# SimplerQMS Reviews 2026. Verified Reviews, Pros & Cons | Capterra

> Is SimplerQMS the right Quality Management solution for you? Explore 32 verified user reviews from people in industries like yours to make a confident choice.

Source: https://www.capterra.com/p/235957/SimplerQMS/reviews

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SimplerQMS

4.6 (32)

[View alternatives](https://www.capterra.com/p/235957/SimplerQMS/alternatives/)

Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Learn more](https://www.capterra.com/our-story/)

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Last updated March 4th, 2026

# Reviews of SimplerQMS

Ease of use

4.3

Customer Service

5.0

## Pros and Cons in Reviews

MH

Michael H

CEOBiotechnology, Self-employedUsed the software for: Less than 6 months.

“The guidance and training plan for implementing SimplerQMS are impressive and a real support for the digitalisation of your quality processes.“

May 27, 2024

SA

Sumanesh A

VP RA, QAMedical Devices, 2 - 10 employeesUsed the software for: Less than 6 months.

“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“

October 20, 2025

JO

John O

Sr. Director of QualityBiotechnology, 11 - 50 employeesUsed the software for: Less than 6 months.

“Exceptional customer service, excellent "hands on" training, and they are willing to help my team integrate other applications with SimplerQMS.“

April 10, 2024

SA

Sumanesh A

VP RA, QAMedical Devices, 2 - 10 employeesUsed the software for: Less than 6 months.

“The onboarding training is brief and doesn't cover all the functionality.“

October 20, 2025

René Arnfeldt M

CEOMedical Devices, 2 - 10 employeesUsed the software for: More than 2 years.

“Their responsiveness and expertise not only enhance the user experience but also ensure that any issue or query is resolved promptly.“

April 9, 2024

BC

Bonnie C

Sr. DirectorResearch, 11 - 50 employeesUsed the software for: 1-2 years.

“We do find the workflow slightly cumbersome.“

February 28, 2025

René Arnfeldt M

CEOMedical Devices, 2 - 10 employeesUsed the software for: More than 2 years.

“The excellent support team further enhances the overall experience, making any challenges encountered manageable and quickly addressed.“

April 9, 2024

BM

Bryan M

VP, QACosmetics, 11 - 50 employeesUsed the software for: 6-12 months.

“The initial learning curve was steep, and being the only employee in the company working on implementation made it that much more challenging.“

August 8, 2023

## Showing most helpful reviews

Showing 1-25 of 32 Reviews

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Most Helpful

Rating

Company Size

Reviewer's Role

Length of Use

Frequency of Use

JP

Jaana P.  
Quality Manager  
Medical Devices  
Used the software for: 2+ years

### "Review by healthtech start up"

August 8, 2022

4.0

Amount of manual work have decreased with SimplerQMS. Especially document workflow is now less prone for errors. Email reminders and periodic tasks have helped to minimize calendar reminders.

Pros

SimplerQMS offered possibility for ISO 13485 compliant document management and processing. Automated options of the system have minimized our manual work. Simpler team offers their full and easy-to-access support for the customers and have free of charge templates available. System integration was flexible and could be scaled to our small team.

Cons

Sometimes short connection problems prevent use of the system. System is relatively new on the market and has included some bugs.

Alternatives considered

[Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/)[Qualio](https://www.capterra.com/p/134050/Quality-Management-Software/)

Reason for choosing SimplerQMS

Possibility for customer-specific tailoring looked more easy than with other options. Customer communication and service was excellent from the first contact.

Review Source

Response from SimplerQMS

August 16, 2022

Thank you for your kind words, Jaana! We're glad to hear that our QMS software system has been able to help minimize your manual work and improve document workflow. Our team is passionate about providing excellent customer service, so it's great to know that we've been able to exceed your expectations. With regards to the short connection problems, then this should not be happening and needs to be fixed. Our support team will reach out to you and work on finding a solution. We recognize that we had some issues in the early versions of SimplerQMS, which have now been fixed. Please reach out at any time to our helpdesk or hotline if you experience any new issues. Thank you again for choosing SimplerQMS, and we hope you'll continue to find value in our system.

SS

Subba S.  
Chief Technology Officer  
Medical Devices  
Used the software for: 6-12 months

### "SimplerQMS works extremely well for our medical device startup"

August 8, 2022

5.0

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.

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.

