SimplerQMS offers Quality Management Software that is fully validated, cloud-based, and built specifically for companies within the Life Science industries.

Publisher: SimplerQMS

Product Description

Product Description
SimplerQMS specializes in delivering fully validated, cloud-based Quality Management Software tailored specifically for Life Science companies. SimplerQMS is particularly suited for small to medium-sized organizations operating in highly regulated Life Sciences sectors such as Medical Devices, MedTech, Pharmaceuticals, BioTech, IVD, and CRO. By automating processes like document authoring, review, and approval, businesses can save time and work more efficiently.

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.

Documentation and Additional Information

Download Link Description
 Video 21 CFR Part 11 Compliant Electronic Signatures - SimplerQMS
 Video Document Control - SimplerQMS
 Video Change Requests - SimplerQMS
 Video Compliant and Efficient Training Management - SimplerQMS
 Screen shot SimplerQMS screen shot
 Screen shot SimplerQMS screen shot
 Screen shot SimplerQMS screen shot
 Screen shot SimplerQMS screen shot

Support Knowledge Base:

Licensing and Downloads

Licence Type Purchase Required - Contact Publisher for Licensing Information


Contact Information

Sales and More Information
Contact Name Allan Murphy Bruun
Email Address
Phone +1 619 471 4911
Technical Support

Support Email
Support Site
Support Phone +45 93 90 16 14

Product Specifications

Supported Environments

Customer Environment:

M-Files Standard Cloud:

M-Files Isolated Cloud:


 Contact M-Files

 Contact M-Files

Supported Languages English
Regional Availability Global, Australia & New Zealand, Asia Pacific & Japan, Central & Eastern Europe, India, Middle East & Africa, Latin America, United States & Canada, Western Europe