FDA 21 CFR Part 11
What is FDA 21 CFR Part 11?
21 CFR Part 11 (62 FR 13430 March 20 1997) establishes the criteria under which the FDA considers electronic records + electronic signatures to be trustworthy + reliable + equivalent to paper records + handwritten signatures. The regulation applies to ALL electronic records + signatures created + modified + maintained + archived + retrieved + transmitted under any records requirement set forth in any FDA regulation or any electronic records submitted to FDA under the Federal Food + Drug + and Cosmetic Act + Public Health Service Act + Tobacco Control Act. It comprises 13 controls organised across 7 domains, and applies in the United States.
How FDA 21 CFR Part 11 maps to other frameworks
All 13 controls, each one mapped to the equivalent requirement in other standards, with the evidence that carries across and the mappings that were judged and rejected shown alongside. No account needed to look.
See the control mappings →The 7 domains FDA 21 CFR Part 11 groups its controls into
Frameworks that share controls with FDA 21 CFR Part 11
Each of these has at least one control mapped to a control in FDA 21 CFR Part 11. The number is how many FDA 21 CFR Part 11 controls are shared, counted from the mapping graph.
Annex 11 to EU GMP - Computerised Systems
9 shared controlsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)
7 shared controlsUS Consumer Product Safety Commission (CPSC) - Connected Product Safety
6 shared controlsASD Strategies to Mitigate Cyber Security Incidents
6 shared controlsVermont Artificial Intelligence and Consumer Data Act (AICDA)
5 shared controlsUK Defence Standard 05-138 - Cyber Security for Defence Suppliers
5 shared controlsPrivacy Act 1988 (Australia)
5 shared controlsLaw No. 172-13 on the Protection of Personal Data
5 shared controlsWhere FDA 21 CFR Part 11 overlaps with the standards you already hold
Analysis of FDA 21 CFR Part 11
What FDA 21 CFR Part 11 means in your sector
What FDA 21 CFR Part 11 means for your job
Questions people ask about FDA 21 CFR Part 11
What is FDA 21 CFR Part 11?
How many controls does FDA 21 CFR Part 11 have?
Where does FDA 21 CFR Part 11 apply?
What frameworks does FDA 21 CFR Part 11 map to?
How do I get started with FDA 21 CFR Part 11 compliance?
Query FDA 21 CFR Part 11 programmatically
FDA 21 CFR Part 11, its 13 controls and every mapping into other standards are available over a REST endpoint and an MCP server, so an agent can read them directly. The free tier is 10 calls a day and needs no signup.
FDA 21 CFR Part 11 API reference and MCP config →What FDA 21 CFR Part 11 requires, control by control
Each page carries the requirement text for one FDA 21 CFR Part 11 control and what an assessor expects to see as evidence.
- PART11-10 Controls for closed systems (21 CFR §11.10)
- PART11-100 Electronic signatures - general requirements (21 CFR §11.100)
- PART11-200 Electronic signature components and controls (21 CFR §11.200)
- PART11-30 Controls for open systems (21 CFR §11.30)
- PART11-300 Controls for identification codes and passwords (21 CFR §11.300)
- PART11-ACCESSANDAUTH Access control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
- PART11-AUDITTRAIL Audit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
- PART11-CSV Computer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
- PART11-RECORDRETENTION Record protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
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