What is SimplerQMS?

SimplerQMS is a specialized electronic Quality Management System (eQMS) tailored specifically for organizations in the Life Sciences sector. Designed by industry experts, our eQMS ensures compliance with essential regulations such as FDA, ISO, and GxP by facilitating automated and audit-ready quality processes.

The platform effectively centralizes and automates fundamental quality workflows within a fully validated, cloud-based system, allowing clients to minimize manual tasks, decrease errors, and maintain consistently organized records that are always inspection-ready.

In contrast to standard QMS tools, SimplerQMS is pre-configured to meet the unique requirements of the Life Sciences industry, incorporating templates, workflows, and controls that align with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other relevant standards.

Furthermore, clients benefit from a reliable partnership that provides extensive regulatory and quality knowledge, which includes access to audit-proven insights, advice from compliance experts, ongoing system validation, user training, round-the-clock global support, seamless implementation and data migration, along with dedicated Customer Success Experts.

Our mission is to empower Life Science companies in efficiently managing quality and regulatory documentation, enabling organizations to thrive from initial growth stages to global operations while enhancing compliance, operational control, and fostering a robust quality culture. By leveraging our expertise, businesses can streamline their processes and ensure they meet the highest industry standards.

Pricing

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

Integrations

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

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.

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
Mac
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
1-10
11-50
51-200
201-500
501-1000
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
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

CAPA Software

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

Audit Software

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
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...
    Official SimplerQMS 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.
  • Reviewer Name: A Verified Reviewer
    Position: Head of QA and Compliance
    Has used product for: 1-2 Years
    Uses the product: Daily
    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

    Excellent Service

    Date: Oct 29 2026
    Summary

    Great experience. I was nervous at first as I hadn't had good experiences with other eQMS programs in the past, but the ongoing transition has been easy and everyone on the SimplerQMS team has been very supportive; in particular Paolo Navarro.

    Positive

    The SimplerQMS team have made the transition from a paper based system stress-free and have provided excellent support for my team.

    Negative

    Some of the existing work flows don't work with our particular processes and we have had to find work arounds.

    Read More...
    Official SimplerQMS Response
    Date: Nov 02 2026
    Thank you for sharing your experience with SimplerQMS! We truly appreciate your trust. We're glad to hear that our team has made your transition from a paper-based QMS seamless and provided ongoing support. We also appreciate your constructive feedback. We're continuously working to improve the SimplerQMS platform and services to better support the evolving needs of life science companies and their quality processes. It's a pleasure to be your partner on this journey. If there's anything else we can do to support you, please don't hesitate to reach out to our Customer Support team. Thank you again for your trust and partnership!
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