Our solution is designed to help meet Life Science regulatory requirements, such as GxP, ISO 13485:2016, FDA 21 CFR Part 210, 211, 820, ICH Q10, EU MDR and IVDR, ISO 9001:2015, and others.

Integrated into our QMS software are various QMS processes important to the Life Science industry, such as Document Control, Change Control, Training Management, Form and Template Management, Complaint Management, Non-conformance/Deviation Management, CAPA Management, Design Control, Audit Management, Supplier Management, Equipment Management, Product Management, Risk Management, and more. This unified approach streamlines operations and ensures a comprehensive Quality Management System solution for our clients.

SimplerQMS is built on trusted M-Files and Microsoft Azure technologies, providing enterprise-level security. To guarantee data security, SimplerQMS utilizes Microsoft Azure Cloud Storage. Data encryption at rest and during transmission is provided by Microsoft Azure Cloud. Regular data backups every 15 minutes, continuous monitoring by specialized professionals, and global data storage locations further ensure data integrity.

Our software seamlessly integrates with Microsoft Azure Active Directory (Azure AD) for user data management and single sign-on capabilities. Additionally, integration with Microsoft Office 365 enables users to work with familiar applications like Word, PowerPoint, and Excel directly within SimplerQMS, eliminating the need for repetitive downloads and uploads.

SimplerQMS also offers integration with other applications such as Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM), Customer Relationship Management (CRM), and more. Through an application programming interface (API) and plugins, clients can further extend the integration possibilities to various other applications, enhancing workflow efficiency.