In GxP work, the record is the evidence
Regulators expect data to be attributable, legible, contemporaneous, original and accurate (ALCOA), and computerized systems to be validated for their intended use. Any AI tool that touches an SOP, a deviation or a batch record has to fit inside that framework.
So the AI drafts and cross-checks, people approve, and every AI-assisted step is logged. Your QA team owns validation. We build to make it practical.
- Human sign-off on anything that touches a submission or a controlled record
- Audit trails that show what the AI produced and what a person changed
- Least-privilege access to QMS, LIMS and document systems
- Self-hosted model options when data can't leave your environment
Where we can help
Regulatory & Clinical Documentation
Draft and cross-check regulatory and clinical document sections from approved sources, with a qualified reviewer on every output.
Quality & GxP Compliance
Speed up deviation write-ups, SOP revisions and CAPA evidence assembly inside your existing eQMS and approval workflow.
Lab & Research Data
Search, summarize and report on LIMS and ELN data without changing the records.
Private AI for Sensitive Data
Run AI on data that can't go to a hosted model, using self-hosted or open-weight models in an environment you control.
What we've built that applies here
Our VP of AI Engineering, Michael Fethe, spent 15 years inside publicly traded agriculture and life science corporations. We bring that experience together with the documentation, audit-trail and private-deployment patterns we've built for regulated manufacturing and finance clients.
We don't have a life-science client reference yet. Related work in other regulated settings: an EU Declaration of Conformity generator with an audit layer, compliance-aware AI deployment planning for a registered investment adviser, and self-hosted model R&D for clients whose data can't go to hosted models.
Why work with us
Straight answers on experience
We'll tell you what we've built, what we haven't, and where the risks are.
Built for your QA team
Defined intended use, access controls and audit trails give your QA team what it needs to validate the tool.
Your data stays yours
Data stays in your tenant where possible, with self-hosted models when it can't leave your environment.
Fixed-fee Discovery first
Discovery is fixed-fee, typically about 30 days, and ends with a Findings & Opportunity Report ranking use cases by dollar impact.