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Validierung kleiner Herstell- und Laborgeräte

Fallbeispiele GAMP 5 – Herstell- und Laborgerät Waage: Softwarekategorie 3

Prof. Dr. Ingrid Müller¹, Dipl. Ing. (FH) Elke Weber¹, Dipl. Ing. Hartmut Meier², Dipl. Ing. Klaus Thornagel³

¹ Hochschule Albstadt-Sigmaringen
² Ingenieurbüro IHM Hartmut Meier, Engen
³ Sartorius AG, Göttingen

Korrespondenz: Klaus Thornagel, Sartorius AG, Weender Landstraße 94–108, 37075 Göttingen (Germany), e-mail: KThornagel@aol.com

Validation of Small Manufacturing and Laboratory Devices

GAMP^® 5 is a hands-on Guide which supports engineers and quality managers by offering a risk based strategy for computer system validation in the GMP production. As a positive result a risk based validation for software became more time and cost efficient.
Most of nowadays production and laboratory devices are based on computerized systems. This short article is focused on software in small devices; often called “embedded software”.

Key words GAMP^® 5 • Kleines Herstellgerät • Kleines Laborgerät • Risiko • Softwarekategorien • Templates • Waagen