GAMP 5 - Good Automated Manufacturing PracticevsAnnex 11 to EU GMP - Computerised Systems
See exactly how GAMP 5 - Good Automated Manufacturing Practice controls map to Annex 11 to EU GMP - Computerised Systems. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
GAMP 5 - Good Automated Manufacturing Practice maps to Annex 11 to EU GMP - Computerised Systems with 45% coverage across 5 directly mapped controls. Analysis of 11 GAMP 5 - Good Automated Manufacturing Practice controls identifies 6 compliance gaps — primarily concentrated in GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates.
Source: TheArtOfService Knowledge Graph | 11 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 12 of 12 mapped controls across 5 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
GAMP 5: 2nd Edition (2022) - AI/ML + Cloud + Agile + DevOps + Computer Software Assurance (CSA)(1 mappings)
GAMP 5: V-Model Lifecycle and Specification Documents (URS, FS, DS, IQ, OQ, PQ)(3 mappings)
GAMP 5: Risk-Based Approach, Critical Thinking and 5 Key Concepts(3 mappings)
GAMP 5: 5 Software Categories (Cat 1 Infrastructure, Cat 3 Non-Configured, Cat 4 Configured, Cat 5 Custom)(1 mappings)
GAMP 5: Supplier Assessment, Operational Phase, Change Control and Periodic Review(4 mappings)
Related Comparisons
Other GAMP 5 - Good Automated Manufacturing Practice comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
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What are the key differences between GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
GAMP 5 - Good Automated Manufacturing Practice has 11 controls across its framework, while Annex 11 to EU GMP - Computerised Systems covers 17 controls. Direct mapping analysis identifies 5 overlapping controls (45% coverage). The frameworks diverge most significantly in GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates, where 5 GAMP 5 - Good Automated Manufacturing Practice controls have no direct Annex 11 to EU GMP - Computerised Systems equivalent.
How many controls map between GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
Of 11 total GAMP 5 - Good Automated Manufacturing Practice controls, 5 map directly to Annex 11 to EU GMP - Computerised Systems controls — representing 45% coverage. The remaining 6 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping GAMP 5 - Good Automated Manufacturing Practice to Annex 11 to EU GMP - Computerised Systems?
6 GAMP 5 - Good Automated Manufacturing Practice controls have no direct equivalent in Annex 11 to EU GMP - Computerised Systems. The highest concentration of gaps is in GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates 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 GAMP 5 - Good Automated Manufacturing Practice and Annex 11 to EU GMP - Computerised Systems?
The domain with the highest gap count is GAMP 5: ISPE Guide Status, Copyright, GxP Regulatory Coordination and 2024-2025 Updates (5 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
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