SimplerQMS

SimplerQMS offers a comprehensive suite of features designed to streamline quality management for life science organizations. The platform includes fully validated modules for document control, training management, CAPA (Corrective and Preventive Actions), audit management, change control, and risk management. It automates workflows to ensure regulatory compliance with standards like ISO 13485, FDA 21 CFR Part 11, and EU MDR. Users benefit from seamless integration with Microsoft Office 365, enabling them to create, edit, and manage documents within familiar tools like Word and Excel while maintaining full traceability and audit trails. SimplerQMS also supports electronic signatures, real-time reporting, and secure cloud hosting via Microsoft Azure. With unlimited training and 24/7 support, the platform is designed to be user-friendly and scalable, making it ideal for small to mid-sized life science companies seeking to digitize and simplify their quality processes.