ZenQMS is the right fit for Omega Therapeutics

There are a lot of electronic quality management systems (eQMS) on the market, all with benefits and drawbacks. The challenge for Omega Therapeutics was to find the solution that would meet their current needs but could also be flexible enough to grow with them as their quality processes mature. 

“I helped build the Quality function at Omega and needed to identify an electronic quality management process that could help us with our needs quickly,” said Jennifer Hagan, Head of Quality. ”At the time, we were managing in a hybrid work environment and needed to be able to work remotely, so we didn’t want a paper system.”

Jennifer had implemented eQMS solutions at previous companies, including the traditionally more expensive ones that everyone has heard of. So, when the time came for her to research and pick a system for Omega, she started with the ones she knew. But this time around, those familiar systems just weren’t right-sized. 

“I thought there must be a better, less expensive option available,” said Jennifer. “Knowing from  experience, those [other] systems also require IT expertise to implement, configure, and make minor modifications…expertise I didn’t have. It was important to find an eQMS that fit the needs of Omega without trading quality for cost."

For a pre-clinical/early-stage clinical company like Omega, the time, money, and effort required to implement a complicated eQMS didn’t make sense. That meant she had to keep looking for a more practical solution – without sacrificing feature capabilities.

Jennifer’s search led her to explore the many “out-of-the-box” eQMS solutions on the market. As their name suggests, those systems are ready to be used right out-of-the-box, sacrificing flexibility for budget-friendliness. For quality teams new to eQMS, they might make sense...for a while. However, Jennifer knew what to be wary of, as looks can be deceiving.

“It’s important to know that with those cost-effective systems, there are always limitations.”

The limitations she’s speaking of are rigid templates and pricing based on seat licenses. When there aren’t as many users or SOPs to keep track of, these flaws can be overlooked. If the implementation can be fast and simple and the price seems right, what’s not to like? 

But cracks start to appear if you want options beyond basic functionality:

• Custom configurations come at an additional cost or are at the mercy of pending software releases 
• Rigid templates force companies to design their workflows around the software instead of the other way around 
• And seat license fees can cause sticker shock if a company grows too fast 

“If you’re starting out at a company, you may not always know what the growth trajectory is going to look like,” said Jennifer. “If you have 50 users today and the company grows to 200 over time, will the system still be cost-effective?”

Suddenly, that inexpensive solution isn’t so affordable. Without knowing how Omega could grow in the coming years, or how many seat licenses they were going to need, the out-of-the-box options weren’t going to be the right fit either. It was time to keep looking.

“The key thing about ZenQMS is that you can configure customized workflows without added support from an in-house IT team.”

Because the Quality community is tight-knit, Jennifer found out about ZenQMS through a trusted colleague who had experience using the platform. She added it to her list, scheduled a product demo, and soon realized it had the features and configurability Omega needed and was the right price for her budget. 

“Along with the affordable price and unlimited users, the key thing about ZenQMS is that you can configure customized workflows without added support from an in-house IT team”, said Jennifer. “Setting up those other systems is something I wouldn’t even think of doing myself. But with ZenQMS, it was really easy to drag and drop and put workflows together without worrying about the back-end.”

Coincidentally, Amanda Green was hired as Omega’s Quality Assurance Manager soon after Jennifer made her selection, and had actually only worked at companies that operated ZenQMS.

“At my previous company, I was able to implement ZenQMS by myself. I was the only person in quality and completed the whole audit and qualification of the system in two weeks because I was familiar with it. Even if you’re starting out and you don’t have all the resources, you can still do it yourself.”

Free from having to rely on internal IT support or outside contractors for implementation and configuration assistance, Jennifer and Amanda have been able to get even more value out of the ZenQMS platform.

“This is the first time I’ve been able to put vendor notifications into an eQMS,” said Jennifer. “It’s the process I’m most excited about. Companies will normally use an Excel spreadsheet and log their receipts on paper, but it’s a process that’s often not managed in an eQMS. Because we outsource our GxP operations, as a sponsor, we need to evaluate changes at our vendors to maintain our filing. It’s just easier to do it in ZenQMS.”

What Omega found in ZenQMS was a quality solution that fit perfectly between the pricier, more traditional quality systems and the stripped-down “out-of-the-box” solutions that offer little configurability or options. You might say that for Omega, ZenQMS was the Goldilocks of eQMS: juuuust right. 

Other eQMS providers might have you believe that quality management has to be complicated and time-consuming, but based on Omega’s experience, that’s a fairy tale. Keep it simple! You can implement and configure your eQMS yourself, you don’t have to rely on your IT team, and it doesn’t have to break the bank. Your eQMS story deserves a happy ending and we can help. Visit zenqms.com for more information.