Audience

Startups and Growing Life Science Companies – Medical Devices, Pharmaceutical, Biotech, Laboratories, CRO / CMO

About SimplerQMS

SimplerQMS is an electronic quality management system (eQMS) built by life science experts. It helps life science companies stay compliant with FDA, ISO, and GxP requirements while reducing manual work and improving audit readiness. With SimplerQMS, teams can easily manage documents, change control, training, CAPA, analytics, and more on one cloud-based platform. The system is fully validated, so companies can start quickly without a long validation process.

What customers appreciate most:
• Compliant processes and fewer manual errors
• Fast implementation and smooth data migration
• User training and 24/7 global support
• Guidance from compliance experts throughout the journey

Whether you're a growing startup or an established life science company, SimplerQMS gives you the tools and support to build a strong quality culture and stay audit-ready every day.

Pricing

Starting Price:
$17,500 / year
Pricing Details:
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:
Free Trial available.

Integrations

API:
Yes, SimplerQMS offers API access

Ratings/Reviews - 2 User Reviews

Overall 3.0 / 5
ease 3.0 / 5
features 2.5 / 5
design 2.5 / 5
support 3.5 / 5

Company Information

SimplerQMS
Founded: 2017
Denmark
www.simplerqms.com

Videos and Screen Captures

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.

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Product Details

Platforms Supported
Cloud
Windows
Mac
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?
SimplerQMS works with these users and organization types: Mid Size Business, Small Business, Enterprise, and Startup.
Q: What languages does SimplerQMS support in their product?
SimplerQMS supports these languages: English.
Q: What kind of support options does SimplerQMS offer?
SimplerQMS offers support via phone support, 24/7 live support, and online.
Q: What other applications or services does SimplerQMS integrate with?
SimplerQMS integrates with: Microsoft Entra ID and Microsoft 365.
Q: Does SimplerQMS have an API?
Yes, SimplerQMS has an API.
Q: Does SimplerQMS have a mobile app?
Yes, SimplerQMS has a mobile app for Android, iPad, and iPhone.
Q: What type of training does SimplerQMS provide?
SimplerQMS provides training in the form of documentation, live online, and videos.
Q: Does SimplerQMS offer a free trial?
Yes, SimplerQMS offers a free trial.
Q: How much does SimplerQMS cost?
Pricing for SimplerQMS starts at $17,500 / year.
Q: What pricing for support is available for SimplerQMS?
SimplerQMS offers support included with purchase.
Q: What pricing for training is available for SimplerQMS?
SimplerQMS offers training included with purchase.

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
    Head of QA and Compliance
    Used the software for: 1-2 Years
    Frequency of Use: Daily
    User Role: User
    Company Size: 1 - 25
    Design 4 out of 5 stars
    Ease 5 out of 5 stars
    Features 4 out of 5 stars
    Pricing 4 out of 5 stars
    Support 5 out of 5 stars
    Probability You Would Recommend? 10 out of 10

    "Excellent Service"

    5 out of 5 stars Posted 2026-10-29

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

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

    Overall: 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.

    Read More...
    Reply from SimplerQMS
    Posted 2026-11-02
    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!
  • 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 1 out of 5 stars
    Ease 1 out of 5 stars
    Features 1 out of 5 stars
    Pricing 1 out of 5 stars
    Support 2 out of 5 stars
    Probability You Would Recommend? 1 out of 10

    "Cumbersome system, very difficult contract termination"

    1 out of 5 stars 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...
    Reply from SimplerQMS
    Posted 2026-09-30
    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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