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Cross-Framework Mapping

NIST SP 800-171A Rev 3 - Assessing CUI Security RequirementsvsFDA Quality Management System Regulation (QMSR)

See exactly how NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

14
Controls Mapped
21
Gaps Found
26%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements maps to FDA Quality Management System Regulation (QMSR) with 26% coverage across 9 directly mapped controls. Analysis of 35 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls identifies 26 compliance gaps — primarily concentrated in System Protection and Communications.

Source: TheArtOfService Knowledge Graph | 35 controls analysed | 718 frameworks | 332K+ cross-framework mappings

Control Mappings

Showing 14 of 14 mapped controls across 5 domains. Sign up to explore all 332K+ mappings across 718 frameworks.

Access Control and Identification(4 mappings)

3.1Physical Security4 targets
→QMSR-820.10Requirements for a Quality Management System - ISO 13485:2016 Sections 4-8 incorporation (§820.10)
→QMSR-ISO13485-Sec6Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)
→QMSR-ISO13485-Sec8Measurement, analysis and improvement (ISO 13485:2016 Section 8)

Incident Response and Media Protection(3 mappings)

3.16System and Services Acquisition
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)
3.17Supply Chain Risk Management
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)
3.5Securely Dispose of Data
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)

Awareness, Training, and Personnel(2 mappings)

3.2Establish and Maintain a Data Inventory2 targets
→QMSR-ISO13485-Sec6Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)

Audit, Assessment, and Monitoring(3 mappings)

3.3Configure Data Access Control Lists
→QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)
3.4Enforce Data Retention2 targets
→QMSR-ISO13485-Sec6Resource management (ISO 13485:2016 Section 6 - incorporated via §820.10)
→QMSR-ISO13485-Sec7_PurchasingPurchasing controls + supplier management (ISO 13485:2016 Section 7.4)

System Protection and Communications(2 mappings)

FEDRAMP-CM-6Configuration Settings
→QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)
FEDRAMP-CP-9System Backup
→QMSR-ISO13485-Sec5Management responsibility (ISO 13485:2016 Section 5 - incorporated via §820.10)

Related Comparisons

Other NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements comparisons

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Other FDA Quality Management System Regulation (QMSR) comparisons

ICH E6(R3) - Good Clinical Practice vs FDA Quality Management System Regulation (QMSR)6 mappingsSWIFT CSCF vs FDA Quality Management System Regulation (QMSR)5 mappingsBRCGS Global Standard for Food Safety Issue 9 vs FDA Quality Management System Regulation (QMSR)5 mappingsIEC 62304:2015 Medical Device Software Lifecycle Processes vs FDA Quality Management System Regulation (QMSR)5 mappings21 CFR Part 211 - Current Good Manufacturing Practice vs FDA Quality Management System Regulation (QMSR)4 mappingsIEC 60601-1 - Medical Electrical Equipment Safety vs FDA Quality Management System Regulation (QMSR)4 mappingsGLOBALG.A.P. Integrated Farm Assurance (IFA) Standard v6 vs FDA Quality Management System Regulation (QMSR)4 mappingsISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence vs FDA Quality Management System Regulation (QMSR)4 mappings

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What are the key differences between NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements and FDA Quality Management System Regulation (QMSR)?

NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements has 35 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 13 controls. Direct mapping analysis identifies 9 overlapping controls (26% coverage). The frameworks diverge most significantly in System Protection and Communications, where 13 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements and FDA Quality Management System Regulation (QMSR)?

Of 35 total NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls, 9 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 26% coverage. The remaining 26 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements to FDA Quality Management System Regulation (QMSR)?

26 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in System Protection and Communications with 13 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 NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is System Protection and Communications (13 gaps). Export the full domain-by-domain gap breakdown via the Professional tier to generate a prioritised remediation roadmap.

Related Resources

How to Map Controls Across Frameworks|Multi-Framework Compliance Guide|Compliance Glossary

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