A Survey of Next-Generation Electronic Quality Management Systems for Global Regulated Enterprises

Abstract

Next-generation Electronic Quality Management Systems (eQMS) represent the evolution of traditional paper-based quality systems into intelligent, cloud-based, and compliance-driven digital ecosystems. This study examines the organizational architecture, regulatory alignment, enabling technologies, and implementation challenges associated with next-generation eQMS in regulated industries such as pharmaceuticals and advanced manufacturing. Modern eQMS platforms integrate core quality modules including document control, CAPA, audit management, training, and change control into centralized and automated systems that enhance traceability, data integrity, and operational efficiency. The paper further evaluates compliance with global regulatory frameworks, including ICH E6(R2/R3), USFDA 21 CFR Part 11, EMA Annex 11, and PIC/S guidelines, with a focus on inspection readiness and lifecycle-based validation. Emerging technologies such as artificial intelligence, machine learning, cloud computing, blockchain, digital twins, and the Internet of Things are enabling predictive, real-time, and proactive quality management. Despite these advancements, implementation remains challenging due to legacy system integration, data complexity, resource constraints, and organizational resistance to digital transformation.