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The template streamlines internal and external compliance audits through preconfigured artifacts, audit checklists, traceable links, and configurable dashboards. 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Compliance assessments are greatly simplified thanks to the preconfigured artifacts, processes, and traceable links between work items that this template provides out of the box.  \nThe template simplifies audit preparation & execution, and enables you to manage Corrective and Preventive Actions in a convenient and fully traceable manner.  \nWhy use the Medical Audit & CAPA Template?  \n1  \nSimplified compliance audits  \nPlan and schedule audits, and build comprehensive and actionable audit checklists. Execute compliance audits in a central quality control platform.  \n2  \nActionable continuous improvement  \nManage all customer complaints, feedback, non-conformities, improvement potentials, Root Cause Analyis, and CAPA in an integrated system.  \n3  \nIntegrated quality and regulatory management  \nMaintain a shared and integrated information management system for all your audit activities. Tie in engineering process control using the Medical Software Engineering Template.  \nMedical Audit & CAPA Template  \nCapabilities of the  \nMedical Audit & CAPA Template  \nAll-in-one Audit Management  \nThis template supports your entire audit management lifecycle for MedTech regulations. The template provides predefined artifacts and processes to accelerate compliance verification, and best practices to help you perform audits effectively. Compile re-usable audit checklists for various medical standards. Plan and manage audits in a traceable manner. Customize audit dashboards for immediate access to detailed information and high-level visual data analytics charts. Use this template to provide auditors with an efficient platform to record audit evidence during audits.  \nMedical Audit & CAPA Template  \nNon-conformity and  \nImprovement Management  \nRecord and manage non-conformities and any potential for improvement in a central platform using the Medical Audit & CAPA Template. Link audit reports to non-conformities and improvement artifacts to trace them through their lifecycles. Define custom workflows for non-conformities and improvements.  \nRoot Cause Analysis  \nAnalyze non-conformities and record the results of Root Cause Analysis in this template. Couple RCA with the investigation of customer complaints, and trace improvement actions from identification to execution.  \nISO 9001:2015  \nExport of  \nNon-conformity Report  \n[www.intland.com](www.intland.com)  \nMedical Audit & CAPA Template  \nCorrective Actions, Preventive Actions  \nProvide your CAPA team with a comprehensive platform to compile action plans for corrective actions based on RCA. Use the Medical Audit & CAPA Template to attach timing and efficiency check results to the original action plans. Record Preventive Actions using preconfigured artifacts to manage improvement potentials. Trace Corrective and Preventive Actions back to non-conformities and improvement potentials, as well as to corresponding audit reports.  \nComplaint Registration, Adverse Incident Reporting  \nUse this template to manage your complaint file compilation repository based on the key requirements of the FDA 21CFR820 .198. Extend investigation records of complaint files to RCA and towards Adverse Incident Reporting. Maintain all Adverse Incident Record documents in this template with optinal FDA 21CFR11-compliant electronic signatures.  \nManagement Review Record  \nRecord management review records by integrating review items including Corrective and Preventive actions, complaint records, and adverse incident reporting. Record and monitor review act","cbCaif3pvsp684XN","https://ap.wps.com/l/cbCaif3pvsp684XN","pdf",1659284,8,"English","# Why use the Medical Audit & CAPA Template?\n## Simplified compliance audits\n## Actionable continuous improvement\n## Integrated quality and regulatory management\n# Capabilities of the Medical Audit & CAPA Template\n## All-in-one audit management lifecycle\n## Non-conformity and improvement management\n## Root cause analysis\n## Export of non-conformity report\n## Corrective and preventive actions\n## Complaint registration and adverse incident reporting\n## Management review record","[{\"question\":\"What compliance standards does the Medical Audit \\u0026 CAPA Template support?\",\"answer\":\"It provides compliance support for ISO 13485:2016 and FDA Title 21 CFR Part 820.\"},{\"question\":\"How does the template help prepare and execute medical compliance audits?\",\"answer\":\"It enables planning and scheduling audits, building actionable audit checklists, executing audits in a central quality control platform, and recording audit evidence with traceability.\"},{\"question\":\"How are CAPA activities managed in the template?\",\"answer\":\"Corrective actions are compiled as action plans based on RCA, with timing and efficiency results attached, while preventive actions are recorded via preconfigured artifacts and traced back to non-conformities, improvement potentials, and audit reports.\"}]","Medical Audit & CAPA Template - Comprehensive Compliance Audit and CAPA Management | PDF",1789216835]