Solution for Compliance in a Regulated Environment

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IBM® Solution for Compliance in a Regulated Environment automates the sharing and management of controlled content.

It helps organizations in the Life Sciences and Healthcare sectors comply with regulations such as GxP and 21CFR11 for R&D manufacturing.

• Provides full document life cycle and Electronic Common Technical Document life cycle management from creation through submission
• Delivers compound document assembly, Electronic Common Technical Document assembly, communications and correspondence management and registration status tracking
• Includes enhanced support to run in a service-oriented architecture (SOA) environment, including Web services interfaces to ease integration with other applications
• Applies to regulated business processes, including R&D, clinical trials, regulatory affairs/submissions, packaging and labeling, marketing materials and advertising
• Helps you manage the impact on your regulated document value chain by managing standard operating procedures (SOPs), material safety datasheets and more

Product framework

Product line overview Content Management Activate content with processes to add value and transform your business. Included components DB2 Content Manager 8.3 manages all types of digitized content - Web content, document images, electronic office documents, printed output, audio, and video. WebSphere Portal Enable 5.1 includes all features of WebSphere Portal Server plus significant added portal content management and portal workflow functionality. WebSphere Business Integration Server Foundation 5.1 extends and integrates your existing IT assets using a next generation integration platform. WebSphere Application Server 5.1.1 delivers the secure, scalable, resilient application infrastructure you need for a Service Oriented Architecture (SOA). WebSphere Studio Application Developer Integration Edition 5.1.1 is optimized for building composite applications that deploy to IBM WebSphere Business Integration Server Foundation. IBM FileNet Content Federation Services IBM FileNet P8 Platform IBM FileNet System Monitor View all components

Additional products, services and solutions

Services Content Manager Implementation Services: Ensure you have a deployment-ready infrastructure and knowledgeable staff to lay the groundwork for your long-term ECM strategy. Solutions The next generation in compliance solutions Focus on compliance, gain business value.