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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

Zeigt 26 Bewertungen

Andrew E.
Andrew E.
Co-founder Director of Operations in Kanada
Verifizierter Nutzer auf LinkedIn
Medizinische Geräte, 11-50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Easy to use and implement eQMS

5 vor 2 Jahren

Kommentare: Qualio team was very supportive with the transition to an eQMS system.

Vorteile:

- Qualio team was awesome helping us migrate to their system - streamlined employee quality training, SOPs, and overall QMS efficiency - clear audit trail for signatures and approvals - east to navigate and simple interface

Nachteile:

- none thus far, we continue to find more and more value from this eQMS system

Antwort von Qualio

vor 2 Jahren

Thanks for the review, Andrew! So happy to hear you've enjoyed your experience so far.

Rob T.
Sr Director of IT and Security Officer in USA
Gesundheit, Wellness & Fitness, 201-500 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

This is one of the most often used apps and was selected for its ease of use and compliance focus

5 vor 3 Jahren

Vorteile:

- ease of use! It's all right there, easy to find and easy to teach! - compliance: we pull multiple reports from Qualio for our compliance audits and they are never questioned - reporting: very thorough, detailed reports for training completion and distribution - support listens to both feature requests and existing changes that are needed and addresses all promptly

Nachteile:

- one feature that is missing is automatic reminders of incomplete assigned training (supposed to be on the roadmap, though!) - most software will encounter an error now and then. While it is infrequent with Qualio, the error messages can be vague, prompting support calls that could be avoided with better detail.

Antwort von Qualio

vor 2 Jahren

Ease of use and compliance are key parts of Qualio's offering, so it's great to hear you're benefiting from these in particular. We're also pleased that you've found our support department so valuable. We will be continuing with this approach to customer service, and will take on board the improvements you have suggested. Thank you so much for your feedback Rob!

Jonas T.
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 vor 5 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 2 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.

Verifizierter Rezensent
Senior Quality Assurance Manager in USA
Verifizierter Nutzer auf LinkedIn
Biotechnologie, 11-50 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

The perfect system for startups and young organizations

5 vor 3 Jahren

Vorteile:

I like the simplicity of the software, and the ease of configuration for the user. If a new document type is needed, it's literally just a few clicks away. I like the intuitive navigation and the ease of adoption by the end users.

Nachteile:

At this time, the only place I can fault Qualio is in the data reporting capabilities. Running basics like how many open/closed NCRs or how many SOPs approved is fine, but without more capability built out, or an external API (like a BI report or crystal intelligence tool), I can't get to more data within records. I do know they are working on this however, and generally at the start up level, you're not yet in need of super detailed reporting within your QMS yet anyway. The basics they provide will more than get you off the ground!

Antwort von Qualio

vor 2 Jahren

An intuitive and simple interface is at the core of Qualio's software, so it's fantastic that you've really benefited from this. Thank you for your feedback on our data reporting capabilities too we are looking to rollout improvements to this functionality soon.

Mallory M.
Clinical Trial Associate in USA
Forschung, 51-200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

User friendly platform

5 vor 2 Jahren

Kommentare: Being able to easily access crucial training documents and processes is paramount. Qualio makes it easy to locate and review said documents.

Vorteile:

Our company uses Qualio to house our Quality Management System. The homepage is simple with links that are appropriate for diving into the system. The documents are clean and easy to read. Overall, I enjoy logging into Qualio and navigating the system to quickly get what I need!

Nachteile:

The login process is split into two pages, enter email first then the password page appears. If the email and password pages could be grouped and the extra page eliminated, that would be ideal! Along with the option to remember the login credentials.

Antwort von Qualio

vor 2 Jahren

Thank you, Mallory! We're so glad you can get to what you need in Qualio. Excellent feedback too! We'll get that shared with the product team for review.

Colin R.
CTO/CIO in USA
Krankenhausversorgung & Gesundheitswesen, 51-200 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

A quick path to SOC II type II

5 vor 5 Jahren

Kommentare: With Qualio we were able to get SOC 2 Type II certified in about a year and a half, which is very impressive. This has lead to increased trust with our customers and helps us grow our business faster.

