ICH E6(R3) - Good Clinical PracticevsISO 13485:2016
See exactly how ICH E6(R3) - Good Clinical Practice controls map to ISO 13485:2016. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ICH E6(R3) - Good Clinical Practice maps to ISO 13485:2016 with 22% coverage across 2 directly mapped controls. Analysis of 9 ICH E6(R3) - Good Clinical Practice controls identifies 7 compliance gaps — primarily concentrated in ICH E6 Data Mgmt + External Data + Regulatory.
Source: TheArtOfService Knowledge Graph | 9 controls analysed | 718 frameworks | 330K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 330K+ mappings across 718 frameworks.
ICH E6 Annex 1 - Electronic Systems(3 mappings)
ICH E6 Scope + Principles(1 mappings)
Related Comparisons
Other ICH E6(R3) - Good Clinical Practice comparisons
Other ISO 13485:2016 comparisons
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What are the key differences between ICH E6(R3) - Good Clinical Practice and ISO 13485:2016?
ICH E6(R3) - Good Clinical Practice has 9 controls across its framework, while ISO 13485:2016 covers 60 controls. Direct mapping analysis identifies 2 overlapping controls (22% coverage). The frameworks diverge most significantly in ICH E6 Data Mgmt + External Data + Regulatory, where 1 ICH E6(R3) - Good Clinical Practice controls have no direct ISO 13485:2016 equivalent.
How many controls map between ICH E6(R3) - Good Clinical Practice and ISO 13485:2016?
Of 9 total ICH E6(R3) - Good Clinical Practice controls, 2 map directly to ISO 13485:2016 controls — representing 22% coverage. The remaining 7 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ICH E6(R3) - Good Clinical Practice to ISO 13485:2016?
7 ICH E6(R3) - Good Clinical Practice controls have no direct equivalent in ISO 13485:2016. The highest concentration of gaps is in ICH E6 Data Mgmt + External Data + Regulatory 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 ICH E6(R3) - Good Clinical Practice and ISO 13485:2016?
The domain with the highest gap count is ICH E6 Data Mgmt + External Data + Regulatory (1 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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