Annex 11 to EU GMP - Computerised SystemsvsGAMP 5 - Good Automated Manufacturing Practice
See exactly how Annex 11 to EU GMP - Computerised Systems controls map to GAMP 5 - Good Automated Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
Annex 11 to EU GMP - Computerised Systems maps to GAMP 5 - Good Automated Manufacturing Practice with 41% coverage across 7 directly mapped controls. Analysis of 17 Annex 11 to EU GMP - Computerised Systems controls identifies 10 compliance gaps — primarily concentrated in Operational Phase - Data Management.
Source: TheArtOfService Knowledge Graph | 17 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.
Operational Phase - Change and Configuration(3 mappings)
Operational Phase - Release and Continuity(2 mappings)
General Requirements (Annex 11)(5 mappings)
Project Phase(1 mappings)
Operational Phase - Data Management(1 mappings)
Related Comparisons
Other Annex 11 to EU GMP - Computerised Systems comparisons
Other GAMP 5 - Good Automated Manufacturing Practice comparisons
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What are the key differences between Annex 11 to EU GMP - Computerised Systems and GAMP 5 - Good Automated Manufacturing Practice?
Annex 11 to EU GMP - Computerised Systems has 17 controls across its framework, while GAMP 5 - Good Automated Manufacturing Practice covers 11 controls. Direct mapping analysis identifies 7 overlapping controls (41% coverage). The frameworks diverge most significantly in Operational Phase - Data Management, where 4 Annex 11 to EU GMP - Computerised Systems controls have no direct GAMP 5 - Good Automated Manufacturing Practice equivalent.
How many controls map between Annex 11 to EU GMP - Computerised Systems and GAMP 5 - Good Automated Manufacturing Practice?
Of 17 total Annex 11 to EU GMP - Computerised Systems controls, 7 map directly to GAMP 5 - Good Automated Manufacturing Practice controls — representing 41% coverage. The remaining 10 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 GAMP 5 - Good Automated Manufacturing Practice?
10 Annex 11 to EU GMP - Computerised Systems controls have no direct equivalent in GAMP 5 - Good Automated Manufacturing Practice. The highest concentration of gaps is in Operational Phase - Data Management with 4 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 GAMP 5 - Good Automated Manufacturing Practice?
The domain with the highest gap count is Operational Phase - Data Management (4 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
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