validation criteria; accreditation; total error concept
Abstract :
[en] In order to achieve the harmonization of validation strategies, the interpretation of several validation criteria is proposed. Furthermore, a simple and visual decision tool to assess the validity of an analytical procedure is described: the accuracy profile based on the estimation of the total error of the measurements. This profile build with beta-expectation tolerance intervals can also compute with efficiency the uncertainty related to the results of a laboratory, which is an essential parameter for the accreditation of laboratories under ISO 17025.
Hubert Ph., Nguyen J.J., Boulanger B., Chapuzet E., Chiap P., Cohen N Compagnon P.-A., Dewé W., Feinberg M., Lallier M., Laurentie M., Mercier N., Muzard G., Nivet C., Valat L. Harmonization of strategies for the validation of quantitative analytical procedures A SFSTP proposal-part I. J. Pharm. Biomed. Anal. 2004, 36, 579-86.
Feinberg M., Boulanger B., Dewé W., Hubert Ph. New advances in method validation and measurement uncertainty aimed at improving the quality of chemical data. Anal Bioanat Chem. 2004; 380: 502-14.
ISO/DTS 21748 (2003) Guide to the use of repeatability, reproducibility and trueness estimates in measurement uncertainty. ISO, Geneva.
