IRISYS is a contract development and manufacturing organization (CDMO), headquartered in San Diego, that helps biotech and pharmaceutical firms manufacture FDA-approved clinical drugs, drug delivery technologies and formulations for rare diseases and orphan drugs.
IRISYS assists its partner firms with R&D, manufacturing and regulatory processes, as well as running a small product portfolio of its own that includes the Scot-Tussin family of sugar- and alcohol-free cough medicines.
IRISYS was founded in 1996 and relied for over 20 years on a paper-based quality management system where everything - including all SOPs - were printed out, signed by hand, scanned, and put on a shared network drive. This manual legacy process was both onerous and time-consuming.
While this system worked well enough for a company with a handful of staffers, it began to creak as IRISYS scaled up. Between 2014 and 2017, the company's workforce expanded from 10 to 50 full-time employees.
It started to become a burden. QA was getting overwhelmed because everything was paper-based.
This process was slowing us down.
IRISYS quickly realized they needed a specialized digital solution for quality management that would enable them to move, operate and grow faster.
Adolfo Ramirez, Director of Information Systems and Data Compliance, led his team in conducting the search, turning to Google and LinkedIn to explore the latest quality management technology. Adolfo ended up with a list of over 30 eQMS systems and began narrowing them down.
Adolfo and the IRISYS team realized that while platforms like MasterControl and Veeva appeared functionally rich, many features were simply superfluous and overly expensive for a small CDMO.
After testing the sandbox of a different system and finding a series of bugs, the team turned to Qualio.
After a thorough vetting and investigation process, the IRISYS team ultimately decided to invest in Qualio as their eQMS platform.
The Qualio sandbox worked as designed. The UI is actually very user-friendly.
I was able to go into a sandbox and immediately start using it productively. It’s very easy to use compared to a lot of the other systems we looked at, which required lots of training and sifting through documentation to figure out.
By ditching their paper-based system and moving to Qualio, IRISYS has experienced a raft of benefits that have enabled them to develop more products and deliver more value to their clients.
1. Increased productivity
First and foremost, Qualio has enabled the QA team at IRISYS to keep up with their increased workload.
Where other platforms require quality teams to upload files, then download, revise and re-upload in the event of changes, Qualio enables IRISYS’ QA staff to embed smart and fast document management.
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 weren't disappointed.
Adolfo remarked that 'standardization is built in' with Qualio, providing unshakeable consistency and control of IRISYS' quality information.
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.
That was the main goal, and that has been fulfilled. Everything is in the system and it’s just a lot easier.
3. Increased compliance
As a CDMO, IRISYS gets randomly audited randomly by the FDA, FDB (California), and DEA.
Since moving to Qualio, the company hasn’t had any problems passing audits: Adolfo and team can quickly retrieve and present any required QMS information at the touch of a button to demonstrate continued compliance.
4. Targeted support
When migrating to Qualio, IRISYS had to upload more than 500 documents to the system.
This process was complex and detail-critical since all SOP numbers had to stay the same. IRISYS reached out to the Qualio team for support and found that, due to Qualio’s smaller size and SME focus, the support team was more accessible and responsive than a larger company might be.
I know that some of the things we asked for weren't what the engineering team is usually asked to do. But they did it anyway, and we were definitely grateful for that.
We knew Qualio was going to take care of us better than the bigger guys. All the feedback I’ve given has been taken into consideration.
5. Simplified and growth-ready operations
Qualio has also enabled IRISYS to move away from clunky, bloated processes that were unnecessarily complicated - freeing up time, resource and effort for continuous quality improvement and business growth.
We changed our quality system to fit to whatever Qualio does. Truth be told, it’s a lot easier.
There were a lot of unnecessary steps and a lot of unnecessary signatures. Qualio simplified things a lot for us.
And now that we’re electronic, we can grow to 500 or 1,000 employees. Since we don’t need to grow the QA team as much, we can put more resources into employees who make us money, like scientists and manufacturing personnel.