The FDA recently issued its final guidance intended to help the medical device industry determine applicable requirements for making a change to a medical device manufacturing site.

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Many FDA-regulated manufacturers find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems requiring many hours of work to resolve.

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Corrective and Preventive Action (CAPA) routinely tops the list of most-cited inspectional observations year after year, making it a clear target for investigators. When problems are found in your CAPA program, it can open your broader QMS up to intense scrutiny.

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In FDA-regulated manufacturing, genuine human errors do occur but they’re cited far more frequently than they probably should be.

In truth, most problems that appear to be caused by human error — especially those that occur multiple times — are actually rooted in processes or systems that when left unchanged, will keep producing the problem despite the convenient band-aids often placed over them.

When human error is identified more frequently than it should be expected to happen, it signals to investigators that problems aren’t being internally investigated thoroughly enough. This can quickly shift the investigator into problem-hunting mode and open your quality management system up to even greater scrutiny.

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Poor or outdated systems for managing documents can pose unnecessarily large risks for medical device companies dealing with an already staggering (and increasingly daunting) number of documents each day.

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