Equipment Qualification is a comprehensive process to demonstrate and document that all equipment, instruments, and systems used across manufacturing, testing, or quality control are fit for their intended purpose, ensuring they operate accurately and reliably within set specifications. It encompasses installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), assessing equipment installation, functionality, and performance. This critical procedure verifies compliance with regulatory standards, manufacturers’ specifications, and quality requirements, underpinning process control, accuracy, and dependability in production.
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