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  • Quality by Design in Knowledge Management in a Biosimilar Industry. Evaluation of the value of implementing a knowledge-based quality and risk management tool.
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  • Útdráttur er á ensku

    The biopharma industry is information and knowledge heavy and the individual and collective knowledge are amongst the biggest asset of the company. In development of a biological product the information and knowledge play a central role when decisions are made on updates or changes to the process. It is therefore vital that information is available and not isolated from the rest of the organization within different departments. Quality by Design (QbD) is the concept of building quality into a product from the start. Multiple testing does not automatically improve quality for products but quality must be designed into the product from the start. The focus of this study was to establish an understanding of current state knowledge management within a biosimilar company and understanding the current guidance on risk and document management, with the goal to identify the benefits of using a knowledge management system (QbDVision), designed for the industry within development departments. This was performed by importing data/knowledge from selected product, already in development process within the company, into QbDVision software. An assessment was made on management, in the current system used within the company, of storage, structure and management of development information for this specific product. The current system was compared to the system QbDVision and evaluation made of this systems benefits for use within the development departments of the biosimilar industry. This thesis displays benefits of using QbDVision, a QbD principle-based software system for knowledge management. There were several findings, first and foremost is the breaking of silos between departments, secondly, the improvement of visualization of process flows within the company and the overview of risk for every process and parameter related to the product.

  • 8.2.2022

Skráarnafn Stærð AðgangurLýsingSkráartegund 
MS ritgerð _ Arna Albertsdotttir.pdf3.98 MBOpinnHeildartextiPDFSkoða/Opna
Scan_sigurbjorg_rutardott_202202030009_001.pdf55.47 kBLokaðurYfirlýsingPDF