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Qualifizierung
Dokumentierter Nachweis, dass Anlagen, Systeme oder Komponenten für ihren vorgesehenen Einsatz geeignet sind.
Inhaltsverzeichnis
01
Definition
02
Bedeutung für Rhein-Plast
03
Abgrenzung zur Validierung
01
Definition
Die Qualifizierung ist ein strukturierter Prozess zur Bestätigung, dass ein System oder Produkt spezifikationsgerecht funktioniert. Sie ist insbesondere in regulierten Industrien ein wesentlicher Bestandteil der Qualitätssicherung.
02
Bedeutung für Rhein-Plast
Kundenspezifische Liner, Folienpakete und Containment-Komponenten müssen häufig in bestehende qualifizierte Systeme integriert werden. Dabei spielen technische Dokumentation und reproduzierbare Produktqualität eine wichtige Rolle.
03
Abgrenzung zur Validierung
Die Qualifizierung bewertet die Eignung von Anlagen und Komponenten, während die Validierung zusätzlich den reproduzierbaren Prozessnachweis betrachtet.
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