1. A Validation Lifecycle Management System (VLMS) is a comprehensive platform designed to manage the entire validation process for computerized systems in life sciences. It supports activities like equipment qualification, process validation, and compliance with regulations such as 21 CFR Part 11. VLMS solutions, like Xybion’s QMS Validation Management System, offer paperless workflows to track requirements, execute tests, and generate compliance reports. These systems promote operational efficiency by reducing manual documentation and enabling real-time monitoring of validation status. By integrating risk-based approaches, VLMS ensures that high-risk systems receive rigorous validation while optimizing resources for lower-risk ones. This results in enhanced compliance, reduced costs, and faster time-to-market for regulated products.
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