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 The problems we solved with the product was 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.
"The review and approval features are a big step up for our small company. It's also easy to create new versions of documents and do all the necessary linking between documents. Having those links is very helpful, much easier than digging through a file repository manually. The editing features are very similar to Word, or other text editors, and the import from Word works surprisingly well. That's important for importing the large number of existing documents we have. The revision history is easily tracked, which is critical for medical devices. We have a specific process we need to follow for development of both software and hardware, Qualio is easily used for both and allows that customization. We used to pass papers around to sign by hand, which is especially difficult to manage during quarantine when everyone is remote. Again, we made it work but this is a significant improvement."
"The overall setup is easy and very user-friendly. gets rid of the paperwork, quick & easy signatures. Simple to use, affordable. Everyone who has tried it in my training class has agreed the software is simple to use. It is very convenient to have all of the documents together in one place and to use digital signatures. We receive emails when a new Qualio has been uploaded on the dashboard. I do like the way the website is set up, you know where to click, and it's not a guessing game. Any company that needs their employees to sign and agree to documents, this is for you! The Qualio program is a must-have to help organize a companies documents that they need the employee to read, sign and date. The program/site is very user-friendly, quick, and simple! Be sure to check it out to see if this is the right move for you and your business."
"Who knew going paperless would be such fun?! Qualio is the most efficient, adaptable and user friendly document control system I have ever used. I especially love the 100% paperless and automated change control process."
"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."
"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."
"I would recommend Qualio to small companies implementing a quality system for the first time. Qualio helped us to reduce workload and paper trail in a cost effective and easy manner that is flexible to grow with the company."
"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!"
“Without Qualio we would not have been able to achieve our critical milestone of ISO 13485 certification before the end of 2015.”
"As consultants we have the pleasure of working with the good, the bad, and at times, the ugly, when it comes to Quality Management software. Qualio simplifies the approach to effective document control management. The web-based software is intuitive, which greatly reduces the amount of time required for users to come up to speed with a new platform."
"I find the idea of partnering with Qualio very exciting. They understand that the services that I can provide need to dovetail with their own offerings, and I have already identified opportunities where my clients can benefit from Qualio."
"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."
“We look to work with vendors who share a similar culture, It has been clear from the very beginning that Qualio is responsive and has a strong customer service ethic that is in line with ours.”
"My favorite thing is how Qualio keeps us in a constant state of audit readiness. We chose Qualio as we needed our system to be scalable to support our rapid growth and facilitate quick employee onboarding. Qualio’s simple-to use-interface and automated workflows ensure high employee engagement, supporting full compliance and audit readiness. We couldn’t do it without them."
"Qualio enabled us to seamlessly work through the ISO 13485:2016 requirements and design errors out of our quality management system. One way Qualio achieves this is to ensure that changes flow through our system and are applied globally."