Deviation Impact Assessment Template

Equipment Details

Equipment: Isolator / RABS (NDDS Filling)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Description of Deviation: [Insert detailed description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

Deviation Classification: [Insert classification, e.g., Major, Minor]

Product/Patient Impact

Impact Assessment: [Insert assessment of impact on product and/or patient]

Data Integrity Impact

Data Integrity Assessment: [Insert assessment of data integrity impact]

Affected Batches/Studies

Affected Batches/Studies: [Insert list of affected batches or studies]

Investigation

Investigation Summary: [Insert summary of investigation conducted]

Investigation Findings: [Insert findings]

Corrective and Preventive Actions (CAPA)

CAPA Plan: [Insert detailed CAPA plan]

Responsible Person: [Insert name]

Due Date: [Insert due date]

Re-test/Requalification Decision

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

Details: [Insert details if applicable]

Quality Assurance Disposition

QA Disposition: [Insert QA disposition]

Comments: [Insert any additional comments]

Signatures

Prepared By: [Insert name]

Date: [Insert date]

Reviewed By: [Insert name]

Date: [Insert date]