Overwrap Machine (Bag) – Deviation Impact Assessment

Deviation Impact Assessment Template

Equipment Details

Equipment: Overwrap Machine (Bag)

Area: Packaging/Primary

Criticality: Major

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Data Integrity Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

CAPA Summary:

Re-test/Requalification Decision

Decision on Re-test/Requalification:

QA Disposition

QA Disposition:

Additional Comments

Comments:

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