FDA 21 CFR Part 11vsTISAX — Trusted Information Security Assessment Exchange
See exactly how FDA 21 CFR Part 11 controls map to TISAX — Trusted Information Security Assessment Exchange. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
FDA 21 CFR Part 11 maps to TISAX — Trusted Information Security Assessment Exchange with 46% coverage across 11 directly mapped controls. Analysis of 24 FDA 21 CFR Part 11 controls identifies 13 compliance gaps — primarily concentrated in FDA 21 CFR Part 11: Organizational Requirements.
Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 20 of 33 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
FDA 21 CFR Part 11: Patient Data Protection(18 mappings)
FDA 21 CFR Part 11: Administrative Safeguards(2 mappings)
+13 more mappings
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Related Comparisons
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What are the key differences between FDA 21 CFR Part 11 and TISAX — Trusted Information Security Assessment Exchange?
FDA 21 CFR Part 11 has 24 controls across its framework, while TISAX — Trusted Information Security Assessment Exchange covers 47 controls. Direct mapping analysis identifies 11 overlapping controls (46% coverage). The frameworks diverge most significantly in FDA 21 CFR Part 11: Organizational Requirements, where 4 FDA 21 CFR Part 11 controls have no direct TISAX — Trusted Information Security Assessment Exchange equivalent.
How many controls map between FDA 21 CFR Part 11 and TISAX — Trusted Information Security Assessment Exchange?
Of 24 total FDA 21 CFR Part 11 controls, 11 map directly to TISAX — Trusted Information Security Assessment Exchange controls — representing 46% coverage. The remaining 13 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 TISAX — Trusted Information Security Assessment Exchange?
13 FDA 21 CFR Part 11 controls have no direct equivalent in TISAX — Trusted Information Security Assessment Exchange. The highest concentration of gaps is in FDA 21 CFR Part 11: Organizational Requirements with 4 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 TISAX — Trusted Information Security Assessment Exchange?
The domain with the highest gap count is FDA 21 CFR Part 11: Organizational Requirements (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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