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.
Easy to use and implement eQMS Overall: Qualio team was very supportive with the transition to an eQMS system. Pros: - 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 Cons: - none thus far, we continue to find more and more value from this eQMS system
"I didn't realize how much our manual system held us back. I can now accomplish 5X as much using Qualio."
"The big challenge with a legacy system was sorting through what we already had that was correct, what we didn't have - the minor and major gaps - and what we weren't doing correctly and needed to fix."
"In terms of the amount of work that’s now being done compared to the cost, Qualio is the most cost-efficient system we've ever had."
"There were more and more companies using eQMS platforms, and our customers were beginning to ask us if we were using one. The expectation of our customers was that we'd be using a state-of-the-art quality management system. And the tools we use are a factor in whether they work with us or with somebody else."
"Instead of us doing manual training records, it's all automated. That's a huge benefit. We've saved hours every single week managing documents. And our event management - nonconformities, CAPAs, complaints - has gotten much more efficient. Managing them is done in half the time, or less. It's brilliant."
"We couldn't do daily checks with our old system. It was too difficult to document it and get it running. But now we can. Findings are logged as Qualio events and triggered for the right person, and they get fixed. The quality of the entire research facility is up. Findings are drastically down. And we get that feedback from our sponsors who notice that as well. We are super satisfied."