Transcript 2008 EMC Template White External Use Title 24 Point Arial

EMC Documentum Compliance Manager
Managing controlled or regulatory content for life sciences
Name, rank, serial number
Content Management and Archiving
© Copyright 2008 EMC Corporation. All rights reserved.
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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?
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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)
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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
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
Patient Diagnostic
and Treatment
Sales, Marketing and
Distribution
Leads management
Marketing asset management
Distribution management
Everything must be documented and almost everything must be published
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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 capabilities
and stem the proliferation of content that increases risk and expense
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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 industryleading pharmaceutical companies to offer solutions to address your
problems
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Enterprise Compliance Platform for Life Sciences
Discovery &
Research
Preclinical
Collaborate
Clinical
Control Content
Manufacturing
Sales, Marketing,
& Service
Retain/Archive
Publish
Process Templates and Best Practices for Optimized Performance
PARTNER APPLICATIONS
SharePoint
Access
Structured
Product Labeling
eTrial Master
File
Regulatory
Submissions
Configurations
And
COMPLIANCE
ProjectINTERFACE
Documentum
Documentum
Accelerators
Retention
Collaborative
Services
Compliance
Manager
Policy Services
EMC DOCUMENTUM PLATFORM
Process Services
Content Services
Repository Services
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Documentum Compliance Manager (DCM)
An audited environment where users can collaborate, create, review,
revise, approve and distribute controlled content online
Documentum Compliance Manager:
 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
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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
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DCM Components and Complementary Products
Documentum Compliance Manager (DCM)
Controlled
Base
Controlled
Lifecycle
Webtop
Relationship
Enforcement Capabilities
ADTS (or DTS)
PDF
Renditioning
Advanced
PDF
Capabilities
Electronic
Signatures
Trusted Content Services
Digital
Shredding
Encryption
Real-time
Change
Audited
Watermarking Management
Notifications
& Overlays
Print Control Services
Secured
Available
late
Controlled
Print
Copies
2008
Activities
Enhanced
Auditing
Retention Policy Services
Policy based
retention and
disposition
Legal Holds
No longer required
for e-signatures
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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
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Controlled Life Cycle
PDF Stamping Service
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Controlled Life Cycle
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E-Signature
Signoff
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E-Signature
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E-Signature Manifestation
06/17/2008
dmadmin
Regulatory Affairs
Default signoff justification
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Overlay/Watermarking
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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
• PDF to PDF Transformation
Merging content to PDF
• Email to PDF support
Watermarks and Overlays • Add Attachments
Header and Footer creation
Virtual Document
Header – Object Name
Footer – Lifecycle state
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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 Enterprise
Integration Applications
Templates
Best Practices
Modeling &
Simulation
Process Services
Process
Execution
Activity
Monitoring
Process
Discovery
Analysis &
Optimization
Forms
Design
Systems
Integration
Queue
Management
Library
Services
eSignatures
Classification
Categorization
Content
Services
Lifecycles
SAFE
Credentialing
Content
Publishing
Relation & Link
Management
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Audit Trail
XML
Management
Repository Services
Information
Rights Mgt.
Security
Access ControlTransformations
Workflow
& Encryption & Renditions
Records
Management
Auditing &
Reporting
Change
Control
Retention
Policies
Archiving
Storage
Optimization
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Solutions for Life Sciences
Discovery &
Research
Preclinical
Clinical
Manufacturing
Sales,
Marketing &
Service
Good (Info)
Governance
Email
Archiving
Enterprise
Records
Management
Regulated
Content with
SharePoint
eDiscovery
EMC Web
Experience
Management
Communications
EMC Customer
EMC Brand
Center
Plant & Asset
Management
Structured
Product
Labeling
Call Center
Management
SOP
Management
Regulatory
Submissions
LOB
Solutions
eTMF
Enterprise Marketing Solution
Compliant
Image
Archiving
Process Services
Content Services
Repository Services
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EMC Documentum
Platform
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Solutions for Life Sciences – World Class Partner
Ecosystem
Discovery
and
Research
Preclinical
Clinical
Manufacturing
Sales, Marketing
& Customer
Service
Partner Applications
MOSS
Integrations
Regulatory
Submissions
SOP
Management
Call Center
Management
Structured
Content
Labeling
eTMF
Enterprise
Marketing
Solution
Compliance Interface
Process Services
Content Services
Repository Services
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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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