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Preventive Action Handbook


MasterControl Inc. provides GxP process management software solutions to help FDA and EU regulated companies effectively and efficiently manage preventive action processes with an automated, connected system.

A sound Corrective Action Preventive Action (CAPA) system organizes and evaluates complaints, non-conformances, and other deviations about products and services in an effort to improve the safety and quality of products, customer satisfaction, and regulatory compliance. MasterControl Inc. provides GxP process management software solutions to help FDA and EU regulated companies effectively and efficiently manage preventive action processes with an automated, connected system.

About MasterControl Inc.
MasterControl Inc. is a leading GxP process management software solution provider for life science companies competing within the rigorously regulated FDA and EU environments. MasterControl™ suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practice for automating and connecting every stage of the product development cycle, including the Corrective Action Preventive Action (CAPA) processes. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise.

White Paper Downloads

White Paper Download:
MasterControl CAPA

Product Data Sheet:
Does Your CAPA need a CAPA
White Paper Download:
How to Kick-Start Your CAPA Process



Improve Your Corrective Action Preventive Action (CAPA) System

In the ten years since the FDA released a regulation that required that medical device manufacturers implement a formal CAPA system, compliance still remains a major challenge for many manufacturers. Given the many challenges posed by the CAPA requirement, MasterControl CAPA™ provides the following software solutions:

  • Automates routing, notification, delivery, escalation, and approval of all corrective action preventive action documents.
  • Provides a secure, centralized, and Web-based repository for all CAPA documents.
  • Integrates the preventive action process with the rest of the quality system for a complete and holistic approach.
  • Form-to-form launching allows a CAPA form to be launched directly from another form to avoid mistakes that can occur during re-entry of data.
  • Tracks quality incidents that can escalate to a corrective action preventive action, such as customer complaints, audit finding, etc.
  • Provides advanced analytics and reporting capability, including online charting and customizable reports.
  • Allows managers to have a real-time view of the CAPA process to more proactively improve their quality system.

Learn More
Learn more about MasterControl’s corrective action preventive action software solution, and any of the other GxP process management software applications, at MasterControl’s Education Centre. You can find industry white papers, case studies, tech papers, online demonstrations, and more so you can make the right decisions about regulatory compliance.

Contact MasterControl Today
An effective preventive action process is at the heart of the quality management system in any life science company. To learn more about MasterControl Corrective Action Preventive Action (CAPA) software solutions, contact MasterControl online or call toll free at 1.800.825.9117 to speak with a representative.

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