Audience

Companies in the Life Science industries - Medical Device, Pharmaceutical, Biotechnology, Laboratory, and others.

About SimplerQMS

SimplerQMS offers a cloud-based Quality Management Software that is fully validated according to GAMP5 and specifically designed for the Life Science industry.

This comprehensive QMS platform 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, ICH Q10, and others.

The software offers a wide range of Life Science QMS modules, such as Document Control, Change Management, Training Management, Supplier Management, Complaints Management, Non-Conformance and Deviation Management, CAPA Management, Audit Management, Technical Documentation Management, Risk Management, Quality KPIs, among others, ensuring a seamless experience.

SimplerQMS enhances document handling by allowing users to work directly in Microsoft Office applications like Word, PowerPoint, and Excel.

Pricing

Starting Price:
$13,750/year
Pricing Details:
Everything is included, with no additional costs for implementation, modules, support, hosting, validation, etc.
Free Trial:
Free Trial available.

Integrations

API:
Yes, SimplerQMS offers API access

Ratings/Reviews - 1 User Review

Overall 1.0 / 5
ease 1.0 / 5
features 1.0 / 5
design 1.0 / 5
support 2.0 / 5

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

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Product Details

Platforms Supported
Cloud
Windows
iPhone
iPad
Android
Training
Documentation
Live Online
Videos
Support
Phone Support
24/7 Live Support
Online

SimplerQMS Frequently Asked Questions

Q: What kinds of users and organization types does SimplerQMS work with?
Q: What languages does SimplerQMS support in their product?
Q: What kind of support options does SimplerQMS offer?
Q: What other applications or services does SimplerQMS integrate with?
Q: Does SimplerQMS have an API?
Q: Does SimplerQMS have a mobile app?
Q: What type of training does SimplerQMS provide?
Q: Does SimplerQMS offer a free trial?
Q: How much does SimplerQMS cost?
Q: What pricing for support is available for SimplerQMS?
Q: What pricing for training is available for SimplerQMS?

SimplerQMS Product Features

Audit

Alerts / Notifications Supported
Audit Planning Supported
Compliance Management Supported
Dashboard Supported
Forms Management Supported
Issue Management Supported
Mobile Access Supported
Risk Assessment Supported
Workflow Management Supported
Exceptions Management Not Supported
Multi-Year Planning Not Supported

CAPA

Audit Management Supported
CAPA Planning Supported
Change Management Supported
Complaint Management Supported
Incident Management Supported
Nonconformance Tracking Supported
Quality Control Supported
Risk Management Supported
Training Management Supported
Root Cause Analysis Not Supported

Compliance

Archiving & Retention Supported
Audit Management Supported
FDA Compliance Supported
HIPAA Compliance Supported
ISO Compliance Supported
Risk Management Supported
Version Control Supported
Workflow / Process Automation Supported
Artificial Intelligence (AI) Not Supported
Compliance Tracking Not Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
Incident Management Not Supported
OSHA Compliance Not Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported

Document Control

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

Quality Management

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

SimplerQMS Additional Categories

SimplerQMS Verified User Reviews

Write a Review
  • A SimplerQMS User
    CEO
    Used the software for: Less than 6 months
    Frequency of Use: Monthly
    User Role: User, Administrator, Deployment
    Company Size: 1 - 25
    Design
    Ease
    Features
    Pricing
    Support
    Probability You Would Recommend?
    1 2 3 4 5 6 7 8 9 10

    "Cumbersome system, very difficult contract termination"

    Posted 2026-09-11

    Pros: 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.

    Cons: 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.

    Overall: 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.

    Read More...
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