FDA 21 CFR Part 11vsIEC 62351 - Power Systems Communication Security
See exactly how FDA 21 CFR Part 11 controls map to IEC 62351 - Power Systems Communication Security. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to IEC 62351 - Power Systems Communication Security with 23% coverage across 3 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 10 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 3 of 3 mapped controls across 2 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(1 mappings)
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 IEC 62351 - Power Systems Communication Security comparisons
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What are the key differences between FDA 21 CFR Part 11 and IEC 62351 - Power Systems Communication Security?
FDA 21 CFR Part 11 has 13 controls across its framework, while IEC 62351 - Power Systems Communication Security covers 34 controls. Direct mapping analysis identifies 3 overlapping controls (23% coverage). The frameworks diverge most significantly in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)), where 2 FDA 21 CFR Part 11 controls have no direct IEC 62351 - Power Systems Communication Security equivalent.
How many controls map between FDA 21 CFR Part 11 and IEC 62351 - Power Systems Communication Security?
Of 13 total FDA 21 CFR Part 11 controls, 3 map directly to IEC 62351 - Power Systems Communication Security controls — representing 23% coverage. The remaining 10 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 IEC 62351 - Power Systems Communication Security?
10 FDA 21 CFR Part 11 controls have no direct equivalent in IEC 62351 - Power Systems Communication Security. The highest concentration of gaps is in 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) with 2 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 IEC 62351 - Power Systems Communication Security?
The domain with the highest gap count is 21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f)) (2 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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