Vision System (Code/Label Verification) – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Vision System (Code/Label Verification)

Area: Packaging/Inspection

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Classification

Minor
Major
Critical

Product/Patient Impact

Data Integrity Impact

Affected Batches/Studies

Investigation

Corrective and Preventive Actions (CAPA)

Re-test/Requalification Decision

Quality Assurance (QA) Disposition

See also  Loss-in-Weight Feeder – DQ Protocol

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