TheArtOfService
Cross-Framework Mapping

Azure Security BenchmarkvsFDA 21 CFR Part 11

See exactly how Azure Security Benchmark controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

13
Controls Mapped
41
Gaps Found
13%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Azure Security Benchmark maps to FDA 21 CFR Part 11 with 13% coverage across 7 directly mapped controls. Analysis of 54 Azure Security Benchmark controls identifies 47 compliance gaps — primarily concentrated in Identity Management.

Source: TheArtOfService Knowledge Graph | 54 controls analysed | 719 frameworks | 428K+ cross-framework mappings

Control Mappings

Showing 13 of 13 mapped controls across 4 domains. Sign up to explore all 428K+ mappings across 719 frameworks.

Azure Security Benchmark: Cloud Governance(1 mappings)

ASB-03Cloud risk assessment
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

Azure Security Benchmark: Identity & Access in Cloud(2 mappings)

ASB-07Multi-factor authentication for cloud
→Part11.300Controls for identification codes and passwords (21 CFR §11.300)
ASB-08Privileged access in cloud environments
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

Azure Security Benchmark: Data Protection in Cloud(9 mappings)

ASB-12Encryption of cloud-stored data3 targets
→Part11.30Controls for open systems (21 CFR §11.30)
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
ASB-13Data residency and sovereignty3 targets
→Part11.30Controls for open systems (21 CFR §11.30)
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
ASB-14Data backup and recovery in cloud3 targets
→Part11.30Controls for open systems (21 CFR §11.30)
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

Azure Security Benchmark: Cloud Operations & Monitoring(1 mappings)

ASB-21Cloud security monitoring and logging
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))

Related Comparisons

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Other FDA 21 CFR Part 11 comparisons

Annex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 119 mappingsAWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappingsUK Defence Standard 05-138 - Cyber Security for Defence Suppliers vs FDA 21 CFR Part 116 mappingsUS Consumer Product Safety Commission (CPSC) - Connected Product Safety vs FDA 21 CFR Part 116 mappingsAWS Well-Architected Security Pillar vs FDA 21 CFR Part 116 mappingsASD Strategies to Mitigate Cyber Security Incidents vs FDA 21 CFR Part 116 mappingsCISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs FDA 21 CFR Part 116 mappingsSpain ENS vs FDA 21 CFR Part 115 mappings

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What are the key differences between Azure Security Benchmark and FDA 21 CFR Part 11?

Azure Security Benchmark has 54 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 7 overlapping controls (13% coverage). The frameworks diverge most significantly in Identity Management, where 5 Azure Security Benchmark controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between Azure Security Benchmark and FDA 21 CFR Part 11?

Of 54 total Azure Security Benchmark controls, 7 map directly to FDA 21 CFR Part 11 controls — representing 13% coverage. The remaining 47 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Azure Security Benchmark to FDA 21 CFR Part 11?

47 Azure Security Benchmark controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Identity Management 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 Azure Security Benchmark and FDA 21 CFR Part 11?

The domain with the highest gap count is Identity Management (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are AI-assisted interpretations and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.