Does CSA reduce documentation?

It reduces low-value documentation and increases evidence quality on the parts that actually affect patient safety and product quality. The goal is proportionality, not less paperwork for its own sake.

Can I use CSA for medical devices as well as pharma?

Yes. The CSA guidance was originally scoped to medical-device manufacturing but the underlying critical-thinking approach applies to any FDA-regulated computerized system.

Does cGen support both classical CSV and CSA?

Yes. You can run a full scripted IQ/OQ/PQ where the risk demands it, and a CSA critical-thinking risk assessment with supplier evidence where it does not — in the same platform, on the same records.

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Computer Software Assurance Software

Computer software assurance (CSA) software aligned to FDA's 2022 guidance

Q: What about AI-generated compliance documents and FDA warning letters?

Recent FDA warning letters make clear that AI cannot approve records. cGen enforces qualified human sign-off on every controlled artefact — AI drafts, humans sign, and the audit trail records both.

CSA reframes validation as risk-based assurance rather than exhaustive documentation. cGen is CSA software built around FDA's Computer Software Assurance guidance: critical-thinking risk assessments, right-sized testing, and AI drafting that only draft — never approve.

Critical thinking, not scripted busywork

The AI Risk Assessor runs CSA-aligned critical thinking on every system: what could go wrong, what is the patient/data impact, what testing does the risk actually justify.

Right-sized testing engine

GAMP 5 categorisation and CSA risk drive test scope automatically. High-risk paths get scripted execution; low-risk paths get supplier evidence and ad-hoc testing.

AI drafts. Humans still sign.

FDA warning letters on AI-generated compliance documents make one thing clear: AI cannot approve records. cGen enforces qualified human sign-off on every controlled artefact.

What CSA actually changes about validation software

The FDA's Computer Software Assurance guidance, first issued in draft in 2022 and finalized in 2026, is a deliberate move away from the "validate everything to the same depth" mindset that dominated Part 11 practice for two decades. Under CSA, the assurance effort you invest in a computerized system is proportional to the risk that a software failure would impact product quality, patient or user safety, and data integrity.

This has direct implications for the software you use to run validation. Old CSV tools generate the same 9-document ritual for a batch scheduler and a bench-top temperature logger. CSA software has to be smarter — it has to know how to apply risk to decide how much evidence is actually needed, and it has to make critical-thinking risk assessments easy to author, review, and revisit.

What good CSA software looks like

CSA software should:

Ask the CSA questions in the workflow, not in a separate document nobody reads: "What could go wrong? What is the impact if it does? What confidence does the intended use actually demand?"
Auto-classify systems against GAMP 5 categories (Cat 1, 3, 4, 5) and let category drive the default test approach
Support supplier evidence, automated testing, and targeted scripted testing as first-class test types — not a footnote
Reduce low-value documentation without reducing evidence quality (the point of CSA is not "less paperwork" — it is "the right paperwork")
Give inspectors a clear rationale trail: this risk, this evidence, this signed record
Coexist with classical CSV where the risk demands it — CSA is not a replacement, it is an approach

How cGen fits

Built for this exact problem

cGen was built CSA-first. Every system that enters the platform is risk-classified before the first test script is generated; the AI Risk Assessor documents the critical-thinking rationale in the workflow itself; the test-script generator produces scripts scaled to the risk category. The FDA's CSA guidance says "assurance effort should be commensurate with risk." cGen makes that operational instead of aspirational.

Computer Software Assurance Software — frequently asked questions

No. CSA is an approach that can be applied within the CSV framework. The Part 11 and Annex 11 requirements for electronic records and signatures still apply; CSA changes how you scope the assurance work.

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