Data Integrity in the Life Science Industry: Searching for the Balance between Customer Demands, Security, and Global Compliance

Abstract

The paper wants to investigate how data integrity can be combined with information security concerns while ensuring compliance with industry regulations and standards, which is to be solved in a global guidance document. For this purpose, a case was selected where Endress+Hauser is the supplier of a certain measurement device for a company, which operates in the Life Science Industry. The case was selected as it provides new insights into the subject of data integrity combined with information security, challenges existing approaches, and proposes a conceptual solution to the issue.