EMC Documentum Compliance Manager

EMC Documentum Compliance Manager
July 2008 EMC Documentum Compliance Manager Notes to Presenter This presentation is intended to introduce the challenges life sciences companies face in managing controlled or regulated content and how Documentum Compliance Manager (DCM) 6.5 addresses these challenges. The audience is customers/clients in life sciences companies, who may or may not be familiar with DCM. Managing controlled or regulatory content for life sciences Name, rank, serial number Content Management and Archiving

EMC Documentum Compliance Manager July 2008
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? Today we will talk about challenges faced by life sciences organizations. For an analyst’s perspective, we will quote Laura Ramos of Forrester and a paper she published on how to exploit unstructured information in pharmaceutical companies. Next, we will introduce EMC’s approach which includes providing a compliance platform based on Documentum as well as the Documentum Compliance Manager – software that helps companies control the content lifecycle and achieve compliance with internal policies and industry regulations. Finally, we will talk specifically about what DCM is, what benefits it brings and what’s new in EMC’s latest version - DCM 6.5.

Content Challenges in Life Sciences Organizations
EMC Documentum Compliance Manager July 2008 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) Expiring patents, thinning pipelines for new drugs and shrinking profit margins have cut into corporate profitability for today’s life sciences companies. Additional business challenges include increased competition from generics and increased regulatory requirements and complexity. In addition, mounting drug safety concerns – after the Vioxx debacle – put pressure on both pharma companies and regulatory bodies such as the FDA. Today’s life sciences companies are driven to reduce costs, increase revenue and increase the safety of their products. Some of the specific challenges that can be helped by content management include: Speed cost effective new drug discovery and development Having a common content infrastructure across multiple functions to manage corporate-wide content increases efficiency. Shorten regulatory cycles by streamlining the submissions process Tightly integrating content management systems with publishing systems (DCTM, DCM and ISI eCTDXpress) help ensure that documents authored in the earlier stages of the drug life cycle can be used at later points in the submission assembly process. Bring safe drugs to market Achieve and maintain regulatory compliance DCM helps companies comply with regulations such as 21 CFR Part 11 and GMP or Good Manufacturing Practice Collaborate with external partners such as Contract Research Organizations (CROs) DCM is integrated with Documentum Collaboration Services to enable both internal and external collaboration. Manage information growth 3

Store, Protect, Optimize and Leverage Your Life Sciences Information
EMC Documentum Compliance Manager July 2008 Store, Protect, Optimize and Leverage Your Life Sciences Information Lab Tests Regulatory Review Sales, Marketing and Distribution Post-Marketing Safety Surveillance This graphic illustrates the Life Sciences Value Chain, showing an overview of all the different phases that a pharmaceutical company needs to go through to bring a new compound or drug to market. Each phase produces a lot of documentation, much of which needs to be managed as controlled content. EMC Documentum offers the Enterprise Compliance Platform for Life Sciences, to help manage each of these phases. Documentum Compliance Manager (DCM) manages the lifecycle of controlled or regulated content to ensure compliance with internal policies or external regulations. In addition, solutions from EMC partners address business problems such as regulatory submissions; structured product labeling; and creating and distributing marketing content. 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

July 2008 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 Laura Ramos is a market research analyst with the Forrester group and a well known speaker on pharmaceutical industry topics. In a 2006 study, she observed that pharmaceutical companies produce more documents than drugs resulting in huge amounts of content. Organizations are prevented by law from disposing of most of this content for a long time, usually until well after the life of the product. This legacy content increases legal risk because companies do not necessarily know what information is discoverable in their “technology dust bins.” Finding relevant content is also a problem which slows time to market and increases costs. Laura Ramos recommends that life sciences companies standardize current document management capabilities to stem the proliferation of content that can increase risk and expense. A document management infrastructure based on Documentum Compliance Manager can help you do that.

July 2008 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 DCM is a core component of the Enterprise Compliance Platform (ECP) for life sciences, an integrated platform that allows life sciences organizations to collaborate on, control, publish and retain or archive content. DCM is the industry’s gold standard for managing regulated or controlled content. DCM is highly configurable so that it can address a variety of content and process issues. For example, it is used to help organizations achieve compliance with 21 CFR Part 11 in many life sciences companies but also can be used to manage documents such as plant engineering drawings in manufacturing companies. EMC Documentum has a rich ecosystem of complementary partners – both system integrators and technology partners – to provide solutions that address problems throughout the life sciences value chain. That’s why so many of the world’s top life sciences organizations – including 25 of the largest pharmaceutical companies and seven FDA centers – rely on EMC software. EMC draws on the best practices derived from years of experience in life sciences to offer solutions to address your problems. Next, let’s define the ECP and the benefits it can bring to life sciences organizations and then delve deeper into what DCM is and the value it brings to customers.

