Cross-Framework Mapping

21 CFR Part 211 — Current Good Manufacturing PracticevsDO-178C / ED-12C — Software Considerations in Airborne Systems

See exactly how 21 CFR Part 211 — Current Good Manufacturing Practice controls map to DO-178C / ED-12C — Software Considerations in Airborne Systems. Pre-computed mappings, identified gaps, and coverage analysis.

12
Controls Mapped
45
Gaps Found
7%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

21 CFR Part 211 — Current Good Manufacturing Practice maps to DO-178C / ED-12C — Software Considerations in Airborne Systems with 7% coverage across 4 directly mapped controls. Analysis of 57 21 CFR Part 211 — Current Good Manufacturing Practice controls identifies 53 compliance gaps — primarily concentrated in Subpart J — Records and Reports.

Source: TheArtOfService Knowledge Graph | 57 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 12 of 12 mapped controls across 4 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Subpart A — General Provisions(3 mappings)

CFR211-A-3Section 211.3 — Definitions3 targets
Table A-1, Obj. 1Software Development Plan
Table A-1, Obj. 2Software Verification Plan
Table A-2, Obj. 2Derived Requirements

Subpart C — Buildings and Facilities(3 mappings)

CFR211-C-48Section 211.48 — Plumbing3 targets
Table A-3, Obj. 4HLR Traceability
Table A-5, Obj. 3Source Code Traceability
Table A-8, Obj. 2Baselines and Traceability

Subpart F — Production and Process Controls(3 mappings)

CFR211-F-113Section 211.113 — Control of Microbiological Contamination3 targets
Table A-3, Obj. 4HLR Traceability
Table A-5, Obj. 3Source Code Traceability
Table A-8, Obj. 2Baselines and Traceability

Subpart I — Laboratory Controls(3 mappings)

CFR211-I-176Section 211.176 — Penicillin Contamination3 targets
Table A-3, Obj. 4HLR Traceability
Table A-5, Obj. 3Source Code Traceability
Table A-8, Obj. 2Baselines and Traceability

Related Comparisons

Other 21 CFR Part 211 — Current Good Manufacturing Practice comparisons

Other DO-178C / ED-12C — Software Considerations in Airborne Systems comparisons

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What are the key differences between 21 CFR Part 211 — Current Good Manufacturing Practice and DO-178C / ED-12C — Software Considerations in Airborne Systems?

21 CFR Part 211 — Current Good Manufacturing Practice has 57 controls across its framework, while DO-178C / ED-12C — Software Considerations in Airborne Systems covers 36 controls. Direct mapping analysis identifies 4 overlapping controls (7% coverage). The frameworks diverge most significantly in Subpart J — Records and Reports, where 9 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct DO-178C / ED-12C — Software Considerations in Airborne Systems equivalent.

How many controls map between 21 CFR Part 211 — Current Good Manufacturing Practice and DO-178C / ED-12C — Software Considerations in Airborne Systems?

Of 57 total 21 CFR Part 211 — Current Good Manufacturing Practice controls, 4 map directly to DO-178C / ED-12C — Software Considerations in Airborne Systems controls — representing 7% coverage. The remaining 53 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 DO-178C / ED-12C — Software Considerations in Airborne Systems?

53 21 CFR Part 211 — Current Good Manufacturing Practice controls have no direct equivalent in DO-178C / ED-12C — Software Considerations in Airborne Systems. The highest concentration of gaps is in Subpart J — Records and Reports with 9 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 DO-178C / ED-12C — Software Considerations in Airborne Systems?

The domain with the highest gap count is Subpart J — Records and Reports (9 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

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.