SimplerQMS is a cloud-based 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. It automates document review, approval, and routing, and links records to support traceability. Electronic signatures and time-stamped audit logs are provided; 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 to the system. 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. Subscriptions include implementation, validation, migration, training, hosting, templates, and 24/7 emergency phone support. A free Viewer license provides read-only access. Starter costs $17,500/yr for up to 15 users; Team & Enterprise pricing is by quote.
Who it is for
SimplerQMS is intended for life science organizations, including medical device, pharmaceutical, biotech, laboratory, and CRO/CMO companies. The free Viewer license may suit invited auditors or collaborators needing read-only access.
What is good
- Modules span documents, training, audits, and risk management.
- Automates document review, approval, and routing.
- Microsoft 365 integration supports document editing and saving.
- Subscriptions include implementation, validation, migration, and training.
- Free Viewer license offers read-only access.
What to know first
- Starter costs $17,500/yr for up to 15 users.
- Team & Enterprise pricing is by quote.
- Implementation typically takes five to six weeks.
Verdict
SimplerQMS brings quality workflows, traceability, and life-science-focused modules into a cloud subscription. Starter is $17,500/yr for up to 15 users, while larger plans require a quote.
SimplerQMS plans and pricing
All plansCompared on quality management software
- Free plan
- Yes
- Document control
- Yes
- Audit management
- Yes
- Corrective actions
- Yes
- Nonconformance tracking
- Yes
- Compliance records
- Yes
- Approval workflows
- Yes
- Deployment
- cloud