Vorteile:

User interface, ease of use, ability to get staff to love using it.

Nachteile:

Nothing.

Antwort von Qualio

vor 2 Jahren

It's always great to be told there are no cons to our software, so thank you very much for your positive feedback Colin! We're glad that we've enabled you to gain certifications quicker and unlock business growth.

Drew M.
Director of Quality in USA
Biotechnologie, 2-10 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Perfect Start-up QMS System

5 letztes Jahr

Kommentare: My experience with Qualio has been positive. Everything from the initial communication, to the validation work, to the migration of existing documents into the system. The training and implementation to my team members was very easy as well. The system is extremely easy to use while maintaining the high level of quality that the biotech industry demands.

Vorteile:

All required aspects of a quality management system are present in Qualio. Everything from the initial software validation, to the implementation and in software features like version control, track changes, electronic signatures, etc.

Nachteile:

To date I have no cons to mention. Qualio is an incredible product for the price.

Theo S.
QC Microbiology Supervisor in USA
Biotechnologie, 51-200 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Very user friendly

5 vor 2 Jahren

Kommentare: So much better than a paper-based doc control system; it's faster, everything is tracked within the system and a lot less work!

Vorteile:

The user interface for this program is great, it's all around super easy to use (much more so than other EQMS systems I've used). I love that it's web-based which is great when you're working from home. It's simple to navigate the program and creating, reviewing and approving documents is relatively painless.

Nachteile:

I only wish there were more options for tables when creating a form or worksheet; there are limited features when adding tables but I've been able to work around some of the limitations by creating a table how I want it in Microsoft Word and then copy/pasting the image into Qualio.

Antwort von Qualio

vor 2 Jahren

Thanks for the review and product feedback, Theo! We'll get this to our product team to review. So glad you've had a great experience so far!

Sally A.
AC/ACT in USA
Tierarzt, 2-10 Mitarbeiter
Verwendete die Software für: Mehr als 2 Jahre
Herkunft der Bewertung

Review

5 vor 2 Jahren

Kommentare: Very good information

Vorteile:

It gives alot of good information, up to date information

Nachteile:

That no cons i can think of. Information is good.

Pamela R.
Director of Clinical Development in USA
Medizinische Geräte, 11-50 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Overall Experience

5 letztes Jahr

Kommentare: I find Qualio a brilliant software.

Vorteile:

The software is very user friendly and simplified compared to other quality systems I used in the past.

Nachteile:

During the initial set up phase some of the features weren't streamlined to get the validation completed but with Qualio's great customer service and technical support concerns were resolved fast.

Antwort von Qualio

letztes Jahr

Thank you for the great review and feedback, Pamela. We look forward to continuing to serve you.

Peter M.
Managing Director in Irland
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Great at helping us keep on top of SOPs and training. In short, it's great!

5 vor 7 Jahren

Kommentare: In the pharmacy sector, the Pharmacy Act and regulations had placed a responsibility on our business to provide "Standard Operating Procedures" (SOPs) that attempt to describe in great detail how activities and tasks are performed. This has meant the creation of hundreds of SOPs. Managing these SOPs can be difficult and much of the material goes out of date quickly, requiring re-print, re-acknowledgement and endless reams of paper hanging around our dispensaries. In order to eliminate this problem I was very interested to hear what the team at Qualio had to say. And I was hooked. Taking advantage of advances in technology to improve SOP management, by developing and delivering online SOPs has meant we have a seamless notification directly by email to all our staff. SOPs can be easily updated and changed on-line, and appointed senior staff can contribute and negotiate on detail. Our staff found it to be novel and enjoy using it - and the facility to distribute a few at a time means it is manageable for all individuals. In short, it's great!

Antwort von Qualio

vor 2 Jahren

Thank you for taking the time to write such an in-depth review of our software we really appreciate it! There's nothing we like better than helping businesses manage SOPs effectively.

David K.
QA Manager in USA
Baumaterial, 10.000+ Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

The greatest thing since sliced bread !!!!!

