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La Validation intégrée : Test, commissioning et qualification dans le management de la qualité
Posted on 2010-05-28
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More La validation, la qualification, ou le commissioning consistent à donner la preuve qu'un système, outil de production, logiciel... a les fonctionnalités et les performances attendues par le client. Au-delà des activités techniques telles que la planification et le test, sont abordés les outils et méthodes permettant de conduire un projet de validation, intégré dans le système qualité du fournisseur et du client : Définition du besoin utilisateur, Gestion des compétences, Acceptation et réception, Maîtrise des anomalies et des changements, Transfert de propriété, Maintien de la performance, Amélioration continue. Véritable guide pratique, cet ouvrage présente également les principes de maintien et d'amélioration des systèmes qualifiés. Il s'adresse aux chefs de projets, aux responsables de services qualité, ingénierie, méthodes, essais, qualification et validation et à leurs équipes. Daniel Mouton. Pharmacien, certifié Black Belt Six Sigma, il exerce depuis vingt ans des fonctions de responsable de la qualité ou de la qualification/validation dans l'industrie. Au cours de projets de tailles et de complexités différentes, il a pu se constituer une expérience dans la qualification des systèmes informatiques, les procédés et les installations industrielles. or
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