Deviation Impact Assessment Template

Equipment Details

Equipment: Labeling Machine

Area: Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

Minor
Major
Critical

Product/Patient Impact

Describe the impact on product/patient:

Data Integrity Impact

Describe the impact on data integrity:

Affected Batches/Studies

List affected batches/studies:

Investigation

Summary of Investigation:

Corrective and Preventive Actions (CAPA)

Describe proposed CAPA:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

Approval

Approver Name:

Approval Date: