Cross-Framework Mapping

AWS Well-Architected Security PillarvsFDA 21 CFR Part 11

Name: AWS Well-Architected Security Pillar to FDA 21 CFR Part 11 Control Mapping Dataset
Creator: TheArtOfService

See exactly how AWS Well-Architected Security Pillar controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

Controls Mapped

Gaps Found

Coverage

According to the TheArtOfService Compliance Knowledge Graph:

AWS Well-Architected Security Pillar maps to FDA 21 CFR Part 11 with 8% coverage across 7 directly mapped controls. Analysis of 89 AWS Well-Architected Security Pillar controls identifies 82 compliance gaps — primarily concentrated in Identity & Access Management.

Source: TheArtOfService Knowledge Graph | 89 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.

Cloud Security Overview(1 mappings)

AWS-WA-03Cloud risk assessment

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

AWS Well-Architected Security Pillar: Identity & Access in Cloud(2 mappings)

AWS-WA-07Multi-factor authentication for cloud

→Part11.300Controls for identification codes and passwords (21 CFR §11.300)

AWS-WA-08Privileged access in cloud environments

→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))

AWS Well-Architected Security Pillar: Data Protection in Cloud(9 mappings)

AWS-WA-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))

AWS-WA-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))

AWS-WA-15Secure data deletion 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))

AWS Well-Architected Security Pillar: Cloud Operations & Monitoring(1 mappings)

AWS-WA-21Cloud security monitoring and logging

→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))

Related Comparisons

Other AWS Well-Architected Security Pillar comparisons

Other FDA 21 CFR Part 11 comparisons

Annex 11 to EU GMP - Computerised Systems vs FDA 21 CFR Part 119 mappings AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappings UK Defence Standard 05-138 - Cyber Security for Defence Suppliers vs FDA 21 CFR Part 116 mappings US Consumer Product Safety Commission (CPSC) - Connected Product Safety vs FDA 21 CFR Part 116 mappings Azure Security Benchmark vs FDA 21 CFR Part 116 mappings ASD Strategies to Mitigate Cyber Security Incidents vs FDA 21 CFR Part 116 mappings CISA Cross-Sector Cybersecurity Performance Goals (CPG) 2.0 vs FDA 21 CFR Part 116 mappings Spain ENS vs FDA 21 CFR Part 115 mappings

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What are the key differences between AWS Well-Architected Security Pillar and FDA 21 CFR Part 11?

AWS Well-Architected Security Pillar has 89 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 7 overlapping controls (8% coverage). The frameworks diverge most significantly in Identity & Access Management, where 15 AWS Well-Architected Security Pillar controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between AWS Well-Architected Security Pillar and FDA 21 CFR Part 11?

Of 89 total AWS Well-Architected Security Pillar controls, 7 map directly to FDA 21 CFR Part 11 controls — representing 8% coverage. The remaining 82 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping AWS Well-Architected Security Pillar to FDA 21 CFR Part 11?

82 AWS Well-Architected Security Pillar controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in Identity & Access Management with 15 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 AWS Well-Architected Security Pillar and FDA 21 CFR Part 11?

The domain with the highest gap count is Identity & Access Management (15 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.