Evaluation of Technological Solutions to Support Trend Analysis Processes for Quality Incidents in a Pharmaceutical Company

Pharmaceutical companies are strongly committed to quality, making trend analyses vital for monitoring and improving processes. Technologies are transforming these analyses, enhancing quality management, ensuring regulatory compliance, and enabling issue detection to safeguard patient safety.

Maier, Kevin, 2024

Art der Arbeit Bachelor Thesis
Auftraggebende Globales Pharmazeutisches Unternehmen
Betreuende Dozierende Reber, Andreas
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A Swiss pharmaceutical company sees a significant opportunity to improve the efficiency and accuracy of its trend analysis processes for Quality Incidents by implementing a technological solution. However, before implementing such a solution, the company needs to address several critical challenges. These challenges encompass significant variability in process execution across different global sites and undefined requirements for the technological solution. Overcoming these challenges is crucial for successful implementation, which this bachelor’s thesis explores in detail.
A comprehensive foundation is first laid by an in-depth analysis of existing processes at global sites, using BPMN 2.0 to model specific implementations. Surveys conducted with process participants identify issues and challenges in these processes. These insights, combined with both functional and non-functional end-user requirements, shape the definition and prioritization of the technological solution's specifications. Various available technologies are then evaluated against these requirements to find the most suitable technological solution.
The analysis leads to a well-supported recommendation for a technological solution tailored to the pharmaceutical company’s needs. The recommended solution offers several key benefits. It standardizes trend analysis processes across different sites, enhances data accessibility, and fosters cross-departmental collaboration. Moreover, it effectively addresses identified process issues, leading to improved trend analysis quality and ensuring that potential issues are promptly detected and resolved. Implementing the proposed technological solution is expected to significantly boost the efficiency and effectiveness of trend analysis processes, resulting in enhanced product quality, reduced Quality Incidents, and stronger regulatory compliance across the organization.
Studiengang: Wirtschaftsinformatik (Bachelor)
Keywords Pharmaceutical Quality, Process Analysis, Process Improvement, Requirements Engineering
Vertraulichkeit: vertraulich
Art der Arbeit
Bachelor Thesis
Auftraggebende
Globales Pharmazeutisches Unternehmen
Autorinnen und Autoren
Maier, Kevin
Betreuende Dozierende
Reber, Andreas
Publikationsjahr
2024
Sprache der Arbeit
Englisch
Vertraulichkeit
vertraulich
Studiengang
Wirtschaftsinformatik (Bachelor)
Standort Studiengang
Olten
Keywords
Pharmaceutical Quality, Process Analysis, Process Improvement, Requirements Engineering