Structure the event
Extract product, process, symptom, location and immediate context from the approved record.
CAPA INTELLIGENCE AGENT
Prepare the evidence.
Keep people accountable.
Retrieve similar events, identify evidence gaps and prepare review-ready investigation material—without allowing AI to declare root cause, approve disposition or close CAPA.
Open the controlled demo ↗STARTER PILOT£8,500–£12,500 · 4–6 weeksSCOPEOne site and workflowDATAUp to 250 historical recordsAUTHORITYNamed approval
THE CONTROLLED WORKFLOW
From event intake
to review preparation.
The agent supports the repetitive work around an investigation. The customer’s quality process and system of record remain authoritative.
Retrieve similar history
Find potentially related NCRs, CAPAs, complaints or supplier events with direct source links.
Identify evidence gaps
Highlight missing measurements, records, people, samples or tests needed for investigation.
Prepare controlled drafts
Draft a problem statement, investigation plan and testable hypotheses for review.
Record approval
The accountable user accepts, edits or rejects the preparation material.
OUTPUTS
Useful preparation.
Visible evidence.
Every output is designed around an agreed source boundary and a named approval point.
Similar-event pack
Relevant history, recurrence links and previous action with source references.
Evidence request list
Missing information organised for the investigation owner.
Investigation preparation
Problem statement, investigation plan and clearly labelled hypotheses.
Value and governance report
Baseline comparison, user acceptance, limitations and scaling recommendation.
TWO PILOT ROUTES
Historical proof or
controlled production.
Choose based on data readiness and operational risk—not ambition alone.
CAPA Starter Pilot
£8,500–£12,500Up to 250 historical records from CSV or Excel, one site, one workflow and up to five users. No production integration.
- Baseline and final value report
- Similar-event retrieval
- Evidence-gap workflow
- Controlled demo environment
Production Pilot
£15,000–£25,000One connected source, up to 1,000 records, up to ten users, monitoring, training and a customer-reviewed production recommendation.
- Role-based operating workflow
- One agreed source connector
- Named approval controls
- Measured live-workflow outcome
Deliberately outside the agent
Autonomous root-cause declaration, product disposition, CAPA approval or closure, product release, QMS replacement, regulatory certification and unscoped enterprise migration.
Is the CAPA workload
large enough to justify this?
Use the free value call to test event volume, investigation effort, data readiness and the governance boundary.