21 CFR Part 211 — Current Good Manufacturing PracticevsISO 8000 — Data Quality
See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to ISO 8000 — Data Quality. Pre-computed mappings, identified gaps, and coverage analysis.
According to the TheArtOfService Compliance Knowledge Graph:
21 CFR Part 211 — Current Good Manufacturing Practice maps to ISO 8000 — Data Quality with 4% coverage across 2 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 55 compliance gaps — primarily concentrated in Subpart F — Production and Process Controls.
Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings
Control Mappings
Showing 4 of 4 mapped controls across 2 domains. Sign up to explore all 819K+ mappings across 693 frameworks.
Subpart A — General Provisions(3 mappings)
Subpart J — Records and Reports(1 mappings)
Related Comparisons
Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons
Other ISO 8000 — Data Quality comparisons
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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and ISO 8000 — Data Quality?
21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while ISO 8000 — Data Quality covers 25 controls. Direct mapping analysis identifies 2 overlapping controls (4% coverage). The frameworks diverge most significantly in Subpart F — Production and Process Controls, where 8 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct ISO 8000 — Data Quality equivalent.
How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and ISO 8000 — Data Quality?
Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 2 map directly to ISO 8000 — Data Quality controls — representing 4% coverage. The remaining 55 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping 21 CFR Part 211 — Current Good Manufacturing Practice to ISO 8000 — Data Quality?
55 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in ISO 8000 — Data Quality. The highest concentration of gaps is in Subpart F — Production and Process Controls with 8 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 21 CFR Part 211 — Current Good Manufacturing Practice and ISO 8000 — Data Quality?
The domain with the highest gap count is Subpart F — Production and Process Controls (8 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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