Abstract
Data governance systems
Several guidance documents that have been published since 2015 require the implementation of data governance. No guidance document for the life sciences industries mentioned this term thus far. Hence, industry representatives wondered what data governance exactly means. This article is dedicated to this topic of data governance, and describes explicit requirements pertaining to it. The purpose of the data governance system described in this article is not limited to ensuring data integrity only, as many cited guidance documents suggest. Instead, the author has extended its purpose to meet the broader concept of data quality. Such a data governance system not only ensures an adequate level of data integrity; it also covers other essential and legally required data quality attributes. The organizational structure, processes and procedures, as well as tools are described in detail, as the pillars sustaining an adequate level of data quality. The author provides examples illustrating different topics in more detail. Many references are provided allowing for a deeper dive into the different covered topics and requirements in order to facilitate their integration into existing quality management systems.
Zusammenfassung
In mehreren, seit 2015 erschienenen, Richtlinien und Leitfäden wird die Einführung einer Data Governance (Datenlenkung) gefordert. Dieser Begriff wurde bis dahin in den Regularien der Life-Sciences-Industrien nicht verwendet. Es stellt sich daher die Frage, was genau darunter zu verstehen ist. Dieser Beitrag greift das Thema auf und beleuchtet bestehende explizite Anforderungen an die Datenlenkung. Dabei geht er über die Zielgröße der Datenintegrität hinaus und beschreibt die verschiedenen Elemente eines ganzheitlichen Datenlenkungssystems, das auf die übergeordnete Datenqualität ausgerichtet ist. Diese
