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InterVAL - Software for In-House Validation
InterVAL is a program that ensures a comprehensive, legally compliant validation of your in-house method, thus meeting the requirements of ISO / IEC 17025. Developed by QuoData, the underlying concept has already been incorporated into European legislation (Commission Decision 657/2002) and is recommended by the European Reference Laboratory (EURL) in Berlin.
InterVAL increases the efficiency and reduces the costs of your validation study. The study is designed in such a way that precision, trueness, sensitivity and measurement uncertainty are determined simultaneously.
Matrix and sampling effects are determined with no need for further analysis thanks to optimized orthogonal-factorial experimental designs.
Up to eight factors (noise factors) can be examined. The experimental designs allow investigation of robustness and determination of the in-house reproducibility standard deviation across matrices.
A comfortable planning module allows easy specification of the study design and automatically generates corresponding report templates.
Although InterVAL does not require repeated measurements and requires significantly less testings, the reliability of validation results is much higher than in conventional studies.
Statistics in accordance to the newest standards
In its statistical analysis, InterVAL applies the methods put forward in the European Commission`s 2002/657/EC. InterVAL also allows a reliable evaluation according to ISO 11843 and DIN 32645.
For the analysis of test results, the following procedures are provided:
- Cochran`s test
- Grubbs test
- test for factorial dispersion effects
- recovery rate (as a function of concentration)
- repeatability standard deviation
- in-house standard deviation
- critical concentrations CCα and CCβ
- power function for screening and confirmatory methods
All parameters can be determined under various conditions, the effects of influence factors are quantified, and the corresponding uncertainty components are computed. In addition, InterVAL allows the determination of the total measurement uncertainty on the basis of validation data (top-down approach).