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

Abstract

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

Keywords

• ALCOA
• data integrity
• regulatory compliance
• ontology technology
• pharmaceutical industry
• SWRL