IEC 62443vs21 CFR Part 211 - Current Good Manufacturing Practice
See exactly how IEC 62443 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:
IEC 62443 maps to 21 CFR Part 211 - Current Good Manufacturing Practice with 5% coverage across 4 directly mapped controls. Analysis of 81 IEC 62443 controls identifies 77 compliance gaps, primarily concentrated in 62443-3-3 System Security Requirements.
Source: TheArtOfService Knowledge Graph | 81 controls analysed | 686 frameworks | 310K+ cross-framework mappings
Control Mappings
Showing 6 of 6 mapped controls across 2 domains. Sign up to explore all 310K+ mappings across 686 frameworks.
IEC 62443: Asset Identification & Governance(3 mappings)
IEC 62443: Supply Chain & Configuration(3 mappings)
A IEC 62443 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 IEC 62443 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 5% in the header counts how many IEC 62443 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 IEC 62443 comparisons
Other 21 CFR Part 211 - Current Good Manufacturing Practice comparisons
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What are the key differences between IEC 62443 and 21 CFR Part 211 - Current Good Manufacturing Practice?
IEC 62443 has 81 controls across its framework, while 21 CFR Part 211 - Current Good Manufacturing Practice covers 76 controls. Direct mapping analysis identifies 4 overlapping controls (5% coverage). The frameworks diverge most significantly in 62443-3-3 System Security Requirements, where 24 IEC 62443 controls have no direct 21 CFR Part 211 - Current Good Manufacturing Practice equivalent.
How many controls map between IEC 62443 and 21 CFR Part 211 - Current Good Manufacturing Practice?
Of 81 total IEC 62443 controls, 4 map directly to 21 CFR Part 211 - Current Good Manufacturing Practice controls, representing 5% coverage. The remaining 77 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.
What are the compliance gaps when mapping IEC 62443 to 21 CFR Part 211 - Current Good Manufacturing Practice?
77 IEC 62443 controls have no direct equivalent in 21 CFR Part 211 - Current Good Manufacturing Practice. The highest concentration of gaps is in 62443-3-3 System Security Requirements with 24 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 IEC 62443 and 21 CFR Part 211 - Current Good Manufacturing Practice?
The domain with the highest gap count is 62443-3-3 System Security Requirements (24 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 AI-assisted interpretations 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.