When manufacturers capitalize on CAPA processes, they see vast improvements in process performance. An effective CAPA system is not only vital to compliance with regulations like the FDA’s QSR and ISO 13485 – it also is a key practice in
achieving good product quality. Yet corrective and preventive action failures are the most frequently cited problem by FDA officials for medical device companies, accounting for 21% of all observations noted during inspections in 2005.
And with industry giants receiving FDA injunctions for their inadequate CAPA processes, it seems that no one is invulnerable. By implementing these key strategies, your
company can avoid regulatory sanctions and reap the benefits of a streamlined CAPA system.
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