Evaluation of the Benefits of Architecture and Process Models from the Perspective of Quality Assurance in the Context of Application System Development in the Pharmaceutical Industry

Large pharmaceutical companies struggle to implement computerized systems to sup-port user requirements, end-to-end business processes, and R&D (research and devel-opment) data governance. This is due to the size of the companies, the complexity of large international studies, the market’s pressure to rationalize and the associated or-ganizational and regulatory effort. SaaS (Software-as-a-Service) solutions are seen as a suitable approach to solve these problems and simplify business processes. However, the transition from self-developed systems to SaaS poses new challenges in terms of planning and overview. The central question of this master’s thesis is whether the use of architecture and process models for the implementation of digital systems can bring advantages in this environment. A widely used Enterprise Architecture Management (EAM) tool, ArchiMate, is tested using a case study. An error analysis is carried out with a comparative modeling of approaches. The analysis is done from a Quality Assurance (QA) perspective to reduce risk to data integrity and GCP. The presented ArchiMate case study demonstrates that the systematic application of EAM can improve the coordination of projects in dynamic and complex business contexts by integrating communication be-tween teams and functions. The main contribution of this work is to show that an appropriate architecture and process analysis helps to ensure fitness-for-purpose of systems and compliance with requirements of the health authorities and thus the quality of R&D, study implementation and patient welfare.

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Thesis for degree:



Maira Frisch