Deviation Impact Assessment Template

Equipment Details

Equipment: Sterile Filtration Skid

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation:

Classification

Classification of Deviation:

Major
Minor

Product/Patient Impact

Product/Patient Impact Assessment:

Data Integrity Impact

Data Integrity Impact 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: