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1. The role of validation in the life cycle
1.1 Concept of a method's life cycle
First of all, we need to clarify when a method needs to be validated. Indeed, like any process, analysis methods are born, evolve and disappear; this journey can be summarized in the form of a life cycle, a concept already widely used in the systems approach. Figure 1 summarizes the life cycle of an analysis method. By convention, the main stages and sub-stages are represented in rectangles, and the associated tools as ellipses.
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The role of validation in the life cycle
Validation vocabulary
Bibliography
Software tools
There are few software packages dedicated to method validation. Arlenda ( http://www.arlenda.com/ ) has developed one called "e-noval®". It uses the accuracy profile and produces a certified report. Its originality lies in the fact that it operates via the Internet (Web-based solution): the user copies the data into an Internet interface,...
Websites
AOAC (Association of Official Analytical Chemists): originally American, this association of analysts has become international. In addition to its standardizing role, it validates methods according to various protocols http://www.aoac.org/
EURACHEM, a network of European organizations whose aim is to set up a forum for the traceability...
Standards and norms
Association française de normalisation Afnor
- Water quality – Protocol for initial assessment of method performance in a laboratory - NF T90-210 - 2009
- Exigences générales concernant la compétence des laboratoires d'étalonnages et d'essais - NF EN ISO/CEI 17025 - 2005
- Laboratoires d'analyses de biologie médicale....
International Organization for standardization ISO
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