An Ontology based Conceptualization of Data Integrity Regulatory Compliance in Pharmaceutical Industry: The SPuMoNI Case
Date
2021Language
en
Sujet
Résumé
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.
Collections
Related items
Showing items related by title, author, creator and subject.
-
User modeling for pedestrian navigation services
Kikiras, P.; Tsetsos, V.; Papataxiarhis, V.; Katsikas, T.; Hadjiefthymiades, S. (2009)Human-centered and user-adaptive systems are at the heart of the Design for All and Ambient Intelligence concepts. Evidently, user models are necessary "ingredients" of such systems. We present a user model for navigation ... -
Semantic based search engine for 3D shapes: Design and early prototype implementation
Vasilakis, G.; Pitikakis, M.; Vavalis, M.; Houstis, C. (2005)Searching for 3D resources is gradually becoming one of those intriguing research topics that have the potential to shape how users will access and interact with the internet in the years to come. Search engines like Google ... -
A personalized audio server using MPEG-7 and MPEG-21 standards
Skondras, E.; Michalas, A.; Louta, M.; Anagnostopoulos, I. (2010)This paper presents a semantic model which delivers personalized audio information. The personalization process is automated and decentralized. The metadata which support personalization are separated in two categories: ...