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Über Qualio

QMS für medizinische Geräte, Pharma und Biotech. Vollständige FDA-/ISO-/GxP-Konformität. fünfmal schnellere Dokumentenkontrolle, Training, CAPA, NCRs, Audits und mehr.

Erfahre mehr über Qualio

Vorteile:

Qualio is very well and highly integrated. There is a relatively short learning curve, then quite intuitive.

Nachteile:

It is a bit tricky to understand the management of NCRs.

Bewertungen zu Qualio

Durchschnittliche Bewertung

Benutzerfreundlichkeit
4,5
Kundenservice
4,7
Funktionen
4,3
Preis-Leistungs-Verhältnis
4,5

Weiterempfehlungsquote

8,5/10

Qualio hat eine Gesamtbewertung von 4,6 von 5 Sternen basierend auf 123 Nutzerbewertungen auf Capterra.

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Nutzerbewertungen filtern (123)

Atul Pratap
Atul Pratap
Sales And Marketing Specialist in Indien
Verifizierter Nutzer auf LinkedIn
Informationstechnologie & -dienste, 2–10 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Great eQMS software

5,0 vor 2 Jahren

Kommentare: This software is a quick and effective method of managing quality procedures. The system keeps track of everything. It is suitable for small businesses and is also scalable as they expand.

Vorteile:

This software has a relatively simple learning curve. The programme has a lot of flexibility and lets you format procedures and records anyway you choose. The software contains useful features, easy-to-use interface, and finding documents is not too difficult either. Tech support is also excellent.

Nachteile:

It's challenging to create documents with Qualio. The formatting options could be improved. Some areas lack audit trails.

Neil
Head of QA/RA in UK
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Easy to use eQMS

5,0 letztes Jahr

Kommentare: Qualio has made our document management must simpler and easier to access. At our most recent audit, the auditor commented how much better structured our technical files were now that we had switched to Qualio

Vorteile:

We've found Qualio is easy and intuitive for non-expert users to work with. Moving our most common forms directly into Qualio has cut out a lot of minor errors which in turn saves QA a lot of time.

Nachteile:

It took us a bit of time to get our training set up properly although that was partly because we weren't clear what our aims were. When we first started the timings and content of updates was somewhat confusing, however the new system of planned and notified release schedules has made this much simpler and easier for users

In Betracht gezogene Alternativen: SimplerQMS

Gründe für den Wechsel zu Qualio: Ease of use for infrequent users, ease of implementation

Neil
Sr. Director of Quality in USA
Biotechnologie, 51–200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio is a great flexible QMS tool for small companies

3,0 letztes Jahr

Kommentare: Overall, my experience with Qualio is positive and I would recommend other small business owners to purchase this system. The system was fairly easy and quick to implement and covers the basics of what is needed to establish an ISO based QMS. The customer service is excellent and it appears that they are trying to improve both the quality of the product and the features.

Vorteile:

Qualio has great customer service and and the onboarding team was incredibly helpful in setting up the system quickly. The system has great flexibility in setting up customized processes using their Events feature and I'm excited to implement their new analytics features. The process for change control is simple and intuitive.

Nachteile:

As compared to other eQMS systems, there seems to be some basic functionality that is missing. For example, change control must be applied to one document at a time where most eQMS can revise multiple documents at a time. The system does unfortunately have bugs throughout all of their modules and the editing tool and tracking changes tool is quite tedious and burdensome. Lastly, their design control module is really a requirements management tool and does not actually assist with design control.

Savneet
Senior Quality Manager in USA
Kosmetik, 51–200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio set up and execution

5,0 letztes Jahr

Kommentare: Training has become much easier.

Vorteile:

User Friendly, Team that helps you onboard and provides help along the way is amazing!! Having access to Quality specialist is a big plus and both the onboarding manager and Quality specialist have been knowledgeable, patient and great. Feedback is taken positively and shared with internal teams.

Nachteile:

Complaints module - having editable udf's (feedback shared with Qualio team). Document collaboration could be improved. Tag- ability to type in a tag instead of selecting from a drop-down list. Categorizing tags in the drop-down Template- linking a template in documents. Sending a template for review prior to approval Forms- Revision control. Stamping a form with the form number automatically instead of a manual addition.

