Web Reference: (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal... Feb 21, 2026 · FDA 21 CFR Part 11 defines requirements for electronic records and electronic signatures in FDA-regulated industries. This guide covers all three subparts, audit trail requirements, common 483 findings, and a compliance checklist for pharma, biotech, and medical devices.
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