Alternatives considered

[Arena](https://www.capterra.com/p/186809/Arena/)[Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/)[MasterControl Quality Excellence](https://www.capterra.com/p/148577/MasterControl/)[Qualio](https://www.capterra.com/p/134050/Quality-Management-Software/)

Reason for choosing SimplerQMS

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

Review Source

Response from SimplerQMS

September 5, 2022

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!

HN

Helle N.  
QA RA Manager  
Medical Devices  
Used the software for: 2+ years

### "SimplerQMS review"

April 9, 2024

4.0

Satisfied with overview and management of documentation

Pros

The version control The documentation management

Cons

The possibility to manage the access for different employers

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for your review, Helle! We're pleased to hear that you find the version control and documentation management features beneficial. Your feedback on enhancing the access management for different users is incredibly valuable. We have recently added more features to manage access and will reach out to you to help you use these. We're committed to making SimplerQMS as user-friendly and efficient as possible for all our customers. Thanks for sharing your thoughts!

JCM

Jean Claude M.  
Head of Hardware and Software Development  
Medical Devices  
Used the software for: 1-2 years

### "SimplerQMS is indeed simple to use. Very good quality to money ratio"

August 16, 2022

4.0

SimplerQMS is indeed simple to use. Very good quality to money ratio. We are very happy with the selection of SimplerQMS as our eQMS tool.

Pros

Easy to work with. Intuitive. Rather easy to setup. Very good customer support. Good quality to price ratio.

Cons

Product/ Article Management not proper integrated. Only a work around is implemented that we use for the moment but is not the optimal solution yet.

Reason for choosing SimplerQMS

price. overall impression of the tool during the demos.

Switched from

[QCBD](https://www.capterra.com/p/107192/QCBD/)

QCBD did not support all our needs. Training Management, etc. Very out dated tool. Bad usability.

Review Source

Response from SimplerQMS

September 5, 2022

Thank you for choosing SimplerQMS, Jean Claude! We're glad to hear you find our product easy to use, with a good quality-to-price ratio, and that our customer support has been up to par. Concerning Product/Article Management, we will reach out to you to get your input on how this can be improved. We have some upcoming improvements in the pipeline, but we would very much appreciate your feedback on this area. Thank you for your feedback and for choosing SimplerQMS!

MT

Michael T.  
Director Quality  
Pharmaceuticals  
Used the software for: 6-12 months

### "eQMS with no hassle"

April 11, 2024

5.0

Very good experience, great and very fast support.

Pros

User-friendly and simple to use. Easy to customize to fit your individual needs. Modular system ensures that users can only see relevant modules.

Cons

Learning Rules must be established to assign users to read & understand documents instead of having read & understand requirements as default settings for relevant document types

Alternatives considered

[Veeva Vault](https://www.capterra.com/p/173465/Veeva-Vault/)

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for your review, Michael! We're delighted to hear that you find SimplerQMS user-friendly and adaptable to your specific needs. It's great to hear that the modular eQMS system is effectively helping manage user access to relevant information. Your feedback regarding the learning rules and document understanding requirements is very helpful. We have added this enhancement request to our backlog and will get in touch with out about this subject. We're happy to hear that our support team has been able to assist you promptly and effectively. Thanks again for choosing SimplerQMS. We look forward to continuing to support your success!

VC

Vlad C.  
Quality Manager  
Medical Devices  
Used the software for: 6-12 months

### "CathVision "

April 9, 2024

4.0

Pros

SimplerQMS comes with plenty of feathers which helps a lot in keeping the daily work inside the eQMS. I and our team find the system user-friendly and simple to use. Whenever challenges and issues arise, the support team from SimplerQMS immediately takes action to find the solution and solve the problems for us as Customers.

Cons

Speaking from my role as a Quality Manager and Administrator of the eQMS system, I would like to have more access from an administrative/admin account point of view. Sometimes we do updates and changes to the processes and It would be great if access to modify the workflows for some of the features would be possible.

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for your detailed feedback, Vlad! It's great to hear that you and your team find SimplerQMS user-friendly and effective for managing your daily work. We appreciate your positive comments about our support team's responsiveness. Regarding your suggestion for enhanced administrative access, we take such feedback seriously as it helps us to better cater to the needs of our users, particularly those in critical roles like yours. We are continually working on improving our system's flexibility and will be adding a new “Super Admin Role”, which is addressing your feedback. Thanks again for choosing SimplerQMS. We look forward to continuing to support your team's needs!

NEH

Niels Erik H.  
CEO  
Medical Devices  
Used the software for: 2+ years

### "Simpler QMS review"

April 9, 2024

5.0

Would not like to work without it after introduction of MDR and FDA regulation.

