The FDA's December 18th guidance on Data Integrity and Compliance with Drug CGMP

The FDA's December 18th guidance on Data Integrity and Compliance with Drug CGMP

Brand: GMPWebSource
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This document outlines the FDA's requirements for data integrity controls in the pharmaceutical industry.

  • The document details the FDA's requirements for data integrity controls, including record and metadata retention, audit trail reviews, backups, access controls, unique logins, and record storage locations.
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