FDA Quality Management System Regulation (QMSR) vs SOC 2
What is the difference between FDA Quality Management System Regulation (QMSR) and SOC 2?
FDA Quality Management System Regulation (QMSR) is a quality management framework applying in the United States, with 13 controls across 7 domains. SOC 2 is a other framework applying in the United States, with 61 controls across 5 domains. They govern different subjects, so the overlap is limited to the governance requirements they share. The mapping below shows where that is.
FDA Quality Management System Regulation (QMSR)13 controls
SOC 261 controls
Questions people ask about FDA Quality Management System Regulation (QMSR) and SOC 2
What is the difference between FDA Quality Management System Regulation (QMSR) and SOC 2?
FDA Quality Management System Regulation (QMSR) has 13 controls while SOC 2 has 61 controls. Both frameworks address compliance requirements but differ in scope, focus, and applicability. Use our platform to explore the exact control-to-control mappings.
Do I need both FDA Quality Management System Regulation (QMSR) and SOC 2?
Whether you need both depends on your industry, regulatory requirements, and customer expectations. Many organizations implement multiple frameworks simultaneously. Our compliance platform helps you map controls between FDA Quality Management System Regulation (QMSR) and SOC 2 so you can identify shared requirements and avoid duplicate effort.
How do FDA Quality Management System Regulation (QMSR) and SOC 2 controls map to each other?
Our platform maps controls between FDA Quality Management System Regulation (QMSR) and SOC 2 at a granular level. Each mapping shows whether controls are fully aligned, partially aligned, or represent gaps. This helps you prioritize implementation when pursuing both frameworks.
Which framework should I implement first, FDA Quality Management System Regulation (QMSR) or SOC 2?
The best starting point depends on your specific regulatory requirements, industry, and customer demands. Consider which framework is most urgently required by your stakeholders or regulators. Use our free compliance platform to run a gap analysis and determine the optimal implementation sequence.
Each framework on its own
Comparisons people read next
Each of these compares one of the two standards above against another it shares controls with.
FDA Quality Management System Regulation (QMSR) vs SWIFT CSCF5 shared controlsFDA Quality Management System Regulation (QMSR) vs NIST SP 800-171A Rev 3 - Assessing CUI Security Requirements5 shared controlsFDA Quality Management System Regulation (QMSR) vs BRCGS Global Standard for Food Safety Issue 95 shared controlsSOC 2 vs ISO 27701:201947 shared controlsSOC 2 vs NIST SP 800-53 Rev 545 shared controlsSOC 2 vs C5 (Germany)39 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between FDA Quality Management System Regulation (QMSR) and SOC 2 on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.