Deviation Impact Assessment Template

Equipment Details

Equipment: Stainless Steel Reactor (SSR)

Area: Production

Criticality: Critical

Product Impact: Direct

CSV Required: Yes

Deviation Details

Deviation Description: [Insert description of the deviation]

Date of Deviation: [Insert date]

Reported By: [Insert name]

Classification

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

Product/Patient Impact

Impact Assessment: [Insert detailed assessment of product/patient impact]

Data Integrity Impact

Data Integrity Assessment: [Insert details on data integrity impact]

Affected Batches/Studies

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

Investigation

Investigation Summary: [Insert summary of the investigation]

Investigation Completion Date: [Insert date]

Corrective and Preventive Actions (CAPA)

CAPA Summary: [Insert summary of CAPA]

CAPA Implementation Date: [Insert date]

Re-test/Requalification Decision

Decision: [Insert decision regarding re-test/requalification]

Re-test/Requalification Date: [Insert date]

Quality Assurance Disposition

QA Disposition: [Insert QA disposition]

Disposition Date: [Insert date]