ISO/IEC 27010:2015vs21 CFR Part 211 - Current Good Manufacturing Practice
See exactly how ISO/IEC 27010:2015 controls map to 21 CFR Part 211 - Current Good Manufacturing Practice. Pre-computed mappings, identified gaps, and coverage analysis.
Need this as a report you can hand to an assessor? A coverage crosswalk for this pair can be built to order.
According to the TheArtOfService Compliance Knowledge Graph:
ISO/IEC 27010:2015 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 3% coverage across 2 directly mapped controls. Analysis of 59 ISO/IEC 27010:2015 controls identifies 57 compliance gaps, primarily concentrated in Superseded batch representation – ISO/IEC 27010:2015.
Source: TheArtOfService Knowledge Graph | 59 controls analysed | 1,113 frameworks | 315K+ cross-framework mappings
Control Mappings
Showing 4 of 4 control mappings across 1 domains. Sign up to explore all 315K+ mappings across 1,113 frameworks.
Superseded batch representation – ISO/IEC 27010:2015(4 mappings)
A ISO/IEC 27010:2015 to 21 CFR Part 211 - Current Good Manufacturing Practice crosswalk, built to order
The table above lists candidate mappings. A crosswalk answers the narrower question you are probably here for: which 21 CFR Part 211 - Current Good Manufacturing Practice controls your existing ISO/IEC 27010:2015 work already satisfies, which are real gaps, and the reasoning behind every claim so you can check it. One pair, $299, one time.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
This direction has not been through crosswalk review and sign off, so no coverage figure is published for it. Reporting an unreviewed number would be worse than reporting none. It can be built to order at the same price as a pair that is already on the shelf.
If the two frameworks turn out to have too little in common for a crosswalk to help you, we say so and refund it rather than send a number worth nothing.
- Every evidenced control, with the reasoning behind it
- Every gap, with what it requires
- Its level of review stated plainly, not a bare number
Why this page shows two different percentages. The 3% in the header counts how many ISO/IEC 27010:2015 controls carry at least one candidate mapping in the graph, before any review. The crosswalk percentage counts something stricter: how many 21 CFR Part 211 - Current Good Manufacturing Practice controls are actually evidenced, after a pass that argued against each mapping and kept only what survived. They answer different questions and they are not meant to agree.
A crosswalk narrows the work. It does not replace an audit, and your assessor may take a different view on individual controls. Mappings between frameworks are judgements, not text printed in either standard, which is why every claim in the report shows its reasoning. Questions go to support@theartofservice.com.
Related Comparisons
Other ISO/IEC 27010:2015 comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
Stop Paying Consultants to Read Spreadsheets
Cross-framework mappings across 1,113 frameworks, at a fraction of consulting costs.
Free
- ✓ 1,113 framework browser
- ✓ Cross-framework mappings (315K+)
- ✓ 824 compliance assessments
- ✓ 3 AI queries & searches per day
Professional
- ✓ Unlimited AI Compliance Advisory
- ✓ Unlimited full-text search
- ✓ Framework self-assessment
- ✓ PDF, Excel & CSV exports
What are the key differences between ISO/IEC 27010:2015 and 21 CFR Part 211 - Current Good Manufacturing Practice?
ISO/IEC 27010:2015 has 59 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 76 controls. Direct mapping analysis identifies 2 overlapping controls (3% coverage). The frameworks diverge most significantly in Superseded batch representation – ISO/IEC 27010:2015, where 26 ISO/IEC 27010:2015 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.
How many controls map between ISO/IEC 27010:2015 and 21 CFR Part 211 - Current Good Manufacturing Practice?
Of 59 total ISO/IEC 27010:2015 controls, 2 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls, representing 3% coverage. The remaining 57 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping ISO/IEC 27010:2015 to 21 CFR Part 211 - Current Good Manufacturing Practice?
57 ISO/IEC 27010:2015 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in Superseded batch representation – ISO/IEC 27010:2015 with 26 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/IEC 27010:2015 and 21 CFR Part 211 - Current Good Manufacturing Practice?
The domain with the highest gap count is Superseded batch representation – ISO/IEC 27010:2015 (26 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.
Related Resources
This platform provides educational compliance tools, not legal, regulatory, or professional compliance advice. Cross-framework mappings are judged interpretations, grounded in the source text of both frameworks, and do not reproduce or replace official standards. Framework names and trademarks belong to their respective owners. Consult qualified professionals for your specific compliance requirements. See our Terms of Service.