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EMC Documentum Compliance Manager

EMC Documentum Compliance Manager. Managing controlled or regulatory content for life sciences. Name, rank, serial number Content Management and Archiving. Agenda. Content Challenges in Life Sciences Organizations An Analyst’s Observations EMC’s Approach

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EMC Documentum Compliance Manager

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  1. EMC Documentum Compliance Manager Managing controlled or regulatory content for life sciences Name, rank, serial number Content Management and Archiving

  2. Agenda • Content Challenges in Life Sciences Organizations • An Analyst’s Observations • EMC’s Approach • Documentum Compliance Manager (DCM) Value Proposition • What is DCM? • What’s New in DCM 6.5?

  3. Content Challenges in Life Sciences Organizations • Speed cost effective new drug discovery and development • Shorten regulatory cycles by streamlining the submissions process • Bring safe drugs to market • Achieve and maintain regulatory compliance • Collaborate with external partners such as Contract Research Organizations (CROs) 3

  4. Store, Protect, Optimize and Leverage Your Life Sciences Information Lab Tests Regulatory Review Sales, Marketing and Distribution Post-Marketing Safety Surveillance Basic Research and Discovery Pre-clinical Development Clinical Trials Patient Diagnostic and Treatment Manufacturing R&D, Clinical Trials, Regulatory Submission Lab information management systems High performance computing Clinical research Clinical trials management Manufacturing GMP & Quality Management CAPA Batch content & Production scheduling Labeling and packaging Sales, Marketing and Distribution Leads management Marketing asset management Distribution management Everything must be documented and almost everything must be published

  5. Observations: • Pharmaceutical companies produce more documents than drugs making unstructured information management a business imperative • Terabytes of legacy content in “technology dust bins”increase legal risk as organizations spend millions annually “crawling through these sources” • While records management policies have been written and could minimize this risk, they have not been implemented • Knowledge management remains illusive- researchers/scientists are struggling to discover information to shorten drug development timelines Recommendation: Standardize current document management capabilitiesand stem the proliferation of content that increases risk and expense

  6. EMC’s Approach • Provide the Enterprise Compliance Platform for Life Sciences, an integrated platform of both EMC Documentum and partner products and services • Provide DCM to control content in an audited environment and achieve compliance with 21 CFR Part 11, GxP processes and other imperatives • Nurture a rich ecosystem of partner solutions to extend the Enterprise Compliance Platform for Life Sciences • Draw on best practices derived from years of experience in industry-leading pharmaceutical companies to offer solutions to address your problems

  7. Enterprise Compliance Platform for Life Sciences Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing, & Service Configurations And Project Accelerators Process Services Content Services Repository Services Collaborate Control Content Retain/Archive Publish Process Templates and Best Practices for Optimized Performance PARTNER APPLICATIONS SharePoint Access eTrial Master File Structured Product Labeling Regulatory Submissions COMPLIANCE INTERFACE Documentum Collaborative Services Documentum Compliance Manager Retention Policy Services EMC DOCUMENTUM PLATFORM

  8. Documentum Compliance Manager (DCM) Automates processes for collecting, sharing, approving and using content in order to meet stringent quality goals and compliance requirements Reduces costs and improves efficiencies through automation Helps organizations achieve compliance with external regulations, including 21 CFR part 11, and internal policies Meets requirements in many market segments where customers face controlled content challenges An audited environment where users can collaborate, create, review, revise, approve and distribute controlled content online Documentum Compliance Manager:

  9. Features and Benefits DCM - Features • Controlled lifecycle – automatically attached to document • Real-time overlays and watermarking • Change management • Automated review and approval with eSignatures • Adheres to requirements in 21 CFR Part 11 Controlled Lifecycle management Create Review Approve DCM – Benefits • Quickly determine when, why and who has interacted with content • Enforce signatures and proper approvals • Ensure content authenticity and retention • Easily respond to regulatory agencies and auditors Publish Retire Retain Dispose

  10. Documentum Compliance Manager (DCM) No longer required for e-signatures DCM Components and Complementary Products Controlled Lifecycle Enforcement BaseWebtopCapabilities Controlled Relationship Electronic Signatures AuditedNotifications Real-timeWatermarking & Overlays ChangeManagement EnhancedAuditing Trusted Content Services Print Control Services Retention Policy Services ADTS (or DTS) Controlled Copies Secured Print Activities Available late 2008 Digital Shredding Encryption Policy based retention and disposition Legal Holds PDF Renditioning Advanced PDF Capabilities

  11. What’s new in DCM 6.5? • Integration and alignment with Documentum D6.x platform • Simplified architecture / easier deployment • Totally native code: Watermarking, Overlays, e-Signatures • Single-sever deployment • Initial entry into SOA • Certification with Branch Office Caching (BOCS), Retention Policy Services (RPS), and Collaboration Services (CS) • XML document support to manage controlled content authored in XML

  12. Controlled Life Cycle PDF Stamping Service

  13. Controlled Life Cycle

  14. Signoff E-Signature

  15. E-Signature

  16. E-Signature Manifestation 06/17/2008 dmadmin Regulatory Affairs Default signoff justification

  17. Overlay/Watermarking

  18. Header – Object Name Footer – Lifecycle state Transformations with ADTS Content Services Web Publishing SAFE Credentialing Transformation XML Management Large File Handling Ingestion Restore Advanced Document Transformation Services Features • MS Office to PDF • Merging content to PDF • Watermarks and Overlays • Header and Footer creation • PDF to PDF Transformation • Email to PDF support • Add Attachments Virtual Document Confidential

  19. Enterprise Compliance Platform for Life Sciences As the platform grows, DCM’s value increases Compliance Interface Collaborative Workplaces Regulated Content Content Capture Enterprise Search Portal Authoring Tool Integration Enterprise Applications Process Services Templates Best Practices Modeling & Simulation Process Execution Activity Monitoring Forms Design Process Discovery Analysis & Optimization Queue Management Systems Integration Content Services Access Control & Encryption Transformations & Renditions Workflow Library Services Classification Categorization eSignatures Lifecycles SAFE Credentialing Content Publishing Relation & Link Management Audit Trail XML Management Change Control Repository Services Information Rights Mgt. Retention Policies Records Management Security Auditing & Reporting Archiving Storage Optimization

  20. Solutions for Life Sciences Preclinical Clinical Manufacturing Sales, Marketing & Service Discovery & Research Enterprise Marketing Solution Plant & AssetManagement Structured ProductLabeling EMCWebExperienceManagement eTMF Regulatory Submissions SOPManagement CallCenterManagement EMCCustomerCommunications EMCBrandCenter LOB Solutions Email Archiving Enterprise Records Management Regulated Content with SharePoint eDiscovery CompliantImageArchiving Good (Info) Governance Process Services Content Services EMC Documentum Platform Repository Services

  21. Solutions for Life Sciences – World Class Partner Ecosystem Sales, Marketing & Customer Service Discovery and Research Preclinical Clinical Manufacturing Partner Applications MOSS Integrations Regulatory Submissions Call Center Management Structured Content Labeling eTMF Enterprise Marketing Solution SOP Management Valiance Compliance Interface Process Services Content Services Repository Services

  22. What Sets EMC Documentum Apart? • Integration with Documentum Platform • Standard, easy to upgrade environment • Highly configurable environment eliminating need for custom code • Rich ecosystem of SI partners for services • Gold standard in Pharmaceutical Industry* • Almost 90% of top 40 pharmaceutical companies use Documentum • Almost 60% of the same top 40 use DCM * Top 40 as listed by The Pharm Exec 50 2008

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