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.
Free · no loginStructured outputPaste up to 50,000 charactersCurrent-source checks when useful
Paste the quality event, evidence, investigation and proposed actions
Try an example
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 publish this pasted text or generated workpaper. It is processed for this review and sent to our AI provider. Avoid patient-identifying information and confidential material you are not authorized to share.
About this agent
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.
- 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.
- 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.
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