FDA 21 CFR Part 11 vs ASD Strategies to Mitigate Cyber Security Incidents
What is the difference between FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents?
FDA 21 CFR Part 11 is a other framework applying in the United States, with 13 controls across 7 domains. ASD Strategies to Mitigate Cyber Security Incidents is a other framework applying in Australia, with 37 controls across 9 domains. Both govern the same subject, so their requirements overlap; the mapping below shows which controls carry across and which are asked for by only one of them.
FDA 21 CFR Part 1113 controls
ASD Strategies to Mitigate Cyber Security Incidents37 controls
Questions people ask about FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents
What is the difference between FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents?
FDA 21 CFR Part 11 has 13 controls while ASD Strategies to Mitigate Cyber Security Incidents has 37 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 ASD Strategies to Mitigate Cyber Security Incidents?
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 ASD Strategies to Mitigate Cyber Security Incidents so you can identify shared requirements and avoid duplicate effort.
How do FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents controls map to each other?
Our platform maps controls between FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents 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 ASD Strategies to Mitigate Cyber Security Incidents?
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 21 CFR Part 11 vs Annex 11 to EU GMP - Computerised Systems9 shared controlsFDA 21 CFR Part 11 vs AWWA Cybersecurity Guidance for the Water Sector (American Water Works Association)7 shared controlsFDA 21 CFR Part 11 vs US Consumer Product Safety Commission (CPSC) - Connected Product Safety6 shared controlsASD Strategies to Mitigate Cyber Security Incidents vs NIST SP 800-53 Rev 535 shared controlsASD Strategies to Mitigate Cyber Security Incidents vs CIS Controls v834 shared controlsASD Strategies to Mitigate Cyber Security Incidents vs FedRAMP Moderate33 shared controls
See all control mappings with interactive gap analysis
Explore the complete mapping between FDA 21 CFR Part 11 and ASD Strategies to Mitigate Cyber Security Incidents on our compliance platform.
Written and maintained by Gerard Blokdyk, The Art of Service.