The program is used to carry out an assessment of the validation characteristics of analytical methods in accordance with ICH Q2 (R1) and CLSI EP15-A3 as a within-laboratory study and according to standard ISO 5725 a inter-laboratory study. The software consists of 7 modules.
Basic module functions:
- Module PRECISION is used to perform the analysis of method precision (instrument, repeatability and/or intermediate precision) based on the value of the response of the instrument and/or the value of the method for different concentration levels and groups in accordance with ICH Q2 (R1).
- Module ACCURACY is used to perform the analysis of method accuracy based on the declared value and the measured value in accordance with ICH Q2 (R1).
- Module LINEARITY/CALIBRATION is used to perform the analysis of linearity/calibration based on the declared value and the value of the response of the instrument or the method in accordance with their Q2 (R1).
- Module LOQ/LOD is used to carry out the analysis of the limit of detection and quantitation based on the value of the blank or calibration curve in accordance with their Q2 (R1).
- Module GROUPS COMPARISON is used to carry out a comparative analysis of two groups of results obtained during the transfer method transfer between laboratories, before/after making changes in the method or a comparison of two alternative methods.
- Module REGRESSION CURVE COMPARISON is used to carry out a comparative analysis of simple linear regression obtained when verification of the equivalence of calibration curves.
- Module ACCURACY acc. to ISO 5725 is used to perform the analysis of accuracy (trueness and precision) and estimation of the uncertainty of measurement method based on the inter laboratory study.
- Configuration of the contents of a report with a choice of a range of statistical analysis and analyses criteria
- Generation of reports in PDF/Word, including the English version
- Creation of standardized templates that contain configured range of statistical analysis
- Option: storing data in the database with audit trail
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Process development, validation, verification. Module 3: Process validation