Cross-Framework Mapping

API 1164vsEU GMP Annex 11: Computerised Systems

See exactly how API 1164 controls map to EU GMP Annex 11: Computerised Systems. Pre-computed mappings, identified gaps, and coverage analysis.

15
Controls Mapped
9
Gaps Found
46%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

API 1164 maps to EU GMP Annex 11: Computerised Systems with 46% coverage across 11 directly mapped controls. Analysis of 24 API 1164 controls identifies 13 compliance gaps — primarily concentrated in API 1164: Asset Identification & Governance.

Source: TheArtOfService Knowledge Graph | 24 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 15 of 15 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

API 1164: Access Management(4 mappings)

API1164-06Physical and logical access controls
Clause 12Security
API1164-07Personnel risk assessment2 targets
Clause 1Risk management
Clause 12Security
API1164-09Interactive remote access security
Clause 12Security

API 1164: Systems Security(1 mappings)

API1164-14System security hardening
Clause 10Change and configuration management

API 1164: Incident Response & Recovery(3 mappings)

API1164-17Recovery plan for critical systems
Clause 13Incident management
API1164-18Reporting obligations to authorities
Clause 13Incident management
API1164-19Coordination with sector-specific agencies
Clause 13Incident management

API 1164: Supply Chain & Configuration(7 mappings)

API1164-21Supply chain risk management for critical components2 targets
Clause 1Risk management
Clause 3Suppliers and service providers
API1164-22Configuration management for OT systems2 targets
Clause 10Change and configuration management
Clause 3Suppliers and service providers
API1164-23Change management procedures2 targets
Clause 10Change and configuration management
Clause 3Suppliers and service providers
API1164-24Vulnerability assessment for critical systems
Clause 1Risk management

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What are the key differences between API 1164 and EU GMP Annex 11: Computerised Systems?

API 1164 has 24 controls across its framework, while EU GMP Annex 11: Computerised Systems covers 23 controls. Direct mapping analysis identifies 11 overlapping controls (46% coverage). The frameworks diverge most significantly in API 1164: Asset Identification & Governance, where 5 API 1164 controls have no direct EU GMP Annex 11: Computerised Systems equivalent.

How many controls map between API 1164 and EU GMP Annex 11: Computerised Systems?

Of 24 total API 1164 controls, 11 map directly to EU GMP Annex 11: Computerised Systems controls — representing 46% coverage. The remaining 13 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping API 1164 to EU GMP Annex 11: Computerised Systems?

13 API 1164 controls have no direct equivalent in EU GMP Annex 11: Computerised Systems. The highest concentration of gaps is in API 1164: Asset Identification & Governance with 5 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 API 1164 and EU GMP Annex 11: Computerised Systems?

The domain with the highest gap count is API 1164: Asset Identification & Governance (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.