Digitalisierung der Produktionsdokumentation im Medizinproduktebereich

Abstract

The digitalization of process documentation in the medical device sector faces the challenge of replacing traditional paper-based batch documentation with more efficient digital systems. This is particularly important for companies such as Takeda Österreich GmbH that are involved in the manufacture and release of medical devices. The current paper-based documentation is time-consuming and prone to human error, which can lead to discrepancies and delay the release of products that are already produced and ready for shipment. These discrepancies have a potentially negative impact on patient safety and company reputation. Therefore, the implementation of a Manufacturing Execution System (MES) is seen as a solution to digitize and automate the documentation processes. This thesis is divided into two main parts: the theoretical and the empirical part. The theoretical part (chapter 2) describes the basics of the medical device industry, regulatory requirements, the functionality and benefits of MES and EBRS, methodological approaches for implementation and the relevant quality criteria as well as change management are explained. The empirical part (Chapter 3) comprises a qualitative content analysis using expert interviews to examine the practical challenges and benefits of MES implementation. The results of the interviews were transcribed, analyzed and the resulting findings summarized. Finally, the empirical part was linked to the theoretical foundations and the research questions were answered and reflected upon. The analysis showed that the implementation of an MES offers benefits for the documentation processes in the medical device industry. Key findings include improved documentation accuracy and real-time detection of errors, leading to greater efficiency and safety in production. The experts emphasize the benefits of digital documentation, in particular better data availability and the simplification of audits by authorities and customers. For Shopfloor employees, the MES reduces documentation complexity and minimizes human error. Top management benefits from improved data quality, transparency and more efficient resource management. In addition to the benefits, the challenges that can arise when implementing an MES are highlighted and how these can be overcome. Overall, the paper shows that the digitalization of process documentation through MES can significantly improve production processes in the medical device industry if these challenges are addressed appropriately.

Date of Award	2024
Original language	German (Austria)
Supervisor	Thomas Wolff (Supervisor)