SimplerQMS Description

SimplerQMS offers a cloud-based Quality Management Software, specifically designed for the Life Science industry.

SimplerQMS helps ensure compliance with various regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and ICH Q10, among others. The system is fully validated according to GAMP5.

The system offers a range of Life Science QMS modules such as Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs and more.

SimplerQMS integrates with Microsoft Office and allows users to work with documents in applications such as Word, PowerPoint, and Excel.

Overall, SimplerQMS delivers efficient, paperless workflows that align with the compliance requirements of the Life Science industry.

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Pricing

Pricing Starts At:
$13,750/year
Pricing Information:
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial:
Yes

Integrations

API:
Yes, SimplerQMS has an API
View Integrations

Reviews - 1 Verified Review

Total
ease
features
design
support
See More Reviews Write a Review

Company Details

Company:
SimplerQMS
Year Founded:
2017
Headquarters:
Denmark
Website:
www.simplerqms.com
Update This Listing

Media

Play Video Change Request for Control of Quality Records SOP Change Request Editing in Microsoft Word CAPA Management Module Views Audit SOP and Electronic Signature Training KPI Report List of Pending Training Assignments
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Product Details

Platforms
Web-Based
Windows
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
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

CAPA Software

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

Compliance Software

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
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...
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