SimplerQMS

SimplerQMS is a specialized electronic Quality Management System (eQMS) tailored for life science organizations that operate in highly regulated environments. Founded in 2017 by Allan Murphy Bruun and Jacob Sjørslev Hyrdum—both former executives at Ambu, a Danish medical device company—SimplerQMS was built to address the challenges of compliance, documentation, and quality assurance in industries such as pharmaceuticals, biotechnology, and medical devices. The platform is fully validated according to GAMP5 Category 4 standards and supports compliance with a wide range of international regulations, including ISO 13485:2016, FDA 21 CFR Part 210/211/820, EU MDR and IVDR, ICH Q10, and ISO 9001:2015. This makes it a robust solution for companies seeking to maintain regulatory alignment across multiple jurisdictions. SimplerQMS offers a comprehensive suite of QMS modules that cover every aspect of quality management. These include document control, training management, change control, CAPA (Corrective and Preventive Actions), audit management, risk management, complaint handling, equipment calibration, supplier management, and design control. Each module is designed to automate workflows, reduce human error, and ensure traceability throughout the quality lifecycle. One of the standout features of SimplerQMS is its seamless integration with Microsoft Office 365. Users can work directly within familiar environments like Word and Excel while maintaining secure audit trails and version control. This reduces the learning curve and facilitates smoother transitions from legacy systems or paper-based processes. The platform is cloud-hosted, ensuring secure, remote access to documentation and quality processes. It also includes electronic signatures compliant with FDA 21 CFR Part 11, enabling global teams to collaborate and approve documents efficiently. SimplerQMS supports real-time analytics and reporting, allowing organizations to monitor key quality metrics and identify areas for improvement. Customer support is a major strength of SimplerQMS. The company offers unlimited training and 24/7 assistance through email, phone, video calls, and a dedicated support portal. This ensures that clients receive continuous guidance during implementation and beyond, which is especially valuable for small and mid-sized teams with limited internal IT resources. SimplerQMS is priced transparently with all-inclusive annual licenses that cover software modules, validation, onboarding, training, and support. This eliminates hidden costs and simplifies budgeting for quality management initiatives.

SimplerQMS distinguishes itself from competitors through a combination of regulatory rigor, user-centric design, and unmatched customer support. While many QMS platforms offer similar modules, SimplerQMS excels in delivering a fully validated, all-in-one solution specifically built for life sciences. One of its key advantages is its compliance-first architecture. SimplerQMS is validated according to GAMP5 Category 4 and supports a wide array of global standards including ISO 13485, FDA 21 CFR Part 11, EU MDR, and ICH Q10. This depth of regulatory coverage ensures that companies using SimplerQMS are well-prepared for audits and inspections, a critical requirement in the life sciences sector. Another competitive edge is its seamless Microsoft Office 365 integration. Unlike many QMS platforms that require users to adapt to new environments, SimplerQMS allows teams to work within familiar tools like Word and Excel. This reduces training time and enhances user adoption, especially for organizations transitioning from paper-based systems.

• Small Businesses (1-99)
• Mid Market (100-500)
• Enterprise (500+)