Deviation Impact Assessment Template

Equipment Details

Equipment: Coding Machine (Laser / Inkjet)

Area: Packaging

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description:

Classification

Classification:

Minor
Major
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Data Integrity Impact Assessment:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Summary:

Corrective and Preventive Actions (CAPA)

CAPA Actions:

Re-Test/Requalification Decision

Re-Test/Requalification Decision:

QA Disposition

QA Disposition:

Submit Assessment