What is SimplerQMS?

SimplerQMS provides a cloud-centric Quality Management Software tailored specifically for the Life Science sector.

This innovative platform ensures adherence to an array of regulatory standards, 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, and is fully validated under GAMP5 guidelines.

The software encompasses a comprehensive suite of Life Science QMS modules, including Document Control, Change Control, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, and Quality KPIs, among additional functionalities.

Moreover, SimplerQMS seamlessly integrates with Microsoft Office, enabling users to manage documents within familiar applications like Word, PowerPoint, and Excel.

In summary, SimplerQMS not only streamlines operations through efficient, paperless workflows but also ensures that organizations can meet the stringent compliance mandates essential in the Life Science industry. Furthermore, its user-friendly interface and robust capabilities make it an indispensable tool for companies looking to enhance their quality management processes.

Pricing

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

Integrations

Offers API?:
Yes, SimplerQMS provides an API
All SimplerQMS Integrations
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Screenshots and Video

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

Company Facts

Company Name:
SimplerQMS
Date Founded:
2017
Company Location:
Denmark
Company Website:
www.simplerqms.com
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Product Details

Deployment
SaaS
Windows
iPhone
iPad
Android
Training Options
Documentation Hub
Online Training
Video Library
Support
Standard Support
24 Hour Support
Web-Based Support

Product Details

Target Company Sizes
Individual
1-10
11-50
51-200
201-500
501-1000
1001-5000
5001-10000
10001+
Target Organization Types
Mid Size Business
Small Business
Enterprise
Startup
Supported Languages
English

SimplerQMS Categories and Features

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

Medical Quality Management Systems

ISO Compliance Software

Electronic Batch Records (EBR) Software

Document Control Software

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

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

CAPA Software

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

More SimplerQMS Categories

SimplerQMS Customer Reviews

Write a Review
  • Reviewer Name: A Verified Reviewer
    Position: CEO
    Has used product for: Less than 6 months
    Uses the product: Monthly
    Org Size (# of Employees): 1 - 25
    Feature Set
    Layout
    Ease Of Use
    Cost
    Customer Service
    Would you 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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