SimplerQMS

About SimplerQMS
SimplerQMS offers Quality Management Software that is fully validated, cloud-based, and built specifically for companies within the Life Science industries.
Businesses can send documents through an automated workflow for processes such as document authoring, review, and approval, allowing you to save time and work more efficiently.
With SimplerQMS you can manage audits, document control, training, CAPAs, NCRs, suppliers, Electronic batch records, equipment calibration, change control, design control, and much more. It helps you stay in compliance with regulatory standards like FDA 21 CFR Part 11, GxP, cGMP, GAMP 5, GDPR, EU IVDR & EU MDR, ISO 13485:2016, 21 CFR Part 820, and others.
Out-of-the-box, the system is pre-validated and follows the validation requirements of GxP, FDA 21 CFR Part 11, and ISO 13485:2016.
FDA 21 CFR Part 11 compliant electronic signatures and audit trails allow for full traceability of your documentation.
SimplerQMS is built on M-Files and Microsoft Azure technologies. This ensures enterprise-level security to assure the privacy and security of your data. M-Files Document Management technology platform is used as the core technology. M-Files provides information management solutions to more than 5,000 organizations around the world. As a matter of fact, some of the M-Files customers have more than 10,000 users.
Regarding cloud storage, SimplerQMS uses a Microsoft Azure Cloud Storage solution. With SimplerQMS, out-of-the-box, you get 200 GB of file storage, allowing you to store more than 150,000 documents. Bear in mind, that upon request this storage can be increased. With our cloud storage provider, Microsoft Azure Cloud, you get data encryption at rest and during transmission.
Furthermore, data backups are executed every 15 minutes, the system is monitored by highly specialized professionals 24/7, and data is stored in multiple locations around the world.
SimplerQMS allows you to connect to Microsoft Azure Active Directory (Azure AD) user data management as well as the single sign-on.
The SimplerQMS software solution integrates with Microsoft Office 365, this allows you to work with Microsoft Office applications, such as Word, PowerPoint, and Excel. In SimplerQMS, all documents are edited in the Microsoft Office interface. After you finish working on the document, you can easily save the document in SimplerQMS with one click. Therefore, there is no need to download, edit, and then upload the document to the system, every time the user makes a change.
SimplerQMS can also be integrated with other applications. For example, you can integrate SimplerQMS with Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM), Customer Relationship Management (CRM), and others. Additionally, SimplerQMs provides an application programming interface (API). This allows you to integrate SimplerQMS not only with to above-mentioned applications but also with many other applications.
Pricing starting from:
US$1,150.00/month
- Free Version
- Free Trial
- Subscription
Key benefits of SimplerQMS
- Streamline your documentation processes by sending documents through an automated workflow for authoring, review, and approval.
- Sign documents with Electronic Signatures to speed up your document control processes, wherever you are.
- Take the advantage of Quality Management Software that is designed specifically for the Life Science organizations operating in industries such as Medical Device, MedTech, Pharmaceutical, BioTech, IVD, and CRO.
- Access your documentation and present it to the auditor, wherever you are – all data is stored in a single, cloud-based storage, and integrated into other quality processes.
- Get an overview of your entire quality system with our built-in KPI reports - analyze data, identify patterns, and understand what is impacted by each quality event.
- Save time by using our pre-made form package which includes ISO 13485:2016 and 21 CFR 820 compliant Quality Manual, Procedures, Forms, and Instructions.
- No need to spend time and resources on system validation processes – SimplerQMS offers a pre-validated solution.
- QMS software solution that is in compliance with 21 CFR Part 11, ISO 13485, 21 CFR Part 820, GAMP5, cGMP, GxP, EU MDR, EU IVDR, GDPR, and others.
- Implement your Quality Management Software in 5-6 weeks.
- A dedicated project manager that assists you throughout the entire implementation phase.
- Access ongoing support by email, phone, and video calls, which is included in the subscription price.
- Fully transparent pricing - SimplerQMS offers an all-in-one solution for one subscription price, depending on the number of licenses you decide to purchase.
- 200 GB of file storage which allows you to store more than 150,000 documents.
- Highly secure cloud storage with data encryption, backups every 15 minutes, servers in multiple locations, and 24/7 system monitoring.
Typical Customers
- Freelancers
- Small Businesses (2-50)
- Mid-size Companies (51-500)
- Large enterprises (500 and more)
Deployment
- Cloud-based
- On-premise
Supported Languages
English
Pricing starting from:
US$1,150.00/month
- Free Version
- Free Trial
- Subscription
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Features
Total features of SimplerQMS: 47
Alternatives
Scilife

