Computer System Validation Software
CSV software replaces the spreadsheets, Word templates, and stitched-together Jira boards that most GxP validation programs run on today. cGen is AI-native computer system validation software purpose-built for FDA-regulated life sciences — one platform for the whole lifecycle, inspection-ready by default.
URS, FRS, IQ, OQ, PQ, RTM, deviations, CAPA and periodic review all live in one tool. No hand-offs between Word, Excel, SharePoint and email.
The cGen AI Assistant generates URS items, test scripts, gap analyses and risk assessments — with a qualified human sign-off on every controlled record.
Every record ships with re-auth, meaning, reason, and MFA on the signature; tamper-evident audit trail on every edit; ALCOA++ markers throughout.
CSV software has one job: prove — in a form an FDA, EMA or MHRA inspector will accept — that a computerized system does what the business says it does, consistently and within specification, throughout its GxP lifecycle. That means user requirement authoring, functional specification, risk-based test planning aligned to GAMP 5 categories, IQ/OQ/PQ execution with evidence capture, requirements traceability, deviation and CAPA handling, periodic review, and inspection-ready evidence packs — all under 21 CFR Part 11 controls for electronic records and signatures.
Most teams still cobble this together across Word, Excel, a document management system, a ticketing tool, and email. That approach was defensible in 2005. In 2026, with the FDA's Computer Software Assurance (CSA) guidance explicitly encouraging risk-based automation and AI-assisted authoring, it is no longer the fastest — or the most defensible — path.
Any tool that calls itself computer system validation software should give you the following out of the box, not as bolt-on modules:
How cGen fits
cGen is that platform. It was designed by a 37-year FDA compliance veteran who spent 100+ engagements watching CSV programs go wrong. Every module — validation projects, GxP inventory, the AI Assistant, Inspector Mode, continuous monitoring, the migration wedge — was built to remove one of the failure modes that trip inspections. Pricing is public and transparent, starting at $2,500/month; the AI Assistant is included in every tier, not a paid add-on.
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