Method Validation, Fitness for purpose of analytical methods Part-1

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What is Analytical method validation?
What is different between Method Validation and verification?
Why Method Validation necessary?
When should methods be validated or verified?
How should method be validate?

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Simple and concise, it tackles the whole viewpoint of ISO med lab practice... Scientifically, practically concise and accurate validation method-I am making use of Westgard Quality Control Validator /Calculator- regression statistics/bias/cv%/ CLIA TAe/Sigmametrics/MOU/... Instruments in our JPC lab has built - in robust intrinsic MOU- measurement of uncertainty, the traceability, estimate using RMSE/ the repeatability--getting the SD in the very day... Thanks for New Extended QC troubleshooting software, RMSE-root mean squared error alerting Total error, inaccuracyI precision - RE/(cv%) ;SE/(bias/TE), thus QC troubleshooting, if out of range- repeat the control process, if still out of range-repeat with a new control, verify the process of handling and mixing the viaks;if a parameter has bias or systematic error, verify the calibration;and if there is random error or imorecision verify the reproducibility using a patient sample, if it fails call the engineer... XB Analysis if enabled, the weighted moving average of freshly drawn blood samples serves as most appropriate QC material, as the analyzer is considered to be in control when the 3 parameters of MCV MCH MCHC are within the 3%of the expected mean indices of 20 samples, these RBC parameters are fairly stable and thus target or mean values reflecting entire patient population of the lab... The best policy we can ever adopt is this, in the years to come, (in the standpoint of being a senior laboratorian) - - - - All the QC Regulatory Body, such as CLIA, Ricos, Rilibak, CAP- meet a unified consortium of TAe- most medically be-fitted %requirement for all lab analytes, that can really standardized the Rules of Quality Control.... Within this precept, medical decision limits, globally taken standard ADA strict 5.85 mmol/L glucose level is at risk for DM.... STANDARDIZATION IS not an option, it is a strict obligation for all scientific personnel to PLAN, to ACT and to DO, an ever cyclical biorythmic clock of our beings... Thanks

honorinanuguid

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