FDA 21 CFR Part 11 vs SOC 2
Compare FDA 21 CFR Part 11 and SOC 2 across controls, requirements, and compliance scope. Use our compliance platform to see the full control-to-control mapping between these two frameworks.
FDA 21 CFR Part 1124 controls
SOC 254 controls
Frequently Asked Questions
What is the difference between FDA 21 CFR Part 11 and SOC 2?
FDA 21 CFR Part 11 has 24 controls while SOC 2 has 54 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 21 CFR Part 11 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 21 CFR Part 11 and SOC 2 so you can identify shared requirements and avoid duplicate effort.
How do FDA 21 CFR Part 11 and SOC 2 controls map to each other?
Our platform maps controls between FDA 21 CFR Part 11 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 21 CFR Part 11 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.
Learn More About Each Framework
See all control mappings with interactive gap analysis
Explore the complete mapping between FDA 21 CFR Part 11 and SOC 2 on our compliance platform.