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Medical device companies are required to establish and maintain a corrective and preventive actions procedure and policies in accordance with the guidance and regulations set out by the FDA and ISO for medical devices sold in the United States and around the world. The corrective and preventive action form - or CAPA form - is one of the most important tools of the CAPA process.
When a medical device company identifies a non-conformance issue, it must invoke its non-conformance management plan, which requires it to identify the problem, document it, evaluate it, segregate instances of nonconforming product and dispose of it in the most appropriate way. If the evaluation signals to a quality manager that a corrective action could be possible, the issue is escalated using a CAPA form. The CAPA form is the mechanism by which nonconformance issues are initiated into the CAPA process so they can turn into business process improvements.
If done correctly, a single CAPA form can be used to track a nonconformance issue from its initiation into the CAPA process until its resolution. This ensures that all data pertaining to this specific CAPA issue can be accessed and viewed together. The important components of a CAPA form are:
The FDA and authorities that regulate medical device companies around the world require the establishment and maintenance of a CAPA process within a medical device quality management system (QMS). Medical device companies must document all CAPA events, maintaining policies and procedures for implementing CAPA plans and following document control procedures in accordance with international standards and FDA guidelines.
Greenlight Guru's CAPA Management Software is the best way for medical device companies to automate their CAPA processes, streamline compliance, and put their focus squarely on quality by creating a single source of truth and information repository for all CAPA events.
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