White Paper

White Paper - Achieving Life Sciences GxP and 21 CFR Part 11 Compliance with EMC

This paper will review the FDA's recent policy shifts, specifically in their change in orientation to a "Risk Based" approach to GMPs and the new guidance for industry related to 21 CFR Part 11. Additionally, this paper will highlight an enabling technology solution that facilitates life sciences companies' adherence to regulatory requirements and standards. PDF format.
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