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GMP deviations in production and the lab. AI agents draft the investigation and the CAPA from batch records, lab results and similar deviations, so QA decides and the batch can be released.
Trusted by leading enterprises
Trusted by leading enterprises





The challenge
Every deviation needs an investigation and a CAPA before the batch can be released. The data sits in batch records, LIMS and old deviations, so investigations start late and come back.
Deviation DEV-26-0187 · Batch 26B114 · opened Mon 06:20Granulation moisture above limit
Release in 2 daysRoot cause
Rejected by Dr. K. Voss, QA · Tue 11:05
"Human error" is not an acceptable root cause. Please investigate equipment and process data and assess the other batches.
Human error during drying.
Operator retrained on SOP-114.
Required
Required
The solution
From batch records, lab results and past deviations. QA decides.
Deviation DEV-26-0187 · batch 26B114Granulation moisture 4.1 %, limit 3.0 %
Open deviationData from
The solution
From batch records, lab results and past deviations. QA decides.
Deviation DEV-26-0187 · batch 26B114Granulation moisture 4.1 %, limit 3.0 %
Open deviationData from
Impact
Measured with you, in your process.
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Why Operaide
Why Operaide
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On your own infrastructure, with the AI models you approve.
Each decision is logged with its inputs. IT and audit see the full trace.
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