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

Markets

Afghanistan, Albania, Algeria, American Samoa, Andorra and 223 others

Supported Languages

English

Pricing starting from:

US$1,150.00/month

  • Free Version
  • Free Trial
  • Subscription

Images

SimplerQMS Software - SimplerQMS Document Control Management features enforce the use of standardized and approved forms which are created by Microsoft Office. This allows users to easily draft new documents like instructions, CAPAs, and others, based on your customized forms.
SimplerQMS Software - SimplerQMS provides Electronic Signatures that are compliant with the FDA 21 CFR Part 11 and the GxP Guidelines. SimplerQMS allows users to sign and send any document with eSignatures through an automated workflow from practically anywhere in the world.
SimplerQMS Software - SimplerQMS provides built-in dashboards to overview any post-market event by product, process, customer, equipment, supplier, or other data points. Automated KPI reports allow users to view trends and address areas of concern before they become a reality.
SimplerQMS Software - With SimplerQMS you can maintain a list of approved suppliers and use forms to create records like contracts, surveys, evaluations, certificates, and inspections. Schedule reoccurring supplier reviews and receive notifications about pending tasks.
SimplerQMS Software - In SimplerQMS you can get a real-time overview of your organization’s training activities. Our dashboard can, for example, show activities by process, department, person, or document.
View 6 more
SimplerQMS video
SimplerQMS Software - SimplerQMS Document Control Management features enforce the use of standardized and approved forms which are created by Microsoft Office. This allows users to easily draft new documents like instructions, CAPAs, and others, based on your customized forms.
SimplerQMS Software - SimplerQMS provides Electronic Signatures that are compliant with the FDA 21 CFR Part 11 and the GxP Guidelines. SimplerQMS allows users to sign and send any document with eSignatures through an automated workflow from practically anywhere in the world.
SimplerQMS Software - SimplerQMS provides built-in dashboards to overview any post-market event by product, process, customer, equipment, supplier, or other data points. Automated KPI reports allow users to view trends and address areas of concern before they become a reality.
SimplerQMS Software - With SimplerQMS you can maintain a list of approved suppliers and use forms to create records like contracts, surveys, evaluations, certificates, and inspections. Schedule reoccurring supplier reviews and receive notifications about pending tasks.
SimplerQMS Software - In SimplerQMS you can get a real-time overview of your organization’s training activities. Our dashboard can, for example, show activities by process, department, person, or document.

Features

Total features of SimplerQMS: 47

  • API
  • Access Controls/Permissions
  • Activity Dashboard
  • Activity Tracking
  • Alerts/Escalation
  • Alerts/Notifications
  • Approval Process Control
  • Audit Management
  • Audit Trail
  • Change Management
  • Complaint Management
  • Compliance Management
  • Corrective and Preventive Actions (CAPA)
  • Customizable Forms
  • Customizable Reports
  • Customizable Templates
  • Data Import/Export
  • Data Visualization
  • Defect Tracking
  • Document Coding & Control
  • Document Management
  • Document Review
  • Document Storage
  • Equipment Management
  • Forms Management
  • ISO Standards Management
  • Incident Management
  • Inspection Management
  • Issue Management
  • Maintenance Management
  • Monitoring
  • Quality Control
  • Real-Time Analytics
  • Real-Time Data
  • Real-Time Reporting
  • Real-Time Updates
  • Reporting & Statistics
  • Risk Assessment
  • Risk Management
  • Role-Based Permissions
  • Supplier Management
  • Supplier Quality Control
  • Task Management
  • Third-Party Integrations
  • Training Management
  • Version Control
  • Workflow Management

Alternatives

Scilife

4.4
#1 Alternative to SimplerQMS
All-in-one, pre-validated and cloud-based platform to improve quality management, processes, and product development...

MasterControl Quality Excellence

4.5
#2 Alternative to SimplerQMS
The MasterControl Quality Management System (QMS), called "MasterControl Quality Excellence", enables companies to...

Arena

4.5
#3 Alternative to SimplerQMS
Arena creates group rooms for any event, live, and streaming allowing users to discuss and talk about your content....

QCBD

4.6
#4 Alternative to SimplerQMS
QCBD is a Windows-based QMS (quality management system) for small to mid-size manufacturing companies which supports a...

Reviews

Overall rating

4.6 /5
(29)
Value for Money
4.6/5
Features
4.4/5
Ease of Use
4.3/5
Customer Support
5/5

Already have SimplerQMS?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 29
René Arnfeldt
René Arnfeldt
Overall rating
  • 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.

Cameron
Overall rating
  • 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!

Helle
Overall rating
  • 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!

Mads
Overall rating
  • 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

Scilife

Reasons for Switching to SimplerQMS

Costs and local customer support were main contributors

Response 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.

John
Overall rating
  • 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.

Alternatives Considered

Arena, ZenQMS, MasterControl Quality Excellence and Qualio

Reasons for Choosing SimplerQMS

We received poor customer service from Greenlight Guru.

Switched From

Greenlight Guru

Reasons 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!

Showing 5 reviews of 29 Read all reviews

SimplerQMS FAQs

Below are some frequently asked questions for SimplerQMS.

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!

SimplerQMS has the following typical customers:

2–10, 11–50, 51–200, 201–500, 501–1,000

SimplerQMS supports the following languages:

English

SimplerQMS supports the following devices:

Android (Mobile), iPhone (Mobile), iPad (Mobile)

SimplerQMS integrates with the following applications:

Jira

SimplerQMS offers the following support options:

Email/Help Desk, Knowledge Base, Phone Support

Related categories

See all software categories found for SimplerQMS.