About SimplerQMS

SimplerQMS offers quality management software that is pre-validated, cloud-based, and built specifically for organizations 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 its 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 being executed every 15 minutes, the system is being 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:

€12,500.00/year

  • 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

Andorra, United Arab Emirates, Afghanistan, Antigua and Barbuda, Anguilla , Albania, Armenia, Angola, Argentina, American Samoa, Austria, Australia, Aruba, Åland Islands, Azerbaijan, Bosnia and Herzegovina, Barbados, Bangladesh, Belgium, Burkina Faso, Bulgaria, Bahrain, Burundi, Benin, Bermuda, Brunei, Bolivia, Brazil, Bahamas, Bhutan, Botswana, Belarus, Belize, Canada, Congo - Kinshasa, Central African Republic, Congo - Brazzaville, Switzerland, Cook Islands, Chile, Cameroon, China, Colombia, Costa Rica, Cuba, Cape Verde, Cyprus, Czechia, Germany, Djibouti, Denmark, Dominica, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Eritrea, Spain, Ethiopia, Finland, Fiji, Falkland Islands, Micronesia, Faroe Islands, France, Gabon, United Kingdom, Grenada, Georgia, French Guiana, Guernsey, Ghana, Gibraltar, Greenland, Gambia, Guinea, Guadeloupe, Equatorial Guinea, Greece, Guatemala, Guam, Guinea-Bissau, Guyana, Hong Kong SAR China, Honduras, Croatia, Haiti, Hungary, Indonesia, Ireland, Israel, Isle of Man, India, Iraq, Iran, Iceland, Italy, Jersey, Jamaica, Jordan, Japan, Kenya, Kyrgyzstan, Cambodia, Kiribati, Comoros, Saint Kitts and Nevis, South Korea, Kuwait, Cayman Islands, Kazakhstan, Laos, Lebanon, Saint Lucia, Liechtenstein, Sri Lanka, Liberia, Lesotho, Lithuania, Luxembourg, Latvia, Libya, Morocco, Monaco, Moldova, Montenegro, Saint Martin, Madagascar, Marshall Islands, North Macedonia, Mali, Myanmar (Burma), Mongolia, Macao SAR China, Northern Mariana Islands, Martinique, Mauritania, Montserrat, Malta, Mauritius, Maldives, Malawi, Mexico, Malaysia, Mozambique, Namibia, New Caledonia, Niger, Norfolk Island, Nigeria, Nicaragua, Netherlands, Norway, Nepal, Nauru, New Zealand, Oman, Panama, Peru, French Polynesia, Papua New Guinea, Philippines, Pakistan, Poland, Saint-Pierre-et-Miquelon, Puerto Rico, Palestinian territories, Portugal, Palau, Paraguay, Qatar, Réunion, Romania, Serbia, Russia, Rwanda, Saudi Arabia, Solomon Islands, Seychelles, Sudan, Sweden, Singapore, Saint Helena, Slovenia, Svalbard and Jan Mayen, Slovakia, Sierra Leone, San Marino, Senegal, Somalia, Suriname, São Tomé and Príncipe, El Salvador, Syria, Eswatini, Turks and Caicos Islands, Chad, Togo, Thailand, Tajikistan, Timor-Leste, Turkmenistan, Tunisia, Tonga, Turkey, Trinidad and Tobago, Tuvalu, Taiwan, Tanzania, Ukraine, Uganda, United States, Uruguay, Uzbekistan, Vatican City, Saint Vincent and the Grenadines, Venezuela, British Virgin Islands, US Virgin Islands, Vietnam, Vanuatu, Wallis and Futuna, Samoa, Yemen, Mayotte, South Africa, Zambia, Zimbabwe

Supported Languages

English

Pricing starting from:

€12,500.00/year

  • 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: 48

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

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Reviews

Overall rating

4.5 /5
(13)
Value for Money
4.6/5
Features
4.3/5
Ease of Use
4.2/5
Customer Support Software
5/5

Already have SimplerQMS?

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

Showing 5 reviews of 13
Subba
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 Software
  • Likelihood to recommend 10.0 /10

SimplerQMS works extremely well for our medical device startup

Reviewed on 8/8/2022

Simpler is much better than our previous paper-based QMS system. Document management, including...

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.

Reasons for Switching to SimplerQMS

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

Response from SimplerQMS

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!

Jaana
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 Software
  • Likelihood to recommend 10.0 /10

Review by healthtech start up

Reviewed on 8/8/2022

Amount of manual work have decreased with SimplerQMS. Especially document workflow is now less...

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 and Qualio

Reasons for Switching to SimplerQMS

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

Response from SimplerQMS

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.

Sanne
Overall rating
  • Industry: Medical Devices
  • Company size: 501-1,000 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 7.0 /10

SimplerQMS

Reviewed on 8/9/2022

Great service and support. Easy to get started. Well working in document control.

Great service and support. Easy to get started. Well working in document control.

Pros

- Easy to create and sign documents
- Well-working document control and overview of audit trail

Cons

- The organization needs to adapt to using meta data

Response from SimplerQMS

Thank you for your honest review, Sanne. We're glad to hear that you find SimplerQMS easy to use and that find our document control capabilities well-working.

It's true that metadata can take some getting used to, but it's a powerful way to organize and find your documents quickly. We often see that our customers get a much better structure of their data and improve their ability to easily find information due to the use of metadata.

We hope you'll continue to find value in our product.

Jean Claude
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

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

Reviewed on 8/16/2022

SimplerQMS is indeed simple to use. Very good quality to money ratio.
We are very happy with the...

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.

Response from SimplerQMS

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!

Henrik
Overall rating
  • Industry: Medical Devices
  • Company size: 11-50 Employees
  • Used Daily for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Review of SimplerQMS

Reviewed on 8/5/2022

Having an electronic QMS system, which is CFR Part 21 compliant and where all the documents are...

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.

Response from SimplerQMS

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.

Showing 5 reviews of 13 Read all reviews

SimplerQMS FAQs

Below are some frequently asked questions for SimplerQMS.

SimplerQMS offers the following pricing plans:

  • Starting from: €12,500.00/year
  • Pricing model: Subscription
  • Free Trial: 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, PLM

SimplerQMS offers the following support options:

Email/Help Desk, Knowledge Base Software, Phone Support

Related categories

See all software categories found for SimplerQMS.