Quality
Deviation
Approved exception from the procedure — investigated, justified, and signed off.
A deviation is any departure from the approved procedure, master record, or specification. Planned deviations are pre-approved (e.g. a one-off equipment substitution); unplanned deviations are caught at the time. Either way the regulator wants an investigation, impact assessment, disposition, and (often) a linked CAPA. V5 makes deviation capture a structured form on the kiosk so operators cannot proceed without recording one.
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