SimplerQMS 2026: Benefits, Features & Pricing

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Overview
Pricing and Plans
Features
Integrations
User Reviews

Overview

SimplerQMS

4.6

(32)

Pricing

Starting at $1,200.00 per month

About SimplerQMS

SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes.

The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records.

Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards.

Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes:

• Audit-proven insights

• Guidance from compliance specialists

• Continuous system validation

• Unlimited user training

• 24/7 customer support

• Smooth implementation and data migration

• Dedicated Customer Success Experts

With a mission to help Life Science companies manage quality and regulatory docum...

SimplerQMS Screenshots

SimplerQMS Pricing and Plans

Starting price: $1,200.00 per month

Free Trial

Free Version

Starter

$1,200.00

flat rate, per month

Plan includes:

All eQMS modules
Full system implementation
Fully validated system
Continuous re-validation
Dedicated project manager
User training
Cloud-hosting
Integrations to other enterprise solutions

Team & Enterprise

Pricing available upon request

Plan includes:

For More than 10 users

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SimplerQMS Features

Popular features found in Quality Management
Change Management
Complaint Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Management
Electronic Signature
Incident Management
Quality Control
Risk Management
Task Management
Training Management
More features of SimplerQMS
Access Controls/Permissions
Activity Dashboard
Activity Tracking
Alerts/Escalation
Alerts/Notifications
API
Approval Process Control
Assessment Management
Audit Management
Audit Trail
Calibration Management
Certification Tracking
Compliance Management
Compliance Tracking
Customizable Forms
Customizable Reports
Customizable Templates
Data Import/Export
Data Security
Data Visualization
Digital Signature
Document Coding & Control
Document Review
Document Storage
Equipment Management
FDA Compliance
Forms Management
Inspection Management
ISO Compliance
ISO Standards Management
Issue Management
Maintenance Management
Monitoring
Nonconformance Tracking
Real-Time Analytics
Real-Time Data
Real-Time Reporting
Real-Time Updates
Regulatory Intelligence Feeds
Reporting & Statistics
Risk Assessment
Role-Based Permissions
Supplier Management
Supplier Quality Control
Third-Party Integrations
Version Control
Workflow Management

SimplerQMS Integrations

Jira

Microsoft Outlook

Microsoft PowerPoint

Microsoft Excel

Microsoft Word

SimplerQMS User Reviews

Overall Rating

4.6

Ratings Breakdown

56%

44%

Secondary Ratings

Ease of Use

4.3

Value for money

4.5

Customer support

5.0

Functionality

4.4

René Arnfeldt M.

Verified reviewer

Medical Devices

2-10 employees

Used weekly for more than 2 years

Review source

Reviewed April 2024

Flexible and Excellent Support

I have been using SimplerQMS for several years and have consistently been impressed with its flexibility and range of features. These features have met all my needs in every aspect, facilitating a smoother and more efficient management of quality documents and processes. The user-friendly interface and the system's adaptability to changing regulations and business needs have significantly eased the complexity of quality management. The excellent support team further enhances the overall experience, making any challenges encountered manageable and quickly addressed. My satisfaction with SimplerQMS is profound, as it continues to exceed my expectations, proving to be an essential tool for effective quality management.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

What stands out the most about SimplerQMS is its flexibility and contemporary design, which thoroughly addresses my needs. The system's ability to adapt to various scenarios and requirements makes it an invaluable tool in managing quality management processes efficiently. Moreover, the support team deserves special mention for their exceptional assistance. Their responsiveness and expertise not only enhance the user experience but also ensure that any issue or query is resolved promptly. This level of support is rare and highly appreciated, making SimplerQMS not just a tool, but a reliable partner in quality management.

Cons:

I have not discovered any serious issues

Vendor Response

Hi René, Thank you for your wonderful review! We're happy to hear that you appreciate the flexibility and contemporary design of SimplerQMS. It's great to know that our eQMS software and support team have met your needs and expectations so well. Your satisfaction and trust mean a lot to us, and we're delighted to be your partner. If you ever have any suggestions or further feedback, please don't hesitate to reach out.

Replied May 2024

Sumanesh A.

Verified reviewer

Medical Devices

2-10 employees

Used daily for less than 6 months

Review source

Reviewed October 2025

75 days after go-live.

