cGen digitalises the full computer system validation lifecycle for GxP-regulated pharma, biotech and medtech. appico built it end to end.
appico's role: Product, design and engineering, end to end
In regulated industries, software has to be proven, not just built. Computer system validation is the process of proving it, and it is slow, document-heavy work. cGen is an AI-native platform that digitalises that whole lifecycle.
The rule we built to is simple. AI does the heavy, repetitive drafting and checking. A person stays accountable for every control that matters.
User and functional requirement specifications, test scripts and risk assessments drafted by AI for human review.
Electronic records and e-signatures designed for 21 CFR Part 11 and EU GMP Annex 11.
A live test-execution console with audit trails, real-time monitoring and an Inspector Mode.
Connections to Jira, ServiceNow, Veeva Vault and SharePoint.
A focused look at the idea, goals and timeline, ending in a buildable spec and a clear technical roadmap.
Product structure, stack selection and AI integration, chosen around the delivery goals.
AI-accelerated development in parallel, with real commits every day.
Automated test suites plus manual QA, across devices.
Deployed to production and monitored, ready for real users.
Fixes and iteration as the user base grows.