Overview
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Max FEINBERG: former Director of Research at INRA, Paris
INTRODUCTION
You work in a physico-chemical and/or biochemical analysis laboratory. Everywhere you go, you hear that the methods you develop need to be validated, so that the end-user can have confidence in the results you produce, or so that the Cofrac auditor does not conclude that they are non-compliant. It was with the introduction of quality assurance systems in laboratories, principally Good Laboratory Practice and accreditation, that the validation stage became mandatory.
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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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