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."
Qaulity and functionality Overall: It has been exceptionally great, easy to access SOPs and readable Pros: SOPs, compliance and updates, CAPA features are very impacting Cons: so far no features are missing accordingly
“When I think about the platform, the first word that comes to mind is simplicity, Qualio makes a great first impression. People don’t have the same reaction that I’ve seen with larger, more complex solutions that tend to seem overwhelming.”
“It started to become a burden, QA was getting overwhelmed because everything was paper-based. This process in place was slowing us down.”
“Eventually, there came a time where we wanted to do things the software wasn’t letting us do anymore, Whenever we got audited, documentation was just a mess.”
“As a startup, the pace of innovation is important, The system we were using didn’t seem to meet our needs. It was clumsy and everything took forever.”
“The turnaround is very quick and very different compared to a standard pharma approach, Traditionally, a pharma company might take weeks or even months to make a batch. We’re looking at hours.”
“We really needed a process we could make our own, Qualio is flexible, it’s a great price compared to the competitors out there, and we can put all of our company inside the system.”
“We needed a simple but comprehensive solution to document management for a small company that was cost-efficient, Part 11 compliant, flexible in configuration, but still easy to use and with reliable tech support."
“We rued the day we chose paper. Everytime we wanted to change a document, we needed five signatures. Papers would get lost on someone’s desk. It was a cumbersome process that slowed us down.”
"I have never been a fan of most QMS software as it is bulky and tedious to manage workflows. However, Qualio is almost foolproof. I really appreciate how much time this software saves. Worth the cost if you need to streamline certification processes."
"Passed our MDSAP Recertification Audit! The intuitive ease of use for archiving records is what I like best about using Qualio."
"Qualio is a great tool for documentation. The organized digital lab notebooks, pages, and sections in a document are some of my favorite features. Everything helps to categorically arrange and save information. Organizing and recording data properly is a problem we are solving by using Qualio. Making work instructions etc. It also helps in training new people on the team on a regular basis."