INSTRUMENT AND TEST METHOD VALIDATION DR DEEPAK SANGHAVI DOCTOR INCHARGE IMMUNOCHEMISTRY METROPOLIS HEALTHCARE LTD.

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Presentation transcript:

INSTRUMENT AND TEST METHOD VALIDATION DR DEEPAK SANGHAVI DOCTOR INCHARGE IMMUNOCHEMISTRY METROPOLIS HEALTHCARE LTD

INSTRUMENT INSTALLATION QUALIFICATION (IQ) DONE BY COMPANY ENGINEERS SPACE ELECTRICITY POINTS VOLTAGES KITS AVAILBLITY CERTIFICATE CE APPROVED

OPERATIONAL QUALIFICATION (PQ) DONE BY ENGINEERS WITH HELP OF TECHINICANS WATER QUALITY CUVETTES TEMPERATURE SOFTWARE CHECK

PERFORMANCE QUALIFICATION (PQ) DONE BY TECHINICANS CALIBRATION CONTROL RUNNING OF TEST VALIDATION OF TEST RESULTS QC CHECK VALIDATION DONE BY QA DEPT AND DIRECTOR OF LAB

TEST METHOD VAILDATION ACCURACY – BIAS % PRECISION – Cv % Intraassay Interassay Reproducilblity RANGE LIMIT OF DETECTION LINEARITY SPECIFICITY ROBUSTENESS

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