CAPA signifies Corrective and Preventive Action which is an integral part of quality management and also plays an important role in documenting actions which is taken to avoid issues before they arise. Qualityze CAPA management software easily categorize the action plans as correction, corrective, preventive or the risk based. This software also tracks and manages CAPA plans, verifies effectiveness over the time and integrates with the related quality processes that includes change control and training.
Qualityze is been designed in adherence with the industry standards and also the best practices which is defined by the regulatory authorities that includes 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 the Qualityze is designed with an implementation task to help creating action plans which can eliminate or minimize the cause of the quality issue. This software also provides the multiple investigation tools, including five whys. CAPA management software system of Qualityze allows users to create and track workflows and other documentation with extensive flexibility in defining every step in CAPA.
CAPA management software offers the visibility into critical product quality characteristics, failures and also the resolutions to all those issues for a smarter decision across the global and extended enterprise. It is suggested to select the best corrective and preventive action CAPA software named as Qualityze which enables you to recognize and overcome product quality issues and also facilitates continuous improvement.
One of the best and most accurate way to implement CAPA management system is with Qualityze CAPA management software. That means, in this technical era, having a software system which has an inbuilt robust CAPA management workflow integration is the best solution to prevent recurrence of the issues. By using this Qualityze CAPA management software to fit your exact needs and to manage entire CAPA management process from initiation to post-implementation of corrective actions.
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.
