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A quality audit systematically examines a company's quality management system (QMS). It ensures processes and ...

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When the FDA inspector finds gaps in compliance during an inspection, it sends an FDA Form 483—a formal warnin...

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Every process update, SOP revision, or system patch carries hidden risks—and without a formal, risk-based fram...

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Lengthy, paper-driven CAPA cycles steal precious engineering hours, frustrate regulators, and allow the same d...

From the raw materials at the loading bay to cutting-edge non-destructive tests, every inspection plays a uniq...

In a sector guided by life-critical choices and international public eye, GxP compliance in pharma is the corn...

The importance of GMP medical devices cannot be overstated: They save lives, prioritizing health and well-bein...