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Corrective and Preventive Action (CAPA)

The FDA mandates that each medical device manufacturer establish and maintain a corrective and preventive action (CAPA) process, whose goal is to analyze sources of information about a non-conforming product, then implement actions that address the causes of non-conforming product and prevent them from adversely affecting the customer.

The CAPA process is one of the core processes that exist within the quality system of each medical device company. The FDA mandates that medical device companies analyze quality audit reports, work operations, returned products, service records, concessions, processes, and other sources of quality data (here's more on what qualifies), and work to discover the root causes of non-conforming product. Once causes are identified, companies should determine how to address the problem, verify or validate the solution, implement the needed changes, and report changes along with other relevant changes for management review. The CAPA process ensures that medical device companies are managing risk as part of an ongoing process that exists throughout the product life cycle.

Greenlight Guru’s QMS Software Supports An Effective And Compliant CAPA Process

Greenlight Guru's QMS Software effectively supports the CAPA process at medical device companies across the United States by providing an integrated, high visibility platform that increases transparency throughout your organization and addresses some of the key issues with CAPA execution:

Greenlight Guru Promotes Cross-Functional CAPA Teams - Who determines when a customer complaint becomes a CAPA issue? Usually, it's your quality team that holds the keys to CAPA - they review the quality data, they decide when a complaint is elevated to a CAPA issue - but is that really the best way? To best understand why complaints are happening, you'll need a cross-functional group that includes team members from engineering, manufacturing, supply chain, and other departments (and they'll need to understand what should really trigger a CAPA). Greenlight Guru's QMS Software helps you manage document sharing across departments, keeping everyone on the same page about the most pressing issues facing your cross-functional CAPA management team.

Greenlight Guru Supports a Well-Defined CAPA Process - Throughout all FDA quality audits from 2010 to present, the number one violation discovered by inspectors was a poorly defined CAPA process. Outlining a clear process for assessing and triggering a CAPA request is vital to the efficiency of your CAPA process (we outlined a great methodology here, so feel free to copy), and standardizing the process across your organization helps ensure that you're not letting recurrent quality issues slip through the cracks. Greenlight Guru is the perfect place to safeguard your documented CAPA process where everyone in your organization can access and review it.

Greenlight Guru Helps Manage CAPA Documentation - The CAPA process is the heart and soul of your medical device company's QMS - after all, what's the point of a quality system if there's no process in place for correcting and preventing quality problems? CAPA generates a huge amount of paperwork - data from processes, work operations, quality audit reports, customer complaints and service records, meeting notes, CAPA forms, root cause analysis documents, and more. Subpart J of 21 CFR Part 820 even says that all activities required as part of CAPA, and their results, shall be documented! Greenlight Guru QMS Software makes it easy to assign case numbers to each CAPA investigation, keeping your documents organized and accessible for approval and review as you investigate potential CAPA events.

As with all quality processes, establishing and documenting policies and procedures early and often is the best way to stay organized and effectively implement the CAPA process at your organization.

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Looking for an all-in-one QMS solution to advance the success of your in-market devices and integrates your quality processes with product development efforts? Click here to take a quick tour of Greenlight Guru's Medical Device QMS software →


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