Corrective Action Preventive Action (CAPA) Plan

Software Solutions for Corrective Action and Preventive Assure Compliance with 21 CFR Part 11

Unveil the pivotal world of Corrective Action Preventive Action (CAPA) planning, a cornerstone for compliance with rigorous regulations such as 21 CFR Part 11, 21 CFR 820.100, 21 CFR 211.180, and ISO 8402. Our software solution ensures seamless adherence to these standards while efficiently tackling existing issues and preventing their resurgence. Establishing a comprehensive CAPA strategy within your organization proves prudent, safeguarding resources and promoting continual improvement. Experience the efficiency of the automated MasterControl CAPA system, seamlessly integrated within the quality management suite, streamlining corrective action planning and bolstering compliance with FDA requirements. Elevate your CAPA approach with MasterControl, simplifying global compliance and optimizing operational excellence.

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Hundreds of companies around the world use MasterControl to automate core business processes and document management activities to promote collaboration, improve decision making, and accelerate time to market.

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Data Sheet: MasterControl CAPA
Industry Brief: Simplify CAPA in 7 Steps Industry Brief: The 4 Phases of CAPA Maturity: A Guide to Mastering Quality Event Management

Why You Need a CAPA Plan to Meet CAPA Standards

A CAPA 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.

An effective CAPA 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 CAPA 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

Customers 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.