Cross-Framework Mapping

DO-178C / ED-12C — Software Considerations in Airborne SystemsvsFDA Quality Management System Regulation (QMSR)

See exactly how DO-178C / ED-12C — Software Considerations in Airborne Systems controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

11
Controls Mapped
25
Gaps Found
19%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

DO-178C / ED-12C — Software Considerations in Airborne Systems maps to FDA Quality Management System Regulation (QMSR) with 19% coverage across 7 directly mapped controls. Analysis of 36 DO-178C / ED-12C — Software Considerations in Airborne Systems controls identifies 29 compliance gaps — primarily concentrated in Testing and Integration Verification (Tables A-6 & A-7).

Source: TheArtOfService Knowledge Graph | 36 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 11 of 11 mapped controls across 5 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Software Planning Process(2 mappings)

Table A-1, Obj. 1Software Development Plan
ISO 13485 Cl. 5.5Responsibility and Authority
Table A-1, Obj. 2Software Verification Plan
ISO 13485 Cl. 5.5Responsibility and Authority

Software Development Process(1 mappings)

Table A-2, Obj. 2Derived Requirements
ISO 13485 Cl. 5.5Responsibility and Authority

Verification of Requirements (Tables A-3 & A-4)(2 mappings)

Table A-3, Obj. 4HLR Traceability2 targets
ISO 13485 Cl. 6.4Work Environment and Contamination Control
ISO 13485 Cl. 7.5.2Cleanliness and Contamination Control

Verification of Design and Code (Tables A-4 & A-5)(2 mappings)

Table A-5, Obj. 3Source Code Traceability2 targets
ISO 13485 Cl. 6.4Work Environment and Contamination Control
ISO 13485 Cl. 7.5.2Cleanliness and Contamination Control

Configuration Management (Table A-8)(4 mappings)

Table A-8, Obj. 2Baselines and Traceability2 targets
ISO 13485 Cl. 6.4Work Environment and Contamination Control
ISO 13485 Cl. 7.5.2Cleanliness and Contamination Control
Table A-8, Obj. 3Problem Reporting2 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)

Related Comparisons

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

Other FDA Quality Management System Regulation (QMSR) comparisons

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What are the key differences between DO-178C / ED-12C — Software Considerations in Airborne Systems and FDA Quality Management System Regulation (QMSR)?

DO-178C / ED-12C — Software Considerations in Airborne Systems has 36 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 34 controls. Direct mapping analysis identifies 7 overlapping controls (19% coverage). The frameworks diverge most significantly in Testing and Integration Verification (Tables A-6 & A-7), where 6 DO-178C / ED-12C — Software Considerations in Airborne Systems controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between DO-178C / ED-12C — Software Considerations in Airborne Systems and FDA Quality Management System Regulation (QMSR)?

Of 36 total DO-178C / ED-12C — Software Considerations in Airborne Systems controls, 7 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 19% coverage. The remaining 29 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping DO-178C / ED-12C — Software Considerations in Airborne Systems to FDA Quality Management System Regulation (QMSR)?

29 DO-178C / ED-12C — Software Considerations in Airborne Systems controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in Testing and Integration Verification (Tables A-6 & A-7) with 6 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 DO-178C / ED-12C — Software Considerations in Airborne Systems and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is Testing and Integration Verification (Tables A-6 & A-7) (6 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.