FDA 21 CFR Part 11vsICAO Annex 17 - Aviation Security (AVSEC)
See exactly how FDA 21 CFR Part 11 controls map to ICAO Annex 17 - Aviation Security (AVSEC). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to ICAO Annex 17 - Aviation Security (AVSEC) 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 | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(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 ICAO Annex 17 - Aviation Security (AVSEC) comparisons
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What are the key differences between FDA 21 CFR Part 11 and ICAO Annex 17 - Aviation Security (AVSEC)?
FDA 21 CFR Part 11 has 13 controls across its framework, while ICAO Annex 17 - Aviation Security (AVSEC) covers 10 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 3 FDA 21 CFR Part 11 controls have no direct ICAO Annex 17 - Aviation Security (AVSEC) equivalent.
How many controls map between FDA 21 CFR Part 11 and ICAO Annex 17 - Aviation Security (AVSEC)?
Of 13 total FDA 21 CFR Part 11 controls, 2 map directly to ICAO Annex 17 - Aviation Security (AVSEC) 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 ICAO Annex 17 - Aviation Security (AVSEC)?
11 FDA 21 CFR Part 11 controls have no direct equivalent in ICAO Annex 17 - Aviation Security (AVSEC). 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 ICAO Annex 17 - Aviation Security (AVSEC)?
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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