FDA 21 CFR Part 11vsFIDO2 and W3C WebAuthn Standard
See exactly how FDA 21 CFR Part 11 controls map to FIDO2 and W3C WebAuthn Standard. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to FIDO2 and W3C WebAuthn Standard with 12% coverage across 3 directly mapped controls. Analysis of 24 FDA 21 CFR Part 11 controls identifies 21 compliance gaps — primarily concentrated in FDA 21 CFR Part 11: Administrative Safeguards.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 5 of 5 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
FDA 21 CFR Part 11: Patient Data Protection(1 mappings)
FDA 21 CFR Part 11: Technical Safeguards(4 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other FIDO2 and W3C WebAuthn Standard comparisons
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What are the key differences between FDA 21 CFR Part 11 and FIDO2 and W3C WebAuthn Standard?
FDA 21 CFR Part 11 has 24 controls across its framework, while FIDO2 and W3C WebAuthn Standard covers 22 controls. Direct mapping analysis identifies 3 overlapping controls (12% coverage). The frameworks diverge most significantly in FDA 21 CFR Part 11: Administrative Safeguards, where 6 FDA 21 CFR Part 11 controls have no direct FIDO2 and W3C WebAuthn Standard equivalent.
How many controls map between FDA 21 CFR Part 11 and FIDO2 and W3C WebAuthn Standard?
Of 24 total FDA 21 CFR Part 11 controls, 3 map directly to FIDO2 and W3C WebAuthn Standard controls — representing 12% coverage. The remaining 21 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping FDA 21 CFR Part 11 to FIDO2 and W3C WebAuthn Standard?
21 FDA 21 CFR Part 11 controls have no direct equivalent in FIDO2 and W3C WebAuthn Standard. The highest concentration of gaps is in FDA 21 CFR Part 11: Administrative Safeguards with 6 unmapped controls. These gaps represent areas where additional controls, policies, or documentation must be created to achieve compliance with both frameworks.
Which control domains have the most gaps between FDA 21 CFR Part 11 and FIDO2 and W3C WebAuthn Standard?
The domain with the highest gap count is FDA 21 CFR Part 11: Administrative Safeguards (6 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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