5 vor 2 Jahren

Kommentare: 5 STARS !!!

Vorteile:

I liked the fact that it helps you meet requirements of ISO accreditation.

Nachteile:

I can't think of a single issue that I have had.

Antwort von Qualio

vor 2 Jahren

It's always great to be told there are no cons to our software, so thank you very much for your positive feedback David! We're glad that we've enabled you to meet the requirements for ISO accreditation quicker and unlock business growth.

Elias B.
Medical technologist in USA
Biotechnologie, 501-1.000 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Qaulity and functionality

5 vor 2 Jahren

Kommentare: It has been exceptionally great, easy to access SOPs and readable

Vorteile:

SOPs, compliance and updates, CAPA features are very impacting

Nachteile:

so far no features are missing accordingly

Antwort von Qualio

vor 2 Jahren

Thanks for the review, Elias! Glad the SOP and CAPA features are impacting.

Verifizierter Rezensent
Senior Director, Regulatory Affairs CMC at Ultragenyx Gene Therapy in USA
Verifizierter Nutzer auf LinkedIn
Biotechnologie, 201-500 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Easy system for compliance documents

5 vor 4 Jahren

Vorteile:

Retrieval of documents is easy, system is appropriate for a small company but also scalable as the company grows.

Nachteile:

I've had no issues with the system. Some colleagues consider that more flexibility regarding usage is necessary.

Antwort von Qualio

vor 2 Jahren

Thank you for your feedback it's great to hear that you've benefited from Qualio's scalability and aren't experiencing any issues. We're always working to improve the QMS, so incorporating more flexibility is something we'll be advancing our systems with in the future.

Lisa W.
Head of QA/RA in Schweden
Medizinische Geräte, 11-50 Mitarbeiter
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Easy to use, hard to do wrong.

5 vor 3 Jahren

Kommentare: Better control of our documentation. Easy when the requirements from FDA is automatically handled.

Vorteile:

Easy to make document updates and to send for review and approval.

Nachteile:

It is a bit tricky to understand the management of NCRs . But I think it will be easier once you have used the system a bit more.

Antwort von Qualio

vor 2 Jahren

Thanks for such great feedback Lisa. Our QMS is the only one that incorporates the latest practices like FDA, so it's fantastic that you're benefiting from this particular feature. We're sorry to hear you've had trouble with managing NCRs there's guidance available over in our docs section to assist: docs.qualio.com/functionailty-overviews/quality-events-overview

Shameera A.
IT Security Analyst in Deutschland
Biotechnologie, 201-500 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Simple & Easy to use QMS

5 vor 2 Jahren

Vorteile:

Great repository of all office documents. Hence I need not depend on any colleagues to get any documentation such as SOPs. User friendly GUI. I have been using this since 1 year and i never had an issue. Impressed with the approvals with electronic signatures.

Nachteile:

I did not find anything that i dislike in Qualio

Brian C.
Director in Irland
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

We will have no problems passing inspections by the regulator thanks to Qualio

5 vor 7 Jahren

Kommentare: Qualio has been invaluable in helping our business comply with industry regulations. It has replaced our paper system which we found very cumbersome and hard to maintain across multiple stores. Now, all our workflows are automated, we have excellent visibility over our compliance status and the recording of compliance information such as electronic signatures makes us sure that we will have no problems passing inspections by the regulator in the future.

Antwort von Qualio

vor 2 Jahren

It's great to hear how effective Qualio has been in crushing audits for you Brian! Paper just doesn't work in our online world, so we're glad to have helped you go digital as well as assist with compliance and boosting efficiency. Thank you for such a positive review!

Melissa L.
Clinical Research Coordinator in USA
Medizinische Geräte, 11-50 Mitarbeiter
Verwendete die Software für: Mehr als 1 Jahr
Herkunft der Bewertung

Audits are so easy now!

5 vor 2 Jahren

Vorteile:

I like how tags can be applied to documents for quick document navigation

Nachteile:

There is no app available for the software yet.

