Quality Management System (QMS) Update in a Regulated Environment
In a world demanding quality healthcare software, this thesis aims to show how a company remains competitive by improving a QMS, examining key components, global standards and effective change management. It gives insights into audits, best practices, and quality's profound impact on performance.
Steven Njuguna, 2023
Bachelor Thesis, Neurostatus-UHB AG
Betreuende Dozierende: Stephan Jüngling
Keywords: QMS, Audit, Compliance, ISO, Quality, GxP, PDCA
The company XYZ discussed in the study, develops software for clinical research on Multiple Sclerosis (MS). Yet, their QMS (containing SOPs and other important quality documents) implemented in 2020 is out of date and misaligned with current best practices, posing compliance and performance risks. Some of its defined processes are not followed, leading to an oversight of responsibilities, including maintaining the QMS. In light of emergent challenges, this inadequacy highlights the need for an immediate QMS update.
Pairing a Literature Review with a Case Study on Company XYZ that included several lively discussions, this study conducted exhaustive searches on platforms such as Scopus, Google Scholar, and IEEE Xplore with terms including "Audits" and "QMS". Scite AI, an AI-powered tool, further assessed the credibility of papers. Based on criteria such as peer-reviewed papers and publications from 2010 to 2023, an initial selection of 80 articles was reduced to 60 following an evaluation. These were systematically categorized to facilitate in-depth analysis and assure a holistic view of the subject.
This thesis examines the complexities of updating a QMS in a regulated environment, highlighting its significance for an organization's ideal performance and compliance with regulations. For Company XYZ:
•The company's QMS evaluation revealed issues, such as inconsistencies, noncompliance with ISO standards, ambiguous role definitions, and process gaps.
•Aligning Company XYZ's QMS with best practices and regulations like ISO and ICH, will boost compliance and ensure reliable operations.
•Careful transition planning, focused on employee participation and strategic communication, is vital to curb change management resistance.
•Improved Organisational Performance: The proposed QMS changes, including Q-KPIs, clarified roles, and regular audits, are intended to refine operational dynamics, thereby ensuring sustained improvement and greater alignment.
By heeding these insights, Company XYZ can achieve enhanced efficiency, strengthened regulatory compliance, clear employee roles and overall growth. By fostering continuous improvement, the company is positioned for long-term success. This study emphasises the importance of a solid QMS in guiding businesses towards superior performance.
Studiengang: Business Information Technology (Bachelor)
Fachbereich der Arbeit: