21 CFR Part 11

In Data & data management

Also known as: Part 11

21 CFR Part 11 is the United States regulation setting the conditions under which the FDA accepts electronic records and electronic signatures instead of paper. It requires validated systems, secure access control, audit trails, and signatures that are uniquely linked to one person. Europe's comparable expectations are set out in Annex 11 of the EU GMP guidelines.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.