Document Type : Original Article
Authors
1
Department of Computer Engineering, Ra.C., Islamic Azad University, Rasht, Iran, arasi@iaurasht.ac.ir
2
Department of Software and Information Systems, Faculty of Computer Science and Engineering, Shahid Beheshti University, Tehran, Iran
3
Department of Computer Engineering, Ra.C., Islamic Azad University, Rasht, Iran, azgomi@iaurasht.ac.ir
Abstract
Pharmaceutical ecosystems involve interdependent enterprises, regulators, healthcare providers, patients, and digital platforms whose interactions create substantial organizational, governance, and interoperability challenges. Existing contributions address important parts of this problem through domain ontologies, enterprise-architecture frameworks, process models, and digital-platform perspectives, but remain fragmented at the ecosystem level. This study presents CM-PharmE 1.0, a business-architecture-informed and UFO-grounded conceptual model expressed in OntoUML. A PRISMA-guided review identified 380 records, of which 17 studies were retained for qualitative thematic synthesis. The resulting modeling concerns were organized into five interrelated domains and translated into UFO/OntoUML constructs through an explicit concept- and relation-selection procedure. Assessment combined a scenario-based comparative benchmark, qualitative review by four experts, a focused manual inspection of eight selected OntoUML-informed anti-pattern categories, competency-question analysis, illustrative vaccine-distribution instantiation, and repository-supported computational checks. All eight competency questions were operationalized as executable queries and returned the predefined bounded results against the formalized model and machine-readable scenario; automated ROBOT/HermiT reasoning also completed without reporting a logical inconsistency or unsatisfiable named classes in the current axiom set. The resulting evidence provides preliminary support for the model’s conceptual traceability, cross-domain coherence, ontological discipline, and bounded computational consistency, while reference-architecture adoption, contextual extensibility, operational interoperability, empirical completeness, and implementation effectiveness remain to be evaluated. CM-PharmE 1.0 is therefore positioned as an extensible conceptual baseline for governance reasoning, interoperability-oriented analysis, requirements engineering, and subsequent architectural development in regulated pharmaceutical ecosystems rather than as a complete or operationally validated ontology.
Keywords
Subjects