In Betracht gezogene Alternativen: QT9 QMS

Gründe für den Wechsel zu Qualio: Access to Qualio Quality staff and user-friendly system

Michele
Head of Regulatory & Quality Assurance in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Qualio is the Perfect eQMS - Simple and easy to use

4,0 letztes Jahr

Kommentare: Experience overall has been great. Qualio has been super responsive to all questions and issues. They recognize where problems exist and where improvements can be made. They pay attention to the customer's requirements (needs and wants) and they implement them to improve the functionality and performance of the eQMS' features. Qualio is always working on new things to help facility the end user's IeQMS and remain compliant within the industry.

Vorteile:

The ability to have all documents maintained electronically in one system. I managed a manual QMS for 13+ years...it was manageable, but Qualio made it so much easier! The change control element and the Training module was a huge bonus - especially when this was originally done manually all those years.

Nachteile:

The cumbersome document editor seemed old and outdated and was not easy to use. However, Qualio has made many improvements to the document editor making it much easier to create and edit documents.

In Betracht gezogene Alternativen: Polarion ALM

Gründe für den Wechsel zu Qualio: The price was a huge factor as well as the Design module.

Michael
QA Director in USA
Medizinische Geräte, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Excellent solution for most quality management systems

5,0 letztes Jahr

Vorteile:

Almost endless configuration capabilities allowing the creation of documents and events that fit your QMS instead of rebuilding your QMS to fit the software.

Nachteile:

Inability to hot-swap an approver when they are not available. Instead the document needs to be reverted to draft, the approver changed, and then the document rerouted.

Jonathan
Quality Assurance Manager in USA
Biotechnologie, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Quality is in it's name and it delivers!

5,0 vor 6 Monaten

Kommentare: I, and the company, have had a good experience with Qualio. Though there have been a few troubled spots we have always been reassured and received the improvements that have fixed issues. We are reassured that the Qualio team is working hard to give its clients the best quality management experience possible.

Vorteile:

Qualio is a platform that we've seen grow over the years. They are a team that strives to deliver a product that meets the needs of its clients and is continually improving upon past versions to deliver a product and experience that is unobtrusive to workflow at a reasonable cost. Their service team ensures you have what you need, and diligently works to implement needed changes if a feature is not available. It's clean and navigable. I highly recommend it for smaller businesses or startups.

Nachteile:

We have waited on occasion past a couple of feature releases for much-needed editor and supplier management changes. The review process and audit trail are good, but change control (requesting approval to create drafts, risk assessment features, and tracking changes between versions) are lacking. Sometimes it shows large chunks of text as removed and replaced when only a few changes were made. Sometimes it shows all it's changes in rich text code which is unreadable for most.

John
John
Quality Manager in USA
Verifizierter Nutzer auf LinkedIn
Medizinische Geräte, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Qualio helps lead the way through our MDSAP recertification audit.

4,0 vor 3 Jahren

Kommentare: Qualio serves as my document repository, my "source of truth" for all required records within our 13485/MDSAP compliant QMS. Recertification was completed in 2021 and the auditor noted the speed with which all document records were presented, without a backroom runner!

Vorteile:

Software is easy to use and navigate, and to train others to use at different levels. Record and report output is quick and organized.

Nachteile:

Software has presented with many fix opportunities. That said the Qualio team is quick to remediate bugs and provide module upgrades that address new user needs!

Antwort von Qualio

vor 3 Jahren

Hi John, congrats on your 13485/MDSAP recertification and we're ecstatic to hear positive feedback from your auditor as well!

Hanifa
Quality Assurance Officer in Kenia
Pharmazeutika, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

The solution to management of QMS activities and Events

5,0 vor 5 Monaten

Kommentare: It has been an interesting learning experience and the solution to the tedious manual QMS.
Work is simplified and distributed evenly.
Is a fairly lean system.

Vorteile:

Qualio has been improving every quarter to satisfy customer needs by incorporating suggestions for improvements made by customers and advancement of the feature available for use as per the current GMP regulations.

Nachteile:

One has to adapt very fast with the changes to enjoy the benefits. So much good not to miss out on the advantages.

chandini
Clinical data associate in Indien
Schreiben & Editieren, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

The best app for using your and reviewing your documents during your work.

5,0 vor 6 Monaten

Kommentare: I must say that its the best and Excellent everyone must OWN.

