ISO 20000-1vsFDA 21 CFR Part 11
See exactly how ISO 20000-1 controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 20000-1 maps to FDA 21 CFR Part 11 with 2% coverage across 1 directly mapped controls. Analysis of 51 ISO 20000-1 controls identifies 50 compliance gaps — primarily concentrated in ISO 20000-1: Service Operation.
Source: TheArtOfService Knowledge Graph | 51 controls analysed | 706 frameworks | 324K+ cross-framework mappings
Control Mappings
Showing 1 of 1 mapped controls across 1 domains. Sign up to explore all 324K+ mappings across 706 frameworks.
Performance Evaluation(1 mappings)
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What are the key differences between ISO 20000-1 and FDA 21 CFR Part 11?
ISO 20000-1 has 51 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 1 overlapping controls (2% coverage). The frameworks diverge most significantly in ISO 20000-1: Service Operation, where 5 ISO 20000-1 controls have no direct FDA 21 CFR Part 11 equivalent.
How many controls map between ISO 20000-1 and FDA 21 CFR Part 11?
Of 51 total ISO 20000-1 controls, 1 map directly to FDA 21 CFR Part 11 controls — representing 2% coverage. The remaining 50 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 20000-1 to FDA 21 CFR Part 11?
50 ISO 20000-1 controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in ISO 20000-1: Service Operation with 5 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 ISO 20000-1 and FDA 21 CFR Part 11?
The domain with the highest gap count is ISO 20000-1: Service Operation (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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