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Cross-Framework Mapping

ASD Strategies to Mitigate Cyber Security IncidentsvsFDA 21 CFR Part 11

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

9
Controls Mapped
28
Gaps Found
16%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ASD Strategies to Mitigate Cyber Security Incidents maps to FDA 21 CFR Part 11 with 16% coverage across 6 directly mapped controls. Analysis of 37 ASD Strategies to Mitigate Cyber Security Incidents controls identifies 31 compliance gaps — primarily concentrated in Preventing Malware Delivery and Execution.

Source: TheArtOfService Knowledge Graph | 37 controls analysed | 719 frameworks | 428K+ cross-framework mappings

Control Mappings

Showing 9 of 9 mapped controls across 3 domains. Sign up to explore all 428K+ mappings across 719 frameworks.

Preventing Malware Delivery and Execution(1 mappings)

ASD37-17TLS encryption between email servers (Limited)
→Part11.30Controls for open systems (21 CFR §11.30)

Limiting the Extent of Cyber Security Incidents(7 mappings)

ASD37-18Restrict administrative privileges (Essential)
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
ASD37-20Multi-factor authentication (Essential)2 targets
→Part11.300Controls for identification codes and passwords (21 CFR §11.300)
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
ASD37-23Protect authentication credentials (Excellent)
→Part11.300Controls for identification codes and passwords (21 CFR §11.300)
ASD37-27Outbound data loss prevention (Very Good)3 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))

Preventing Malicious Insiders(1 mappings)

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

Related Comparisons

Other ASD Strategies to Mitigate Cyber Security Incidents 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 mappingsAzure Security Benchmark vs FDA 21 CFR Part 116 mappingsAWS Well-Architected Security Pillar 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 ASD Strategies to Mitigate Cyber Security Incidents and FDA 21 CFR Part 11?

ASD Strategies to Mitigate Cyber Security Incidents has 37 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 6 overlapping controls (16% coverage). The frameworks diverge most significantly in Preventing Malware Delivery and Execution, where 16 ASD Strategies to Mitigate Cyber Security Incidents controls have no direct FDA 21 CFR Part 11 equivalent.

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

Of 37 total ASD Strategies to Mitigate Cyber Security Incidents controls, 6 map directly to FDA 21 CFR Part 11 controls — representing 16% coverage. The remaining 31 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ASD Strategies to Mitigate Cyber Security Incidents to FDA 21 CFR Part 11?

31 ASD Strategies to Mitigate Cyber Security Incidents controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Preventing Malware Delivery and Execution with 16 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 ASD Strategies to Mitigate Cyber Security Incidents and FDA 21 CFR Part 11?

The domain with the highest gap count is Preventing Malware Delivery and Execution (16 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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