UC-417
GMP Batch Release and Deviation Review
Reads the executed batch record against the master, lists every exception with its evidence, and drafts the deviation investigation.
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The Challenge
Release waits on a page-by-page human read of executed records and one unexplained entry holds stock for days. Records, LIMS results and deviation files live apart, and the reviewer changes between shifts.
How It Works
- Reads executed and master batch records, LIMS results, equipment logs and open deviation files.
- Compares each executed step to the master, lists exceptions and links repeats to prior CAPA.
- Puts a release checklist and drafted investigation to the qualified person, who decides.
What It Removes
- Page-by-page manual review of executed batch records
- Chasing LIMS results to close a release checklist
- Retyping deviation facts into the investigation form
Input Data RequirementsExecuted batch records, master batch records, LIMS results, equipment and environmental monitoring logs, deviation and CAPA history, change controls
Output FormatRelease checklist with every exception listed and evidenced, drafted deviation investigation, repeat-deviation trend view per line and per product
“Nothing ships until someone has read every page twice, and the second read still finds what the first one missed”