Digitalization in the pharmaceutical industry : an example of pharmaceutical application of enterprise resource planning software

Abstract

This study investigates the implementation of Enterprise Resource Planning (ERP) system upgrades within the pharmaceutical industry in Good Manufacturing Practice (GMP) environments. The aim was to develop, validate, and apply a specialized framework tailored for guiding ERP upgrades and providing a tool for industry application. Following a literature review, the study proposed an original ERP upgrade framework, based on theoretical basis. The framework underwent a validation process via a focus group comprising experts from Quality Control, Quality Assurance, Production, and Supply Chain departments in the pharmaceutical sector. The objective of the validation process was to refine the framework, ensuring its practical applicability and relevance within the pharmaceutical industry context. An observational analysis of an ERP upgrade in a GMP setting was subsequently conducted. The implementation was monitored during the critical go-live phase and the following days, recording and analyzing encountered issues and milestones. This period provided valuable insights into the practical challenges and achievements of ERP implementation, through a retrospective evaluation of the framework's efficacy. This study successfully delivered a comprehensive framework tailored for ERP system migration within the pharmaceutical industry, addressing unique challenges to the industry such as compliance with rigorous regulatory standards and the critical nature of products. Through a detailed literature review, expert validation, and a practical case study, the framework was tested and refined, ensuring its applicability and effectiveness. The final framework consists of 8 pillars covering preliminary assessment, timelines, customization, data migration, testing, change management and monitoring following roll out. Additionally, the retrospective application to a real-world ERP migration case provided actionable recommendations. These recommendations serve as a valuable resource for pharmaceutical organizations planning ERP system upgrades, ensuring a smoother transition that aligns with both operational and compliance requirements.