Über SimplerQMS

SimplerQMS ist eine elektronische Qualitätsmanagementsoftware, die speziell für die Life-Science-Industrie entwickelt wurde. Die Systemfunktionen und Workflows sind für Life-Science-Organisationen konzipiert und zugeschnitten, um eine höhere Effizienz und einfachere Compliance zu gewährleisten. Die Lösung erfasst Daten automatisch, sendet Benachrichtigungen und ermöglicht Routing, Follow-ups, Genehmigungen und Eskalation überfälliger Aktivitäten. Du kannst bestimmten Mitarbeitenden Aufgaben zuweisen, die dank der Funktion der automatischen Workflows sofort über die Zuweisung informiert werden. Anpassbare Dashboards ermöglichen es dir dann, die Leistung deines Teams zu verfolgen und Termine einfach zu überprüfen. Wenn es um die Verwaltung von Qualitätsprozessen geht, bietet die Nutzung dieser Funktionen deinem Unternehmen erhöhte Effizienz und zeitsparende Möglichkeiten. Kundschaft kann auf einer vertrauten Microsoft Office-Oberfläche arbeiten. Es ist nicht erforderlich, geänderte Dokumente herunterzuladen, zu bearbeiten und wiederholt hochzuladen. Automatische Benennung, Nummerierung und Versionierung erleichtern das Dokumentenmanagement und die vollständige Integration ermöglicht es dir, Dokumente mit nur einem Klick zu speichern. Innerhalb des Systems kannst du Dokumentationsdokumente, Dateien und Aufzeichnungen einfach mit Produkten, Lieferunternehmen, Kundschaften, Komponenten oder Geräten verknüpfen. Du kannst deine Qualitätsprozesse integrieren und nahtlos an ihnen arbeiten, während sie alle sicher an einem einzigen Ort gespeichert werden. Auf diese Weise erhältst du auch einen besseren Überblick über Nichtkonformitäten und kannst die Ursachen leichter ermitteln. Ein hohes Maß an Rückverfolgbarkeit ist ein weiterer Vorteil der vollständig implementierten SimplerQMS-Software. Du kannst genau ermitteln, welcher Mitarbeitende Änderungen an einem Dokument vorgenommen hat, welche Änderungen das waren, wann sie angewendet wurden und welche Auswirkungen die Änderungen hatten. Gleichzeitig gewährleisten elektronische Signaturen gemäß FDA 21 CFR Part 11 die Einhaltung von Vorschriften. Die zeitgestempelten Audit-Trails bieten zusammen mit den integrierten Berichterstattungsfunktionen eine noch höhere Präzision bei der Rückverfolgbarkeit deiner Qualitätsmanagementprozesse. SimplerQMS ist nach ISO 13485:2016 zertifiziert und vollständig konform mit FDA 21 CFR Part 11, GxP, cGMP, GAMP 5, EU MDR, EU IVDR, 21 CFR Part 820 und anderen regulatorischen Anforderungen. SimplerQMS ist eine vorab validierte, sofort einsatzbereite Lösung. Das bedeutet, dass du keine zusätzlichen Mittel für Systemvalidierungsprozesse aufwenden musst. Gleichzeitig werden alle QMS-Module in einem Paket angeboten, bei dem die Implementierung der Module bereits im Anfangspreis des Pakets enthalten ist.
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SimplerQMS Video
SimplerQMS Software - 1 - Vorschau
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SimplerQMS Preis

SimplerQMS bietet keine Gratisversion und keine kostenlose Testversion. Die kostenpflichtige Version von SimplerQMS ist ab 1.150,00 $/Monat verfügbar.

Startpreis:
1.150,00 $/Monat
Kostenlose Version:
Nein
Kostenlose Testversion:
Nein

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René Arnfeldt
René Arnfeldt
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Wöchentlich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 9.4.2024

Flexible and Excellent Support

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

Antwort von 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.

Beantwortet am 27.5.2024
Mads
  • Branche: Pharmazeutika
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
4
Bedienkomfort
5
Kundenbetreuung
5

4
Bewertet am 15.4.2024

Simple system, easy to set up

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.

In Betracht gezogene Alternativen

Scilife

Gründe für den Wechsel zu SimplerQMS

Costs and local customer support were main contributors

Antwort von 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.

Beantwortet am 30.4.2024
Bonnie
  • Branche: Forschung
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Wöchentlich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
4
Bedienkomfort
3
Kundenbetreuung
5

4
Bewertet am 28.2.2025

Excellent solution for a small imaging trial service group

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

Vorteile

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

Nachteile

We do find the workflow slightly cumbersome.

Cameron
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
4
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 4.12.2024

SimplerQMS is our EssentialQMS

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.

In Betracht gezogene Alternativen

Docusign, Veeva Vault und MasterControl Quality Excellence

Warum SimplerQMS gewählt wurde

Moved to a new company and needed to implement a QMS program.

Gründe für den Wechsel zu 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.

Antwort von 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!

Beantwortet am 23.12.2024
John
  • Branche: Biotechnologie
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für 1-5 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 10.4.2024

Best in class eQMS.

