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The abbreviation CAPA stands for “corrective action and preventive action”. In 21 CFR Part 820.100, FDA mandates that every medical device manufacturer establish and maintain CAPA procedures to address systemic or highly critical issues in their quality system.
While nonconforming product is often the issue that will trigger a CAPA, there are many different types of CAPAs, and your procedures should help identify CAPA-worthy issues from a variety of sources.
The CAPA process is one of the core processes that exist within the quality system of each medical device company.
The purpose of the CAPA process is to detect and investigate existing and potential causes of nonconforming product and other quality problems, and then implement and verify corrective or preventive actions. The actions taken should prevent the occurrence or recurrence of the nonconformance or quality issue.
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, and work to identify the root causes of nonconformances or other quality issues that qualify for a CAPA. Once causes are identified, the company must determine how to address the problem, implement the solution, and verify its effectiveness. Each step in the CAPA process must also be thoroughly documented.
Greenlight Guru's QMS Software effectively supports the CAPA process of medical device companies across the world by providing an integrated, high visibility platform that increases transparency throughout organizations and addresses some of the key issues with CAPA execution:
Greenlight Guru enables 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 and decide when a complaint is elevated to a CAPA issue. But is that really the best way?
To really understand why complaints are happening, you 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 CAPA 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 inspections from 2010 to present, the number one violation discovered by inspectors is a poorly defined CAPA process. Outlining a clear process for assessing and triggering a CAPA request is vital to the efficiency of your process.
Standardizing the process across your organization helps ensure that you're not letting recurring 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 - 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 eQMS 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 a CAPA process at your medical device company.
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 →