Deviation Impact Assessment Template

Equipment Details

Equipment: Capsule/Blister Filler for DPI

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Deviation Classification:

Minor
Major
Critical

Product/Patient Impact

Impact Assessment:

Data Integrity Impact

Data Integrity Assessment:

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: