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Qualification
Preuve documentée que les installations, systèmes ou composants sont adaptés à l'utilisation prévue.
Table des matières
01
Définition
02
Importance pour Rhein-Plast
03
Distinction par rapport à la validation
01
Définition
La qualification est un processus structuré visant à confirmer qu’un système ou un produit fonctionne conformément aux spécifications. Elle est, en particulier dans les secteurs réglementés, un élément essentiel de l’assurance qualité.
02
Importance pour Rhein-Plast
Les gaines, les ensembles de films et les composants de confinement sur mesure doivent souvent être intégrés à des systèmes qualifiés existants. La documentation technique et la qualité reproductible des produits jouent alors un rôle important.
03
Distinction par rapport à la validation
La qualification évalue l’aptitude des installations et des composants, tandis que la validation examine en plus la preuve reproductible du processus.
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systèmes de confinement et emballages primaires.