CAPA - Corrective Action Preventive Action

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.


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Product Information

Discover how MasterControl CAPA Software can manage your CAPA process, all while mitigating risk, improving speed-to-market, and generating ROI.

Product Data Sheets
Product Data Sheets
  • Avoid 'death by CAPA' and learn about how MasterControl CAPA software automates, streamlines and manages not only all CAPA-related documentation and activities, but also the documents and tasks of other quality processes.
  • In this FDA-approved workshop you will learn root cause analysis (RCA), risk based issue review and quality event management (QEM) methodologies, which are critical when implementing CAPAs.
Product Data Sheets
Q&A's
  • Learn from QMS/CAPA guru Ken Peterson about how good event management is essential to a reliable QMS that can withstand the toughest regulatory scrutiny.

Toolkits & Demos

Get in-depth, comprehensive resources to guide development of your CAPA program

Product Data Sheets
Interactive and Live Demonstrations
  • The MasterControl quality management system (QMS) delivers a wide range of software solutions for quality management, document control, product lifecycle management, supplier management, audit management, training management, and more based on your business needs. This overview demonstration shows how MasterControl's QMS eliminates waste, simplifies audits, and facilitates compliance with regulatory guidelines.
Product Data Sheets
Toolkits
  • Tailored specifically for Quality Managers. Find out how closed-loop quality management can help you connect people, processes, and data across the value chain. Includes: 4 webinars, 3 white papers and much more.

Educational Materials

Get insider information about the most relevant issues in CAPA today, and how to navigate and overcome the complexities of FDA and ISO Compliance.

Product Data Sheets
White Papers
  • Medical device manufacturers are seeing increased warning letters, resulting in supply chain delays and even plant closures. CAPA guru Ken Peterson shows you how to kick-start your CAPA process and keep the FDA off the radar screen.
  • Learn how to identify, correct and prevent problems that plague weak CAPA systems as well a seven distinct procedures that can insure compliance with FDA and ISO requirements.
  • Learn why the FDA, ISO and other regulatory agencies place so much emphasis on CAPA and closely scrutinize the amount of open CAPAs an organization has. Also examine the pros and pitfalls of three different approaches to CAPA management.
Product Data Sheets
Webinars
  • Learn the number one item cited by the FDA in 483s and warning letters. And why poor investigation techniques only identify superficial symptoms rather than root cases.


Why is a Corrective Action Preventive Action (CAPA) System Important?


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.


CAPA Software from MasterControl


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:

  • Automated routing, notification, approval, and escalation
  • Form-to-form launching
  • Advanced CAPA task tracking
  • Superior reporting and analytics capabilities
  • Web-based system provides easy access to authorized users
  • Central and secure repository for all documentation related to CAPA
  • Best-practice electronic forms
  • Best-practice workflow routes
  • User-friendly CAPA forms
  • Integration with other applications

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.


Benefits of MasterControl CAPA for Corrective Preventive Action


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


To Learn More About Corrective Action Preventive Action contact a MasterControl representative.

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