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Meeting The Day-to-Day Challenges in an FDA-Regulated Environment

It may sound trite, but a quality organization must meet the demands set for a quality organization every day. Those of us facing this reality may give a knowing nod and smile upon hearing this obvious fact. Those working at some distance from it may think the statement is just another attempt by the Quality Assurance Unit to blow its own horn. This is a problem, because it is not the Quality Assurance Unit (QAU) that makes a quality organization. Rather, it is management’s commitment to and involvement in quality that rolls everyone up into the quality organization, including of course those identified as working in the QAU.

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