Deviation Impact Assessment Template

Equipment Details

Equipment: Solvent Storage Tank (SS / GL)

Area: Production

Criticality: Critical

Product Impact: Indirect

CSV Required: Yes

Deviation Details

Deviation Description: [Enter deviation details here]

Date of Deviation: [Enter date]

Reported By: [Enter name]

Classification

Deviation Classification: [Enter classification]

Product/Patient Impact

Potential Product Impact: [Describe impact]

Potential Patient Impact: [Describe impact]

Data Integrity Impact

Data Integrity Impact Assessment: [Describe impact]

Affected Batches/Studies

Affected Batches/Studies: [List affected batches/studies]

Investigation

Investigation Summary: [Enter investigation summary]

Investigation Findings: [Enter findings]

CAPA (Corrective and Preventive Action)

CAPA Plan: [Describe CAPA]

Responsible Person: [Enter name]

Due Date: [Enter due date]

Re-Test/Requalification Decision

Re-Test/Requalification Required: [Yes/No]

Details: [Enter details]

QA Disposition

QA Disposition: [Enter QA disposition]

Disposition Date: [Enter date]

Approval

Prepared By: [Enter name]

Approved By: [Enter name]

Approval Date: [Enter date]