Enterprise Compliance Platform for Life Sciences
Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing, & Service Collaborate Control Content Retain/Archive Publish Process Templates and Best Practices for Optimized Performance Configurations And Project Accelerators PARTNER APPLICATIONS At each stage of the Life Sciences Value Chain shown at the top, workers need to document almost everything they do. This results in an enormous amount of unstructured content. Workers often create this content as a team, hence they need to collaborate. The content almost always is regulated hence needs to be controlled. The content is usually published in diverse formats across various internal or external departments or agencies. At the end of the content’s life, it is retained in an archive. The ECP consists of key capabilities of the traditional Documentum stack that address these requirements. They are shown using a tiered approach and are referred to as repository services, content services and process services. The three tiers, at the bottom of the slide, are the core features that Documentum provides but we have also a forth layer seen in green called the Compliance Interface. This interface layer provides an end user with a web- based view that delivers an intuitive and graphical access point to the platform capabilities specifically for controlled or regulated content. The ECP allows our partners to extend our core capabilities by applying project accelerators, best practices, industry expertise, and migration, configuration and validation capabilities for their own customer base. This approach reduces the complexity of implementing an enterprise ECM solution for the life sciences industry. Now let’s delve a little further into the platform … Key Messages: Any one customer or application can leverage a wide array of compliance services. Falling under the three main categories that were described earlier, these services ensure Integrity, Security and Accessibility, providing specific capabilities necessary to meet a broad set of compliance needs across an organization. How does a compliance infrastructure help users? First, users can have pervasive access to information throughout the organization as well as in legacy and outside information sources. Plus, having a compliance platform with one security model, a unified audit trail and one administrative console makes for a more secure system that offers better accountability, visibility and usability. SharePoint Access eTrial Master File Structured Product Labeling Regulatory Submissions COMPLIANCE INTERFACE Documentum Collaborative Services Documentum Compliance Manager Retention Policy Services EMC DOCUMENTUM PLATFORM Process Services Content Services Repository Services

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

July 2008 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 A critical capability in regulatory compliance is controlled lifecycle management. Controlled lifecycle management consist of policies that can be applied at each state of a document’s life. Lifecycles are flexible, so you can have as many states as needed to map to business processes. How does that apply to compliance? Well, when content is promoted or demoted between states - for example the states an SOP goes through during it’s review and approval cycle - other activities can occur, such as changing security settings, changing access control privileges, moving files to a new location such as a portal site, changing file formats (e.g. automatically generating secure PDFs), and so on. Organizations set up business rules to determine what changes when. <click> Lifecycle management is a powerful feature. DCM helps companies enforce compliance throughout their business processes and allows organizations to quickly respond to any regulatory inquiries. Most importantly, it ensures that companies can determine when, why and who has interacted with any particular piece of content, otherwise know as tracking chain of custody. DCM extends standard lifecycle functionality provided by the Documentum platform to provide document and regulatory controls including template assignment, signatories, e-signatures, and workflows by content type. These lifecycle extensions are highly configurable, as are the lifecycles themselves, and may involve many states or only a few. DCM is the only application within the Documentum platform to immediately apply a lifecycle to controlled content upon creation. This lifecycle then governs what can happen to the document at each stage of its evolution from initial creation until final disposition. 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