Pros

Ease og speed to find documents. Very useful during audits

Cons

That i have to read and understand a procedure that I already have approved

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for the wonderful review, Niels Erik! We're delighted to hear that SimplerQMS has made it easier and faster for you to find documents, especially during audits. It's great to know that our eQMS software has become indispensable to you following the introduction of MDR and FDA regulations. Regarding your concern about having to review procedures you've already approved, we understand how that might seem redundant. We aim to ensure compliance and thorough understanding at all levels, but we appreciate your feedback and will consider how we might streamline this process for a more efficient user experience. We do have an upcoming release that will allow admins to only require “Read & Understood” on specific document updates. Thanks again for sharing your thoughts and for relying on SimplerQMS. We're here to support your continued success!

MK

Muctehit K.  
QA Manager  
Pharmaceuticals  
Used the software for: 1-2 years

### "Feedback after 1 year of deployment/use"

April 11, 2024

5.0

Pros

implementation process, easy to learn and use

Cons

Some default settings do not always maintain the nomenclature of previous systems

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for your review, Muctehit! We're glad to hear that you've found the implementation process easy and the system user-friendly over the past year. Your feedback about the default settings and classification is very helpful, and we'll consider how we can improve in maintaining consistency with previous systems in our future updates. We appreciate you taking the time to share your experiences after extensive use, and we are here to support any further needs or suggestions you might have. Thank you for being a valued user of SimplerQMS!

DM

Dirk M.  
Regulatory and Quality Affairs Manager  
Biotechnology  
Used the software for: 1-2 years

### "A happy customer"

April 9, 2024

5.0

Pros

Amazing customer support and help. The system is clearly structured. After the introduction, it is easy to use.

Cons

Mac user interface is inferior to Windows. When starting with the system it has an old-fashioned look on a Mac but the functionality is there. One just needs to get used to it.

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for your feedback, Dirk! We're glad to hear that you're pleased with our customer support and find the system easy to use after the initial setup. We appreciate your comments regarding the Mac user interface; we are currently working on a much-improved user experience for Mac users. We will get in touch with you as soon as the new modern interface has been thoroughly tested and validated. We're always here to ensure your experience with SimplerQMS is nothing short of excellent. Thanks for being a valued customer!

AG

Anders G.  
QA Manager  
Medical Devices  
Used the software for: 2+ years

### "SimplerQMS for MedTech startup"

April 15, 2024

4.0

Pros

Easy to install and implement, easy to start using and great customer support when needed.

Cons

Less graphic and intuitive than larger systems, but that trade-off is outweighed by price and simplicity.

Review Source

Response from SimplerQMS

April 30, 2024

Thank you for your review, Anders! It's great to hear that you found SimplerQMS easy to implement and use. We're glad that our customer support team has been there for you when needed. We appreciate your feedback on the system's graphics and intuitiveness; this is something we are currently in the process of improving. Especially the graphical elements are a strong focus of ours, with the addition of the Dashboard and Visual Workflows during the past months, we are putting resources into addressing this. Thank you for choosing us and for sharing your perspective. We look forward to continuing to support your business's growth and success!

PAE

Per Anders E.  
Regulatory Affairs Manager  
Medical Devices  
Used the software for: 1-2 years

### "Managing documentation and records for medical devices"

August 8, 2022

5.0

Pros

The software is indeed trustworthy for managing and maintaining good document control. After onboarding and some training, the system is also very easy to use.

Cons

The user interface could have been more intuitive.

Review Source

Response from SimplerQMS

August 16, 2022

Thank you for choosing SimplerQMS, Per Anders. We're glad to hear that you find our software trustworthy and easy to use. Our goal is to make document control simple for everyone, and we appreciate your feedback on our user interface. In an upcoming release, the user interface will be updated to a modern look and feel. There will also be a better visual way of overviewing workflows, making the user interface more intuitive. Thank you again for choosing SimplerQMS!

SA

Sumanesh A.  
VP RA, QA  
Medical Devices  
Used the software for: Less than 6 months

### "75 days after go-live."

October 20, 2025

4.0

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.

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

Alternatives considered

[QuickBooks Online](https://www.capterra.com/p/190778/QuickBooks-Online/)

Reason for choosing SimplerQMS

Price and features plus unlimited free (email) tech support

Review Source

MT

Malin T.  
Head of R and D  
Medical Devices  
Used the software for: 1-2 years

### "Easy to use e-QMS"

April 10, 2025

4.0

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.

