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Get inspection-ready reasoning.

Your finished product release. Your CCP deviation disposition. Your supplier non-conformance call. Drafted in 90 seconds — then see the question an FDA investigator or third-party auditor will still ask that your record doesn't answer.

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Event: CCP-1 thermal excursion · Root cause: pump cycling · Actions: Engineer lethality calc · Disposition: Released
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Inspection-ready reasoning

01 — Paste

Your actual record

Finished product release, CCP deviation, corrective action, supplier non-conformance. Whatever lives in your FSMA records today.

02 — Receive

Reasoning in 90 seconds

Drafted against 21 CFR 117 language and structured for the authorization logic an FDA investigator and third-party auditor both look for.

03 — See the gap

Flags and open questions

The tool surfaces the exact questions your current record can't answer — before an inspector or auditor does.

The line that matters

An investigator does not ask for better language. They ask who authorized this decision, based on what evidence, and why it was justified. The signature on the release form names a person. It does not answer the question.

FDA 21 CFR 117 FSMA PCHF Decision defensibility