Qualification
Documented evidence that equipment, systems or components are suitable for their intended use.
Table of contents
01
Definition
02
Importance for Rhein-Plast
03
Distinction from validation
01
Definition
Qualification is a structured process for confirming that a system or product functions in accordance with the specification. It is an essential part of quality assurance, particularly in regulated industries.
02
Importance for Rhein-Plast
Custom liners, film packs and containment components often have to be integrated into existing qualified systems. Technical documentation and reproducible product quality play an important role in this process.
03
Distinction from validation
Qualification assesses the suitability of systems and components, while validation additionally considers the reproducible process evidence.
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