Flexible Digitization of Highly Individualized Workflows Demonstrated Through the Quality Control of Patient-Specific Cytostatic Application Bags: Digitization from the Perspective of Small and Medium-Sized Laboratories.

Abstract

In order to ensure a high level of product quality and safety, regular quality controls are mandatory, especially in the pharmaceutical industry. These quality controls are strictly regulated and require a high level of documentation. With the goal of complete traceability, these regulations are constantly being tightened, while a majority of laboratories are working still completely paper-based. This leads to an ever-increasing workload that keeps laboratory staff away from value-adding analytical work. In order to realize complete traceability, a reduction in documentation errors and at the same time a reduction of the individual workload, the digitization of complete workflows seems to be a promising solution.Due to the ongoing shortage of IT specialists and the resulting high implementation costs, many laboratories are understandably hesitant. In this chapter an alternative is presented on how to approach the digitization of complete workflows without the need for IT specialists. The example of quality control analysis of cytotoxic drug solutions was chosen to demonstrate the challenges of such a digitization project. In this way, we contribute to a comprehensive understanding of the tools already available, which can also help other laboratories in their digitization efforts. At the end compliance with GMP and EN ISO/IEC 17025 (2017) regulations was reached.