An SQWRL-Based Method for Assessing Regulatory Compliance in the Pharmaceutical Industry

Nowadays, data integrity has become a critical issue in the pharmaceutical regulatory landscape, one that requires to be compliant ALCOA principles (i.e., must Attributable, Legible, Contemporaneous, Original, and Accurate). In this paper, we propose method which exploits semantic web technologies represent pharma manufacturing unified manner evaluate systematic their compliance. To purpose, context of environment, ontology (DIOnt) is proposed utilized as basis for representation production associated compliance management processes. We further show annotations can used required information, reasoning combined with SQWRL queries The approach been implemented proof-of-concept prototype validated real world data, supporting execution SWRL rules aim support assessment calculate non-compliance percentages per each principle.