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VALIDAÇÃO, INCERTEZA E
QUALITY CONTROL

 

ConfLab Validation

The ConfLab Validation software performs many calculations, considering different validation parameters, focusing on the compliance of references for method validation and the new ISO 17025: 2017. The idea is that the user only enters with the experimental values and the software, automatically, calculates the parameters, presents the results and allows the printing of a fully customizable validation report, with all the traceability data required by the quality management systems . It is also compatible and meets the requirements of Good Laboratory Practices (GLP). Among the parameters for the Validation of Methods, is highlighted:
  • Precision (Repeatability)
  • Intermediate Precision
  • Accuracy
    • Accuracy with Fortified Samples
    • Accuracy with Use of Reference Material
  • Linearity
    • Homoscedasticity Evaluation
    • Regression of Ordinary Least Squares (MMQO) and Weighted Least Squares Regression (MMQP)
      • General Testing
      • Normality
      • Independence
      • Anova
      • Significance of Intercept
      • Absolute residue
      • Relative residue
      • Outliers (Grubbs by Level)
      • Outliers (Total Grubbs)
      • Accuracy
      • Coefficient of variation
    • Regression of Ordinary Least Squares (MMQO) Versus Regression of Weighted Minimum Least Squares (MMQP)
  • LOD and LOQ
    • Theoretical Calculations - White Sample standard deviations (or lower quantifiable level) - IUPAC / INMETRO
    • Theoretical Calculations - White Sample standard deviations (or lower quantifiable level) - FDA / ANVISA
    • Theoretical Calculations - Standard Deviation of Signal Intercept - FDA / ANVISA
    • Experimental Calculations
  • Matrix Effect
    • Differences Between Calibration Curves
    • Deviations from FMNs
  • Robustness
    • Youden's Test



Validation, uncertainty and quality control
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