9robots GxP LLM
Stage: In developmentPharma domain model with deep regulatory knowledge — understands the regulation, not just the data.
What it is
Pharma domain model fine-tuned on GMP, Annex 11, 21 CFR Part 11, ALCOA+, and the full validation lifecycle (IQ/OQ/PQ). Understands regulatory context, not just data patterns.
Proven in production
We have already trained a purpose-built model on SOPs and production data for recipe validation. First iteration for any new pharma domain can be delivered within weeks once training data is available.
What it powers
BatchGuard and OpsPulse run on GxP — domain expertise generic models lack. When reviewing batch records or answering production queries, the model understands the regulation, not just the data.
Where we are today
In development as a productised offering. The underlying technique is proven; the productisation is what's new. Available via ColdVault — cloud or sovereign deployment.
What it is
A pharma domain model with deep regulatory knowledge. Fine-tuned on GMP, Annex 11, 21 CFR Part 11, ALCOA+ data integrity principles, and the full pharmaceutical validation lifecycle — IQ, OQ, PQ. The model knows what a batch record looks like, what fields matter, and what kind of anomaly indicates a real deviation versus a benign variation.
Proven in production
We have already trained a purpose-built model on Standard Operating Procedures and production data for recipe validation against SOPs. This is not a planned capability — we have done it. The first iteration of a custom model for any new pharma domain can be delivered within weeks once training data is available. What's in development is the productised offering, not the underlying technique.
What it powers
BatchGuard and OpsPulse run on GxP — domain expertise that generic frontier models lack. When reviewing batch records or responding to production queries, the model understands regulatory context, not just data patterns. Manual review covers 5% of pharma records at best; GxP enables 100% coverage by embedding regulatory knowledge directly into the model — no prompt engineering required to make it understand GxP terminology and compliance requirements.
Where we are today
In development as a productised standalone offering. Available via the ColdVault API — cloud or sovereign deployment. Runs on encrypted infrastructure. Annex 22 ready.