1. Increase Productivity
First and foremost, Qualio has enabled the QA team at IRISYS to keep up with their increased workload.
“The reason we were looking into an eQMS in the first place was to help QA be more efficient and keep up with everything because they were so far behind,” Ramirez says. “That was the main goal, and that has been fulfilled.”
Whereas other solutions require teams to upload files, download them, revise them, and reupload them—in a process Ramirez describes as unnecessarily “cumbersome”—Qualio enables IRISYS’ QA staff to move much faster.
“Everything is in the system,” Ramirez explains. “It’s just a lot easier.”
Additionally, Qualio has helped IRISYS collaborate effectively, even when being forced to work remotely due to COVID-19.
IRISYS hoped that moving from a paper-based system to an eQMS would make it much easier to standardize all of their SOPs, and Qualio has delivered on that front.
“With Qualio, you have no choice,” Ramirez says. “Standardization is built in.”
3. Increased compliance
As a CDMO, IRISYS gets audited randomly by the FDA, FDB (California), and DEA; they don’t submit to be certified, Ramirez explains. Since moving to Qualio, the company hasn’t had any problems passing audits.
“We’ve never had an issue with it,” Ramirez says. “The changelog in Qualio has been particularly helpful. We can print it out and give it to the auditor to show we’re still compliant since we validated two years ago, for example.”
4. Excellent support
When migrating to Qualio, IRISYS had to upload more than 500 documents to the system. This process was arduous because all SOP numbers had to stay the same. To expedite it, IRISYS reached out to the Qualio team.
“I know that some of the things we asked for wasn’t what the engineering team is usually asked to do,” Ramirez says. “But they did it anyway. We were definitely grateful for that.”
According to Ramirez, the IRISYS team enjoys the fact that Qualio is a small business that sells to SMBs in the life sciences space. Due to Qualio’s smaller size, the support team is more accessible and responsive than larger companies might be.
“We knew Qualio was going to take care of us better than the bigger guys,” Ramirez says. “All of the feedback I’ve given has been taken into consideration.”
5. Simplified Operations
Qualio has also enabled IRISYS to move away from clunky, bloated processes that were unnecessarily complicated.
“We changed our quality system to fit to whatever Qualio does,” Ramirez continues. “Truth be told, it’s a lot easier. The way we had it was a really old way of doing things. There were a lot of unnecessary steps and a lot of unnecessary signatures. Qualio simplified things a lot more for us.”
6. Future-proofing operations
By moving to Qualio, IRISYS is better positioned to scale even further in the future.
“Now that we’re electronic, we can grow to 500 employees or 1,000 employees,” he says. “Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money—scientists, manufacturing personnel, people like that.”