MasterControl Offers CAPA Management Software Systems for Automating Corrective Action Processes in Regulatory Environments
Corrective and preventive action (CAPA) is the core of any quality system. Effective CAPA management is especially crucial for life science companies and other organizations doing business in regulatory environments. The overall effort to investigate and correct quality issues to prevent recurrence is vital not only to achieving regulatory compliance but also to overall product quality. Maintaining compliance with globally recognized regulatory requirements (such as those set forth by the FDA and ISO) are singularly critical to success. When implemented properly, CAPA management software systems can enhance product quality and safety, increase customer satisfaction, and most importantly, ensure compliance with regulatory standards.
How can CAPA Management Software Systems Benefit You?
CAPA management software systems come in many sizes and flavors. MasterControl CAPA™ is a robust, user friendly system designed to effectively manage the corrective action / preventive action process and integrate it with other processes critical to regulatory compliance, such as change control, audit, and customer complaints. MasterControl CAPA software addresses some of the major challenges that organizations are confronted with when establishing effective CAPA processes.
Some of the CAPA management challenges companies face include:
Paper-based and hybrid CAPA management systems may seem inexpensive initially. But compare paper-based systems with the long term effectiveness of proven, automated CAPA management software systems. Paper-based systems are inefficient, requiring tremendous man-hours in terms of routing CAPA tasks and other documentation, obtaining approval and signatures, and manual search and retrieval of documents during audits or inspections.
A CAPA may be triggered by Form 483 findings, ISO quality audits, customer complaints, or another similar source. With manual and hybrid CAPA management software systems, these sources are disconnected, making data collection tedious and often incomplete. Without the proper connectivity, critical information falls through the cracks, and root causes of investigations are likely to be unreliable.
As happens all too frequently with limited CAPA management software systems, poor implementation of CAPA leads to the issuance of a Form 483. These problems often stem from the inability to track and monitor open CAPAs and proactively improve the CAPA process.
Here are some of the ways that top-of-the-line CAPA management software systems are helping companies overcome such challenges:
MasterControl CAPA management software systems automate routing, notification, delivery, escalation and approval of CAPAs and all related documentation. MasterControl automates the management of entire CAPA process, from initiation to investigation and, ultimately, all the way through to closure. It provides a secure, centralized, and Web-based repository for all CAPA-related documents.
MasterControl CAPA management software systems integrate the CAPA process with the rest of the quality system, resulting in a holistic, connected solution. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and retraining of employees on the new SOP.
MasterControl CAPA management software systems track quality incidents that can escalate into a CAPA, such as customer complaints, audit findings, etc. The system provides advanced analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a real-time view of the CAPA process and can be more proactive about improving their quality system. The corrective action management software system available from MasterControl also maintains links so users can review a completed process and easily see what triggered the CAPA.
Features You Should Look for in CAPA Management Software Systems
Best-Practice Forms: Companies subject to regulatory requirements need best-practice electronic forms and workflow routes that can be used as is or customized based on company needs. An "8D" process can guide the quality team through every step of CAPA implementation, from identification of the problem to investigation of root cause through correction of the problem and prevention of reoccurrence.
Connected Quality Processes: Effective CAPA management software systems should be designed as "closed loop" solutions that streamline processes, connect all quality subsystems, and tracking quality incidents that can potentially escalate into a CAPA. Customers, vendors, and others outside the company should be able to submit a form from any location with an internet location. For example, customer complaint forms or product issue reports that could lead to CAPA should be remotely accessible. Off-site and traveling users should also have the capability to complete forms pertaining to the CAPA process without being directly connected to the CAPA management software system. They should be able to complete forms offline and then upload.
Integration Potential: The CAPA management software system should be able to integrate with other elements of the quality system (the training application, for instance) to form a more efficient overall system. A CAPA that causes a change in product design or function should automatically trigger training tasks upon approval of any change. Also, the CAPA management software system should have the ability to automate the distribution and grading of online exams, which can be used as proof of personnel competency during FDA inspections or ISO audits.
Advanced Analytics and Reporting: CAPA coordinators need the ability to monitor the entire quality management lifecycle, from input to closure. An effective CAPA management software system should provide a complete picture of the quality system. The following reporting capabilities should be taken into consideration when shopping for CAPA management software systems: Ability to dynamically capture, trend, and link data needed to solve problems; improvement of quality processes; and viable implementation of effective preventive measures. A variety of reports (issue summary, aging/overdue, cycle time, etc.) should come standard with the system. The CAPA management software system should also offer customizable reports for issue review, problem prevention, etc.
The Last Word on CAPA Management Software Systems
At very least, CAPA management software systems should provide increased efficiency through automation. MasterControl automates all tasks pertaining to each corrective action, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant.
For More Information on CAPA Management Software Systems
To learn more about CAPA management software systems and how MasterControl can help your company achieve the CAPA benchmarks your industry demands contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.
MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.