Corrective Action (CAPA) Tracking Software

Paper Systems Are Inefficient Time Wasters

Manual and paper-based CAPA tracking systems have no built-in functionality to assist users in tracking and monitoring CAPAs and proactively improving the CAPA process. They are inherently wasteful and time consuming.

Quality Events Have No Connection

A CAPA may be triggered by quality audits, consumer complaints, Form 483 findings, or other similar sources. With a paper-based CAPA process these sources are not integrated, meaning that CAPA data may be incomplete. When quality systems are not connected, critical information is lost and root causes of investigations are undependable.

You Get What You Pay For...Or Worse!

Initially, many organizations mistakenly believe paper-based CAPA tracking systems offer the most affordable option to suit their needs. Take into account, however, the time and resources that are wasted when manually managing and tracking CAPAs. If one compares paper-based systems with the efficiency and reduced waste furnished by automated Corrective Action tracking software the long-term savings far outweigh the value of outdated manual systems. Paper-based systems are inefficient and are the prime culprit for the waste of innumerable man-hours on responsibilities that could otherwise be automated (such as manually routing CAPA tasks and other documentation, chasing down approvers to obtain signatures, and searching for and retrieving binders and folders of necessary documentation during audits or inspections).

The MasterControl CAPA tracking software automates routing, notification, delivery, escalation and approval of CAPAs and all CAPA-related documentation. The entire CAPA lifecycle, from initiation to investigation to closure, is automated and simplified. Also, MasterControl's secure, Web-based repository allows authorized users to access and work on CAPA-related documents from anywhere in the world at their convenience.

MasterControl is useful for tracking all quality incidents that can eventually escalate into a CAPA, such as customer complaints, audit findings, or nonconformances. The MasterControl system offers advanced analytics and extensive reporting functionality, including customizable reports and online charting. Through the reports the system generates, managers can have a real-time view of ongoing CAPA processes and preemptively improve the quality system. In addition, MasterControl effectively maintains links so users can review a completed process and straightforwardly see what events are triggering CAPAs.

MasterControl connects CAPA processes with the rest of the quality system, which results in a holistic, integrated solution. For example, the resolution of a corrective action may automatically trigger a design change that leads to an SOP change, which consequently requires retraining of personnel on the new SOP. An effective corrective action tracking system should be able to seamlessly integrate with other elements of the quality system (training processes, for instance) to form a more effective system in general. A CAPA that causes a change in product design or function should automatically trigger training tasks upon approval of any change.

CAPA managers also need the ability to monitor the entire quality management lifecycle, from input to closure, using practical analytics and reporting tools. Effective software gives users an all-inclusive overview of the quality system. Some beneficial features of the MasterControl CAPA software includes the 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.) come standard with the system. The system also offers customizable reports for such needs as issue review, problem prevention, and so forth.

One certain trait of effective CAPA tracking systems is a "closed loop" design that simplifies business processes, unites quality subsystems, and tracks all quality incidents that could potentially escalate into a CAPA. Customers, vendors, and others outside the company should be able to submit forms from any location with an internet connection (e.g., customer complaint forms or similar product issue reports that could lead to CAPA should be remotely accessible). Remote users should also have the ability to complete forms that are relevant to CAPA processes without being directly connected to the system or they should have an option to complete forms offline and then upload them at a later time.