An organization's corrective action preventive action (CAPA) process is central to all control points. Corrective actions are intended to determine the cause of nonconformances that have been detected, while preventive actions are the plan put in place to stop the problem from happening again in the future. Replacing a paper-based CAPA process with an electronic system is challenging, not to mention connecting it with change control, training and other quality systems. The resources below explain what to look for in an electronic system and how an automated corrective action preventive action system clearly brings great benefits, not only in terms of cost savings but also in terms of product safety and effectiveness.
The methods for dealing with CAPA require a high level of accuracy and flexibility. Rigorous regulatory and traceability requirements exist in industries such as aerospace, automotive, defense, life sciences or any other manufacturing operation. Implementing a corrective preventive action (CAPA) system enterprise-wide using state-of-the-art CAPA software should be an important part of any corporate quality system, regardless of industry.
Corrective action preventive action (CAPA) systems can serve as the cornerstone of Six Sigma, Lean and other cost reduction and process improvement efforts. MasterControl CAPA is software designed specifically to automate the processes for corrective preventive action. MasterControl CAPA is an integral piece of the MasterControl quality management suite. The software was the first software to enable pharmaceutical, biotechnology, medical device and other FDA-regulated industries to comply with 21 CFR Part 11 and meet FDA GMP, GLP and GCP requirements.
The MasterControl CAPA solution for corrective actions is part of the integrated MasterControl GxP process management software solution. The solution for CAPA is designed to automate corrective actions according to regulatory requirements. MasterControl CAPA automates corrective actions such as routing, notification, escalation, and approvals. The entire system for corrective actions is automated by MasterControl, starting with the initiation of corrective actions and the subsequent investigations, all the way through to the closure and resolution of those corrective actions.
Some features and benefits of our software for corrective actions preventive actions include:
Implementing the solution for CAPA from MasterControl drastically cuts the time and resources necessary for validating the software, thanks to MasterControl's unique "continuous validation" capability.
The MasterControl CAPA solution automates the delivery, escalation and approval of CAPAs and other quality-related documentation. MasterControl provides a web-based, centralized repository for documents and powerful search and retrieval functionalities that can be used during inspections and/or audits. MasterControl also integrates CAPA functionality with a complete quality management system. When a CAPA is resolved for example the MasterControl QMS system can automatically trigger an SOP change and once the SOP is revised training tasks can be automatically released to specified employees. MasterControl CAPA forms can also be launched from other forms such as nonconformance or customer complaint forms.
To Learn More About Corrective Action Preventive Action contact a MasterControl representative.