Deviation Impact Assessment

Equipment Information

Equipment: Cap Tightening / Capping Machine

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

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:

QA Disposition

Disposition:

Signatures

Prepared By: ________________________

Reviewed By: ________________________

Approved By: ________________________