Extremely simple setup and administration. Quality teams can set up and administer the system without the help of a technical IT team. If you do need any type of assistance, the Qualio support team is one of the best that I have ever worked with. They take all of your questions/concerns seriously, find you answers and keep you updated on status all along the way. Every single employee uses Qualio and there are very few complaints or issues. In a fast paced environment, we just need tools to work. Qualio does !! Qualio has continued to evolve the product over time and takes the time to listen to their customers for input. Their new "release trains" (i.e. bundling new functionality together with advance notice) allows clients to evaluate the changes and address the continuous validation requirements of this industry.

We are excited for future updates ! We really love it.

There are some small issues related to the number of organizations that Qualio services. Pharma research has different needs than technology providers who have different needs than manufacturing companies. Qualio works for all of them, but we sometimes have to work around small issues as a result. Putting a focus on Qualio as a management tool will go a long way in the future (right now, management has limited access to things like assigning training or seeing their teams training records, and there are limited reports that provide useful information for continuous improvement ). But they are happy to take input and have included feedback on their long term product goals !!

Qualio is a 21 CFR Part 11 compliant QMS that houses all of our procedures and facilitates review, approval (with 21 CFR Part 11 signatures), archiving... and simplifying the training process too !!

I love using Qualio because it is very user friendly and the system has a modern feel to it. Qualio is constantly making improvements to the system making it more efficient. They are super responsive when it comes to new inquiries for product enhancements or general support questions.

At the moment we have not experienced any major issues with Qualio.

We used to have a paper-based Quality System that required a lot of resources to maintain. Qualio has helped us automate many processes, maintain traceability, and increase overall efficiencies.

The SOP system is fantastic and it is what was the pirmary factor. The template-based system forces all procedures, forms, etc, to be in a consistent format. The review and approval system is also perfect utilizing email reminders and e-signatures. Quality Events (CAPAs, incident reports, etc.) are also in the same template-based system which forces adherenace to specific areas that can be user defined. The suppliers module is also robust utilizing a matrix-based approach to determine what documents or actions are required based on the supplier type. We are not a medical device organization so we have no experince with the design controls module. The onboarding experience was also great - our onboarding manager walked us through the entire process. During onboarding, they can help with whatever or it can be self-driven in some aspects. We utilized both and had a very smooth onboarding and deployment process.

Outside of SOP training, there isn't a great system for documenting employee training. The work-arounds are somewhat clunky (utilizing the templates etc), and are not a great fit for our organization. The documentation of SOP training is fantastic using the training plans they have built-in. However, it is not a great system for documenting other types of training (on-the job training, etc).

Our biggest problem, and the one that Qualio solved almost immediately, was compliance with SOP training. We are a geographically widespread organization and ensuring prompt deployment of new and/or updated SOPs (and documenting the training thereof) was always a challenge. Once everythign is set up and configured properly, Qualio will automatically send out training (and weekly reminders if not completed) to affected staff. The system also functions as a central repisotory of controlled documents, forcing compliance with procedures.

Qualio's User Interface is by far the best on the market, with a very easy-to-use layout and not too many granular menus that do a good job in scaring users away. Our implementation has been fantastic, with a very hands-on onboarding manager, and we went for the optional extra of Qualio Plus which gives us access to a very knowledgable and helpful advisor for all things Quality related. We are young in our journey, but so far the support has been exemplary, and getting our scientists to engage with the software has so far been an easy task, with many using Qualio every day. With numerous features to apply to our workflows, Qualio has been the centre of our processes since the moment our contract went live, and the software has integrated and adapted seamlessly with our previous methods. 10/10, definitely recommend.

There aren't many downsides to Qualio. The lack of granularity in the API could be considered a negative factor with administrators, but I would say it is a positive factor with users. Another potential downside could be considered as the narrow scope for document types, e.g. equipment records are simply documents with a different (bespoke) template, whereas with other systems I have used, equipment records are considered there own unique entity within the system(s).

Document control, audits, CAPA processes, collaboration.

Qualio is a smart and efficient solution, easy to implement and with lot of additional material and knowledge. The customer service and the onboarding is brilliant.

Actually the layout of export documents needs improvement.

Implementing a QMS and get certified in ISO 9001 / 27001

compliance with GxP requirements in case of documentation, change management, CAPA etc.

Powerful but easy. We brought up a complete QMS with Qualio in under a year and passed our 13485 certification audit.

The ability to hot link other Qualio documents was a real plus in our audit where we could easily follow the track of interrelated documents.

Forms capability gives us lots of flexibility in designing ways to collect and manage critical quality information. We could not have implemented a quality system within our time frame without the forms capabilities in Qualio.

Tags are great way for us to easily sub select quality records based on customer, product, process, etc. This is really helpful for us to quickly find customer related quality documents.

Review process for new documents that allows us to enter comments and edits.

Love the ability to have the system identify action items whether they are CAPAs, document reviews, supplier updates, audits, etc.

