REMEDIUMREMEDIUM1561-59362658-3534Joint-Stock Company Chicot172510.32687/1561-5936-2024-28-4-421-426Original ArticleDigital transformation as a means of ensuring GxP complianceKoshechkinKonstantin A.koshechkin_k_a@staff.sechenov.ruSpichakIrina V.spichak@gxp-academy.orgI. M. Sechenov First Moscow State Medical University, Moscow, RussiaEurasian Academy of Good Practices, Moscow, Russia15122024442142615102025Copyright © 2024,2024The 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. 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