SimplerQMS

SimplerQMS is a provider of cloud-based Quality Management System (QMS) software tailored specifically for the life sciences industry. Founded in 2017 and headquartered in Copenhagen, Denmark, the company aims to assist organizations in the medical device, pharmaceutical, and biotechnology sectors in streamlining their quality management processes and ensuring compliance with stringent regulatory standards. The platform is designed to digitize and automate core quality processes, moving companies away from manual, paper-based systems that can impede innovation and efficiency. SimplerQMS offers a comprehensive suite of modules that address critical aspects of quality management, including document control, change management, training management, Corrective and Preventive Actions (CAPA), audit management, and supplier management. This integrated approach helps to reduce the risk of manual errors, shorten approval cycles, and ensure that companies are audit-ready at all times.

The software is built to comply with a wide range of international regulations and standards, such as FDA 21 CFR Part 11, ISO 13485:2016, EU GMP Annex 11, and GxP. By providing a fully validated system, SimplerQMS alleviates the burden of system validation for its clients, allowing them to focus on their core competencies of developing and bringing life-saving products to market. The platform's architecture is based on established technologies, including a core document management system from M-Files and secure hosting on Microsoft Azure. This ensures a high level of reliability, scalability, and data security. SimplerQMS prides itself on a rapid and proven implementation methodology, enabling clients to be up and running on the system within a matter of weeks. The company's mission is to empower life science teams, from startups to established enterprises, to manage their quality processes more effectively and accelerate their path to market while maintaining the highest standards of quality and compliance.