Implementation of an Electronic Quality Management System (eQMS) to Enhance Document Control and Training Compliance in a Regulated Environment

Abstract

The implementation of an electronic Quality Management System (eQMS) marked a significant shift from a paper-based document control and training process at a regulated biopharmaceutical company. Aimed at enhancing operational efficiency, regulatory compliance, and data integrity, the initiative led to the successful migration of 67 controlled documents and the digitalization of 712 training activities—over 58% of which were completed within 15 working days post-Go-Live. The eQMS introduced automated workflows, electronic signatures, audit trails, and role-based access controls, aligning with FDA 21 CFR Part 11 and CGMP standards. As a result, training cycle times were reduced from five days to under one hour, and document approval timelines improved by 50%. Challenges such as license allocation and user adaptation were addressed through strategic planning and stakeholder engagement. The initiative showcases the transformative impact of digital platforms on quality management and establishes a scalable foundation for future organizational growth. Key Terms ⎯ Compliance, Digital Platform, eQMS, Efficiency, Paper-Based, Traceability.