FDA 21 CFR Part 11vsISO 19011
See exactly how FDA 21 CFR Part 11 controls map to ISO 19011. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to ISO 19011 with 15% coverage across 2 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 11 compliance gaps — primarily concentrated in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 700 frameworks | 323K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 323K+ mappings across 700 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(2 mappings)
21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(2 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other ISO 19011 comparisons
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What are the key differences between FDA 21 CFR Part 11 and ISO 19011?
FDA 21 CFR Part 11 has 13 controls across its framework, while ISO 19011 covers 42 controls. Direct mapping analysis identifies 2 overlapping controls (15% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 4 FDA 21 CFR Part 11 controls have no direct ISO 19011 equivalent.
How many controls map between FDA 21 CFR Part 11 and ISO 19011?
Of 13 total FDA 21 CFR Part 11 controls, 2 map directly to ISO 19011 controls — representing 15% coverage. The remaining 11 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 ISO 19011?
11 FDA 21 CFR Part 11 controls have no direct equivalent in ISO 19011. The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 4 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 ISO 19011?
The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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