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Cross-Framework Mapping

FDA 21 CFR Part 11vsASD Strategies to Mitigate Cyber Security Incidents

See exactly how FDA 21 CFR Part 11 controls map to ASD Strategies to Mitigate Cyber Security Incidents. Pre-computed mappings, identified gaps, and coverage analysis.

9
Controls Mapped
4
Gaps Found
46%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to ASD Strategies to Mitigate Cyber Security Incidents with 46% coverage across 6 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 7 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 9 of 9 mapped controls across 4 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)

Part11.10Controls for closed systems (21 CFR §11.10)
→ASD37-37Personnel management (Very Good)

21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(2 mappings)

Part11.30Controls for open systems (21 CFR §11.30)2 targets
→ASD37-17TLS encryption between email servers (Limited)
→ASD37-27Outbound data loss prevention (Very Good)

21 CFR Part 11 Subpart C - Electronic Signatures (§11.200 + §11.300 Components, Controls, ID Codes and Passwords)(2 mappings)

Part11.300Controls for identification codes and passwords (21 CFR §11.300)2 targets
→ASD37-20Multi-factor authentication (Essential)
→ASD37-23Protect authentication credentials (Excellent)

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(4 mappings)

Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))2 targets
→ASD37-18Restrict administrative privileges (Essential)
→ASD37-20Multi-factor authentication (Essential)
Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→ASD37-27Outbound data loss prevention (Very Good)
Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
→ASD37-27Outbound data loss prevention (Very Good)

Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems9 mappingsFDA 21 CFR Part 11 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)7 mappingsFDA 21 CFR Part 11 vs Azure Security Benchmark6 mappingsFDA 21 CFR Part 11 vs AWS Well-Architected Security Pillar6 mappingsFDA 21 CFR Part 11 vs CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.06 mappingsFDA 21 CFR Part 11 vs Vermont Artificial Intelligence and Consumer Data Act (AICDA)5 mappingsFDA 21 CFR Part 11 vs Privacy Act 1988 (Australia)5 mappingsFDA 21 CFR Part 11 vs Ley Orgánica de Protección de Datos Personales (LOPDP)5 mappings

Other ASD Strategies to Mitigate Cyber Security Incidents comparisons

Oman National Cybersecurity Framework vs ASD Strategies to Mitigate Cyber Security Incidents20 mappingsNIST SP 800-171A - Assessing Security Requirements for Controlled Unclassified Information (CUI) vs ASD Strategies to Mitigate Cyber Security Incidents20 mappingsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs ASD Strategies to Mitigate Cyber Security Incidents18 mappingsNIST SP 800-146 vs ASD Strategies to Mitigate Cyber Security Incidents17 mappingsNIST SP 800-145 vs ASD Strategies to Mitigate Cyber Security Incidents17 mappingsNIST SP 800-144 vs ASD Strategies to Mitigate Cyber Security Incidents17 mappingsMTCS (Singapore) vs ASD Strategies to Mitigate Cyber Security Incidents17 mappingsISMAP (Japan) vs ASD Strategies to Mitigate Cyber Security Incidents17 mappings

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What are the key differences between FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents?

FDA 21 CFR Part 11 has 13 controls across its framework, while ASD Strategies to Mitigate Cyber Security Incidents covers 37 controls. Direct mapping analysis identifies 6 overlapping controls (46% 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 ASD Strategies to Mitigate Cyber Security Incidents equivalent.

How many controls map between FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents?

Of 13 total FDA 21 CFR Part 11 controls, 6 map directly to ASD Strategies to Mitigate Cyber Security Incidents controls — representing 46% coverage. The remaining 7 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 ASD Strategies to Mitigate Cyber Security Incidents?

7 FDA 21 CFR Part 11 controls have no direct equivalent in ASD Strategies to Mitigate Cyber Security Incidents. 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 ASD Strategies to Mitigate Cyber Security Incidents?

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.

Related Resources

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

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