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Cross-Framework Mapping

Annex 11 to EU GMP - Computerised SystemsvsFDA 21 CFR Part 11

See exactly how Annex 11 to EU GMP - Computerised Systems controls map to FDA 21 CFR Part 11. Pre-computed mappings, identified gaps, and coverage analysis.

16
Controls Mapped
1
Gaps Found
76%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

Annex 11 to EU GMP - Computerised Systems maps to FDA 21 CFR Part 11 with 76% coverage across 13 directly mapped controls. Analysis of 17 Annex 11 to EU GMP - Computerised Systems controls identifies 4 compliance gaps — primarily concentrated in General Requirements (Annex 11).

Source: TheArtOfService Knowledge Graph | 17 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 16 of 16 mapped controls across 6 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

General Requirements (Annex 11)(2 mappings)

Clause 1Risk management
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)
Clause 2Personnel
→Part11.10Controls for closed systems (21 CFR §11.10)

Operational Phase - Change and Configuration(1 mappings)

Clause 10Change and configuration management
→Part11.10Controls for closed systems (21 CFR §11.10)

Operational Phase - Security and Access(5 mappings)

Clause 12Security2 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))
Clause 14Electronic signatures3 targets
→Part11.100Electronic signatures - general requirements (21 CFR §11.100)
→Part11.200Electronic signature components and controls (21 CFR §11.200)
→Part11.50_70Signature manifestations + signature / record linking (21 CFR §§11.50 + 11.70)

Operational Phase - Release and Continuity(2 mappings)

Clause 15Batch release
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
Clause 17Archiving
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))

Project Phase(1 mappings)

Clause 4Validation
→Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)

Operational Phase - Data Management(5 mappings)

Clause 5Data
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
Clause 6Accuracy checks
→Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))
Clause 7Data storage
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
Clause 8Printouts
→Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))
Clause 9Audit trails
→Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))

Related Comparisons

Other Annex 11 to EU GMP - Computerised Systems comparisons

Annex 11 to EU GMP - Computerised Systems vs NIST SP 800-53 Rev 59 mappingsAnnex 11 to EU GMP - Computerised Systems vs NIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security7 mappingsAnnex 11 to EU GMP - Computerised Systems vs GAMP 5 - Good Automated Manufacturing Practice7 mappingsAnnex 11 to EU GMP - Computerised Systems vs FTC GLBA Safeguards Rule (16 CFR Part 314)7 mappingsAnnex 11 to EU GMP - Computerised Systems vs FedRAMP Rev 57 mappingsAnnex 11 to EU GMP - Computerised Systems vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements7 mappingsAnnex 11 to EU GMP - Computerised Systems vs ISO 28001:2007 Supply Chain Security Management7 mappingsAnnex 11 to EU GMP - Computerised Systems vs Protective Security Policy Framework (PSPF) Release 20246 mappings

Other FDA 21 CFR Part 11 comparisons

AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappingsAzure Security Benchmark 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 mappingsVermont Artificial Intelligence and Consumer Data Act (AICDA) vs FDA 21 CFR Part 115 mappingsPrivacy Act 1988 (Australia) vs FDA 21 CFR Part 115 mappingsLey Orgánica de Protección de Datos Personales (LOPDP) vs FDA 21 CFR Part 115 mappings

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What are the key differences between Annex 11 to EU GMP - Computerised Systems and FDA 21 CFR Part 11?

Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while FDA 21 CFR Part 11 covers 13 controls. Direct mapping analysis identifies 13 overlapping controls (76% coverage). The frameworks diverge most significantly in General Requirements (Annex 11), where 1 Annex 11 to EU GMP - Computerised Systems controls have no direct FDA 21 CFR Part 11 equivalent.

How many controls map between Annex 11 to EU GMP - Computerised Systems and FDA 21 CFR Part 11?

Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 13 map directly to FDA 21 CFR Part 11 controls — representing 76% coverage. The remaining 4 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping Annex 11 to EU GMP - Computerised Systems to FDA 21 CFR Part 11?

4 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in FDA 21 CFR Part 11. The highest concentration of gaps is in General Requirements (Annex 11) with 1 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 Annex 11 to EU GMP - Computerised Systems and FDA 21 CFR Part 11?

The domain with the highest gap count is General Requirements (Annex 11) (1 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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