Leveraging Enterprise Architecture for Resilient Operational Continuity and Regulatory Compliance in MedTech
The clinical IT sector of MedTech is under pressure to comply with rigorous regulatory requirements while maintaining operational continuity across evolving infrastructure and vendor landscapes.
Swain, Ranjit, 2025
Type of Thesis Master Thesis
Client
Supervisor Laurenzi, Emanuele, Montecchiari, Devid
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The present thesis explores the potential of ontology-based enterprise architecture models to facilitate automated validation of regulatory compliance and to underpin continuity-focused architecture decisions within such environments.
A design science research approach was applied to the iterative design and evaluation of an artefact with Varian Medical Systems, a Siemens Healthineers company. The artifact under scrutiny, the Ontology Based Enterprise Architecture Framework (OBAF), combines an OWL ontology with a catalogue of SHACL rules that express selected governance, continuity, and compliance expectations as executable constraints over architecture concepts. The prototype demonstration employs two curated enterprise architecture scenarios and a subset of six rules, namely R1, R5, R7, R10, R11, and R14, while the remaining rules are documented for the purpose of future extension.
The evaluation demonstrates that SHACL-based validation has the capacity to identify compliance-related gaps and traceability issues within the modelled scenarios. Furthermore, it has been shown to reduce reliance on manual inspection in the case study setting. The present contribution to the theoretical framework pertains to a concrete methodology for operationalising architectural principles and control expectations as machine-checkable rules within an ontology-based architectural model. The contribution to practice is a reproducible validation pattern, including ontology, rule catalogue, scenario graphs, and validation outputs, that can be adopted incrementally using open standards and vendor neutral technologies to supportcontinuous compliance checking and resilient operational continuity.
Studyprogram: Business Information Systems (Master)
Keywords
Confidentiality: öffentlich