Deviation Impact Assessment

Equipment Details

Equipment: Vial Crimping Machine

Area: Production/Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification:

Major
Minor
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 Plan:

Re-test/Requalification Decision

Decision:

Retest Required
Requalification Required
No Action Required

Quality Assurance Disposition

Disposition:

Signatures

Prepared By: ____________________

Reviewed By: ____________________

Approved By: ____________________