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.

In Betracht gezogene Alternativen

MasterControl Quality Excellence und Qualio

Warum SimplerQMS gewählt wurde

We received poor customer service from Greenlight Guru.

Gründe für den Wechsel zu SimplerQMS

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

Antwort von 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!

Beantwortet am 30.4.2024
Vlad
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 9.4.2024

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.

Antwort von SimplerQMS

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!

Beantwortet am 30.4.2024
Niels Erik
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
0
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
0

5
Bewertet am 9.4.2024

Simpler QMS review

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

Antwort von SimplerQMS

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!

Beantwortet am 30.4.2024
Michael
  • Branche: Pharmazeutika
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 11.4.2024

eQMS with no hassle

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

In Betracht gezogene Alternativen

Veeva Vault

Antwort von SimplerQMS

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!

Beantwortet am 30.4.2024
Maike
  • Branche: Biotechnologie
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Wöchentlich für 1-5 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
0
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 27.5.2024

Opinion on SimplerQMS

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.

Antwort von SimplerQMS

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.

Beantwortet am 10.6.2024
Helle
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 9.4.2024

SimplerQMS review

Satisfied with overview and management of documentation

Vorteile

The version control
The documentation management

Nachteile

The possibility to manage the access for different employers

Antwort von 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!

Beantwortet am 30.4.2024
Dirk
  • Branche: Biotechnologie
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 9.4.2024

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.

Antwort von SimplerQMS

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!

Beantwortet am 30.4.2024
Muctehit
  • Branche: Pharmazeutika
  • Unternehmensgröße: 51–200 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
4
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 11.4.2024

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

Antwort von SimplerQMS

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!

Beantwortet am 30.4.2024
Carina
  • Branche: Pharmazeutika
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
0
Funktionalität
5
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 30.1.2024

SimplerQMS InDex

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.

Antwort von SimplerQMS

Dear Carina,

We greatly appreciate your positive feedback on SimplerQMS. We're very pleased to hear that you found our support professional and the system user-friendly.

Your constructive comment regarding speed has now been addressed by our Product Team and we recently implemented a fix addressing this issue. Regarding the industry-specific experience, we are now strengthening our teams with two new team members who have more than 20 years of experience in Pharma & Biotech.

Thanks again for this constructive feedback and for choosing SimplerQMS as your QMS software 🙂

Beantwortet am 7.2.2024
Anders
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Wöchentlich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 15.4.2024

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.

Antwort von SimplerQMS

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!

Beantwortet am 30.4.2024
Michael
  • Branche: Biotechnologie
  • Unternehmensgröße: Selbstständig
  • Wöchentlich für 1-5 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 27.5.2024

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.

Antwort von SimplerQMS

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.

Beantwortet am 10.6.2024
Arles
  • Branche: Biotechnologie
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Wöchentlich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
0
Funktionalität
4
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 28.6.2024

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.

Antwort von SimplerQMS

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.

Beantwortet am 8.7.2024
Bryan
  • Branche: Kosmetik
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 8.8.2023

NFI, LLC Implementation Review

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.

Antwort von SimplerQMS

Thank you very much for your kind words, Bryan!

We're glad to hear that you had a great experience with our team and that you found the hands-on training and workshops helpful.

We understand that the initial learning curve can be steep, especially if you're the only employee in the company working on implementation.

We value feedback like yours on how we might be able to further streamline the implementation process and make sure that customers like yourself receive as much training and support as needed - even when only one person is on board.

We appreciate your time in providing us with this information, and should you ever need assistance again, don't hesitate to reach out at any time.

Thank you again for your review!

Beantwortet am 11.8.2023
Subba
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 8.8.2022

SimplerQMS works extremely well for our medical device startup

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.

In Betracht gezogene Alternativen

MasterControl Quality Excellence und Qualio

Gründe für den Wechsel zu SimplerQMS

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

Antwort von 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!

Beantwortet am 5.9.2022
Jaana
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 8.8.2022

Review by healthtech start up

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.

In Betracht gezogene Alternativen

Qualio

Gründe für den Wechsel zu SimplerQMS

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

Antwort von 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.

Beantwortet am 16.8.2022
Henrik
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 5.8.2022

Review of SimplerQMS

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.

Antwort von 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.

Beantwortet am 16.8.2022
Dorthe
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 4.8.2022

Pioneering SimplerQMS

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

Antwort von SimplerQMS

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.

Beantwortet am 16.8.2022
Dick
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 8.8.2022

The easy way to implement a QMS

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

Antwort von SimplerQMS

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!

Beantwortet am 16.8.2022
Louise Flintegaard
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 3.8.2022

Professional QMS tool with great support team

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.

Antwort von SimplerQMS

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!

Beantwortet am 16.8.2022
Jean Claude
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
4
Bedienkomfort
5
Kundenbetreuung
5

4
Bewertet am 16.8.2022

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

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.

Antwort von 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!

Beantwortet am 5.9.2022
Ursina
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
0
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 9.8.2022

Customer Feedback SimplerQMS

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.

