MasterControl's CAPA Application Provides a Framework for All Stages of the CAPA Process
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.
Overcome These Common CAPA Challenges with MasterControl's CAPA Application
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:
- Disparate systems: It's difficult to achieve compliance with homegrown systems that lack universal application or don't interface with each other. And, unlike an electronic system that utilizes an automated corrective active application, a paper-based system requires tremendous man-hours in terms of routing, obtaining approvals, and searching for and retrieving documents. This not only inhibits the flow of information, but also delays the resolution of quality issues. MasterControl's corrective action application allows you to manage all of your event-related information, such as product nonconformances, deviations, and variances, from a centralized repository, making search and retrieval easy during audits and inspection. And because MasterControl's CAPA application is Web-based, it can connect all employees involved in CAPA from virtually anywhere, which can accelerate CAPA closures and compliance.
- Non-collection of trending data or lack of visibility: Employees working in a paper-based, homegrown, or manual CAPA management system instead of an electronic corrective action application tend to track and trend their own data on their own systems. As a result, management is unable to see the full, company-wide compliance picture in real time. Lacking this vision, key decision-makers are unable to predict and prevent possible deficiencies and meet regulatory standards. MasterControl's CAPA application tracks all routing information and data entered into the electronic form, which allows the key personnel across the company to identify bottlenecks and see and understand the entire sequences of events - making CAPA compliance everyone job's, not just the responsibility of the quality department.
- Poor documentation: Regulatory agencies like the FDA and EMEA require regulated organizations to present a complete and detailed documentation chain to show that its CAPA requirements have been meet. This can be difficult to do without the help of an electronic CAPA application like MasterControl CAPA. Often times, procedures and fixes are not properly documented and required steps are not always completed. MasterControl's corrective action application automates the routing, delivery, escalation, and approval of CAPAs and all related documents. Best practice forms guide the quality team through every step of CAPA implementation and simplify the data entry process. Automatic revision control helps users avoid the use of obsolete data or unapproved process by ensuring that only the latest document version is available.
- Lack of Training: Successful CAPA management doesn't end with the correction or closure of an event. Follow-up training is vital to maintaining compliance. For example, the resolution of a CAPA might trigger an SOP change or design modification that requires the retraining of your workforce about the new policy or process. MasterControl's CAPA application will automatically schedule training tasks upon approval of the change.
Maximize Your CAPA Application Investment with Best Practice CAPA Training
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's Pharmaceutical and Biotechnology CAPA Software
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.