INSTRUMENT AND TEST METHOD VALIDATION - PowerPoint PPT Presentation

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instrument and test method validation n.
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INSTRUMENT AND TEST METHOD VALIDATION

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

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

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

  4. 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

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