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Software Assurance

What is Software Assurance?

The level of confidence that software functions as intended, is free of vulnerabilities, and provides a required level of security.

Information Security

Terms that appear alongside software assurance

Each of these is named in at least one of the same controls as software assurance. The number is how many controls name both.

Frameworks that govern software assurance

ISO 27001:2022View framework →NIST Cybersecurity Framework 2.0View framework →CIS Controls v8View framework →

What the standards actually require on software assurance

Requirements naming software assurance across 4 standards, quoted from the control text.

GAMP 5 - Good Automated Manufacturing Practice6 controls

GAMP 5 2nd Edition (July 2022) key updates + FDA Computer Software Assurance (CSA) coordination. AI/ML SYSTEMS: dedicated guidance on validation of AI/ML in pharma (predictive maintenance + image analysis + drug discovery + clinical decision support);

GAMP5-2nd-Edition-AI-Cloud-Agile-CSA · 2nd Edition (2022) - AI/ML, Cloud, Agile, DevOps and Computer Software Assurance (CSA) →
FAA Cybersecurity Framework for Aviation1 control

Vulnerability management + software assurance for aviation systems covers: (a) RTCA DO-178C 'Software Considerations in Airborne Systems' (the airworthiness software-assurance baseline - needs_licensed_copy);

FAA-CSA-VulnMgmt · Vulnerability Management and Software Assurance for Aviation Systems →
Space ISAC (Information Sharing and Analysis Center) - Threat Framework1 control

Apply secure development, code review and verification to flight software, payload firmware and on-board autonomy components.

SISAC-08 · Flight Software Assurance →
FDA 21 CFR Part 112 controls

21 CFR Part 11 has been in force since 20 August 1997 (Final Rule published 20 March 1997 + effective 20 August 1997). The 2003 FDA Scope and Application Guidance significantly narrowed enforcement scope using a risk-based approach + announced enforcement disc...

Part11.Status · 21 CFR Part 11 - corpus status, FDA enforcement landscape, CSA transition →

Questions people ask about software assurance

What is Software Assurance?
The level of confidence that software functions as intended, is free of vulnerabilities, and provides a required level of security.
Why is Software Assurance important for compliance?
Software Assurance is a key concept in Information Security. Understanding software assurance helps organizations meet regulatory requirements, reduce risk, and demonstrate due diligence during audits. Our compliance platform maps 686 frameworks with 311K cross-framework control mappings.
Which compliance frameworks address Software Assurance?
Software Assurance appears in the requirement text of GAMP 5 - Good Automated Manufacturing Practice, FAA Cybersecurity Framework for Aviation, Space ISAC (Information Sharing and Analysis Center) - Threat Framework, FDA 21 CFR Part 11. Across these standards we have identified 10 controls that name it directly, each linked to the control text on the compliance platform.
Where can I learn more about Software Assurance?
Explore our compliance framework pages to see how software assurance applies across different standards and regulations. Our implementation guides provide step-by-step guidance, and the compliance platform offers AI-powered analysis of how this concept maps across 686 frameworks.

See how Software Assurance applies across compliance frameworks

Our platform maps 686 frameworks with 311K cross-framework control mappings. Explore how this concept is addressed across standards.

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Written and maintained by Gerard Blokdyk, The Art of Service.