Enterprise Asset Management Digitalization for Multi-Site Pharmaceutical Manufacturing a Transatlantic Oracle eAM Implementation
DOI:
https://doi.org/10.15680/IJCTECE.2025.0804018Keywords:
Oracle eAM, enterprise asset management, digital transformation, pharmaceutical manufacturing, 21 CFR Part 11, preventative maintenance, multi-site manufacturing, Pharma 4.0, asset governance, predictive maintenanceAbstract
Digitalization of enterprise asset management in pharmaceutical manufacturing is a strategic necessity for global companies. A unique case study on Oracle enterprise asset management was implemented in the manufacturing plants of a global pharmaceutical company in both Indianapolis, USA and the UK. The unified digital system established across these two sites provided synchronized schedules for preventative maintenance and spare parts inventory, while also ensuring 21 CFR Part 11 compliance for electronic records. The methodology used in this project included functional architecture design, cross-functional initiation management, and comprehensive change management amongst international sites. The results of this case study demonstrated how data-driven repair vs. replace decisions resulted in significant cost optimizations on both capital and operating expenditures; how there were no longer production shutdowns due to local stock outs; and how all 100% of employees were proficient in complying with electronic record management. This case study adds to the existing body of literature around Pharma 4.0 by offering an applicable framework to multi-site pharmaceutical companies wishing to harmonize asset management principles while remaining compliant on a global scale within their manufacturing operations
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