FDA 21 CFR Part 11vsISO/IEC 29147:2018
See exactly how FDA 21 CFR Part 11 controls map to ISO/IEC 29147:2018. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to ISO/IEC 29147:2018 with 8% coverage across 1 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 12 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 | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 2 of 2 mapped controls across 1 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(2 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other ISO/IEC 29147:2018 comparisons
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What are the key differences between FDA 21 CFR Part 11 and ISO/IEC 29147:2018?
FDA 21 CFR Part 11 has 13 controls across its framework, while ISO/IEC 29147:2018 covers 40 controls. Direct mapping analysis identifies 1 overlapping controls (8% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 3 FDA 21 CFR Part 11 controls have no direct ISO/IEC 29147:2018 equivalent.
How many controls map between FDA 21 CFR Part 11 and ISO/IEC 29147:2018?
Of 13 total FDA 21 CFR Part 11 controls, 1 map directly to ISO/IEC 29147:2018 controls — representing 8% coverage. The remaining 12 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/IEC 29147:2018?
12 FDA 21 CFR Part 11 controls have no direct equivalent in ISO/IEC 29147:2018. The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 3 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/IEC 29147:2018?
The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (3 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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