Digital Transformation for Operational Effectiveness for a Leading Pharmaceutical Organization
Overview.
The client is a pharmaceutical company leader with a major focus on development and manufacture of IP-led niche finished dosage formulations. They were facing challenges in managing the fragmented processes, disparate systems, inefficient operations, compliance gaps, error-prone workflows, and suboptimal resource allocation across business units. Leveraging Coforge’s Digital transformation proficiency, they were able to harmonize and simplify the procedures enhanced data integrity, traceability, and overall operational effectiveness
The client wanted to create a uniform procurement process for all their manufacturing business units. These included different methodologies and processes for similar activities, inadequate procedures not meeting GxP (GoodxPractice) and mandatory FDA regulatory standards, and manual paper-based documentation leading to traceability issues, documentation errors, and data integrity concerns.
Solution
We conducted a comprehensive review of all manufacturing unit-specific procedures and carried out a detailed impact assessment for each process.
Rewrote procedures considering industry best practices and regulatory standards, simplified process requirements, and obsoleted redundant procedures.
Transitioned critical IT activities from manual paper-based systems to electronic systems using e-Log (Leucine) and ITSM software and implemented a centralized configuration approach in the e-Log application in collaboration with Leucine.
These measures aimed to enhance efficiency, standardization, and compliance across all business units to enable GxP and Non-GxP standards to be future ready for internal and FDA audits.
The Impact
The revamped procedures saved significant time in routine operations and SOP preparation.
Simplified process led to more streamlined training and onboarding process of associates with fewer SOPs. Trained resources can now be utilized across any business unit as needed.
The electronic system ensured regulatory standard requirements were met, facilitated easy tracking and monitoring of activities, eliminated data integrity issues and documentation errors, and reduced human error.
