1. Which validation parameters to choose?
In the literature, there is a wide variety of guides, standards and documents for validating analytical methods. In general, they consist of compiling a collection of so-called validation parameters and, sometimes, comparing them with threshold values where these exist. The approach presented here is a little different, in that it attempts to assess the confidence we can have in the future results a method will produce. This approach is based on the method's accuracy profile, which is a graphical representation and decision-support tool for validation purposes. Its construction requires a collection of measurements, carried out under well-defined conditions, which are intended to simulate the way in which a method will be used routinely.
In general, validation procedures are aimed at proving performance obligations and are organized as follows ( cf. Validating analytical...
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Which validation parameters to choose?
Define the scope of the method to be validated and quantify the objectives
Bibliography
Collège Français de Métrologie: Application of the new VIM3 calibration concept (Reissued 2014)
Commission Decision of August 12, 2002 implementing Council Directive 96/23/EC as regards the performance of analytical methods and the interpretation of results (2002/657/EC)
Feinberg (M.), Labo-Stat: Guide de validation des méthodes d'analyse...
Normative references
ISO 16140: 2003 Microbiology of food: validation protocol for alternative methods (2003) ISO, Geneva
NF EN ISO/CEI 17025 : 2005 General requirements for the competence of testing and calibration laboratories (2005) ISO, Geneva
NF V03-110 (May 2010) Analysis of agricultural and food products – Characterization protocol for the validation of a quantitative analysis method...
Websites
Arlenda is a bio-statistics consultancy that has developed software for validating analytical methods.
This site offers commercial software for validating analytical methods.
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