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.
BatchGuard reads batch records from wherever they live — MES, ERP, LIMS, historian, or eBR. Where your data sources expose the Model Context Protocol (MCP), BatchGuard reads through it. Where they don't, it connects directly via their native APIs.
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.