Technical Controls for Electronic Records and Signatures

The Food and Drug Administration (FDA) has a regulation called 21 CFR Part 11 that specifies requirements for digital records and electronic signatures. It was put in place within the pharmaceutical, medical product, and biologic industries back in 1997 to ensure the correctness, authenticity, and safety of electronic data and signatures.

All digital records that must be kept per FDA standards, including those on product development, production, distribution, and packaging, are covered by the regulation. In today’s article, we’ll be looking at certain technical controls for electronic records and signatures and seeing how they affect 21 CFR Part 11.

21 CFR Part 11 Technical Controls

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