Life Sciences Regulation: IBM Solutions for Healthcare Compliance


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The IBM Solution for Compliance in a Regulated Environment (SCORE) provides life sciences companies with an integrated compliance solution that enables faster regulatory submissions, expedited clinical trials, streamlined manufacturing and better process integration.

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Life Sciences Regulation: IBM Solutions for Healthcare Compliance

  1. 1. IBM SALES AND DISTRIBUTION Implement process-driven compliance Solution Brief IBM Solution for Compliance in a Regulated Environment With massive amounts of content related to drug development and distribution—and increasing regulations—you need to manage more Highlights than documents. You need an integrated compliance solution that ● Go beyond document management by enables faster regulatory submissions, expedited clinical trials, stream- integrating data, applications and lined manufacturing and better process integration. The IBM Solution processes from research and develop- for Compliance in a Regulated Environment (SCORE) can help. ment to the pharmacy shelf ● Comply with regulations such as GxP, Most compliance systems available to life sciences companies focus on FDA 21 CFR Part 11 and Annex 11 of document management, but regulations are increasingly focused on the EU/EC GMP directives business processes. To comply, you need better integration across your ● Control document and submission organization and beyond. With IBM SCORE you can manage docu- assembly, including versioning to improve product quality and speed ments, data and business processes to enable complete, end-to-end development time visibility and control over regulated data and processes. ● Manage large volumes of medical image data—from X-rays, CT scans, With IBM SCORE, you can balance the need for regulatory compli- magnetic resonance I and other ance with the need to speed drug development and approval processes, technologies improve quality and more efficiently bring products to market. To meet these goals, IBM SCORE provides a robust audit trail that includes information about: ● Research and development ● Clinical trials ● Regulatory affairs and submissions ● Manufacturing quality control ● Corrective and preventive actions ● Safety and adverse event reporting ● Packaging and labeling ● Marketing materials and advertising
  2. 2. IBM SALES AND DISTRIBUTION Implement process-driven compliance Solution Brief Transform your processes IBM SCORE provides a compliance management system with a focus on appli- cation integration, collaboration and business process management. By provid- © Copyright IBM Corporation 2009 ing core content lifecycle tools, combined with workflow management, security IBM Corporation and auditing functionality, your organization could more easily: Route 100 Somers, NY 10589 ● Transform complex data and business processes into one streamlined, Produced in the USA integrated system. July 2009 ● Enhance workflow and collaboration across product development, All Rights Reserved manufacturing and marketing. IBM, the IBM logo and are ● Enable swift compliance with current and future regulations. trademarks or registered trademarks of ● Increase productivity and speed time-to-market. International Business Machines Corporation in the United States, other countries, or both. If these and other Eases implementation and ongoing use for accelerated ROI IBM trademarked terms are marked on their first occurrence in this information IBM SCORE provides a host of advanced technical capabilities to ease imple- with a trademark symbol (® or ™), these mentation and integration with enterprise applications, and minimize cus- symbols indicate U.S. registered or tomization. It features out-of-the-box functionality to meet the compliance and common law trademarks owned by IBM at the time this information was management needs of life science and healthcare organizations. At the same published. Such trademarks may also be time, IBM SCORE offers the configuration capabilities to adapt to an organi- registered or common law trademarks in zation’s unique environment, minimizing the need for costly custom coding, other countries. A current list of thereby shortening implementation and validation times and reducing costs. IBM trademarks is available on the Web at “Copyright and trademark information” at Why IBM copytrade.shtml The goal of IBM Healthcare and Life Sciences is to rapidly bring business and Other product, company or IT solutions to customers and IBM Business Partners in the fields of pharma- service names may be trademarks or service marks of others. ceutical research, biotechnology, genomics, health and other life sciences indus- tries. IBM has extensive experience in implementing content management tools and helping the life sciences industry monitor compliance issues. For more information To learn more about IBM SCORE, please contact your IBM representative or IBM Business Partner, or visit: HLS03020-USEN-00