Medical Device Management & Consulting consulting@regpromedical.com +1 (425) 241 - 3092
RegPro Medical
We know WHAT to do. We do it RIGHT. The FIRST Time.
CAPA Program
The Corrective Actions and Preventive Actions (CAPA) system is essential to maintaining compliance and effectiveness of the quality management system and continuously improving it. External regulatory auditors will scrutinize the CAPA system not only to evaluate individual issues and ensure they were dealt with effectively, but also to ensure that the overall process functions effectively. Some organizations may need assistance upgrading the CAPA process, while others may need support to investigate, analyze, plan, and follow through on specific issues, especially if the issues were identified in a regulatory audit or inspection.
What will RegPro Medical Do?
When you are ready to focus on improvement, RegPro Medical will review your CAPA process end-to-end and help you upgrade it to be more effective and more efficient. When you need a hand with a specific issue, we will be there with expert investigation, root cause analysis, and effective corrective and preventive actions with risk assessment and thorough follow-up and effectiveness check.
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Overall CAPA Process Optimization
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CAPA Investigation / Root Cause Analysis
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CAPA Follow-through and Effectiveness Check
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External Audit CAPA response