Cross-Framework Mapping

ASEAN Data Management FrameworkvsFDA Quality Management System Regulation (QMSR)

See exactly how ASEAN Data Management Framework controls map to FDA Quality Management System Regulation (QMSR). Pre-computed mappings, identified gaps, and coverage analysis.

13
Controls Mapped
26
Gaps Found
23%
Coverage

According to the TheArtOfService Compliance Knowledge Graph:

ASEAN Data Management Framework maps to FDA Quality Management System Regulation (QMSR) with 23% coverage across 9 directly mapped controls. Analysis of 39 ASEAN Data Management Framework controls identifies 30 compliance gaps — primarily concentrated in Risk Assessment.

Source: TheArtOfService Knowledge Graph | 39 controls analysed | 693 frameworks | 819K+ cross-framework mappings

Control Mappings

Showing 13 of 13 mapped controls across 3 domains. Sign up to explore all 819K+ mappings across 693 frameworks.

Governance and Oversight(2 mappings)

Art. 17Governance Structure
ISO 13485 Cl. 5.5Responsibility and Authority
DMF-1.2Roles and Responsibilities
ISO 13485 Cl. 5.5Responsibility and Authority

Risk Assessment(2 mappings)

DMF-4.1Impact Assessment
AQAP-5.7Dependability Requirements
DMF-4.2Risk Categorization
§ 820.45Device Labeling and Packaging

Monitoring and Continuous Improvement(9 mappings)

DMF-6.3Continuous Improvement2 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)
DMF-6.4Incident Response and Learning2 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)
ISO28001-MI-02Internal Security Audits3 targets
ISO 13485 Cl. 4.1General QMS Requirements
ISO 13485 Cl. 7.4Purchasing Controls
ISO 13485 Cl. 8.5.2Corrective Action (CAPA)
ISO28001-MI-03Management Review of Security Program
ISO 13485 Cl. 7.4Purchasing Controls
ISO28001-MI-04Corrective and Preventive Actions
ISO 13485 Cl. 7.4Purchasing Controls

Related Comparisons

Other ASEAN Data Management Framework comparisons

Other FDA Quality Management System Regulation (QMSR) comparisons

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What are the key differences between ASEAN Data Management Framework and FDA Quality Management System Regulation (QMSR)?

ASEAN Data Management Framework has 39 controls across its framework, while FDA Quality Management System Regulation (QMSR) covers 34 controls. Direct mapping analysis identifies 9 overlapping controls (23% coverage). The frameworks diverge most significantly in Risk Assessment, where 11 ASEAN Data Management Framework controls have no direct FDA Quality Management System Regulation (QMSR) equivalent.

How many controls map between ASEAN Data Management Framework and FDA Quality Management System Regulation (QMSR)?

Of 39 total ASEAN Data Management Framework controls, 9 map directly to FDA Quality Management System Regulation (QMSR) controls — representing 23% coverage. The remaining 30 controls represent compliance gaps requiring additional documentation or compensating controls to satisfy both frameworks simultaneously.

What are the compliance gaps when mapping ASEAN Data Management Framework to FDA Quality Management System Regulation (QMSR)?

30 ASEAN Data Management Framework controls have no direct equivalent in FDA Quality Management System Regulation (QMSR). The highest concentration of gaps is in Risk Assessment with 11 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 ASEAN Data Management Framework and FDA Quality Management System Regulation (QMSR)?

The domain with the highest gap count is Risk Assessment (11 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.