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A Good Clinical Practice Quality Management System (GCP QMS) is a structured framework that ensures sponsor companies maintain compliance with global regulatory standards throughout a clinical trial's lifecycle. Regulatory bodies such as the FDA (U.S. Food and Drug Administration), ICH (International Council for Harmonisation), and EMA (European Medicines Agency) emphasize the critical role of a robust QMS in safeguarding subject safety, data integrity, and ethical conduct in clinical research.
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