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.
Cytostatic drugs
Digitization
FutureLab.NRW
Lab execution system (LES)
Quality control (QC)
Reporting
Journal
Advances in biochemical engineering/biotechnology
ISSN: 0724-6145
Titre abrégé: Adv Biochem Eng Biotechnol
Pays: Germany
ID NLM: 8307733
Informations de publication
Date de publication:
2022
2022
Historique:
pubmed:
30
1
2022
medline:
9
9
2022
entrez:
29
1
2022
Statut:
ppublish
Résumé
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.
Substances chimiques
Cytostatic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115-129Informations de copyright
© 2022. The Author(s), under exclusive license to Springer Nature Switzerland AG.
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