FDA 21 CFR Part 11vsIACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems
See exactly how FDA 21 CFR Part 11 controls map to IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems with 38% coverage across 5 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 8 compliance gaps — primarily concentrated in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions).
Source: TheArtOfService Knowledge Graph | 13 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 3 domains. Sign up to explore all 332K+ mappings across 718 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 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(1 mappings)
21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(4 mappings)
Related Comparisons
Other FDA 21 CFR Part 11 comparisons
Other IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems comparisons
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What are the key differences between FDA 21 CFR Part 11 and IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems?
FDA 21 CFR Part 11 has 13 controls across its framework, while IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems covers 19 controls. Direct mapping analysis identifies 5 overlapping controls (38% coverage). The frameworks diverge most significantly in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions), where 2 FDA 21 CFR Part 11 controls have no direct IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems equivalent.
How many controls map between FDA 21 CFR Part 11 and IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems?
Of 13 total FDA 21 CFR Part 11 controls, 5 map directly to IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems controls — representing 38% coverage. The remaining 8 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 IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems?
8 FDA 21 CFR Part 11 controls have no direct equivalent in IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems. The highest concentration of gaps is in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions) 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 IACS Unified Requirements E26/E27 - Cyber Resilience of Ships and On-Board Systems?
The domain with the highest gap count is 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions) (2 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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