1 © copyright 2008 emc corporation. all rights reserved. emc documentum compliance manager name,...

1© Copyright 2008 EMC Corporation. All rights reserved.

EMC Documentum Compliance Manager

Name, rank, serial numberContent Management and Archiving

Managing controlled or regulatory content for life sciences


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?


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

Content Challenges in Life Sciences Organizations


Manufacturing

Lab Tests

Manufacturing GMP & Quality Management

CAPABatch content &

Production schedulingLabeling and packaging

Sales, Marketing and Distribution

Leads management

Marketing asset management

Distribution management

R&D, Clinical Trials, Regulatory Submission

Lab information management systemsHigh performance computing

Clinical researchClinical trials management

Regulatory Review

Pre-clinical Development

Clinical Trials

Basic Research and Discovery

Sales, Marketing and Distribution

Patient Diagnosticand Treatment

Post-MarketingSafety Surveillance

Everything must be documented and almost everything must be published

Store, Protect, Optimize and Leverage Your Life Sciences Information


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


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


PARTNER APPLICATIONS

Retain/ArchiveControl ContentCollaborate Publish

EMC DOCUMENTUM PLATFORM

COMPLIANCE INTERFACEDocumentum Collaborative

Services

Documentum Compliance

Manager

Retention Policy Services

SharePoint Access

eTrial Master File

RegulatorySubmissions

Structured Product Labeling

Enterprise Compliance Platform for Life Sciences

Process Services

Content Services

Repository Services

Process Templates and Best Practices for Optimized Performance

Discovery & Research

Preclinical Clinical ManufacturingSales, Marketing,

& Service

ConfigurationsAnd

ProjectAccelerators


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:


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

Features and Benefits

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

Controlled Lifecycle

management

Create

Review

Approve

Publish

Retain

Retire

Dispose


Documentum Compliance Manager (DCM)Documentum Compliance Manager (DCM)

Audited Notifications

Base Webtop Capabilities

Controlled LifecycleEnforcement

ControlledRelationship

Enhanced Auditing

ElectronicSignatures

Real-time Watermarking& Overlays

Change Management

DCM Components and Complementary Products

Digital Shredding Encryption

Trusted Content Services

Secured Print Activities

Controlled Copies

Print Control Services

Policy based retention and disposition

Legal Holds

Retention Policy ServicesADTS (or DTS)

PDF Renditioning

Advanced PDF Capabilities

No longer required for e-signatures

Available late 2008


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


Controlled Life Cycle

PDF Stamping Service


Controlled Life Cycle


E-Signature

Signoff


E-Signature


dmadmin 06/17/2008

Regulatory Affairs

Default signoff justification

E-Signature Manifestation


Overlay/Watermarking


Content Services

Large FileHandling

XMLManagement RestoreWeb Publishing TransformationSAFE

Credentialing Ingestion

Transformations with ADTS

Virtual DocumentVirtual Document

Header – Object Name

Footer – Lifecycle state

• PDF to PDF Transformation• Email to PDF support • Add Attachments

• MS Office to PDF • Merging content to PDF• Watermarks and Overlays • Header and Footer creation

Advanced Document Transformation Services Features


Workflow

Relation & LinkManagement

Transformations& Renditions

XMLManagement

ContentPublishing

LibraryServices

ClassificationCategorization

Lifecycles

Compliance Interface

PortalEnterpriseSearch

EnterpriseApplications

CollaborativeWorkplaces

Content Capture

RegulatedContent

Authoring ToolIntegration

RecordsManagement

RetentionPolicies

StorageOptimization

TemplatesBest Practices

ProcessDiscovery

Modeling &Simulation

Analysis &Optimization

FormsDesign

QueueManagement

SystemsIntegration

ProcessExecution

ActivityMonitoring

ChangeControl

Auditing &Reporting Archiving

InformationRights Mgt.

Security

Process Services

Content Services

Repository Services

Enterprise Compliance Platform for Life Sciences

eSignatures

SAFECredentialing

Access Control& Encryption

Audit Trail

As the platform grows, DCM’s value increases


Solutions for Life Sciences

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Good (Info) Governance

LOB Solutions

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Enterprise Marketing Solution

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Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing

& Service

Email Archiving

eT

MF

Enterprise Records

Management

Regulated Content with SharePoint

eDiscoveryCompliant

Image Archiving

Process Services

Content Services

Repository Services EMC Documentum Platform


Solutions for Life Sciences – World Class Partner Ecosystem

Compliance Interface

Process Services

Content Services

Repository Services

Partner Applications

Call Center Management

Structured Content Labeling

Regulatory Submissions

MOSSIntegrations

SOP Management

eTMF Enterprise Marketing Solution

Discovery and

Research

Discovery and

ResearchPreclinicalPreclinical ClinicalClinical ManufacturingManufacturing

Sales, Marketing & Customer

Service

Sales, Marketing & Customer

Service


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

1 © copyright 2008 emc corporation. all rights reserved. emc documentum compliance manager name,...

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