Overall I am very satisfied. Great support staff and everyone sincerely wants to try and help to make the user experience good. I am still learning how to use several of the features. As I continue to learn the functionality and features, it should become easier to use. I have used several other "brand name" eQMS systems over the years and I find that SimplerQMS offers a lot of the same functionality at a more competitive price.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

1. Comprehensive suite for managing eQMS and includes tools for managing all the main eQMS functions such as Doc Control, Training, CAPA, Products, Change Control, Suppliers, etc, 2. Reasonably intuitive to use and consistent in the way that tasks are performed across modules. 3. Tech support is via email only, but normally replies within 24 hours. 4. Onboarding team is very friendly, helpful, collaborative and patient. 5. Reasonably good quality/content of sample procedures and form templates which they provide as a starting point to develop your QMS in case you do not have your own already. 6. Generous access to the "test" site to experiment and try things out before implementing them in the "production" system.

Cons:

1. Limited ability to generate reports. Have not figured out how to harness the meta data for this purpose. 2. Electronic signatures are displayed very inefficiently and adds 3 pages to the end of the document. Also e-sig doesn't look as professional as Docusign or other e-signature tools. 3. The onboarding training is brief and doesn't cover all the functionality. It didn't cover how to initiate/implement training or how to use Document Collections or Labels and Projects which are powerful features of the software. Onboarding covers several tasks but then the user is left to try an apply those lessons for other modules even though there can be slight differences. 4. M-Files interface can be unstable sometimes, resulting in freezing or certain functions (like approving documents) to become buggy...requiring a reboot of M-files and SimplerQMS

Reasons for choosing SimplerQMS

Price and features plus unlimited free (email) tech support

Malin T.

Verified reviewer

Medical Devices

2-10 employees

Used daily for less than 2 years

Review source

Reviewed April 2025

Easy to use e-QMS

We got great help and training through the whole process and we still get support whenever needed. Good stable solution which is easy to use.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Easy to use and easy to find docs. Everyone in the company knows how and where to find what they need. Good service and onboardin process.

Cons:

The built in system for NC's. I understand the point, but it takes too much time. At least for a samll company like ours. I replaced the NC system with a simple excel sheet but use the rest of the functions.

Vendor Response

Thank you for your feedback, Malin – we’re glad to hear that SimplerQMS has been easy for your team to use and that everyone can quickly find the documents they need. It’s especially great to know that our onboarding and support have met your expectations – we’ll pass your kind words on to the team! We appreciate your honest input regarding the Non-Conformance (NC) module. While it’s designed to support regulatory compliance and traceability, we recognize that smaller companies sometimes prefer lighter-weight processes. Your workaround with Excel is completely understandable, and we’re actively exploring ways to make NC handling more streamlined – particularly for early-stage or smaller teams. Thank you again for choosing SimplerQMS. We’re here to support you as your needs evolve, and always welcome feedback that helps us improve.

Replied July 2025

Cameron J.

Verified reviewer

Medical Devices

2-10 employees

Used daily for less than 12 months

Review source

Reviewed December 2024

SimplerQMS is our EssentialQMS

Very positive. We have had a good year roll-out and I anticipate stronger usage and reception as familiarity grows. We have also had an exceptional experience with the support staff and training teams. This side of the business earns almost the same degree of praise for their friendliness, professionalism, and competency in training.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

The platform is exactly what is needed without the bloat of some of the bigger programs. For a team having relatively little exposure to the fundamentals of QMS, sometimes the bigger (and more expensive!) programs are too intimidating. SimplerQMS offers the bare necessities and is perfect for our needs.

Cons:

Reliance on M-Files means there isn't a dedicated desktop version for non-Windows users. This means some of the help files and shortcuts that we try to establish internally require both desktop and web descriptions.

Reasons for choosing SimplerQMS

Price and familiarity. Price was definitely competitive and the other options seemed to cater to bigger teams and required buying in to more than what was needed.

Reasons for switching to SimplerQMS

Moved to a new company and needed to implement a QMS program.

