Deviation Impact Assessment

Equipment Details

Equipment: Parts Washer (GMP)

Area: Production/Cleaning

Criticality: Major

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 Disposition

Approval

Prepared by: ______________________

Date: ______________________

Approved by: ______________________

Date: ______________________