ZenQMS supplies ClinOne with the power of configurability, visibility, and speed

Working with a slow, complicated electronic quality management system (eQMS) is a productivity killer for quality teams of any size, but when you’re a quality team of one, it can be catastrophic. ClinOne’s Manager of Quality and Compliance, Kendra Beaty, is that quality team of one, which is why she appreciates a user-friendly system like ZenQMS instead of the unforgiving quality tools from her past.

“The system at my old company wasn’t very intuitive,” said Kendra. “It didn’t save automatically and kicked you out after eight minutes, so if you didn’t save your work, it all went away. Plus, there were never enough licenses at certain times of the day because the company never purchased enough for everyone. ZenQMS has been my favorite system I’ve used so far.” 

For Kendra, ease-of-use and intuitiveness in an eQMS are non-negotiable, due to quality control at ClinOne resting squarely on her shoulders. When she joined the company, she replaced their only quality representative, meaning she had to train herself on how to use ZenQMS. Fortunately, there was a place for her to learn.

“I really like the Sandbox feature because there are individual training sessions set up where you can practice. When I was first learning how to upload documents in ZenQMS, the Sandbox allowed me to see the entire workflow before things went live into production.”

Now that she’s more familiar with the ins and outs of ZenQMS, the simplicity of the dashboards and the speed with which she can breeze through daily tasks really stand out. 

“Recently, an engineer sent me a list of ten vendors whose contracts were complete and asked me to deactivate them from the system. It took six minutes. When I receive an email from HR asking to set up an account for a new employee, it takes me ten minutes. We have our training curriculum already loaded into ZenQMS, so I just click on the right training courses and it’s done. I really appreciate how easy it is to use.”

These might seem like simple processes on the surface, but veterans of quality management know just how much time can be wasted fighting with a complicated eQMS. 

“In my last company, I had to submit IT ticket after IT ticket just to get a new user set up in the system,” said Kendra. “It might have been weeks before they had everything. Training on SOPs wouldn’t start until day three or four. It was really frustrating because you want them to hit the ground running, not sitting around not knowing what to do.”

The frustrations didn’t stop there. Even something as simple as document approvals were a complicated ordeal.

“It felt like I was submitting documents to a black box. After 30 days, they might be effective, they might not be. I had no visibility into the process even though I had the same responsibilities I have now. With ZenQMS, I can approve documents and I can see everything. If a document needs to be updated, I can just pull it up and do it myself.”

Even though working at a software company has been a different experience than working in pharma, Kendra still has strong opinions about how processes should be designed, regardless of the level of risk. That’s why the configurability of ZenQMS has been key. She can build a workflow in the Issues module exactly the way she wants instead of being tied to a rigid pre-built template.

“When I got to ClinOne, they didn’t have a separate process for effectiveness checks; they were tied to quality events,” said Kendra. “Where I come from, that doesn’t work. If you’re performing a proper effectiveness check, that can take three months to a year. But a quality event can’t be open that long, you need to be able to close it in 30 days. So I designed an effectiveness check workflow in ZenQMS that separates them but still references the quality event. I really like being able to do that.”

Building workflows to her specifications has not only made her job safer, it’s also put her mind at ease when it comes to preparing for client and regulatory audits.

“I was in pharma manufacturing and labs for twelve years, the majority of which was in quality. Before I started here, there was only one criteria for effectiveness checks in the workflow: ‘Was an effectiveness check performed, yes or no?’ Coming from Pharma, you need to be able to document everything or else an auditor will be all over you. Now that I’ve set up that workflow, I have the documentation to back it up.”

Regardless of the size of your quality team, you deserve tools that offer visibility, configurability, and control over your quality processes without the struggle. If you’re interested in learning more, schedule a demo with ZenQMS and find out how we take the stress out of eQMS.