DCM Components and Complementary Products Documentum Compliance Manager (DCM) Controlled Lifecycle Enforcement Base Webtop Capabilities Controlled Relationship Electronic Signatures Audited Notifications Real-time Watermarking & Overlays Change Management Enhanced Auditing Documentum Compliance Manager is well integrated with the Documentum Platform and is a pure extension of WebTop. As such, any improvements to WebTop are also improvements to DCM. DCM includes the capabilities in the gray box including: Controlled lifecycle management to enforce an organization’s business rules for document review, approval and distribution All capabilities found in WebTop including modal dialogues for better navigation, extended search capabilities, and configurable presets Electronic signatures – to control document signoff, including enforced justifications, to help streamline approvals Notifications and tracking – to notify consumers of changes and thus ensure approved content is in use. Real-time watermarking and overlays – to print effective dates and states on documents in real-time so that workers understand the status of a document. The platform components most often used in association with DCM are: Document Transformation Services Trusted Content Services Print Control Services and Retention Policy Services ADTS or Advanced Document Transformation Services, or DTS, Document Transformation Services, automate the conversion of standard desktop document formats into web-ready formats such as PDF and HTML, and store the renditions in a Documentum repository alongside the original. ADTS provides additional PDF rendering for multi-page TIFF, AutoCAD 2002, Microsoft® Visio, and Project. ADTS also provides additional format and metadata extraction support—a necessity for content authors who use advanced features such as template styles, hyperlinks, and URLs in their source documents and wish to preserve these features in their PDF documents. Either ADTS or DTS is required with DCM because DCM works with PDF documents. The following components are optional but highly useful options for many customer requirements: Trusted Content Services (TCS) provides features for advanced content security such as repository encryption and digital shredding. Prior to DCM 6.5, TCS was required for the eSignature capability. Now that capability is provided natively in DCM 6.5. Print Control Services (PCS) provides the ability to manage controlled copies of approved content. [Click] , it will only be available later in 2008 Retention Policy Services (RPS) manages content retention and disposition. ADTS (or DTS) Trusted Content Services Print Control Services Retention Policy Services No longer required for e-signatures Controlled Copies Available late 2008 Secured Print Activities PDF Renditioning Advanced PDF Capabilities Digital Shredding Encryption Policy based retention and disposition Legal Holds

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 DCM 6.5, released with EMC Documentum 6.5, delivers new functionality in a number of major areas. It is the first version of DCM on the 6.x platform. As a result, DCM now incorporates all of the new functionality delivered with Documentum 6.x. DCM provides the real-time overlay functionality and e-signatures as native code, replacing a third- party product which required a separate environment and install. This simplifies the architecture significantly. The e-signature functionality is provided as a web service. DCM 6.5 is our first entry into SOA or service oriented architecture. Certification with BOCS provides the ability to support a distributed architecture for global implementations of DCM. Certification with RPS provides the ability to control a document from creation through review and approval to eventual disposition. Collaboration services certification provides the ability to work as a team on content during the authoring and informal review process. A user can create a room, invite people to participate and save discussion threads during the informal review. DCM 6.5 now supports XML documents

How DCM works And now I will show screen shots of some of the key capabilities of DCM.

Controlled Life Cycle EMC Documentum Compliance Manager July 2008 This screenshot shows the lifecycle states for this type of document, such as in progress, in approval, approved and effective. An effective document is one that has been approved, signed, and is currently in use and available to the general user population for viewing purposes. DCM’s lifecycle capabilities include: attaching a lifecycle to a document automatically upon creation or import, to facilitate controlled review and approval enforcing specified lifecycle states. preventing a document from being deleted in certain states scheduling automatic review of an approved, effective document making approved documents effective upon a certain date Moving an existing version of a document to the retired state when a new version is made effective Retiring a document upon a certain date Cleaning up or deleting all in progress or draft versions of a document upon approval of a document version PDF Stamping Service 13

Controlled Life Cycle EMC Documentum Compliance Manager July 2008 This screenshot shows the first page of the configuration of PDF Stamping Services for managing the controls provided over a PDF document when it is viewed. 14

E-Signature EMC Documentum Compliance Manager July 2008 Initiate signoff This screen shot shows a signatory initiating a signoff of the document A0.pdf. Sign-offs can be configured for any state of the lifecycle and the My Signoffs screen allows you to track what has been signed off and by whom as well as what is pending. Signoff

E-Signature EMC Documentum Compliance Manager July 2008 This screen shot shows information that a signatory is required to supply, as per the dictate of 21 CFR part 11. [Click]

E-Signature Manifestation
Title Month Year This screen shot shows signoff page – or eSignature manifestation. This page show all the information provided during signoff for each signatory. The page can be configured to be at the beginning or the end of the document. [Click in the center of the page to return to slide 11] 06/17/2008 dmadmin Regulatory Affairs Default signoff justification

Title Month Year New for D6.5 are modal dialogues. When you right click on an object and choose to edit properties – it brings up a pop up window showing the properties page, instead of a whole new screen. If you further choose to edit a repeating attribute, Keywords, for example, another pop up window appears. Previously a new window would have appeared in this instance as well. This was sometimes confusing especially for new or casual users since they often lost their way along the process. With modal dialogues one can now easily trace from where one began. [Click in the center of the page to return to slide 11]

Overlay/Watermarking
This screen shot shows the overlays or watermarks that can be configured in the new PDF Stamping Services functionality within DCM. One can configure headers and footers, use block letters for overlays such as that in ‘Default Letter Portrait’, and there is also the capability to use an image such as that within the blue bar at the bottom. [Click in the center of the page to return to slide 11]

