Deviation investigations your auditors can stand behind.
Stop losing days to drafting reports. Investigations gives your Quality team a strong, structured first draft with the right questions asked up front — so deviations and CAPAs close faster, read consistently, and hold up in the room.
Built for
The backlog isn't a people problem.
It's a writing problem.
Your investigators know the process. What eats their weeks is drafting — assembling the narrative, the impact assessment, the root-cause argument, the CAPA justification — and doing it consistently, every time, under closure-date pressure.
A review-ready draft, not a blank page
Benefits first, machinery second — every capability exists to get a defensible investigation in front of your reviewer faster.
Structured first draft
A complete, consistently structured investigation draft — event description, impact, root-cause reasoning, CAPA logic — in a fraction of the drafting time.
The right questions, up front
Structured questions surface what the investigation needs before writing starts — so evidence gaps show up on day one, not in QA review.
Flags gaps & inconsistencies
Reads across the record and supporting documents to flag missing evidence, weak reasoning, and inconsistencies before an auditor does.
Configured to your procedures
Templates, sections, and review steps configured to your SOPs and QMS expectations — not a generic report bolted onto your process.
Expert review, required
Nothing closes without a qualified human. Your reviewer edits, challenges, and signs — the AI drafts, your expert decides.
Traceable & audit-trailed
Every claim traceable to its source, every AI suggestion and human decision logged — defensible in review, defensible in an inspection.
Four steps from event to defensible closure
Intake
Capture the event and problem statement; bring in the relevant SOPs, batch records, and deviation history.
AI drafts & asks
The agent drafts the investigation — root cause and CAPA logic included — and asks the structured questions the record still needs answered.
QA reviews & challenges
Your qualified reviewer edits, challenges, and approves. Nothing advances without a human decision.
Defensible closure
A traceable, consistently written investigation, ready for your QMS as the record of closure.
Faster closure. Consistent files. Calmer inspections.
*Time savings of 60–70% observed on targeted workflows, depending on adoption and process fit, validated in proof-of-concept.
Straight answers on Investigations
Does the AI decide the root cause?
No. The AI drafts root-cause reasoning from the evidence you provide and flags where the argument is weak — but the root-cause determination, the CAPA, and the closure decision belong to your qualified reviewer. That's by design: it's your investigation, accelerated.
Can it hallucinate a wrong investigation?
No output is released by the AI alone — a qualified human reviews, edits, and signs every result. A proprietary data-minimization technique constrains the model to your provided evidence rather than open-ended generation, and every claim is traceable back to its source, which makes review fast and defensible.
Does it replace our QMS deviation module?
No — it works alongside your existing QMS. The deviation lives in your system of record; Investigations accelerates the thinking and writing in between, and the reviewed output flows back into your QMS. Integration scope is agreed per deployment.
How do we start?
The most common start is a focused, time-boxed pilot on your own recent deviations — so you measure drafting time, consistency, and review effort on your own data before any broader commitment. Talk to us and we'll propose a pilot.
Bring your last five deviations
We'll show you a defensible draft on a real record — with your expert in control the whole way. That's the fastest honest answer to "will this work here?"