TheArtOfService
Cross-Framework Mapping

FDA 21 CFR Part 11vsAnnex 11 to EU GMP - Computerised Systems

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

16
Controls Mapped
0
Gaps Found
69%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

FDA 21 CFR Part 11 maps to Annex 11 to EU GMP - Computerised Systems with 69% coverage across 9 directly mapped controls. Analysis of 13 FDA 21 CFR Part 11 controls identifies 4 compliance gaps — primarily concentrated in 21 CFR Part 11 Subpart A - General Provisions (Scope, Implementation, Definitions).

Source: TheArtOfService Knowledge Graph | 13 controls analysed | 723 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 16 of 16 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 723 frameworks.

21 CFR Part 11 Subpart B - Electronic Records (§11.10 Closed Systems)(2 mappings)

Part11.10Controls for closed systems (21 CFR §11.10)2 targets
→Clause 10Change and configuration management
→Clause 2Personnel

21 CFR Part 11 Subpart C - Electronic Signatures (§11.100 General Requirements)(1 mappings)

Part11.100Electronic signatures - general requirements (21 CFR §11.100)
→Clause 14Electronic signatures

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

Part11.200Electronic signature components and controls (21 CFR §11.200)
→Clause 14Electronic signatures
Part11.300Controls for identification codes and passwords (21 CFR §11.300)
→Clause 12Security

21 CFR Part 11 Subpart B - Electronic Records (§11.30 Open Systems, §11.50 + §11.70 Signature Manifestations and Linking)(1 mappings)

Part11.50_70Signature manifestations + signature / record linking (21 CFR §§11.50 + 11.70)
→Clause 14Electronic signatures

21 CFR Part 11 - Validation, Audit Trail, Operational Controls (§11.10(a) + (e) + (f))(10 mappings)

Part11.AccessAndAuthAccess control + authority + device checks (21 CFR §11.10(d) + (f) + (g) + (h))3 targets
→Clause 12Security
→Clause 15Batch release
→Clause 6Accuracy checks
Part11.AuditTrailAudit trail requirements - secure computer-generated time-stamped (21 CFR §11.10(e))
→Clause 9Audit trails
Part11.CSVComputer system validation + risk-based approach (21 CFR §11.10(a) + 2003 FDA Scope and Application Guidance + 2023 CSA draft)2 targets
→Clause 1Risk management
→Clause 4Validation
Part11.RecordRetentionRecord protection + retention + readiness for inspection (21 CFR §11.10(b) + (c))4 targets
→Clause 17Archiving
→Clause 5Data
→Clause 7Data storage
→Clause 8Printouts

Related Comparisons

Other FDA 21 CFR Part 11 comparisons

FDA 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 ASD Strategies to Mitigate Cyber Security Incidents6 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 Annex 11 to EU GMP - Computerised Systems comparisons

NIST SP 800-53 Rev 5 vs Annex 11 to EU GMP - Computerised Systems9 mappingsNIST SP 800-82 Revision 3: Guide to Industrial Control Systems (ICS) Security vs Annex 11 to EU GMP - Computerised Systems7 mappingsGAMP 5 - Good Automated Manufacturing Practice vs Annex 11 to EU GMP - Computerised Systems7 mappingsFTC GLBA Safeguards Rule (16 CFR Part 314) vs Annex 11 to EU GMP - Computerised Systems7 mappingsFedRAMP Rev 5 vs Annex 11 to EU GMP - Computerised Systems7 mappingsNIST SP 800-171A Rev 3 - Assessing CUI Security Requirements vs Annex 11 to EU GMP - Computerised Systems7 mappingsISO 28001:2007 Supply Chain Security Management vs Annex 11 to EU GMP - Computerised Systems7 mappingsProtective Security Policy Framework (PSPF) Release 2024 vs Annex 11 to EU GMP - Computerised Systems6 mappings

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

FDA 21 CFR Part 11 has 13 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 9 overlapping controls (69% 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 Annex 11 to EU GMP - Computerised Systems equivalent.

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

Of 13 total FDA 21 CFR Part 11 controls, 9 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 69% 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 FDA 21 CFR Part 11 to Annex 11 to EU GMP - Computerised Systems?

4 FDA 21 CFR Part 11 controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. 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 Annex 11 to EU GMP - Computerised Systems?

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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