An Ontology based Conceptualization of Data Integrity Regulatory Compliance in Pharmaceutical Industry: The SPuMoNI Case

Abstract

Data integrity plays a pivotal role in the pharmaceutical regulatory landscape, where data must be attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available, in other words, must be ALCOA compliant. Data in the pharmaceutical industry are complex and come in large amounts and various types, thus making the utilization of information technology systems in managing data integrity compliance, necessary. This study, has been conducted in the context of the SPuMoNI project, and it presents the conceptual design of a regulatory framework for the pharmaceutical domain, which is aligned with the data integrity ALCOA principles and based on ontology engineering technology. In doing so, it proposes the Data Integrity Ontology (DIOnt), which provides a solid basis for the semantic representation of the pharmaceutical manufacturing process and data, and the modeling and management of regulatory requirements. Moreover, a proof-of-concept prototype has been implemented and validated with real world pharmaceutical data in ALCOA principle violation scenarios. © 2021 ACM.