Vendor Response

Hi Cameron, Thank you so much for your detailed and thoughtful review! We’re very happy to hear that SimplerQMS is meeting your needs and providing a streamlined QMS solution without unnecessary complexity. It’s also great to know that our support and training teams have made a positive impression – we’ll be sure to share your kind words with them! We appreciate your feedback about the reliance on M-Files and the challenges for non-Windows users. Your insights help us identify areas for improvement, and we’ll keep this in mind as we continue to refine our QMS platform. Thank you again for choosing SimplerQMS, and we’re excited to support your team as familiarity with the system grows. If you ever have questions or need further assistance, don’t hesitate to reach out!

Replied December 2024

Mads D.

Verified reviewer

Pharmaceuticals

2-10 employees

Used daily for more than 2 years

Review source

Reviewed April 2024

Simple system, easy to set up

Overall very happy with SimplerQMS despite the very few and small issues we have encountered.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Simple system that was incredibly easy to set up. Has almost all the support needed for a functioning QMS. Comes pre-validated which in turn saves the company a lot of time and effort. Great customer support.

Cons:

Not all regulatory requirements are implemented in SimplerQMS by default. You are able to stay compliant by setting up manual processes which takes time.

Reasons for choosing SimplerQMS

Costs and local customer support were main contributors

Vendor Response

Thank you for your review, Mads! We're pleased to hear that you found SimplerQMS easy to set up and that our fully validated eQMS system has been beneficial in saving time and effort for your company. Great customer support is a cornerstone of our service, and we're glad it stands out to you. We appreciate your honest feedback regarding the implementation of regulatory requirements. We strive to make compliance as streamlined as possible and will take your input into consideration as we continue to enhance our system. In our March 24’ release of SimplerQMS, we added default support for more regulatory requirements – based on the feedback from you and other customers. Thank you for choosing SimplerQMS, particularly for our cost-effectiveness and customer support. We look forward to continuing to provide you with a high-quality service and support your needs.

Replied April 2024

John O.

Verified reviewer

Biotechnology

11-50 employees

Used daily for less than 6 months

Review source

Reviewed April 2024

Best in class eQMS.

Exceptional customer service, excellent "hands on" training, and they are willing to help my team integrate other applications with SimplerQMS. They have been true partners in implementing SimplerQMS.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Exceptional customer support! Compliant to 21CFR parts 11, and 20. Compliant to ISO 13485:2015, and the set of templates provided basically makes SimplerQMS a "plug and play". Further, SimplerQMS literally provides around the clock support. There has not been one time in the three months that I've been using SimplerQMS that I have not had a question to a problem answered in more than 24 hours.

Cons:

I cannot think of one single negative experience that I have had with SimplerQMS.

Reasons for choosing SimplerQMS

Easy to use, out of the box compliance to 21CFR and ISO 13485 requirements.

Reasons for switching to SimplerQMS

We received poor customer service from Greenlight Guru.

Vendor Response

Thank you so much for your review, John! We are happy to hear about your positive experiences with SimplerQMS, from our compliance features to our customer support and training. It's particularly encouraging to know that our around-the-clock support has consistently met your needs. We take great pride in being a "plug and play" solution that simplifies compliance and enhances operational efficiency, and we're delighted that this has been your experience. Your feedback is invaluable as we continue to strive for excellence and support our clients like true partners. Thank you for choosing SimplerQMS. We look forward to continuing to support you and your team!

Replied April 2024

Subba S.

Verified reviewer

Medical Devices

2-10 employees

Used daily for less than 12 months

Review source

Reviewed August 2022

SimplerQMS works extremely well for our medical device startup

Simpler is much better than our previous paper-based QMS system. Document management, including versioning and digital signatures, is hugely better. We are just now implementing CAPA and defect management, which is the last piece we needed. We are very happy with Simpler, especially their service and support, and highly recommend it.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

Simpler gave us excellent pricing, customer support for understanding how to use their system and set up our QMS, and is easy to use. We can continue to use Microsoft Office for our documents. They have templates for all of the QMS sections that we could choose to use as the basis for our documents. They provided lots of hours in a structured way to work us through the migration of our paper based system to Simpler. My users have a varied level of technical sophistication with software, and everybody found the system easy to use.

Cons:

My issues are pretty minor. Sometimes the software runs a bit slowly, which I think may be a server issue. Simpler does a good job in keeping track of user training, but can only do "read and understood" acknowledgement. Simpler says that they are working on automated quizzes that can be set up to verify that training was received, but that feature has not been implemented yet. We do the quiz on paper and then upload to Simpler, which is fine at our small scale.

