AI-native compliance tools for regulated industries, computer system validation (CSV) and assurance (CSA) for pharma and biotech QA, built by the team behind cGen, where audit trails and correctness are the product.
In regulated industries, software is not judged on how it looks but on whether it can be trusted and proven. Validation, audit trails, controlled records and traceability are not features you add later, they are the architecture. Get them wrong and the tool is worse than useless, it is a liability in an audit.
We build this the way it has to be built: correctness first, compliance designed into the foundations, with AI used to accelerate the heavy, repetitive validation work rather than to cut corners on it.
Computer system validation and computer software assurance tooling that stands up to audit.
Immutable, traceable records so every change and approval is provable, not just claimed.
Reviews, approvals and e-signatures modelled on how regulated QA actually works.
AI that drafts and checks the heavy validation documentation, with humans accountable for sign-off.
Connections to the QMS, document and inventory systems your process depends on, tested end to end.
The data integrity, access control and security posture regulated work demands from day one.
Computer System Validation (CSV) and Computer Software Assurance (CSA) are how regulated industries prove their software does what it should, reliably and traceably. Compliance software supports that: controlled records, audit trails, validated workflows and the evidence an audit requires.
Primarily pharma, biotech and other regulated industries where QA and compliance are non-negotiable. If your software has to satisfy auditors, not just users, this is the rigour you need.
AI accelerates the heavy, repetitive parts, drafting validation documentation, checking for gaps, summarising, while humans stay accountable for every control and sign-off. Speed on the effort, never on the rigour.
Yes, and we test those integrations end to end with mock data before go-live, confirming every field syncs in the right format. In regulated work, an untested integration is a risk we do not take.
Yes. Code, data and accounts are in your name from day one, with data integrity and access control built in. For validation evidence and audit needs, ownership and traceability are essential, and designed in.