templates •Security templates

The libraries consist of predefined:

•Guided Paths (Metadata Automation)

                 

            

          

 

        

          

              

   y

 

FirstPoint Eliminates Error & Boosts Productivity via “Guided Paths”Productivity via Guided Paths • FirstPoint’s advanced metadata automation tool called Guided Path auto populates metadata where possible

• Guided Path provides consistent data and reduce the volume of dataof avolume datentry – Metadata becomesbecomes more valuable for searchingsearching and workflow automation

Creating a document is faster, easier, and less error prone when it’s pre‐populated with exactly what you need!

             

                 

  

                         

                 

            

            

        

Workflow Guides Secure Collaboration 2. A copy of the document is automatically exported to a

1. Author initiates workflow and invites contributing authors

p controlled SharePoint site

4. An audit trail is kept of 3. Contributing authors and all actions for the external business partners external business partners all actions for the updated document and can simultaneously the collaboration site is collaborate in a secure and deleted upon completion controlled setting using of the workflow Word Track Changes Word Track Changes of the workflow

       

                        

     

          

               

FirstPoint Collaboration

Copy a document from FirstPoint Site to SharePoint Site FirstPoint Main Site FirstPoint Workspace Site

When the workflow is initiated a copy of h dthe document is created and placed on the collaborative workspace

A document with compiled changes is copied back to FirstDoc as a new version.as a new version.

Power of Choice: Software + Services

SERVICESSERVICES

Trusted Cloud ServicesTrusted Cloud Services

For HealthcareFor Healthcare For Financial Services For Government

THANK YOU !THANK YOU !