Vorteile:

The things i like the most is the interface that the Qualio provides which is very user friendly and easy to access and its development through year is incredible

Nachteile:

I never saw anything that is troubling me in Qualio till date thats what made me impressed to use this daily at work.

Jigar
Quality Auditor in Indien
Informationstechnologie & -dienste, 201–500 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio Review

5,0 letztes Jahr

Kommentare: Yeah, it is good to use, good to show someone your documentation and completes the process flow with respect to the features and configurations.

Vorteile:

It is the best document management system which consist of whatever things you required with respect to ISO standards and as well as the company standards. It can be configurable. Best interface, controlled documentation, easy to use and to show external parties.

Nachteile:

There are no such thing that i dislike, but some sort of feature incorporation while releasing a patch or full release can be taken as feedback from current users so that the new feature or full release can contains the things which are mostly required by the end users.

Robert
Quality in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

AMM Qualio Review

5,0 letztes Jahr

Kommentare: My overall experience with Qualio is good. It has helped our company grow and pass many audits. It also helped us reduce a headcount by serving as a document control solution. Qualio solves our companies Quality Management Software needs and helps us to maintain all of our documents in a controlled system. Qualio also helps us organize our training and events such as CAPA's and NCMR's.

Vorteile:

The user interface is very good. It is easy to train new people how to use Qualio.The file organization and linking abilities from documents within documents is very good.

Nachteile:

I do not like how the change control history only limits you to see the last change control. If you want to see previous change control history of older versions of a document you have to create a draft and delete it once you are finished.

Cynthia
Vice President, Regulatory Affairs in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Qualio Review

5,0 vor 3 Jahren

Kommentare: I am very satisfied with Qualio.

Vorteile:

Ease of use, search feature, and the dashboards for overdue training, deviations.

Nachteile:

Quality events feature is a little confusing.

In Betracht gezogene Alternativen: Veeva QualityOne EQMS

Gründe für den Wechsel zu Qualio: Cost and ease of use.

Antwort von Qualio

vor 3 Jahren

Hi Cynthia, we're happy to hear that so many of Qualio's features are enabling your QMS processes. If you'd like to provide any additional details on improvements to our Events feature, please feel free to reach out to me directly.

Stephanie
Quality Consulting Service in USA
Medizinische Geräte, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Qualio review

5,0 letztes Jahr

Kommentare: Implementing Qualio was easy, especially with the prewritten SOP's that could be adapted to the client needs. Qualio has been great for maintaining the quality system from Complaints, NCR's, CAPA's etc.

Vorteile:

Templates are helpful in guiding content creation across the organization. Events are great for managing approvals and maintaining evidence.

Nachteile:

Training module doesn't provide a matrix type status, i.e. Documents versus all used and training requirements/status. Document identification did not allow for using predicate quality system document numbers.

Santino
Student in Jamaika
Bildungsmanagement, 501–1.000 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio Review

4,0 vor 2 Jahren

Vorteile:

Qualio is an awesome document manager especially for persons looking to transition from paper to electronic record keeping. This platform has an excellent user interface that is easy to navigate with practice. Excellent customer support from the team made implementation easier.

Nachteile:

No issues have been experienced with the platform so far.

Jonas
Quality Manager in Norwegen
Informationstechnologie & -dienste, 2–10 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Perfect for Medical Device startups

5,0 vor 8 Jahren

Kommentare: Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of 2015. We are now prepared to take the next steps towards compliance with European regulatory requirements and the CE mark.

Vorteile:

Easy to use with a very intuitive user interface, compliance with CFR 21 part 11, outstanding customer support, swift document navigation

Nachteile:

Author change does not generate notification for new author which makes multiple authoring somewhat cumbersome. Currently lacks CAPA handling.

Antwort von Qualio

vor 5 Jahren

Thank you for your feedback Jonas we're pleased that Qualio was so key in achieving your ISO 13487 certification in such a short timeframe. Our software has since been updated with CAPA-handling capabilities, and we are always utilizing our customer feedback to enhance Qualio's features.

Bastien
Production lead in Kanada
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio for the win !

5,0 vor 3 Jahren

Kommentare: We transitioned from a paper qms to Qualio and we save so much time for archiving, tracking and finding documents !
It is also much more easy and efficient to update documents.