Erin M.
CSR supervisor in USA
Tierarzt, 51-200 Mitarbeiter
Verwendete die Software für: 6-12 Monate
Herkunft der Bewertung

Amazing learning tool!

5 vor 2 Jahren

Vorteile:

The best thing about this software is the ease at which it enables staff members to learn policies and protocols for our organization.

Nachteile:

No cons! Quality has been great overall!

Antwort von Qualio

vor 2 Jahren

Thanks for the review, Erin! So glad to hear Qualio has been useful for your team.

Christopher D.
President in USA
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

QMS Software That is Actually Easy to Use

5 vor 6 Jahren

Kommentare: There are so many options available when it comes to software tools to assist in the managing of an effective Quality Management System (QMS). The Qualio product is easy to deploy and has the functionality needed to support a regulated industry such as the Med-Tech.

Antwort von Qualio

vor 2 Jahren

We really appreciate your feedback Christopher, and it's fantastic that you chose Qualio over anyone else and had such a great experience! Compliance is so key in the medtech industry, so we work on an ongoing basis to ensure all our clients can meet the required regulations.

Paul M.
Co-founder & CEO in
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Recommended for small companies implementing a quality management system for the first time

5 vor 7 Jahren

Kommentare: I would recommend ZenDoc to small companies implementing a quality system for the first time to seriously consider using ZenDoc as a way to reduce workload and paper trail in a cost effective and easy manner that is flexible to grow with the company.

Antwort von Qualio

vor 2 Jahren

Thanks so much for your feedback Paul! Since your review, we have changed our name to Qualio and it's so great to look back and see our software's roots in helping small companies grow. This is something we continuously work on so that this growth comes even easier.

Fionnuala G.
Clinical Trial Liaison Officer in
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Intuitive software for managing quality and compliance

5 vor 7 Jahren

Kommentare: Qualio is an intuitive quality management platform that will lower costs for companies through streamlining time consuming workflows. It is a very exciting system and I've recommended it to a number of companies and consultants.

Antwort von Qualio

vor 2 Jahren

Thank you so much for your positive feedback Fionnuala! Saving both time and money is a core part of our QMS' offering, so it's great to hear that these capabilities have been so valuable for you. We really appreciate that you've gone out of your way to recommend us to others!

Trevor H.
VP, Regulatory and Quality in Irland
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Love the easy to use interface and the timely notifications

5 vor 7 Jahren

Kommentare: Qualio allows me to quickly and efficiently manage my QMS procedures and training. My employees love the easy to use interface and the timely notifications, and I enjoy the ability to track changes and quickly view the status of each procedure.

Antwort von Qualio

vor 2 Jahren

There's nothing better than both a manager and their employees benefiting from Qualio's ease of use we really work hard to make it a solution that works for all. Thanks so much for your positive review Trevor we truly appreciate it.

Tara F.
Quality Manager in Irland
Verwendete die Software für: Nicht angeboten
Herkunft der Bewertung

Qualio has forever-changed how we manage document control

5 vor 7 Jahren

Kommentare: Coming from a manual paper based system, it's amazing how it all just works. It is extremely easy to compare different versions of documents during review and approval. Qualio has forever-changed how we manage document control.

Antwort von Qualio

vor 2 Jahren

We're so grateful for your review Tara it's always fantastic to hear how businesses benefit when they have the tools to go paperless. Managing document control is a tough task, so we're glad you've been able to conquer it with Qualio's help.

Matt Z.
Engineering manager in USA
Medizinische Geräte
Verwendete die Software für: 1-5 Monate
Herkunft der Bewertung

Qulio is very easy and functional. It gives you a great value of safety. The customer service is great

5 vor 4 Jahren

Vorteile:

User friendliness. The format and logical relationship between different categories of quality pages.

Nachteile:

At first is a little confusing. I suggest making some tutorial videos for simple examples. For example how to create files and drafts and templates.

Antwort von Qualio

vor 2 Jahren

Thanks for your feedback Matt, we work hard to make sure Qualio is really user-friendly and secure! We like your idea of tutorial videos. For the time being, there are how-to guides available on our website especially designed for new users.