REGULATORY INFORMATION INSTANTLY ACCESS

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1 Introducing CSC s FirstDoc Suite, the life sciences industry s #1 document management and collaboration solution for simplifying global regulatory compliance INSTANTLY ACCESS REGULATORY INFORMATION

2 Are You: Saddled with aging enterprise content management (ECM) systems that are unable to share information and costly to maintain? Facing product approval delays due to cumbersome processes for writing, issuing and publishing critical regulatory information? Fed up with systems that are difficult to use and that increase the risk of noncompliance? Would You Like To: Give your users a modern Web-based interface that allows them to quickly access and share information anywhere using any desktop, tablet or mobile device? Have instant out-of-the-box access to the business processes you will need to follow to guide your products through the entire development-to-market lifecycle? Embed years of investment in industry-leading best practices to help you ensure compliance in the most convenient and economical manner possible? As patents expire, regulatory controls increase globally and R&D costs soar, life sciences companies are under intense pressure to simplify the management of regulatory information to dramatically speed product approvals, but their aging enterprise content management systems (ECMs) are standing in the way. Initially implemented to help manage critical content to comply with stringent regulatory guidelines, the ECMs had often been put into place in a highly customized and costly manner from an IT focus rather than a business-user focus. Since these content management systems often lack the ability to share critical information across the enterprise, regulatory compliance information is still stored in spreadsheets and disparate systems across multiple information silos, and must be retrieved and shared via paper and manual processes. To further compound the collaboration challenge, today s employees, affiliates and regulatory workers are more mobile and geographically diverse than ever before. Legacy ECM systems were not designed to securely accommodate tablets or mobile devices. Rather than streamlining and simplifying regulatory complexities, then, the aging ECMs have become a business problem in and of themselves. Without a simplified, centralized system to efficiently comply with complex regulations and facilitate the communication with regulatory bodies, regulatory approvals could be delayed. A company may lose out to a competitor who gets to market first. Imagine if all of your global regulatory information was easily and instantly accessible to all stakeholders through a simplified user interface via the Web. If cumbersome business processes were automated and ready to use right out of the box without the need for programmers or customization. If proven best practices were embedded in the system to help ensure compliance with ever-changing and increasingly complex regulatory policies. You can conveniently accomplish all of these actions with CSC s FirstDoc Suite, the life sciences industry s #1 document management and collaboration solution for simplifying global regulatory compliance. 1

3 WHAT IS FIRSTDOC? CSC s FirstDoc Document and Collaboration Management Suite dramatically simplifies regulatory compliance. Designed from the user s point of view, it provides a complete set of out-of-the-box, preconfigured solutions that allow users to be up and running fast from the office desktop, a laptop or any mobile device. Once logged into the Web-based system, users can quickly and easily search and bookmark their favorite documents; collaborate with affiliates, business partners and regulators; or complete simplified document templates and reports to make compliance with complex regulatory requirements fast and easy. Accessibility can be established to limit some users, such as third-party contractors, to specific sets of documentation; business-critical data and intellectual property are locked down in a highly secure manner. Designed and built upon CSC s deep domain experience in the regulatory sector, FirstDoc embeds proven best practices that simplify compliance across all areas of the drug development process. Each business module is fully integrated with the FirstDoc Compliance Platform, which provides all the functionality required to meet global regulatory requirements. We understand the global life sciences business and the intricacies that must be considered to be regulatory compliant and market ready. You will never need to spend time or money customprogramming processes to meet your requirements. CSC s FirstDoc Suite Provides: A modern, highly intuitive user interface Easy-to-configure out-of-the-box solutions Flexible managed-service delivery options from your data center or as a service in a secure private cloud EMC Certified Solution Our FirstDoc Suite has met the highest level of certification standards set by EMC, validating the design, performance and scalability of the solution and earning First- Doc the EMC Certified Solution designation. FirstDoc is also developed, implemented and supported through processes that exceed the rigorous requirements of its ISO 9000:2008 certification. HOW DOES IT WORK? FirstDoc takes advantage of the robust functionality and security of EMC Documentum and adds a number of advanced functions necessary for content management in highly regulated environments, including controlled lifecycle, workflows, auditing, electronic signatures and document collaboration. With its flexible UI, FirstDoc offers access to users through multiple device types desktop, laptop, tablet and other mobile devices with a no-touch deployment; users do not require the assistance of a programmer to gain access to the information, tools and reports when they need them. FirstDoc offers UI choice with SPX, a full-feature Share- Point user interface to extend the use of the suite to secure collaboration portals. FirstDoc provides familiar user interfaces of SharePoint and Microsoft Office tools to enable controlled, real-time coauthoring and edit capabilities, while maintaining the rich functionality and security of a controlled environment. FirstDoc also offers advanced collaboration using FirstDoc CRX, a real-time co-authoring environment that is fully integrated with SharePoint and Microsoft Office. To give you a complete submission management solution, FirstDoc is fully integrated with CSC s market-leading electronic publishing solution, ectdxpress. Figure 1 gives an overview of FirstDoc features. 2

4 FIRSTDOC COMPLETE REGULATED CONTENT MANAGEMENT SOLUTION Regulatory Affiliates CROs Investigators CMOs Supply Chain Business Partners Business Modules Research & Development Clinical/eTMF Quality & Manufacturing Sales & Marketing FirstDoc Compliance Platform Compliance End User Functions Administrative Functions 21 CFR Part 11 Compliance Validation Audit Trail Automatic Naming/numbering Search Automated Security Document Numbering Collaboration PDF Management and Publishing Configuration Utility User & Group Administration : Lifecycle Automation Electronic Signature Management Document Lifecycle Management Watermarking Legal Holds Reporting Personalization Document Templates Controlled Printing Notifications Advanced Workflow Engine Advanced Virtual Documents Management Data Dictionary Management Advanced Repository Management Jobs Bulk Import Bulk Property Updates Web Services No-Touch Deployment Export Folder As a Service Figure 1: FirstDoc Our Complete Regulatory Content Management Solution 3

