The CAPA management system consists of the specific improvements an organization which makes to its processes to eliminate non-conformities. Qualityze CAPA management software has advanced CAPA features that prevent the recurrence of discrepancies, failures and deviations through dashboards which offers a real-time and quick assessment of status of corrective and preventive actions. This software offers you complete flexibility, security and scalability to manage the best CAPA records on a centralized platform. Qualityze CAPA management software further improves accessibility and traceability of records specially for audits and other regulatory inspections.
Qualityze CAPA management software is developed in adherence with industry standards and best practices defined by the regulatory authorities including the Food and Drug Administration (FDA) – 21 CFR Part 820, International Organization for Standardization (ISO) – ISO 9001, ISO 13485 QMS software, Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), China Food and Drug Administration (CFDA), etc.
CAPA management software of Qualityze has an ability to works for all industries that includes Manufacturing, Life Sciences, Pharmaceuticals, Medical Devices, Nutraceuticals, Biologics, Food and Beverages, Automotive, Aerospace, and Defense Logistics, to assess risks and eliminate problems while maintaining compliance with applicable regulatory standards.
CAPA, or “Corrective Action and Preventive Action is a big focus of FDA inspections and ISO audits, so of course you need to ensure your company is on top of it.
Corrective Action and Preventive Action falls under FDA 21 CFR 820.100.
It requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action for CAPA medical device which includes:Analysing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.
Applicable statistical methodology is employed where necessary to detect recurring quality problems.Inspecting the cause of nonconformities relating to product, processes, and the quality systemRecognizing the actions required to correct and prevent recurrence of nonconforming product and other quality issues.Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.Applying and recording changes in methods and procedures needed to correct and prevent identified quality issues.Making certain that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.Evidently there are several important components to CAPA, and they are focus for FDA audits thus it’s a major safety issue to ensure that corrective and preventive actions are taken where essential.
CAPA Management Software is part of your overall Quality Management System (QMS).
The first and most important step in creating any system is to include all regulatory requirements in the firm's standard operating procedures (SOPs).Proper data sources are critical to a CAPA system.