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.

Review Source

Response from SimplerQMS

July 21, 2025

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.

CJ

Cameron J.  
Vice President of Engineering and Quality  
Medical Devices  
Used the software for: 6-12 months

### "SimplerQMS is our EssentialQMS"

December 4, 2024

5.0

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.

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.

Alternatives considered

[Docusign](https://www.capterra.com/p/121506/Docusign/)[Veeva Vault](https://www.capterra.com/p/173465/Veeva-Vault/)[Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/)[Windchill](https://www.capterra.com/p/124676/Windchill-Quality-Solutions/)[MasterControl Quality Excellence](https://www.capterra.com/p/148577/MasterControl/)

Reason 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.

Review Source

Response from SimplerQMS

December 23, 2024

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!

BC

Bonnie C.  
Sr. Director  
Research  
Used the software for: 1-2 years

### "Excellent solution for a small imaging trial service group"

February 28, 2025

4.0

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

Pros

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

Cons

We do find the workflow slightly cumbersome.

Review Source

Response from SimplerQMS

July 21, 2025

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.

René Arnfeldt M.  
CEO  
Medical Devices  
Used the software for: 2+ years

### "Flexible and Excellent Support"

April 9, 2024

5.0

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.

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

Review Source

Response from SimplerQMS

May 27, 2024

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.

AL

Arles L.  
Scientist  
Biotechnology  
Used the software for: 6-12 months

### " "

June 28, 2024

5.0

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.

Review Source

Response from SimplerQMS

July 8, 2024

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.

MV

Maike V.  
Head of QA  
Biotechnology  
Used the software for: Less than 6 months

### "Opinion on SimplerQMS"

May 27, 2024

5.0

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!

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.

Review Source

Response from SimplerQMS

June 10, 2024

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.

MH

Michael H.  
CEO  
Biotechnology  
Used the software for: Less than 6 months

### "A guided eQMS implementation"

May 27, 2024

4.0

Pros

The guidance and training plan for implementing SimplerQMS are impressive and a real support for the digitalisation of your quality processes. In addition to the validation policy offered, these are the two main arguments for choosing this product.

Cons

The terminology of eQMS clearly originates from the field of medical devices. A GMP-compliant vocabulary would certainly be helpful for the pharmaceutical industry.

Review Source

Response from SimplerQMS

June 10, 2024

Dear Michael, Thank you for your feedback and for choosing SimplerQMS! We're glad to hear that our guidance and training plan have been helpful for the digitalization of your quality management system process. We appreciate your suggestion regarding GMP-compliant terminology and are continuously working to improve our alignment in that area. An example of this is that three of our newest team members come with more than 10 years of GMP experience (from both GMP research and manufacturing organizations). If you ever have further suggestions feedback, please let us know.

MD

Mads D.  
Head of Quality Assurance  
Pharmaceuticals  
Used the software for: 2+ years

### "Simple system, easy to set up"

April 15, 2024

4.0

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

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.

Alternatives considered

[Scilife](https://www.capterra.com/p/179853/QualityKick/)

Reason for choosing SimplerQMS

Costs and local customer support were main contributors

Review Source

Response from SimplerQMS

April 30, 2024

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.

JO

John O.  
Sr. Director of Quality  
Biotechnology  
Used the software for: Less than 6 months

### "Best in class eQMS."

April 10, 2024

5.0

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.

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.

Alternatives considered

[Arena](https://www.capterra.com/p/186809/Arena/)[ZenQMS](https://www.capterra.com/p/138691/ZenQMS/)[MasterControl Quality Excellence](https://www.capterra.com/p/148577/MasterControl/)[Qualio](https://www.capterra.com/p/134050/Quality-Management-Software/)

Reason for choosing SimplerQMS

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

Switched from

[Greenlight Guru](https://www.capterra.com/p/140578/greenlight-guru/)

We received poor customer service from Greenlight Guru.

Review Source

Response from SimplerQMS

April 30, 2024

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!

HH

Henrik H.  
QA & RA Manager  
Medical Devices  
Used the software for: 1-2 years

### "Review of SimplerQMS"

August 5, 2022

4.0

Having an electronic QMS system, which is CFR Part 21 compliant and where all the documents are related to each other is a very good thing to support documenting that the company are in compliance e.g., during an external.