Vorteile:

Very nice users interface Easy to use contains mostly everything we need for an eQMS review and approval process flows well

Nachteile:

- it would be nice if the NCR and CAPA module could be linked to in documents (hyperlink) - Currently the comments can only be placed at the end of each document section, however if a section is long it is not the most efficient way to put comment. Comment applicable directly to the text would be ideal.

Antwort von Qualio

vor 3 Jahren

Bastien, we love to hear that you were able to successfully transition from paper to Qualio's eQMS! We appreciate the detailed feedback and have passed this along to our product team.

Kristi
Associate Director of Quality in USA
Medizinische Geräte, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Good for start ups

4,0 vor 3 Jahren

Kommentare: Overall, as a small startup it worked for our needs. As we grew and more people from larger companies joined, there were struggles. I think if you are open to making Qualio work for you and you have stakeholders onboard during implementation its great. If you bring people in who are used to expensive widely used tools its a learning curve. I would use it again if I were starting a company.

Vorteile:

I liked the ability to build and edit the event flows (NCR, CAPA, etc).

Nachteile:

Redline feature is not great right now.

Sharon
HR Manager in Indien
Computer-Software, 51–200 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Great way to manage quality

5,0 letztes Jahr

Vorteile:

Ease of use. Data storage. Ease of access

Nachteile:

The document creation can be improved...

Stephen
Senior Security Manager in USA
Gesundheit, Wellness & Fitness, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio - Quality Control, Document Management and Traceability

4,0 vor 3 Jahren

Kommentare: Overall, the Qualio product has improved our workflow processing ability with excellent artifact collection and retention.

Vorteile:

Qualio is a robust document management system with the ability to link documents and evidence for healthcare GRC needs as well as traceability in the process from cradle to grave.

Nachteile:

The text editing features in Qualio are basic but strides are being taken to improve the features to meet most document composition and updating standards.

Antwort von Qualio

vor 3 Jahren

Hi Stephen, we are always looking to improve our product and appreciate your feedback.

Inge
CRA in Australien
Forschung, 201–500 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Good software for keeping up to date with documentation

5,0 vor 3 Jahren

Kommentare: Easy to use. Easy to find documents that you are looking for with search function

Vorteile:

Training and searching, ease of finding and dowloading forms

Nachteile:

I am not sure what liked least as for what ever I am using it it is doing a good job.

Antwort von Qualio

vor 3 Jahren

Hi Inge, we're happy to hear that Qualio is meeting all your needs and more! Thank you for your input.

Bonnie
Quality Coordinator in USA
Medizinische Geräte, 51–200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qualio review

4,0 letztes Jahr

Kommentare: Our company loves that the training of our entire company Nationwide can train all at once without having to use a separate program

Vorteile:

Getting used to this system was a challenge. But once I learned to navigate it became quite easy. I love that this program works as Quality should and is always improving.

Nachteile:

The fact that I can not archive and retrieve expired supplier documents

Dominika
Quality Representative in Polen
Informationstechnologie & -dienste, 11–50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

SdNcenter's review

5,0 vor 5 Monaten

Kommentare: Very professional and nice support with documents migration

Vorteile:

A system that is user friendly, easy to set-up and meets all requirements of ISO 13485

Nachteile:

documents structure (hierarchy) not visible, impossible to copy events configuration from Sandbox into PROD

Sasiporn
Clinical Quality and Training Manager in Thailand
Forschung, 11–50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Always support, continuous improvement and system is really easy to use

5,0 letztes Jahr

Vorteile:

flexible, able to customize as per company's requirments.

Nachteile:

document editable format is still have some limit function

Nihal
Nihal
Ceo in Kenia
Verifizierter Nutzer auf LinkedIn
Pharmazeutika, 201–500 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Qualio Review

5,0 vor 3 Jahren

Kommentare: We have a very high Qa workload and especially during inspections were reliant on a couple of people. One thing forgotten or not done on time can lead to critical or major reviews. We want to avoid that and also ensure the QA managers are using their time effectively and not chasing paper. We are still
Completing implementation and will be able to measure the efficiency, time saved and capacity developed by end of the year!

Vorteile:

I think the ease of implementation and support. Ease of use… “does what it says”. We still need more time with it but my employees seem excited about it!

Nachteile:

I am not sure at the moment. There were some Minor hitches with implementation . But no feedback on this yet!