StatSoft AMV Analytical Method Validation

The StatSoft AMV Analytical Method Validation application is used for the statistical evaluation of performance characteristics according to ICH Q2(R2) recommendations. It also allows for comparative analysis of two sets of results obtained during method transfer between laboratories, implementing changes in the method, or comparing two alternative methods. Additionally, it supports comparative analysis of simple linear regressions obtained during, for instance, the verification of calibration curve equivalency. The software has been validated according to cGMP requirements.

Main functionalities: Defining the objective, description, and study context Saving/opening raw data in Excel or Statistica format Selecting performance characteristics and statistical data analysis methods Generating reports in Word or PDF format, including English-language options Saving/opening complete studies along with selected settings Repeatability analysis Intermediate precision analysis Accuracy analysis Calibration model analysis Analysis of the lower range limit Group comparison analysis Lines comparison analysis Use case