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

Author:

Lallas Efthimios1,Santouridis Ilias1,Mountzouris Georgios1,C. Gerogiannis Vassilis1,Karageorgos Anthony2

Affiliation:

1. University of Thessaly, Greece

2. School of Technology/AiDigiLab, University of Thessaly, Greece

Funder

SPuMoNI research project

Publisher

ACM

Reference11 articles.

1. Maintaining data integrity;Perez J.R.;Quality Progress,2017

2. Current status, challenges and preventive strategies to overcome data integrity issues in the pharmaceutical industry;Vignesh K.;International Journal of Applied Pharmaceutics.,2020

3. World Health Organization ( 2016 ) WHO guidance on good practices and record management practices . WHO TRS 996, Annex 5 World Health Organization (2016) WHO guidance on good practices and record management practices. WHO TRS 996, Annex 5

4. PIC/S Guidance “ Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments ” July 2021 PIC/S Guidance “Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments” July 2021

5. May 2021;Leal F.,2021

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1. A Survey of Ontologies Considering General Safety, Security, and Operation Aspects in OT;IEEE Open Journal of the Industrial Electronics Society;2024

2. An SQWRL-Based Method for Assessing Regulatory Compliance in the Pharmaceutical Industry;Applied Sciences;2022-10-28

3. Analytics and Blockchain for Data Integrity in the Pharmaceuticals Industry;2022 4th International Conference on Advances in Computer Technology, Information Science and Communications (CTISC);2022-04-22

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