Laboratory compliance in the life sciences industry is crucial as it directly impacts patient safety, product quality, and data integrity. Pharmaceuticals, medical devices, diagnostics, and biotech firms are subject to strict regulations, including the FDA’s Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), 21 CFR Part 11 (Electronic Records; Electronic Signatures), and the Clinical Laboratory Improvement Amendments (CLIA). These regulations create a framework that ensures operational excellence, covering aspects such as sample management, instrument compliance, personnel training, and adherence to standard operating procedures.
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