A company's corrective action preventive action (CAPA) process, which focuses on the systemic investigation of discrepancies (failures and/or deviations) in a quality management system (QMS) to prevent them from recurring, is of paramount importance to the FDA, EMEA, and other global regulatory agencies. Regulated organizations, particularly those in the life science industry, are constantly being asked to focus on quality and, at the same time, increase product efficiencies and lower cost. MasterControl's CAPA application software program is a powerful tool that companies in compliance-centric industry segments can use to propel their continuous quality improvement efforts.
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Why use an automated corrective action application? According to the FDA, more than 50 percent of the top 10 FDA 483s are CAPA related. Relying on disconnected pen-and-paper processes to track and monitor CAPA events, whether triggered by 483s, audit findings, customer complaints, or some other source, is ineffective, as managers are unable to see the big compliance picture. Successful corrective action and prevention action management requires powerful collaboration tools that can be accessed across departments and/or geographical divisions. Fortunately, MasterControl's CAPA application software program is an easy-to-use, closed-loop corrective action application designed to automate and effectively manage the entire CAPA process - from event initiation to closure - and assist regulated industries in maintaining FDA and ISO compliance. What's more, MasterControl CAPA™ seamlessly integrates with other quality processes, such as change control, audit, training, nonconformance, and customer compliance for holistic quality management across the enterprise.
Effective CAPA management is more than just an important regulatory requirement; it's a smart business practice. When combined with a robust CAPA application like MasterControl CAPA, a strong corrective action and preventive action program can not only reduce liability and losses, but also improve customer satisfaction, increase productivity, enhance brand equity, and, in many cases, yield greater profits. That said, there are many obstacles an organization must overcome to achieve continuous CAPA improvement and compliance including:
CAPA is a complex process, but a robust corrective action application like MasterControl CAPA can greatly streamline your corrective action preventive action efforts. Still, even the most advanced corrective action application will be compromised by poor quality processes. MasterControl's Quality and Compliance Consulting Team, consisting of highly experienced QMS lead auditors, provides the education and consulting services regulated organizations need to develop, implement, and maintain their quality management process, including CAPA. Because our education and consulting services are driven by industry best practices, and are not software specific, any organization - with or without an electronic QMS - can benefit from these services. However, if you are planning to implement an electronic CAPA application in the near future, CAPA management training with MasterControl's Quality and Compliance Consulting Team can help you realize software ROI faster.
To learn more about MasterControl CAPA™ or our CAPA training and consulting services, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.