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SPECIFICTION
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SimplerQMS

simplerqms.com

From $1,458.33/mo Free plan WebAPI
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Spec score 7.7 #10 of 28 in Life Sciences Software

What it is

SimplerQMS is a cloud-based electronic quality management system 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. The platform automates document reviews, approvals, and routing, and links records to support traceability. 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. Microsoft 365 integration lets users edit Word, Excel, and PowerPoint files and save them to the system; other listed integrations include ERP, CRM, PLM, and WMS, with an API for scripting environments. Single sign-on is available through Microsoft Entra ID and Google Workspace. Subscriptions include implementation, validation, migration, live training, hosting, templates, and 24/7 emergency phone support. A free Viewer license offers unlimited users read-only access. Starter costs $17,500 a year for up to 15 users; pricing for Team & Enterprise is by request.

Spec sheet

Purpose
SimplerQMS is a cloud-based electronic quality management system purpose-built for life science companies.Read 30 Sep 2026 · simplerqms.com
Intended users
The product is intended for life science organizations, including medical device, pharmaceutical and biotech, laboratory, and CRO/CMO companies.Read 30 Sep 2026 · simplerqms.com
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.Read 30 Sep 2026 · simplerqms.com
Headquarters
Copenhagen, DenmarkRead 28 Sep 2026 · simplerqms.com
Founded
2017Read 28 Sep 2026 · simplerqms.com
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.Read 30 Sep 2026 · simplerqms.com
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.Read 30 Sep 2026 · simplerqms.com
Implementation
The company says implementation typically takes five to six weeks, depending on company size, complexity, migration needs, and available time.Read 30 Sep 2026 · simplerqms.com
Included services
The subscription includes implementation, validation, data migration, unlimited live training, cloud hosting, QMS templates, and 24/7 emergency phone support.Read 30 Sep 2026 · simplerqms.com
Microsoft integration
Users can edit documents in Word, Excel, and PowerPoint and save them to SimplerQMS through its Microsoft 365 integration.Read 30 Sep 2026 · simplerqms.com
Modules
Its modules include document control, change management, training, CAPA, audits, design control, supplier management, equipment management, and risk management.Read 30 Sep 2026 · simplerqms.com
Other integrations
The company says SimplerQMS can integrate with ERP, CRM, PLM, and WMS systems and provides an API for access from scripting environments.Read 30 Sep 2026 · simplerqms.com
Single sign-on
SimplerQMS supports single sign-on through Microsoft Entra ID and Google Workspace.Read 30 Sep 2026 · simplerqms.com
Workflows
The platform automates document reviews, approvals, and routing, and links related records to support traceability.Read 30 Sep 2026 · simplerqms.com

Plans and prices

Viewer license Free FREE Unlimited users · read-only access · invited auditors and collaborators under an active subscription Read 30 Sep 2026 · simplerqms.com
Starter $17,500 a year annually Up to 15 users Read 30 Sep 2026 · simplerqms.com
Team & Enterprise Priced on request Request a quote 15+ users Read 30 Sep 2026 · simplerqms.com

Every SimplerQMS plan and price →

Strong points and limits

Strong points

  • Modules cover document, audit, and risk management.
  • Supports Microsoft 365 document editing.
  • Includes implementation, validation, and data migration.
  • Free Viewer license allows unlimited read-only users.

Limits

  • Starter costs $17,500 a year.
  • Starter supports up to 15 users.
  • Team & Enterprise pricing is by request.

Who it suits

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 and collaborators who need read-only access.

Verdict

SimplerQMS brings quality workflows, traceability, and integrations together for life science organizations. Its included implementation and validation services are notable, while the paid Starter price and user cap merit attention.

Where Specifiction places it

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