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The FDA’s New Enforcement of 21 CFR Part 11 Compliance (An Overview)

The FDA’s New Enforcement of 21 CFR Part 11 Compliance (An Overview)

Part 11 applies to all records that are defined in the underlying acts and regulations which govern activities in the life sciences industries. These underlying acts and regulations, which are referred to as the “predicate rules,” are any requirements set forth in the FDCA Act (Federal Food, Drug and Cosmetic Act), the PHS Act (Public Health Service Act), or any FDA regulation (GLP, GMP, and GCP). The predicate rules mandate what records are to be maintained, the content of those records, whether signatures are required, how long records must be maintained, and so on.

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