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Corrective Action Preventive Action (CAPA) Plan

A corrective action preventive action plan is essential to any company that is expected to meet all CAPA requirements as outlined in the 21 CFR 820.100 and 21 CFR 211.180 regulations and in ISO 8402. A corrective action plan is a strategy for correcting or eliminating a problem that has already occurred or been identified (as opposed to a preventive action plan which defines the steps taken to eliminate the root cause of a problem to prevent it from recurring ). It is important to establish a corrective action preventive action plan throughout your organization because correcting and preventing SOP problems early will cost significantly less than fixing them later. To learn more about CAPA plans and the steps you can take to establish a successful CAPA plan in your company, please watch or download the information provided below about the benefits of implementing an effective CAPA system.

Watch Videos: Learn More About CAPA Plans

Download Free Corrective Action Preventive Action Resources

Educational Materials

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

Product Data Sheets
White Papers
  • 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.
  • 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.
Product Data Sheets
  • 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.

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
  • 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
  • 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.

Why You Need a Corrective Action Preventive Action Plan to Meet CAPA Standards

An effective corrective action preventive action plan requires a high level of accuracy and flexibility. Because of the rigorous regulatory requirements that exist in the life science industries, implementing an efficient CAPA plan sooner rather than later is recommend to avoid regulatory discipline. The consistent use of a comprehensive CAPA system, which includes a corrective action plan, is the cornerstone of a company's cost reduction and process improvement efforts. Organizations who fail to implement and follow effective CAPA plans are often the recipients of CAPA warnings, ISO audits, and FDA investigations.

How Automated CAPA Plans Effectively Achieve Corrective and Preventive Action Compliance

An automated corrective and preventive action plan system like MasterControl CAPA includes electronic forms for implementing a corrective action plan, and is designed specifically to automate the manual processes regularly used to resolve CAPA issues. By instituting a uniform method for investigating problems, including a solid process for verifying and validating corrective actions, your organization can avoid "death by CAPA" and significantly reduce its open CAPAs.

MasterControl's electronic CAPA plan software is an integral component of the MasterControl quality management system (QMS) suite - the first software of its kind to enable FDA-regulated industries to comply with 21 CFR Part 11 and meet FDA GMP, GLP, and GCP requirements.

MasterControl CAPA Helps Companies Worldwide Establish an Effective CAPA Plan

Customer like MasterControl CAPA plan software because it's a configurable, off-the-shelf solution that can be installed, implemented, and validated quickly for faster CAPA compliance. Our CAPA solution eases your regulatory burdens by helping you understand and simplify Part 11 and other complex compliance requirements. We've helped regulated manufacturers around the world automate their corrective action and preventive action plans to achieve 21 CFR Part 11 compliance. We can help you, too.