Stage: PilotingAI-powered data validation for regulated manufacturing records — 100% coverage, not 5%.
What it is
AI-powered data validation for regulated manufacturing records. Every record, every field, every batch — not the 5% manual review can sample.
The pain it solves
Manual batch record review covers roughly 5% of records. The other 95% is unchecked. Deviations are caught after the fact, not prevented.
How it works
Purpose-built pharma domain model that understands regulatory context — not just data patterns. Runs encrypted on ColdVault.
Where we are today
In pilot with a top-five pharma customer. ALCOA+ and Annex 11 ready. Annex 22 aligned by architecture.
What it is
AI-powered data validation for regulated manufacturing records. BatchGuard reads every batch record, every field, on every batch — not just the 5% that manual review can sample. It detects, explains, and prevents quality issues before they become deviations. Designed for the heart of GxP record review: where 95% of records currently pass untouched.
The pain it solves
Manual batch record review covers roughly 5% of records. The other 95% is read by no-one. Deviations get caught after the fact, in audit, or worse — by the regulator. The cost is not just compliance risk; it's release delays, rework, and human reviewers exhausted on paperwork instead of judgement calls.
How it works
Powered by the 9robots GxP LLM — a purpose-built pharma domain model that understands regulatory context, not just data patterns. 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. Runs on ColdVault's encrypted infrastructure — record contents never leave hardware-attested confidential VMs.
Where we are today
In active pilot with a top-five pharma customer. ALCOA+ and Annex 11 compliant. Annex 22 aligned by architecture. Pilot expansion conversations open with additional pharma customers — reach out if your batch review process is the bottleneck you'd like to fix this year.
See: Regulatory alignment
Designed against ALCOA+ data integrity principles and Annex 11 / 21 CFR Part 11 electronic record requirements. Annex 22 (draft) AI guidance alignment is built in through the multi-model audit architecture on ColdVault: when models disagree, the finding is flagged for human review rather than asserted as ground truth.
See: What is inside (ColdVault & the pharma model)
Reasoning runs on ColdVault — hardware-attested confidential VMs, encrypted in-flight and at-rest, with the 9robots GxP LLM carrying the pharma domain knowledge. The same architecture already used by BatchGuard, GlassHood, and TestRobin — proven on production GxP-sensitive workloads.