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7. Practical calculation of validation criteria
7.1 Choosing a calculation tool
The data processing described here calls on statistical techniques that require a great deal of calculation: it's clear that numerical application is becoming a fundamental aspect of validation. Today, all analytical laboratories have spreadsheets that are perfectly suited to these calculations. To process data, you can choose from :
commercial software: Excel® from Microsoft; iWorks from Apple; Lotus 1-2-3 from IBM...
royalty-free software (freeware): OpenOffice.org Calc initially developed by Sun Microsystems ( http://www.fr.openoffice.org/ ) ; LibreOffice published by The Document...
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Practical calculation of validation criteria
Conclusion
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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