10. Our advice
10.1 Always schedule at least one preparatory meeting before taking measurements.
Especially if you work in an accredited laboratory, method validation must be integrated into the quality system. You therefore need to draw up a procedure, for example, based on the steps outlined in this sheet. A preliminary step, not described here, is to set up a working group with a person in charge who will coordinate the work and be responsible for processing the results.
The first meeting of this working group will define the objectives, identify the resource persons and propose a timetable for completion. Following this meeting, it is perfectly possible to plan and budget the study, particularly in terms of reagents, measuring instruments and quantities of validation...
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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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