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Title: Towards a computational approach for the assessment of compliance of ALCOA+ Principles in pharma industry
Authors: Durá, Marta
Sánchez-García, Ángel
Sáez, Carlos
Leal, Fátima
Chis, Adriana E.
González-Vélez, Horacio
García-Gómez, Juan M.
Keywords: ALCOA+ compliance
Data integrity
Pharma manufacturing industry
Issue Date: 25-May-2022
Publisher: IOS Press
Citation: Durá, M., Sánchez-García, Á., Sáez, C., Leal, F., Chis, A. E., González-Vélez, H., & García-Gómez, J. M. (2022). Towards a computational approach for the assessment of compliance of ALCOA+ Principles in pharma industry. Studies in Health Technology and Informatics, 294, 755–759. Repositório Institucional UPT.
Abstract: The pharmaceutical industry is a data-intensive environment and a heavily-regulated sector, where exhaustive audits and inspections are performed to ensure the safety of drugs. In this context, processing and evaluating the data generated in the manufacturing lines is a relevant challenge since it requires compliance with pharma regulations. This work combines data integrity metrics and blockchain technology to evaluate the compliance-degree of ALCOA+ principles among different levels of drug manufacturing data. We propose the DIALCOA tool, a software to assess the compliance-degree for each ALCOA+ principle, based on the assessment of data from manufacturing batch reports and its different levels of information.
ISSN: 0926-9630 (Print)
1879-8365 (Online)
Appears in Collections:REMIT – Artigos em Revistas Internacionais / Papers in International Journals

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