eValidation
Herausforderungen und Chancen von eValidation-Tools in der regulierten Industrie
IT
Abstract
eValidation – Challenges and Opportunities of eValidation Tools in the Regulated Industry
In the life science industry, plant qualification, equipment qualification, process validation, and also the validation of automated and computerized systems (computer system validation) are associated with high costs, personnel expenses and still very high manual, paper-based documentation efforts. For several years, attempts have been made to provide support in this area with software-based tools and programs. In order to be able to understand the application possibilities and the functionalities of these tools, the functional modules of a so-called eValidation tool are presented based on selected application scenarios. In addition, various aspects for reducing validation and qualification costs will be considered and the advantages of working with a new eValidation solution will be shown. However, the very limited spread and acceptance of these tools is also to be discussed. To this end, the article also highlights inherent problems and experiences with the introduction, implementation, and operational use, as well as suggestions for improvement for the introduction of these eValidation tools.
Zusammenfassung
Anlagenqualifizierung, Laborgerätequalifizierung, Prozessvalidierung oder auch die Validierung von automatisierten und computergestützten Systemen (Computer-System-Validierung) sind in der Lifesciences-Industrie mit hohen Kosten, Personalaufwand und immer noch sehr hohem manuell-papierbasierten Dokumentationsaufwand verbunden. Seit etlichen Jahren wird versucht hier Hilfestellungen mit softwaregestützten Werkzeugen und Programmen zu geben. Um die Einsatzmöglichkeiten und die Funktionalitäten dieser Tools verstehen zu können, werden anhand ausgewählter Anwendungsszenarien die
