Can this write a CAPA from one sentence?
A short description is not enough for a defensible CAPA. The tool requires at least 300 characters and works best with event, containment and investigation evidence.
Free CAPA workpaper · No signup
AI Medical Device CAPA Investigation Builder
Paste the actual event and investigation evidence—not just a procedure. The agent separates facts from assumptions and builds a defensible CAPA worklist from problem definition through effectiveness and closure.
Paste up to 50,000 charactersEvidence-first agent workflowBranded A4 report
Structure the quality event
The agent separates supplied facts, documents, assumptions and unknowns.
Test root-cause reasoning
Every finding stays tied to the evidence you actually supplied.
Build actions and effectiveness checks
Turn the result into a practical worklist and save it as a branded PDF.
Build a defensible CAPA investigation workpaper
Paste a complaint trend, nonconformance, audit finding, deviation, containment record, investigation evidence, root-cause work, proposed actions, and any effectiveness data.
Separate documents with headings when possible. Do not paste patient-identifying information.0 / 50,000
Privacy: Pure Global does not save this pasted text or the generated report. The text is sent to our AI provider for this one-time analysis. Avoid confidential information you are not authorized to share.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
What to paste for a useful review
Include the observed problem, requirement, affected products or processes, dates, magnitude and immediate containment.
Add investigation records, competing causal evidence, proposed actions, owners, due dates and any effectiveness criteria or results.
Continue your regulatory workflow
Move from this workpaper into the next connected review. Pasted evidence stays on this page and is never placed in a link.
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Frequently asked questions
Does it distinguish correction and corrective action?
Yes. The review separates immediate correction or containment from actions intended to remove verified systemic causes.
Will it call “operator error” a root cause?
Not without supporting evidence. The workflow asks for causal evidence, system contributors and a way to test competing hypotheses.
Is the report an approved quality record?
No. It is a draft workpaper that must enter your controlled QMS review and approval process.