5 FLEXIBLE DELIVERY OPTIONS FirstDoc provides a wide range of flexible deployment options. It can be delivered through a new, innovative user interface or within a business portal, such as SharePoint, to provide document views and functionality via Web Parts. The Web Parts can be personalized to allow access only to the information that is critical to each user. Through our more than 15 years of experience in document management, we designed FirstDoc to extend Documentum functionality to ensure compliance with 21 CFR Part 11 standards, along with other unique features and functions that meet specific industry needs. These include: 21 CFR Part 11 Compliance FirstDoc provides electronic signature capability, document-level audit trail reporting and enhanced security capabilities, which are all seamlessly integrated into Documentum. Document Templates Based on the specific property values selected, FirstDoc automatically presents the correct template to the author. can be configured to support a multitude of business processes. Workflows can be launched manually or automatically based on metadata conditions or calculated dates. Secure Collaboration All document authoring, review and approval processes are secured across all functions, including with external partners via SharePoint. Event Notifications and Audit Trail Notifications can be quickly configured to inform users of document-related events, including status changes, workflow activities and events associated with related documents. FirstDoc can also capture and report all critical events throughout the document lifecycle. Dynamic Security Access control is automatically applied based on a document s lifecycle state and document-specific parameters. Master Data Maintenance FirstDoc includes easy-to-use tools to manage master data and the hierarchy of relationships between data values. Document Lifecycle Management Users enjoy predefined lifecycles that automatically guide documents from creation through review, approval and retirement. Advanced Workflow Our highly flexible workflow engine 4

6 FIRSTDOC BUSINESS MODULES FirstDoc business modules include: Research & Development We designed the R&D module to allow you to seamlessly manage the documentation that is critical to the drug-development lifecycle. Our R&D module: Provides complete document creation, review, approval, storage and retrieval functionality for submissionrelated documents Maps robust inventory against agency guidance with a highly granular design to promote compliance and document reuse Enables PDF rendition support for direct integration with electronic publishing tools Automatically populates detailed metadata for ectd consumption Clinical/eTMF This module allows you to manage the documentation critical to the clinical activities supporting the Trial Master File (TMF). The module: Provides support for clinical documentation at the product, study and site levels Delivers a robust TMF inventory that is aligned to TMF Reference Model Includes out-of-the-box lifecycles to support both internally authored and imported documents Provides a flexible, advanced security model to support study-level security, as well as the management of security for collaboration with external parties Quality & Manufacturing This module enables convenient online management of all controlled quality- and manufacturing-related content. The module: Fully manages all manufacturing-specific documents that fall under Good Manufacturing Practices (GMP) rules, such as material and packaging specifications, batch records and material Provides a controlled print functionality and the ability to manage paper copies Delivers an advanced periodic review capability that fully automates recurring review cycles Sales & Marketing This module helps manage the creation, review, approval and dissemination of all promotional and sales training materials. The module: Provides a predefined inventory to manage promotional and advertisement materials Allows easy collaborating and information sharing with marketing partners Ensures that approved content is used in all marketing materials 5 5

7 FIRSTDOC: A NEW WAY FORWARD CSC recognizes that clients want an intuitive, modern user interface for wide adoption. You want to provide a holistic solution for both controlled and uncontrolled content. And you want to put ECM in the cloud. That is why CSC s FirstDoc is the life sciences industry s #1 document management and collaboration solution for simplifying global regulatory compliance deployed at 16 of the world s top 20 pharma companies, with more than 200,000 seats sold worldwide. FirstDoc offers a phased and modular approach to ECM and the cloud that will allow you to take a low-risk approach to transforming your ECM services. Our project managers, business process and domain consultants, and technical analysts will transform your product development processes, so you can speed compliance and get new products to market fast. WHY CSC? We have been developing applications in the life sciences space for more 20 years, and, as a result, have a proven product development methodology and a historical track record of delivering functional superiority and application quality. Our deep pharmaceutical domain expertise ranges from R&D to quality and manufacturing allowing us to provide a highly experienced global resource base that provides our clients with local talent throughout the globe. Our tools are highly flexible and configurable, allowing for tailored deployments that result in lower implementation fees. We offer extensive experience hosting infrastructure globally and provide a host of cost-efficient as-a-service offerings that will modernize your systems and boost the productivity and performance of your mobile, geographically diverse workforce. 6

8 Worldwide CSC Headquarters The Americas 3170 Fairview Park Drive Falls Church, Virginia United States Asia, Middle East, Africa Level 9, UE BizHub East 6 Changi Business Park Avenue 1 Singapore Republic of Singapore Australia 26 Talavera Road Macquarie Park, NSW 2113 Australia +61(2) Central and Eastern Europe Abraham-Lincoln-Park Wiesbaden Germany Nordic and Baltic Region Retortvej 8 DK-2500 Valby Denmark South and West Europe Immeuble Balzac 10 place des Vosges Paris la Défense Cedex France UK and Ireland Region Royal Pavilion Wellesley Road Aldershot, Hampshire GU11 1PZ United Kingdom +44(0) About CSC CSC is a global leader in next-generation IT services and solutions. The company s mission is to enable superior returns on our clients technology investments through best-in-class industry solutions, domain expertise and global scale. For more information, visit us at Designed and produced by CSC s Creative Services Computer Sciences Corporation. All rights reserved