The ConfLab Validation software performs numerous calculations across different parameters, focusing on compliance with guides and standards for method validation, and was developed with emphasis on the new ISO 17025:2017. The idea is that the user only enters the experimental values and the software automatically calculates the parameters, presents the results, and allows printing of a fully customizable validation report with all traceability data required by quality management systems. It is also compliant with Good Laboratory Practice (GLP). Among the parameters for Method Validation, the highlights are:

• Precision (Repeatability)
• Intermediate Precision
• Accuracy
  • Accuracy with Spiked Samples
  • Accuracy with Use of Reference Material
• Linearity
  • Assessment of Homoscedasticity
  • Ordinary Least Squares (OLS) and Weighted Least Squares (WLS) Regression
    • General Tests
    • Normality
    • Independence
    • ANOVA
    • Intercept Significance
    • Absolute Residuals
    • Relative Residuals
    • Outliers (Grubbs by Level)
    • Outliers (Grubbs total)
    • Accuracy
    • Coefficient of Variation
  • Ordinary Least Squares (OLS) Versus Weighted Least Squares (WLS) Regression
• LOD and LOQ
  • Theoretical Calculations - Standard Deviations of Blank Sample (or lowest quantifiable level) - IUPAC/INMETRO
  • Theoretical Calculations - Standard Deviations of Blank Sample (or lowest quantifiable level) - FDA/ANVISA
  • Theoretical Calculations - Standard Deviation of Signal Intercept - FDA/ANVISA
  • Experimental Calculations
• Matrix Effect
  • Differences Between Calibration Curves
  • Relative Deviations to FMNs
• Robustness
  • Youden Test