Great supplier support that allows us to easily manage all of our suppliers and maintain supporting documentation for each of our vendors.

Great events management subsystem for CAPAs, problems and issue tracking.

Would like more form formatting as well as features like check boxes and drop down selection menus.

Also would like better approval processes for new or modified forms. it would also be nice to add field constraints such as must fill out, format, data range, etc.

Also, it can be challenging to find the right temples to use. Would like to be able to create and structure custom menus by user type with the forms that they typically use.

The internal hotlink feature is really great with the ability to type in part of a document name but it would be nice to have a way to better organize, find and view documents that you may want to link to with the hotlink feature.

Would like to be able to use events or have forms enhanced to allow us to move data collection and actions through multiple users not just for CAPAs

preparing for 13485 audits and supporting our customers needs for quality management

We started with a Dropbox / DocuSign system designed along with an external consultant. All went well until we got to change management, post-market systems, and training. it was clear that a purpose built digitized system was the way to go. We evaluated all players on the market, narrowed to three, intereview each extensively and came up with Qualio as the best balance of price, capability, and quality of support. Really like the change event management, API flexibility, training tracking, and customer success support.

Qualio Plus was great

We overall are very satisfied. The areas for improvement are relatively small and Qualio has been ready to acknowledge them and put them on the development plan. An example is that their document search function is OK but needs to be improved.

They are growing so quickly, I am hopeful they can continue to provide the exceptional level of support we have come to expect.

Consider all the major players out there. We did. Initially when we started we thought we were going to greenlight another option but by the time we completed our detailed multi-month assessment, it was clear that Qualio had a better product at a better price and superior service. We have not been a customer for more than a year and just signed up for our second contract with them.

FDA compliant Part-11 QMS system. Document controls. Change management with tracked approvals. Training assignment and tracking. Automation via API with our internal systems. We also were using an external QMS consultant to assist us with our QMS but they could not provide us tools to implement their recommendations. When using Qualio along with Qualio Plus, we were able to integrate the two and greatly impove our efficiency and quality of our solution.

For an experienced quality team, Qualio supports a flexible system using customizable templates better than other software system I have used. The growth of new functionality has shown continuous effort. Recent additions of an improved editor and Analytics has been especially well received. They actively seek customer input to identify where improvements are best applied and their response times to issues encountered are timely. I especially like the validation packs that are provided to support rapid software validation of our use of Qualio following the GAMP 5 guidance.

Shortcomings of the product are related to having their own document format which can prove difficult when converting to a more recognized format, such as a .pdf. Document hierachy and parent child linkages are not easily accomplished or viewable. That can make locationg the right procedure more cumbersome than necessary. Also, cloning of records is not available to the customer, a feature that is desirable for manufacturers of product lines with few variations to minimize time to create new documentation.

The operation is a little different than other EDMS systems but it is easy to pick up and works well. Like anything a little practice is needed to get efficient.

Qualio provides a reliable CFR part 11 compliant document management system that allows all types of attachments, including videos, and provides easy linkage to internal documents. They are currently rolling out a series of upgrades that expand the features of the system. The Analytics module automates tracking of many QMS metrics. Improvements in their Events module, a configurable, staged activity function, a more usable feature. Difficulties with document collaboration have been greatly removed with improvements to the editor. Also some rights that were before managed only by Qualio are now shared with the customer, such as providing access to various modules in the system.

The best thing I like about Qualio is how simple the documents are prepared for easy understanding by anyone who has no knowledge on what they're reading, be it a policy or a basic learning document. Whenever I used qualio to read and understand company related policies or documents, it helped me understand everything clearly and also the extra information provided helps. With it's simple word formation and the data that is shown in the form of charts, flowcharts, etc also helps. It also makes sure that there is a completion status and verification. I also like the options available like the library from where you can pick and learn a lot and also the status of our trainings section helps to get a picture when we our in an administrative role. It always helps to have such a platform which lets you take enough time to understand things and learn.

Although there's nothing much that I dislike, I have seen it with some users facing issues with login and credentials. Not too often, but sometimes which I feel is pretty typical and expected with technology.

Although, it's not a platform wherein we come to have fun. I feel it can be a little more interactive. Maybe a few quotes, information that is not just informative but also interesting.

Qualio helps solve the initial communication problems that we face with the new hires. With Qualio, it is easier to understand what awareness people need to have on the company values and policies, etc.

It's a great tool. Once you understand how it works it's really easy to plan out processes and put them into place within the quality management system.

There is nothing I dislike. Improvements can be made to certain aspects of the program but Qualio has another thing, they never stop improving and are happy to get feedback.

Qualio is an excellent tool. We've had two external audits since we started using Qualio and both Auditors have agreed that Qualio is an excellent tool, especially for change control.

Having everything in one place. That you can connect or link documents to other documents and keep the traceability of any changes made or decisions made.