CAPA Management System

MasterControl Offers CAPA Management System 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 systems can enhance product quality and safety, increase customer satisfaction, and most importantly, ensure compliance with regulatory standards.

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Data Sheet: MasterControl CAPA
Industry Brief: The 4 Phases of CAPA Maturity: A Guide to Mastering Quality Event Management Industry Brief: Simplify CAPA in 7 Steps

How can MasterControl CAPA Management System Benefit You?

CAPA management 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:	Here are some of the ways that top-of-the-line CAPA management systems are helping companies overcome such challenges:
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.	MasterControl CAPA management 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.
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.	MasterControl CAPA management 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.
As happens all too frequently with limited CAPA management 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.	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 a CAPA Management System

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 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 system. They should be able to complete forms offline and then upload.
Integration Potential

The CAPA management 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, your CAPA management 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 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 system should also offer customizable reports for issue review, problem prevention, etc.

The Last Word on CAPA Management Systems

At very least, CAPA management 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.

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