Confidential Transformations with ADTS Virtual Document
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 to PDF support Add Attachments Virtual Document Header – Object Name Footer – Lifecycle state This graphic illustrates some of the functionality delivered through ADTS. It shows various content as components of a virtual document being published as one secure PDF with overlay information from the repository. Confidential

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 Templates Best Practices Modeling & Simulation Process Services Process Execution Activity Monitoring Process Discovery Analysis & Optimization Forms Design Systems Integration Queue Management Each of the layers consists of capabilities that showcase our expertise in managing controlled content. I will quickly define each layer and highlight it’s key capabilities: The Compliance Interface is a web-based interface that allows users to manage regulated or controlled content. Some of these applications include DCM – Documentum Compliance Manager, Documentum Collaborative Services (DCS), and desktop tool integration (like Microsoft Office – Word or Excel) provided by Authoring Integration Services (AIS). The Process Services layer manages operational processes, workflows and lifecycles, through defined activities and tasks. This consists of products such as BPM – Business Process Manager. The Content Services layer leverages Documentum’s core features but also adds extended capabilities such as Digital Signatures, detailed audit control, and document transformations such as MS Word to PDF. These products include Trusted Content Services (TCS) and Regulated Publishing Transformation Services (RPTS). The last layer, called repository services controls the way content is stored. Retention Policy Services (RPS) enforces retention and disposition policies automatically. The most important point is how DCM is positioned relative to the other components. Unlike many competitive products, DCM is well integrated with the Documentum platform and the ECP both horizontally with our other UI’s and vertically with the components of the platform. That means DCM plays well with the other components such as BPM, BOCS, and RPS. As the platform grows, DCM increases in functionality and value. For example, any improvements made to WebTop, RPS or BOCs are available to DCM. DCM is also highly configurable, incorporating functionality from over ten years of experience and industry best practices. The result is that DCM will not require customization in most instances and upgrades smoothly with the platform. You pay for the development once and only once as opposed to a custom application where you pay, and then pay, and then pay again with every upgrade. Library Services eSignatures Classification Categorization Content Services Access Control & Encryption Transformations & Renditions Workflow Lifecycles SAFE Credentialing Content Publishing Relation & Link Management Audit Trail XML Management Change Control Information Rights Mgt. Repository Services Retention Policies Security Records Management Auditing & Reporting Archiving Storage Optimization 21

Solutions Let’s look at some of the complementary solutions in EMC Documentum’s portfolio of solutions for the life sciences industry.

Solutions for Life Sciences
Title Month Year Solutions for Life Sciences Discovery & Research Preclinical Clinical Manufacturing Sales, Marketing & Service Enterprise Marketing Solution eTMF Submissions Regulatory SOP Management Call Center Management Structured Product Labeling Plant & Asset Management EMC Web Experience Management EMC Brand Center EMC Customer Communications LOB Solutions We are building a platform of solutions that are key to life sciences, to include both Line of business (LOB) and Good Information Governance solutions. eTMF from CMA Consulting Regulatory Submissions from EMC, Impact Systems and ISI SOP Management from Impact Systems and EMc Call Center Management from RWD Structured Product Labeling from Glemser Plant and Asset Management from McLaren And the Enterprise Marketing Solution from EMC Good Information Governance solutions include products from EMC for archiving, records management, SharePoint integration, eDiscovery and compliant image archiving. Archiving Enterprise Records Management Regulated Content with SharePoint eDiscovery Compliant Image Archiving Good (Info) Governance Process Services Content Services EMC Documentum Platform Repository Services 23

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 This graphic maps the our partners to the life sciences solutions. Valiance Compliance Interface Process Services Content Services Repository Services 24 24

What Sets EMC Documentum Apart?
Title Month Year 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 DCM is quite unique in the market in its level of integration and completeness out of the box Most competitive solutions need to be highly customized for each application. As a result, these applications are difficult to upgrade when new versions of Documentum are released. DCM is upgraded as a component of the platform. DCM is also highly configurable. DCM can be easily adapted to meet varied requirements via configuration. These configurations migrate easily because they are not custom code. EMC has a rich ecosystem of both SI partners and ISV partners to give customer the choice of who to use for additional services and complementary solutions. Finally, Documentum grew up in the Pharmaceutical industry and is the gold standard in life sciences. Almost 90% of top 40 pharmaceutical companies use Documentum and about 60% of the same top 40 use DCM. * Top 40 as listed by The Pharm Exec

Title Month Year Thank you for your time today…. Any Questions?

EMC Documentum Compliance Manager

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