SimplerQMS Description

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes.

The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records.

Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards.

Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes:
• Audit-proven insights
• Guidance from compliance specialists
• Continuous system validation
• User training
• 24/7 global support
• Smooth implementation and data migration
• Dedicated Customer Success Experts

With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.

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Pricing

Pricing Starts At:
$17,500 / year
Pricing Information:
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
Free Trial:
Yes

Integrations

API:
Yes, SimplerQMS has an API
View Integrations

Reviews - 1 Verified Review

Total
ease
features
design
support
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Company Details

Company:
SimplerQMS
Year Founded:
2017
Headquarters:
Denmark
Website:
www.simplerqms.com
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Media

Automate reviews, approvals, and routing while linking related records to maintain traceability across all quality processes.

Automate reviews, approvals, and routing while linking related records to maintain traceability across all quality processes.

Automate reviews, approvals, and routing while linking related records to maintain traceability across all quality processes. Draft and edit documents in Microsoft Word while keeping document control in SimplerQMS. Capture traceable approvals with electronic signatures designed to align with FDA 21 CFR Part 11 requirements. Maintain a clear overview of personal and organization training with centralized dashboards, supporting training oversight and reporting. Keep observations, nonconformances, CAPAs, and related quality records connected throughout the process, supporting clearer traceability without recreating information across disconnected systems. Assign responsibilities and control who can review, edit, or approve CAPA records based on their role.
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Product Details

Platforms
Web-Based
Windows
Mac
iPhone App
iPad App
Android App
Types of Training
Training Docs
Live Training (Online)
Training Videos
Customer Support
Business Hours
Live Rep (24/7)
Online Support

SimplerQMS Features and Options

Quality Management Software

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Audit Software

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA Software

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Training Management

Compliance Software

Archiving & Retention
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control Software

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

SimplerQMS Lists

SimplerQMS User Reviews

Write a Review
  • Name: Anonymous (Verified)
    Job Title: CEO
    Length of product use: Less than 6 months
    Used How Often?: Monthly
    Role: User, Administrator, Deployment
    Organization Size: 1 - 25
    Features
    Design
    Ease
    Pricing
    Support
    Likelihood to Recommend to Others
    1 2 3 4 5 6 7 8 9 10

    Cumbersome system, very difficult contract termination

    Date: Sep 11 2026

    Summary: We were looking for a QMS to centralise controlled documents, SOPs, revision control and approval workflows. SimplerQMS did not solve that problem for us: during evaluation it proved too cumbersome and inflexible for our processes, so we never rolled it out.

    Our dispute over the unused subscription was eventually referred to a collection agency. We paid USD 6,669 after receiving written confirmation from SimplerQMS A/S that this amount constituted full and final settlement of all claims concerning the disputed invoices. Nevertheless, we subsequently received a demand for an additional DKK 9,950.07. In our opinion this contradicted the written settlement confirmation, and it is why we lost trust in the company.

    Our advice: review every termination and renewal clause before signing, cancel well in advance and in writing, obtain explicit confirmation, and preserve copies of all communications. Based on our experience we would not recommend SimplerQMS.

    Positive: The technical staff were the best part of our experience. During onboarding they made a real effort to explain how the system works and to help whenever we had questions, and they were responsive and patient throughout. The platform is built on Microsoft Azure and Microsoft 365, so documents live in a familiar SharePoint/Office environment rather than in a completely proprietary system.

    Negative: In our experience the system is extremely inconvenient, cumbersome and inflexible. Everyday document work requires far more clicks and steps than it should, the interface is heavy, and adapting the workflows to how our company actually operates proved impractical. After evaluating it we decided not to implement it at all.

    The far bigger problem is the commercial side. Read the termination and renewal provisions extremely carefully before signing. Based on our experience you cannot simply stop using the service during the contract year and stop paying. Notice must be given at least 90 days before the renewal date; miss that deadline and you may be invoiced for another full contractual period even though you no longer use the system.

    Termination must be submitted in writing and its receipt expressly confirmed. We told the company twice by telephone that we wanted to discontinue the service, and those conversations were not treated as formal notice. Do not rely on phone calls: send written notice, request written confirmation, and keep all correspondence.

    Read More...
    SimplerQMS Company Response
    Date: Sep 30 2026
    Thank you for sharing your feedback. We truly appreciate your positive comments about our technical support team and the responsive support provided during onboarding. We are likewise sorry that SimplerQMS was not the right fit for your organization. We investigated the additional collection reminder referenced in your review - that is an administrative error, and we have taken corrective action to prevent this from happening again. Your team is informed directly. We truly apologize for that. SimplerQMS takes customer feedback seriously and continuously uses feedback to improve the experience we provide. We are committed to professional, transparent, and respectful customer relationships and to supporting our customers throughout their journey with SimplerQMS. We remain available for direct dialogue regarding any remaining account-specific or contractual concerns.
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