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Deviation records capture unexpected quality events from initial report through investigation and closure, with linked CAPAs where follow-up action is required.

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Deviation Register

All deviations are shown with severity (Critical, High, Medium, or Low), status, source, and date opened. Filter by severity to prioritize higher-risk events, and review aging regularly so open investigations do not stall.

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Investigation Detail

The detail page captures the event description, source, current root-cause and impact notes, timeline, linked CAPA, and closure signature. Starting the investigation assigns an initial investigator (persisted and audit-logged), record the investigation notes and a structured RCA, and create a linked CAPA when corrective or preventive action is needed. Ownership can be handed over later via Reassign investigator, which captures a reason for change.

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Closure Controls

Closing a deviation requires a closure note and credential re-verification from the signer. This creates an attributable, Part 11-style signature manifestation linking the signer, meaning, timestamp, and record transition. Do not close a deviation while evidence, containment, impact assessment, or linked CAPA decisions remain unresolved. For the end-to-end procedure, see Raise a deviation.