
Master the five-stage equipment qualification for clinical labs: design qualification, installation qualification, operational qualification, performance qualification, and document qualification. Ensure accurate testing and reliability through proper documentation and quality management.
Learn how to perform operational qualification (OQ) after installation qualification to verify instrument performance against specifications in the user environment, document calibration and test data, and obtain QA approval.
Master performance qualification (PQ) to verify instrument performance under actual conditions. Learn how PQ protocols, acceptance criteria, and documentation ensure ongoing equipment qualification.
Design qualification defines functional and operational specifications and the supplier selection process, forming the basis for installation, operation, and validation, guided by user requirements specification and design and functional specifications.
Explore how static and dynamic equipment documents underpin the quality system in clinical laboratories, detailing IQ, OQ, PQ, change control, and comprehensive maintenance records.
This course will help to understand and and perform the equipment qualification protocol in clinical laboratory. Equipment qualification in laboratory includes design qualification, instillation qualification, operational qualification, performance qualification and document qualification. It also includes the importance of performing equipment qualification. The course is useful not only for biomedical engineers but also for clinical laboratory professional