Antwort von SimplerQMS

Thank you for your review, Ursina! We're glad to hear that you found SimplerQMS easy to use and that it covers FDA Part 11 requirements. We're very glad to hear that you've had such a positive experience with our customer service team. I'll be sure to pass on your compliments to our team.

Today you are able to create classroom training documentation today based on templates. However, we noted the need for a dedicated and more automated classroom/on-site feature. This is therefore being developed and will be a part of our upcoming release.

We understand that every company has its own specific processes and it's not always possible to configure a pre-validated QMS software system to exactly fit your needs.

However, our newest releases are adding more configuration options that are still pre-validated. This means that you get the best of two worlds: A time and cost-saving pre-validated system and the possibility to configure it (within certain limits).

Thank you for using SimplerQMS!

Beantwortet am 5.9.2022
Mike
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 2–10 Mitarbeiter
  • Täglich für 6-12 Monate genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
0
Funktionalität
4
Bedienkomfort
3
Kundenbetreuung
0

5
Bewertet am 10.8.2022

SimplerQMS from the software developer's perspective

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.

Antwort von SimplerQMS

Thank you for your honest feedback, Mike. We're glad to have you as a customer and we appreciate your input.

Many of our users love the seamless editing experience, where documents are opened directly in Word, Excel, etc. and changes are instantly saved without manual up- and downloading of files. It also enables you to re-use all of your current QMS documents, when moving to SimplerQMS. However, we do understand that some users prefer a non-document-based way of working.

Regarding the possibility to compare two documents, then this is possible today. You need to right-click on the document and choose to Compare > Compare with Another Version. Please feel free to reach out to our support if you need any help with this.

Thank you for your feedback and for choosing SimplerQMS!

Beantwortet am 5.9.2022
Bjarne
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 201–500 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
4
Funktionalität
3
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 8.8.2022

Good, easy to use - but consider license structure

Good.
Ability and willingness to provide service and help.

Vorteile

In many aspects intuitive to use/flow.
Possibility to adjust to the company needs
Flexible layout.
Relative easy to learn/manoeuvre.
Many options/modules to add to the basic document control
"hands off" in relation to validation

Nachteile

License structure/flexibility - requires some administratrive resources.
Some aspects not intuitive (template/change)
Amount of notifications

Antwort von SimplerQMS

Thank you for taking the time to provide feedback on SimplerQMS, Bjarne. Your insights are valuable as we continue to work to make our product the best it can be.

I'm glad you find our eQMS software intuitive and flexible, and that you appreciate our team's willingness and ability to provide service and help.

With regards to the license structure, we are making it easier to get an overview of your company's current licensing and to make changes to the set-up.

Regarding the number of notifications, then this is highly configurable. Meaning that you can basically switch notifications on and off as you wish. We will reach out to you to help adjust the notification set-up.

Thank you again for using SimplerQMS, and please don't hesitate to reach out if there's anything else we can do to make your experience better.

Beantwortet am 16.8.2022
Troels
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 11–50 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
4
Bedienkomfort
5
Kundenbetreuung
5

5
Bewertet am 5.8.2022

SimplerQMS

Vorteile

Powerfull search feature makes finding anything easy, both during audits and every day work. Easy to implement and and adapt to. Very responsive customer service. Validation package. Traceability and compliance.

Nachteile

User interface is a bit old fashioned, and there is a couple seconds wait when approving multiple documents.

Antwort von SimplerQMS

Thank you for your kind words about SimplerQMS, and for taking the time to write a review. We're glad to hear that you find our search feature powerful and that you appreciate our customer service. We'll pass on your compliments to them!

We're also happy to hear that you find our product easy to implement and adapt to, as well as that you find it valuable for traceability and compliance.

In an upcoming release, the user interface will be updated to a modern look and feel. We are also constantly looking for ways to improve performance and already made some significant improvements in the latest version of SimplerQMS.

Thank you again for choosing SimplerQMS, and we hope you'll continue to find it helpful in your work.

Beantwortet am 16.8.2022
Per Anders
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 51–200 Mitarbeiter
  • Täglich für Mehr als 1 Jahr genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
5
Funktionalität
5
Bedienkomfort
4
Kundenbetreuung
5

5
Bewertet am 8.8.2022

Managing documentation and records for medical devices

Vorteile

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.

Nachteile

The user interface could have been more intuitive.

Antwort von SimplerQMS

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!

Beantwortet am 16.8.2022
Sanne
  • Branche: Medizinische Geräte
  • Unternehmensgröße: 501–1.000 Mitarbeiter
  • Täglich für Mehr als 2 Jahre genutzt
  • Quelle der Bewertung
Preis-Leistungs-Verhältnis
3
Funktionalität
4
Bedienkomfort
4
Kundenbetreuung
5

4
Bewertet am 9.8.2022

SimplerQMS

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

Vorteile

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

Nachteile

- The organization needs to adapt to using meta data

Antwort von 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.

Beantwortet am 16.8.2022
30 Bewertungen

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