Reasons for choosing SimplerQMS

Price, feature set, ease of use, and most importantly support and help with setup/startup.

Vendor Response

Thank you for choosing SimplerQMS, Subba! We're glad to hear that you're satisfied with our product and our customer support. It's great to know that our software is easy to use for your team and that you find our templates helpful. Document controls, versioning, electronic signatures, and Microsoft Office Integration are some of the most popular features among our customers, so we're happy to hear that those are also working well for you. Regarding the speed issue, you should not be experiencing this problem. We have reached out to you to find the root cause and fix it. Our automated Quiz (Training Assessment) feature is now released, so you can benefit from this improvement instantly. Thank you for being a SimplerQMS customer and for your continued feedback!

Replied September 2022

Bonnie C.

Verified reviewer

Research

11-50 employees

Used weekly for less than 2 years

Review source

Reviewed February 2025

Excellent solution for a small imaging trial service group

We use it for our SOPs, controlled study documents, quality manual. We do not use products so we do not use suppliers, complaints, etc.

Ratings Breakdown

Ease of use

Value for money

Customer support

Functionality

Pros:

The system is comprehensive and can accommodate a variety of documents and processes.

Cons:

We do find the workflow slightly cumbersome.

Vendor Response

Thank you for your thoughtful review, Bonnie! We’re pleased to hear that you find SimplerQMS to be a comprehensive solution that supports your documentation needs across SOPs, study documents, and your quality manual. We appreciate your feedback regarding the workflow experience. While our workflows are designed to support rigorous life science compliance requirements, we recognize that ease of use is equally important. That’s why we’re actively working on new updates to improve workflow navigation and user interaction – including more intuitive visuals and simplified task handling. It’s also great to know that you’ve found value in the areas of the platform you use most. Many of our modules are designed to work independently or together, depending on your specific needs. Thank you again for choosing SimplerQMS, and for helping us continue to evolve with your input. If there’s ever anything you’d like to explore or improve, our team is always happy to support you.

Replied July 2025

Maike V.

Verified reviewer

Biotechnology

2-10 employees

Used weekly for less than 6 months

Review source

Reviewed May 2024

Opinion on SimplerQMS

We are still at the beginning and haven't worked with it too much yet, but it seems to be a good system that we can customise very well for our purposes. Sometimes I'm still looking for functions, but it's getting better and the tutorials are very good. If necessary, you can always ask the team, thank you very much!

Ratings Breakdown

Ease of use

Customer support

Functionality

Pros:

I find it mostly clearly organised. All changes can be tracked afterwards and the users are reminded for their tasks (for example upcoming training courses or versioning or other checks by suppliers). There are certainly a lot more mistakes made manually because you have to think about everything yourself. I also think the support is great, we can always ask questions and everyone endeavours to implement our requirements in the system or help us to find the exact functions we need.

Cons:

I don't like the continuous numbering of all processes and documents together in the system so much. I would have preferred to have differentiations as to whether I have an SOP or am just starting a change control for example. In addition, the system is often quite slow, at least for us.

Vendor Response

Hello Maike, Thank you for sharing your experience with SimplerQMS! We're pleased to hear that you find the system organized and our support team helpful. With regards to the speed of the system, we have made some recent changes to significantly improve your experience. We will reach out to you during the coming days to ensure that your experience is optimal. Your feedback on the numbering system is valuable and this is something that we have planned to improve in SimplerQMS. We're also glad the tutorials are helpful and that you're finding the system increasingly user-friendly. If you ever have further feedback, please don't hesitate to reach out.

Replied June 2024

Arles L.

Verified reviewer

Biotechnology

2-10 employees

Used weekly for less than 12 months

Review source

Reviewed June 2024

Ratings Breakdown

Ease of use

Customer support

Functionality

Pros:

The ease of use, customizability and the support given by the technical support team. I particularly like how the tech support team are always available for my questions and very fast in their response

Cons:

The release notes and patches could have been better communicated.

Vendor Response

Hi Arles, Thank you for your review! We're delighted to hear that you find our QMS software easy to use and customizable and that our tech support team has been responsive to your queries. We appreciate your feedback regarding the communication of release notes and patches and have improved this process. This means that all relevant users now receive email notifications about release notes and patches in due time. Furthermore, these are also published in our Knowledge Base.

Replied July 2024

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