Deviation Impact Assessment Template

Equipment Details

Equipment: Sterile Hold Tank (Pressurized)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Minor
Major
Critical

Product/Patient Impact

Description of Product/Patient Impact:

Data Integrity Impact

Description of Data Integrity Impact:

Affected Batches/Studies

List of Affected Batches/Studies:

Investigation

Investigation Details:

Corrective and Preventive Action (CAPA)

CAPA Details:

Re-test/Requalification Decision

Re-test/Requalification Decision:

QA Disposition

QA Disposition: