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A-Simplified-Version-of-CAPA-Effectiveness-Template

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A Simplified Version of “CAPA Effectiveness Review and Acceptance” Template: (not pretend to be complete) General Area / Department Date of Assessment Form no. Lead Assessor / Assessor Members / Responsibilities (affected area, where CAPA has been implemented): Project Brief Description of the Assessment Activity CAPA – Post Implementation Report of the continual monitoring activity during the period between implementation and effectiveness assessment: Remarks Agreed Criteria met? Y/N Observations Results Checked by/Date 1) Type of work performed? 2) Team/individual involved? 3) Changes (adopted) in processes? 4) Changes (adopted) in procedures 5) Other?? Problems / Issues Has the problem reoccurred since the actions were implemented? 1) Nature of the problem 2) Any action taken 3) Any change to the accepted CAPA plan/implementation process 4) Other?? Attachments Records/reports (attach copies) 1) 2) 3) Conclusion Action Review & Comments Recommendations Follow-Up Actions 1) 2) 3) Re-Review Date Approval Signature (Management/Quality Assurance Date © PHARMAREAD 2022-2024 | All rights reserved.