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Digital transformation as a means of ensuring GxP compliance
- Authors: Koshechkin K.A.1, Spichak I.V.2
- Affiliations:
- I. M. Sechenov First Moscow State Medical University, Moscow, Russia
- Eurasian Academy of Good Practices, Moscow, Russia
- Issue: No 4 (2024)
- Pages: 421-426
- Section: Articles
- URL: https://remedium-journal.ru/journal/article/view/1725
- DOI: https://doi.org/10.32687/1561-5936-2024-28-4-421-426
- Cite item
Abstract
The circulation of medicines is a highly regulated area of activity and is regulated by a set of good practice standards (GxP). Digital transformation involves the replacement of manual, paper-based processes with digital alternatives. The goal of this endeavor is to investigate methods for putting digital systems into place while making sure they adhere to GxP standards. In addition to Internet resources, the scientific electronic library of eLIBRARY.RU and electronic databases of articles from the Central Scientific Medical Library were used for the literature evaluation. Consequently, the essential building pieces that enable adherence to GxP criteria were found. These include the following: change control, equipment maintenance and management, laboratory test management, electronic batch records, master data management, logistics chains management, clinical system functionality, regulatory information management, pharmacovigilance, electronic document management, business process management, learning management, electronic forms, and risk and impact assessment. Thus, various components of digital systems are used to ensure compliance with the requirements of GxP standards and allow for a comprehensive digital transformation in the field of drug circulation.
Keywords
digital transformation, quality management system, product lifecycle management, enterprise resource planning, laboratory information management system, manufacturing execution system, supply chain management, clinical trial management system, electronic trial master file, electronic data capture.
About the authors
Konstantin A. Koshechkin
I. M. Sechenov First Moscow State Medical University, Moscow, Russia
Email: koshechkin_k_a@staff.sechenov.ru
Irina V. Spichak
Eurasian Academy of Good Practices, Moscow, Russia
Email: spichak@gxp-academy.org
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