![]() ![]() At a basic level CAPA requires organizations to identify the nonconformity, determine the root cause and create a plan and implement that plan into action to fix the issue. Since the FDA cannot be at every facility every day, they need a system in place that supports continuous self- improvement. And that is often a function of a poor set of risk filters built into the process.ĬAPA is in place to help the FDA regulate medical device manufacturing facilities. ![]() But where many CAPA processes lose steam is in either over or under responding. Following a set problem-solving procedures ensures that critical elements and resources will not be lost and wasted along the way.
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