Laboratory Information Management Systems (LIMS) and Laboratory Automation: Enhancing Data Integrity and Regulatory Compliance

Abstract

Laboratory Information Management Systems (LIMS) and laboratory automation are the foundational technologies in contemporary analytical, clinical, and pharmaceutical laboratories. These digital platforms create the smoothest workflow, optimize data management, comply with regulations, and reduce both human error and operational disruptions. The current publication is a review of the evolution, main functions, and advantages of LIMS and Laboratory Automation focused on the ways in which they strengthen data integrity, traceability, and meeting regulatory requirements, including GLP, GMP, ISO, and FDA 21 CFR Part 11. It also emphasizes the integration with advanced technologies such as artificial intelligence (AI), Internet of Things (IoT), cloud computing, and the challenges and forward-looking orientation for the transformations of the digital lab ecosystem. As a paper, this article reflects the need for laboratories to embrace integrated LIMS and automation frameworks in the digital transformation to stay competitive, compliant, and efficient in the era of digital transformation