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    What is Corrective Action and Preventive Action, CAPA FDA
    Author: Freyr Solutions
    Website: https://www.freyrsolutions.com/blog/effective-regulatory-strategies-for-medical-devices-registration
    Added: Thu, 17 Jun 2021 13:13:22 +0000
    Category: Health
    Printable version | Email | Bookmark

    Corrective Action Preventive Action (CAPA) is an approach used to investigate and resolve quality issues along with identifying their causes. It was introduced as a result of Food and Drug Administration’s (FDA) requirement under FDA 21 CFR 820.100. The CAPA mainly consists of two functions:

    Corrective Action – The goal of Corrective Action is to identify the root cause of the product and quality problems and take appropriate action against them. This includes:
    Review and definition of a problem
    Identification of the root cause of a problem
    Development of action plan for correction and prevention
    Implementation of the plan
    Evaluation of the plan efficiency
    Preventive Action – The goal of Preventive Action is to prevent the problem from recurring in the near future. This includes:
    Identification of potential problems
    Identification of root cause of the problem
    Development of recurrence prevention plan
    Implementation of the plan
    Review of effectiveness of actions taken for prevention
    CAPA and The Procedures
    To implement an effective CAPA plan, the following steps must be followed:

    Identify potential problems related to quality, product or non-conformity
    Evaluate the seriousness of the problem and how it would impact the business
    Evaluate the available procedures for investigation
    Analyze the problem with accurate data
    Create an action plan that addresses all the problems and solutions to prevent them
    Implement the plan
    Perform regular follow-ups to ensure the effectiveness of the solutions
    A CAPA plan is necessary to ensure problems and non-conformity are reported and prevented in stipulated time. To know more about how to streamline CAPA procedures and other robust quality solutions, reach out to Freyr at sales@freyrsolutions.com.

    View all Freyr Solutions's articles


    About the Author:
    This article talks about the effective regulatory strategies for Medical Devices registration across the globe.

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