MasterControl Quality Excellence

Arena

QCBD

Reviews
Already have SimplerQMS?
Software buyers need your help! Product reviews help the rest of us make great decisions.

- Industry: Medical Devices
- Company size: 2–10 Employees
- Used Weekly for 2+ years
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 10.0 /10
Flexible and Excellent Support
Reviewed on 2024/04/09
I have been using SimplerQMS for several years and have consistently been impressed with its...
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
Response from SimplerQMS
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.
- Industry: Medical Devices
- Company size: 2–10 Employees
- Used Daily for 6-12 months
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 10.0 /10
SimplerQMS is our EssentialQMS
Reviewed on 2024/12/04
Very positive. We have had a good year roll-out and I anticipate stronger usage and reception as...
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.
Reasons for Choosing SimplerQMS
Moved to a new company and needed to implement a QMS program.Reasons for Switching to 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.Response from SimplerQMS
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!
- Industry: Medical Devices
- Company size: 2–10 Employees
- Used Daily for 2+ years
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 7.0 /10
SimplerQMS review
Reviewed on 2024/04/09
Satisfied with overview and management of documentation
Satisfied with overview and management of documentation
Pros
The version control
The documentation management
Cons
The possibility to manage the access for different employers
Response from SimplerQMS
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!
- Industry: Pharmaceuticals
- Company size: 2–10 Employees
- Used Daily for 2+ years
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 8.0 /10
Simple system, easy to set up
Reviewed on 2024/04/15
Overall very happy with SimplerQMS despite the very few and small issues we have encountered.
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
ScilifeReasons for Switching to SimplerQMS
Costs and local customer support were main contributorsResponse from SimplerQMS
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.
- Industry: Biotechnology
- Company size: 11–50 Employees
- Used Daily for 1-5 months
-
Review Source
Overall rating
- Value for Money
- Ease of Use
- Customer Support
- Likelihood to recommend 10.0 /10
Best in class eQMS.
Reviewed on 2024/04/10
Exceptional customer service, excellent "hands on" training, and they are willing to help my team...
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.
Reasons for Choosing SimplerQMS
We received poor customer service from Greenlight Guru.Switched From
Greenlight GuruReasons for Switching to SimplerQMS
Easy to use, out of the box compliance to 21CFR and ISO 13485 requirements.Response from SimplerQMS
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!
SimplerQMS FAQs
Below are some frequently asked questions for SimplerQMS.Q. What type of pricing plans does SimplerQMS offer?
SimplerQMS offers the following pricing plans:
- Starting from: US$1,150.00/month View Pricing Plans
- Pricing model: Subscription
- Free Trial: Not Available
With SimplerQMS you get everything for one subscription price, depending on the number of licenses. We offer three license types - Concurrent/Multi-User Licenses; Named/Single-User Licenses; Read and Sign User Licenses. Contact sales to get a pricing quote tailored to your organization's needs!
Q. Who are the typical users of SimplerQMS?
SimplerQMS has the following typical customers:
2–10, 11–50, 51–200, 201–500, 501–1,000
Q. What languages does SimplerQMS support?
SimplerQMS supports the following languages:
English
Q. Does SimplerQMS support mobile devices?
SimplerQMS supports the following devices:
Android (Mobile), iPhone (Mobile), iPad (Mobile)
Q. What other apps does SimplerQMS integrate with?
SimplerQMS integrates with the following applications:
Jira
Q. What level of support does SimplerQMS offer?
SimplerQMS offers the following support options:
Email/Help Desk, Knowledge Base, Phone Support
Related categories
See all software categories found for SimplerQMS.