The best CAPA management software should offer reporting and analytics features to generate insights and track key performance indicators (KPIs). Customizable reports and dashboards should provide a clear overview of CAPA status, trends, and metrics, aiding in decision-making and continuous improvement. Implementing a Qualityze CAPA management software solution can bring several benefits to an organization. This software helps streamline and automate the entire CAPA process, from issue identification to resolution. It centralizes data, automates workflows, and assigns tasks, ensuring that CAPA activities are managed efficiently and completed in a timely manner.
Qualityze CAPA software empowers organizations to efficiently manage and resolve issues, enhance quality processes, comply with regulations, and drive continuous improvement. It helps organizations maintain customer satisfaction, reduce costs associated with poor quality, and foster a culture of excellence. This software collectively enable organizations to effectively manage the CAPA process, identify and address issues, promote continuous improvement, ensure compliance, and enhance overall quality management.
Qualityze CAPA management software promotes collaboration and communication among team members involved in the CAPA process. It allows for centralized data sharing, real-time updates, notifications, and comments. This collaborative approach facilitates effective problem-solving, decision-making, and accountability.
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.
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