MasterControl's CAPA Systems are designed by industry practitioners for automating the Corrective and Preventive Action (CAPA) process in any organization. A CAPA software system is the crux of any quality and compliance process. It is a regulatory requirement that FDA / global regulatory inspectors and ISO auditors consider critical. An automated CAPA system reduces audit time and findings, and a decreases risk of product recalls. It improves product quality and safety, increases customer satisfaction, and ensures FDA and ISO compliance.
MasterControl's Corrective Action software is a robust, easy-to-use system designed to effectively manage the corrective action / preventive action process and integrate it with other quality processes critical to regulatory compliance, such as change control, audit, and customer complaints. Here's how the CAPA systems from MasterControl addresses some of the major challenges that companies face in establishing and maintaining effective corrective action and preventive action processes:
Paper-based and hybrid systems for Corrective Action and Preventive Action are inexpensive initially. In the long term, however, these 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 inspections and audits.
The MasterControl Corrective Action system automates routing, notification, delivery, escalation and approval of CAPAs and all related documentation. It automates management of entire CAPA process, from initiation to investigation and all the way through closure. Provides a secure, centralized, and Web-based repository for all CAPA documents.
A CAPA may be triggered by Form 483 findings, ISO quality audits, customer complaints, or some other source. With manual and hybrid systems, these sources are not connected, making data collection slow and incomplete. Without connectivity, critical information may fall through the cracks, and the root cause investigation is likely to be unreliable.
The MasterControl Corrective Action software integrates the corrective action and preventive action processes with the rest of the quality system for a holistic approach. For example, the resolution of a corrective action will trigger an engineering change, an SOP change, and retraining of employees on the new SOP.
When customer complaints, deviations, adverse events, and other incidents that can trigger a Corrective Action and Preventive Action are collected manually, there's no guarantee that all critical information will be captured because it is easy to misplace (and time-consuming to update) paper reports. A hybrid system requires re-entering data from hard copy into an electronic system, a process prone to delay and mistakes.
With the MasterControl CAPA software, a CAPA form can be launched directly from another form (i.e., customer complaint, etc.) to streamline the CAPA process and avoid mistakes during re-entry of data. Links are maintained so users can review a completed process and easily see what triggered the CAPA.
Poor implementation of CAPA systems a top reason for issuance of a Form 483) may stem from the lack of ability to track and monitor open CAPAs and proactively improve the CAPA process.
The MasterControl Corrective Action software tracks 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.
Here's a summary of the MasterControl Corrective Action (CAPA) software system and its powerful features:
Best-Practice Forms: MasterControl's Corrective Action System provides best-practice electronic forms and workflow routes that can be used as is or customized based on a company's needs. The CAPA software solution includes:
Connected Quality Processes: MasterControl CAPA software is designed as a "closed loop" solution, streamlining processes, interconnecting different quality subsystems, and tracking quality incidents that can escalate into a CAPA. For example:
Advanced Analytics and Reporting: With MasterControl, CAPA coordinators can monitor the entire quality management lifecycle, from input to closure. They will get a complete picture of the quality system with the help of the following reporting capabilities:
For additional details about the CAPA Management Software Systems from MasterControl, please feel free to contact a MasterControl representative.