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Where is Part 11 when QA asks whether our e-signatures are compliant?

21 CFR Part 11 is the US regulation on electronic records and electronic signatures. The eCFR holds the current text in three subparts: General Provisions, Electronic Records and Electronic Signatures.

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Official sourceeCFR: 21 CFR Part 11www.ecfr.gov
Checked on October 13, 2026