Deviation Impact Assessment Template

Equipment Details

Equipment: Coding Machine (Inkjet/Laser)

Area: Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

Minor
Major
Critical

Product/Patient Impact

Impact on Product/Patient:

Data Integrity Impact

Impact on Data Integrity:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Details:

Corrective and Preventive Actions (CAPA)

CAPA Details:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition:

Approval

Approver Name:

Approval Date: