Corrective Action (CAPA) Tracking Software Systems
MasterControl's Corrective Action (CAPA) Tracking Software Systems Automate CAPA Processes
For any company doing business in a regulatory environment, the capability to apply and track corrective actions and preventive actions (CAPAs) is crucial to maintaining a compliant quality system. Efforts across the enterprise to investigate, fix, and track quality issues in order to prevent recurrence is also a major component of managing and controlling overall product quality. When properly implemented, corrective action (CAPA) tracking software systems offer valuable tools for enhancing product quality, increasing fulfillment, and perhaps most importantly, ensuring compliance with regulatory standards such as those outlined by the FDA and ISO.
How Can A CAPA Tracking Software System Benefit Your Company?
There is a wide variety of corrective action tracking systems available on the market with varying degrees of specialization designed to meet your organization's needs. MasterControl CAPA™ is a well established, user friendly system that has been specifically engineered to effectively manage corrective action tracking processes and integrate them with other business processes critical to regulatory compliance, such as audits, change control, nonconformance, and customer complaints. The MasterControl CAPA software helps customers overcome some of the CAPA difficulties that companies typically encounter.
Corrective Action Tracking Software Addresses Challenges Your Company May Be Facing
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 CAPA 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).
What to Expect Out of a Suitable Corrective Action Tracking Software System
Here are some examples how the MasterControl CAPA tracking software let customers streamline processes:
The MasterControl CAPA tracking software system 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 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 software 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.
The Bottom Line: CAPA Tracking Software Systems Save Time and Money
CAPA tracking software systems should at very least give an organization increased efficiency and cost savings through automation. By automating all tasks pertaining to each corrective action--including notification, follow-up, and escalation of overdue assignments--MasterControl gives companies the tools they need to make CAPA processes more efficient. Automation also makes the compliance environment less complicated, thereby making it easier for companies to establish compliance and maintain it through the passage of time.
Contact MasterControl Today for Information on CAPA Tracking Software Systems
To learn more about our corrective action tracking software 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.