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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.

13
Controls Mapped
4
Gaps Found
76%
Coverage

Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.

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 | 1,016 frameworks | 316K+ cross-framework mappings

Control Mappings

Showing 16 of 16 control mappings across 6 domains. Sign up to explore all 316K+ mappings across 1,016 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))
Coverage crosswalk

A Annex 11 to EU GMP - Computerised Systems to FDA 21 CFR Part 11 crosswalk, built to order

The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which FDA 21 CFR Part 11 controls your existing Annex 11 to EU GMP - Computerised Systems work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.

Annex 11 to EU GMP - Computerised Systems into FDA 21 CFR Part 11
Not published yet

This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.

If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.

FDA 21 CFR Part 11 into Annex 11 to EU GMP - Computerised Systems
Not published yet

This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.

If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.

Annex 11 to EU GMP - Computerised Systems to FDA 21 CFR Part 11 (built to order)
$299
per framework pair, one time
  • Every evidenced control, with the reasoning behind it
  • Every gap, with what it requires
  • Its level of review stated plainly, not a bare number

Why this page shows two different percentages. The 76% in the header counts how many Annex 11 to EU GMP - Computerised Systems controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many FDA 21 CFR Part 11 controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.

A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.

Related Comparisons

Other Annex 11 to EU GMP - Computerised Systems comparisons

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Other FDA 21 CFR Part 11 comparisons

AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association) vs FDA 21 CFR Part 117 mappingsUS Consumer Product Safety Act (CPSC) Manufacturer and Importer Duties 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 Data Privacy and Online Surveillance Act vs FDA 21 CFR Part 115 mappingsUK Defence Standard 05-138 - Cyber Security for Defence Suppliers vs FDA 21 CFR Part 115 mappingsPrivacy Act 1988 (Australia) vs FDA 21 CFR Part 115 mappingsEcuador Ley 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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