SimplerQMS

Flexible and Excellent Support

Kommentare: 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.

Vorteile:

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.

Nachteile:

I have not discovered any serious issues

SimplerQMS is our EssentialQMS

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

SimplerQMS review

Kommentare: Satisfied with overview and management of documentation

Vorteile:

The version control The documentation management

Nachteile:

The possibility to manage the access for different employers

Simple system, easy to set up

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

Vorteile:

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.

Nachteile:

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

Best in class eQMS.

Kommentare: 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.

Vorteile:

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.

Nachteile:

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

SimplerQMS works extremely well for our medical device startup

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

CathVision

Vorteile:

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.

Nachteile:

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.

Simpler QMS review

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

Vorteile:

Ease og speed to find documents. Very useful during audits

Nachteile:

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

eQMS with no hassle

Kommentare: Very good experience, great and very fast support.

Vorteile:

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

Nachteile:

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

Opinion on SimplerQMS

Kommentare: 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!

Vorteile:

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.

Nachteile:

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.

Feedback after 1 year of deployment/use

Vorteile:

implementation process, easy to learn and use

Nachteile:

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

A happy customer

Vorteile:

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

Nachteile:

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.

SimplerQMS InDex

Kommentare: Very good and very helpful support!
User friendly system

Vorteile:

Super professional support from [sensitive content hidden]

Nachteile:

Could be a little faster! Some more experience from pharmaceutical industry.

A guided eQMS implementation

Vorteile:

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.

Nachteile:

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

SimplerQMS for MedTech startup

Vorteile:

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

Nachteile:

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

Vorteile:

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

Nachteile:

The release notes and patches could have been better communicated.

NFI, LLC Implementation Review

Kommentare: Overall I had a great experience with the SimplerQMS team.

Vorteile:

The hands on training and workshops made it easier to learn the flow of the software.

Nachteile:

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

Review by healthtech start up

Kommentare: 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.

Vorteile:

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.

Nachteile:

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

Review of SimplerQMS

Kommentare: 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.

Vorteile:

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.

Nachteile:

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.

Pioneering SimplerQMS

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

Vorteile:

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

Nachteile:

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

The easy way to implement a QMS

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

Vorteile:

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

Nachteile:

No Apple based app, but the webbrowser works perfectly

Professional QMS tool with great support team

Kommentare: 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.

Vorteile:

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

Nachteile:

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

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

Kommentare: 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.

Vorteile:

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

Nachteile:

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.

Customer Feedback SimplerQMS

Kommentare: Highly recommendable system, good price-performance ratio, best customer service ever experienced for any software application in 15 years business life

Vorteile:

The system comes in a pre-validated state, easy-to-use, covers all requirements that are defined in FDA part 11. Great customer support.

Nachteile:

A functionality for the documentation of classroom trainings is currently missing. Additionally, the upside of having a pre-validated system comes with the downside that it is not possible to adapt certain features to company specific processes.

SimplerQMS from the software developer's perspective

Kommentare: SimplerQMS surely does keep track of all documents and allows for "final" versions generation. I don't have any experience with other systems like SimplerQMS to make a reliable comparison.

Vorteile:

I can use the product within the web browser which does not require any additional software installation.

Nachteile:

It is Word documents based - tracking an issue requires constant opening and modifying of the documents, creating new versions etc. and is not that clear as using web-based ticketing system (e.g. Jira). Furthermore, comparing two versions of a document, to see the differences only, is not possible. Or, at least, I didn't find that option.