Currently there is tremendous growth in the medical device development industry. 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 system
- Recognizing 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. Companies need to identify the data sources they will use to identify existing problems as well as potential problems.
In CAPA management system data is examined on a regular basis. At the very least, companies should use a suitable scientific method of analysis. Trending should be done at least quarterly to be useful. In many cases, trending should be done more frequently, such as on a monthly or daily basis.
For a CAPA system to work on a timely basis it is important that the executives do act promptly and appropriately. The safety of patients must always be the primary concern.
Orcanos solution warrantees successful medical device auditing and regulatory compliance through process automation tools. Orcanos is an Israeli software vendor that provides Orcanos Medical software solutions for regulatory compliance and safety traceability and is designed for medical device manufacturers.
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