A GxP-Compliant Integrated ERP Framework for Synchronizing OPM, SCM, and Quality Lab Systems in Pharmaceutical Manufacturing
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Abstract
The study introduces a framework developed by practitioners which enables the integration of Oracle Process Manufacturing (OPM), Supply Chain Management (SCM), and Quality Laboratory Systems (QLS) within GxP-compliant pharmaceutical production facilities that use Oracle E-Business Suite R12.2.9. The paper utilizes the practical knowledge of a Global Subject Matter Expert who managed the complete system upgrade process. to demonstrate the architectural and functional aspects which enable organizations to achieve complete ERP systems that meet audit requirements and follow regulations. The framework undergoes evaluation through its compliance assessment with major regulatory standards which include 21 CFR Part 11 and EU GMP Annex 11 and GAMP 5 and ICH Q7 and ICH Q10. The proposed integration model undergoes validation through eight complex pharmaceutical manufacturing scenarios which include inventory transfers based on lot control and cross-site financial closes. The research shows that pharmaceutical manufacturers achieve continuous ERP transitions together with complete financial accuracy and Day-One regulatory compliance through a structured SME-led approach. The paper presents an integrated ERP framework which the global pharmaceutical industry can use for standardized implementation
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