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SimplerQMS
Copenhagen, Denmark
What it is
SimplerQMS is a cloud electronic quality management system built for life science organizations, including medical-device, pharmaceutical, biotech, laboratory, and CRO/CMO companies. Its modules cover document control, change management, training, CAPA, audits, design control, supplier and equipment management, and risk management. Workflows automate document review, approval, and routing while linking records for traceability. Electronic signatures and time-stamped audit logs are provided, and the company says they comply with FDA 21 CFR Part 11 and EU GMP Annex 11. Microsoft 365 integration lets users edit Word, Excel, and PowerPoint files and save them in the system. ERP, CRM, PLM, and WMS integrations are listed, alongside an API and single sign-on through Microsoft Entra ID or Google Workspace. AWS hosting includes stated encryption, frequent backups, and multi-location storage. A free Viewer license offers read-only access; Starter is $17,500 a year for up to 15 users.
For and against
For
- Broad quality modules for life science organizations
- Electronic signatures and time-stamped audit logs
- Microsoft 365 document integration
- API and enterprise-system integrations
- Free read-only Viewer license
Against
- Starter costs $17,500 a year
- Team & Enterprise pricing requires a quote
- Cloud deployment only
The verdict
SimplerQMS combines regulated quality modules, workflow automation, integrations, and included implementation services. The free Viewer tier is limited to read-only access, while working-user plans require substantial annual spending.
Who it suits
It is aimed at life science teams managing regulated quality records and workflows. Organizations needing implementation, validation, migration, training, and compliance-oriented controls may suit it.
Plans and prices
Viewer license
Unlimited users · read-only access · invited auditors and collaborators under an active subscription
Read 30 Sep 2026 · simplerqms.com
Starter
Up to 15 users
Read 30 Sep 2026 · simplerqms.com
Team & Enterprise
15+ users
Read 30 Sep 2026 · simplerqms.com
On the record
- Compliance
- The company says SimplerQMS A/S is ISO 13485:2016 and ISO/IEC 27001:2022 certified, and that its software complies with FDA 21 CFR Part 11.simplerqms.com · read 30 Sep 2026
- Electronic signatures
- It provides electronic signatures and time-stamped audit logs that the company says comply with FDA 21 CFR Part 11 and EU GMP Annex 11.simplerqms.com · read 30 Sep 2026
- Hosting and security
- SimplerQMS runs on AWS; the company says data is encrypted at rest and in transit, backed up every 15 minutes, stored across multiple locations, and monitored continuously.simplerqms.com · read 30 Sep 2026
- Implementation
- The company says implementation typically takes five to six weeks, depending on company size, complexity, migration needs, and available time.simplerqms.com · read 30 Sep 2026
- Included services
- The subscription includes implementation, validation, data migration, unlimited live training, cloud hosting, QMS templates, and 24/7 emergency phone support.simplerqms.com · read 30 Sep 2026
- Intended users
- The product is intended for life science organizations, including medical device, pharmaceutical and biotech, laboratory, and CRO/CMO companies.simplerqms.com · read 30 Sep 2026
- Microsoft integration
- Users can edit documents in Word, Excel, and PowerPoint and save them to SimplerQMS through its Microsoft 365 integration.simplerqms.com · read 30 Sep 2026
- Modules
- Its modules include document control, change management, training, CAPA, audits, design control, supplier management, equipment management, and risk management.simplerqms.com · read 30 Sep 2026
- Other integrations
- The company says SimplerQMS can integrate with ERP, CRM, PLM, and WMS systems and provides an API for access from scripting environments.simplerqms.com · read 30 Sep 2026
- Purpose
- SimplerQMS is a cloud-based electronic quality management system purpose-built for life science companies.simplerqms.com · read 30 Sep 2026
- Single sign-on
- SimplerQMS supports single sign-on through Microsoft Entra ID and Google Workspace.simplerqms.com · read 30 Sep 2026
- Workflows
- The platform automates document reviews, approvals, and routing, and links related records to support traceability.simplerqms.com · read 30 Sep 2026
