SimplerQMS
Summary
SimplerQMS is a cloud-based electronic quality management system designed 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 management, equipment management, and risk management. The platform automates document review, approval, and routing workflows, and links related records for traceability. It provides electronic signatures and time-stamped audit logs, which the company says 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 to SimplerQMS. The company also lists ERP, CRM, PLM, and WMS integrations, an API for scripting environments, and single sign-on through Microsoft Entra ID and Google Workspace. A free Viewer license offers read-only access. Starter costs $17,500.00 USD per year for up to 15 users; Team & Enterprise pricing is by request. Subscriptions include implementation, validation, migration, training, hosting, templates, and 24/7 emergency phone support.
Who it is for
SimplerQMS suits life science organizations, including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO companies. Its modules cover quality processes such as document control, audits, CAPA, and supplier management.
What is good
- Includes document, audit, CAPA, and risk modules.
- Automates review, approval, and routing workflows.
- Microsoft 365 integration supports document editing.
- Subscription includes implementation and data migration.
- Free Viewer license offers read-only access.
What to know first
- Free Viewer license is read-only.
- Starter costs $17,500.00 USD per year.
- Team & Enterprise pricing is by request.
- Implementation typically takes five to six weeks.
Verdict
SimplerQMS combines quality-management modules with automated workflows, traceability, and integrations for life science organizations. The free Viewer license is read-only; Starter is $17,500.00 USD per year for up to 15 users.
SimplerQMS plans and pricing
All plansCompared on quality management software
- Free plan
- Yessimplerqms.com
- Document control
- Yessimplerqms.com
- Audit management
- Yessimplerqms.com
- Corrective actions
- Yessimplerqms.com
- Nonconformance tracking
- Yessimplerqms.com
- Compliance records
- Yessimplerqms.com
- Approval workflows
- Yessimplerqms.com
- Deployment
- cloudsimplerqms.com
Facts
- Purpose
- SimplerQMS is a cloud-based electronic quality management system purpose-built for life science companies.simplerqms.com · 30 Sept 2026
- Modules
- Its modules include document control, change management, training, CAPA, audits, design control, supplier management, equipment management, and risk management.simplerqms.com · 30 Sept 2026
- Workflows
- The platform automates document reviews, approvals, and routing, and links related records to support traceability.simplerqms.com · 30 Sept 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 · 30 Sept 2026
- Microsoft integration
- Users can edit documents in Word, Excel, and PowerPoint and save them to SimplerQMS through its Microsoft 365 integration.simplerqms.com · 30 Sept 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 · 30 Sept 2026
- Single sign-on
- SimplerQMS supports single sign-on through Microsoft Entra ID and Google Workspace.simplerqms.com · 30 Sept 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 · 30 Sept 2026
- 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 · 30 Sept 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 · 30 Sept 2026
- Implementation
- The company says implementation typically takes five to six weeks, depending on company size, complexity, migration needs, and available time.simplerqms.com · 30 Sept 2026
- Intended users
- The product is intended for life science organizations, including medical device, pharmaceutical and biotech, laboratory, and CRO/CMO companies.simplerqms.com · 30 Sept 2026
Company
- Founded
- 2017simplerqms.com · 28 Sept 2026
- Headquarters
- Copenhagen, Denmarksimplerqms.com · 28 Sept 2026
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Sources
- simplerqms.com/technology-platform/· checked 30 Sept 2026
- simplerqms.com/modules/· checked 30 Sept 2026
- simplerqms.com· checked 30 Sept 2026
- simplerqms.com/pricing/· checked 30 Sept 2026
- simplerqms.com/qms/software/· checked 30 Sept 2026
- simplerqms.com/about/· checked 30 Sept 2026