Pros

The document control is the basic feature and it works fine. It is good that the change control controls the release of the documents, which each company self decides, so you avoid having closed the change request without released all the related documents. That SOPs relevant for an employee is linked, so when the SOP is updated the employee automatic receives a task to read and sign for having read the updated SOP. You need to learn the workflow and how to use the meta data, which requires practice a few times, and when that is learned, then it is easy to work with.

Cons

The possiblity for the user him/her-self to re-open recorded issues, e.g., Complaints, CAPAs, NCs and locked meta data for modification. The modification must be with traceability. The user interface could be more intuitive, but the risk could be that experienced users would find it irritating.

Review Source

Response from SimplerQMS

August 16, 2022

Thank you for your honest review, Henrik. We're happy to hear that you find our document control features to be functional and help you with compliance. With regards to making the user interface more intuitive, then we are working on several initiatives to accomplish this. One of them is a way to visualize workflows to make the UI easier to use both for experienced and less experienced users. Your input is invaluable to us and helps ensure that we are creating the most effective and user-friendly quality management software possible. Thank you again for choosing SimplerQMS and we hope you'll continue to find value in our product.

DW

Dorthe W.  
QA/RA Manager  
Medical Devices  
Used the software for: 2+ years

### "Pioneering SimplerQMS"

August 4, 2022

5.0

Spending most of my day using SimplerQMS, I would say I am very pleased with the ease of use.

Pros

The migration from an old paper-based system to a digital system is a great advantage in itself. Everybody now knows where to find the information they need. Our Notified Body required us to use a digital system, and transferring documents to them is much easier

Cons

Some of the workflows are not logical to me, so I have had to learn instead of understand

Reason for choosing SimplerQMS

Mainly because it suited our need best, and because it is based in Denmark, so we can get help in Danish

Review Source

Response from SimplerQMS

August 16, 2022

Thank you for choosing SimplerQMS Dorthe, and for taking the time to write such a positive review. We're glad to hear that you find our software easy to use and that the migration from your old system has been smooth. With regards to improving the user experience for some workflows, this is something we are currently working on. We will be releasing a new way to see workflows using a visual overview, which will make it easier to understand and learn how they work. Our goal is to make your work as efficient as possible and we appreciate your feedback so that we can continue to improve our product.

DV

Dick V.  
CEO  
Medical Devices  
Used the software for: 1-2 years

### "The easy way to implement a QMS"

August 8, 2022

5.0

SimplerQMS has given us the means to be able to implement a MDR environment while our whole team is only 5 people

Pros

Creating a controlled quality environment in a way that reflects the workflow without blocking you

Cons

No Apple based app, but the webbrowser works perfectly

Alternatives considered

[Arena](https://www.capterra.com/p/186809/Arena/)

Reason for choosing SimplerQMS

More suited for MDR implementation

Review Source

Response from SimplerQMS

August 16, 2022

Thank you for choosing SimplerQMS, Dick. We're glad to hear you find our product easy to use and that it's been a good fit for your needs. Our team is passionate about making quality management simple and accessible for everyone, and we're happy to know we've been able to help you achieve your goals. With regards to the Apple based app, when we are looking into this option. However, we are very happy that the browser-based option works perfectly for you on the Mac. If you ever have any questions or suggestions on how we can continue to improve, please don't hesitate to reach out. We love hearing from our users and value your feedback. Thank you again for choosing SimplerQMS!

LFE

Louise Flintegaard E.  
QA/RA Manager  
Medical Devices  
Used the software for: 2+ years

### "Professional QMS tool with great support team "

August 3, 2022

5.0

Overall the SimplerQMS Platform solves our need for a QMS system. As the administrator I have only had good experiences with the platform as well as the team behind. If errors occur They are easy to get hold of and it is easy for us to get help.

Pros

SimplerQMS provides the needed overview for us. It helps us to track document trails and secure timely signatures and assignments.

Cons

Users using MAC needs to run the program a bit different which sometimes makes it hard to give directions.

Reason for choosing SimplerQMS

Best stomach feeling - and easy to get started.

Review Source

Response from SimplerQMS

August 16, 2022

Thank you for choosing SimplerQMS, Louise. We're glad to have you with us and that you find our eQMS platform helpful! I'll be sure to pass on your compliments to the team. We understand that using a Mac can be a little different. A new web version of our software will be released soon. The new web User Interface will look like the Windows application and will therefore make it easier to give directions to Mac users. If there are ever any questions or issues, please don't hesitate to reach out. We want you to have the best experience possible with our QMS software solution. Thank you again for choosing SimplerQMS, Louise!

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