Deviations and CAPA
The desk reads the deviation report, the batch record and the governing procedures, looks for earlier deviations like it, assesses product impact, and drafts the investigation for Quality to sign.
Deviations and CAPA
Demo video coming soon
Why it's hard
In the demo
A single temperature excursion looks minor, until the agent finds two earlier deviations on the same chamber. It recommends a CAPA instead of another one-off fix.
How the desk runs it
A deviation report from the floor opens a case, linked to the batch and the equipment.
The agent reads the batch record around the event, finds the procedure step involved, searches past deviations on the same equipment or step, and assesses the impact on product quality.
It proposes a classification, a batch disposition (release, hold or reject) and whether a CAPA is needed, with its rationale.
Quality approves with an e-signature.
The investigation report is issued, a CAPA is opened with an owner and due date, and the batch disposition goes to your quality system.
The report and signed approval are filed as records under your retention rules.
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