ISO 10006:2003vs21 CFR Part 58 - Good Laboratory Practice (GLP)
See exactly how ISO 10006:2003 controls map to 21 CFR Part 58 - Good Laboratory Practice (GLP). Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
ISO 10006:2003 maps to 21 CFR Part 58 - Good Laboratory Practice (GLP) with 11% coverage across 2 directly mapped controls. Analysis of 18 ISO 10006:2003 controls identifies 16 compliance gaps — primarily concentrated in Product realization – ISO 10006:2003.
Source: TheArtOfService Knowledge Graph | 18 controls analysed | 718 frameworks | 332K+ cross-framework mappings
Control Mappings
Showing 3 of 3 mapped controls across 2 domains. Sign up to explore all 332K+ mappings across 718 frameworks.
Resource management – ISO 10006:2003(2 mappings)
Product realization – ISO 10006:2003(1 mappings)
Related Comparisons
Other ISO 10006:2003 comparisons
Other 21 CFR Part 58 - Good Laboratory Practice (GLP) comparisons
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What are the key differences between ISO 10006:2003 and 21 CFR Part 58 - Good Laboratory Practice (GLP)?
ISO 10006:2003 has 18 controls across its framework, while 21 CFR Part 58 - Good Laboratory Practice (GLP) covers 31 controls. Direct mapping analysis identifies 2 overlapping controls (11% coverage). The frameworks diverge most significantly in Product realization – ISO 10006:2003, where 7 ISO 10006:2003 controls have no direct 21 CFR Part 58 - Good Laboratory Practice (GLP) equivalent.
How many controls map between ISO 10006:2003 and 21 CFR Part 58 - Good Laboratory Practice (GLP)?
Of 18 total ISO 10006:2003 controls, 2 map directly to 21 CFR Part 58 - Good Laboratory Practice (GLP) controls — representing 11% coverage. The remaining 16 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO 10006:2003 to 21 CFR Part 58 - Good Laboratory Practice (GLP)?
16 ISO 10006:2003 controls have no direct equivalent in 21 CFR Part 58 - Good Laboratory Practice (GLP). The highest concentration of gaps is in Product realization – ISO 10006:2003 with 7 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 ISO 10006:2003 and 21 CFR Part 58 - Good Laboratory Practice (GLP)?
The domain with the highest gap count is Product realization – ISO 10006:2003 (7 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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