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. 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