The Problem We Were Brought In To Solve
US pharma manufacturer: 4.2% batch failure ($2.8M per batch loss), 6-week CAPA cycle, manual QC missing 18% of deviations.
How Revino Delivered
Real-time PAT integration, ML deviation prediction, automated CAPA workflow, 21 CFR Part 11 documentation generation.
Measurable Business Impact
✓Batch failure: 4.2%→1.35% (-68%)
✓QC cost: -38%
✓CAPA closure: -44%
✓21 CFR activity trail: automated
✓FDA warning letters: 0
PythonTensorFlowAWS IoTPostgreSQLFastAPIOSIsoft PI
KEY METRICS
-68%
Batch failure
-38%
QC cost
-44%
CAPA cycle
0
FDA warning letters
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