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Jonah Krakow06/27/245 min read

Freedom! 4 ways an eQMS frees teams from common Quality challenges

Quality professionals at life sciences organizations juggle a lot of responsibility. The last thing they need is a quality management tool that slows them down and makes things complicated. Fortunately, an electronic quality management system (eQMS) gives teams the freedom to leave behind the limitations that have held them back in the past. Here are four freedoms Quality teams can celebrate after implementing the right eQMS. 

Freedom to use tools actually built for Quality teams 

Tools like Excel, DocuSign, and Sharepoint weren’t specifically designed for quality, and when a regulatory or sponsor audit hits, you can tell.  Even though these tools are easy to learn and often already familiar to teams, their unregulated nature often means compliance takes a hit, and routine tasks like document, training, and CAPA management become much more difficult. 

Plus, these homegrown systems, cobbled together with multiple pieces of software, end up being more expensive to maintain than you would think. That’s why dedicated electronic quality management systems (eQMS) like ZenQMS were designed in the first place. 

We started looking for an LMS, but I knew about ZenQMS. I pitched it to Leadership as it would allow us to have a robust LMS but would also come with the bonus of being able to capture all of our quality workflows, audits, document control, and be compliant with current 21 CFR Part 11 requirements. And it would stand up in an FDA audit. That’s when I got more buy-in.” - Allie Foco, Quality Systems Manager at Autumn Harp  (Read their customer story here.)

An eQMS frees Quality teams from chasing signatures or frantically looking for information inside multiple cloud drives and folders by keeping everything connected and compliant for a single source of truth. 

Freedom to create flexible Quality workflows 

When regulated companies make the switch from paper/manual systems to an eQMS, simplicity and cost are always top-of-mind. That’s why “off-the-shelf” solutions seem like a great idea. They’re inexpensive and come with built-in templates, so all quality teams have to do is fill in the blanks and they’re all set…sort of.

“It’s important to know that with those cost-effective systems, there are always limitations.” - Jennifer Hagan, Head of Quality at Omega Therapeutics. (Read their customer story here.)

Because no two quality teams are exactly alike, using rigid “one-size-fits-all” quality management templates limits a team’s ability to control how their workflows, uh, flow. Making changes is a slow, difficult ordeal, requiring extensive work by the internal IT team, an external consultant, or the vendor, and may incur sizable costs that the company wasn’t expecting.

“The key thing about ZenQMS is that you can configure customized workflows without added support from an in-house IT team.” - Jennifer Hagan, Head of Quality at Omega Therapeutics

Rather than forcing quality processes to fit 3rd party software, an eQMS like ZenQMS gives quality teams the flexibility to configure their processes to match their own preferences. Teams don’t have to spend extra money and time waiting for IT to make changes because they have the freedom to update processes themselves. This type of DIY configuration allows quality teams to keep moving at their own pace, not the vendor’s.

Freedom to embrace simplicity 

Having the freedom to configure quality processes is one half of a successful quality solution. The other half is simply having the visibility and control to use those tools as they were intended. Many eQMS solutions over-complicate things with unnecessary bells and whistles, or restrictions that slow productivity to a crawl.

“In my last company, I had to submit IT ticket after IT ticket just to get a new user set up in the system. It might have been weeks before they had everything.” - Kendra Beaty, Manager of Quality and Compliance at ClinOne (Read the customer story here.)

Rather than complicate routine tasks, ZenQMS simplifies the process with easy-to-navigate dashboards and simple drop-down menus that allow quality teams to breeze through their day. 

“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.” - Kendra Beaty, Manager of Quality and Compliance at ClinOne

Quality management doesn’t need to be tied to one person holding all the cards. ZenQMS allows permissions to be set at the company, group, or individual level so everyone always has the access and information they need to complete their tasks and get on with their day. 

Freedom to ask questions … and get them answered 

When dealing with quality software (or any technology for that matter), inevitably, something doesn’t make sense or doesn’t go according to plan. When this happens, teams turn to their vendor’s customer support team for answers and wait. And wait. And wait. 

“It would take days to get a response for a support ticket [from the previous vendor]. Now when I put in a ticket with ZenQMS, I can grab a cup of coffee, and 30 minutes later, their team has run the report, made the change, emailed me the report, and closed it out.” - Phillip Strickland, Director of Quality Assurance at TD2 (Read the customer story here.)

The waiting game is a progress killer, but it doesn’t have to be standard practice! ZenQMS knows that not only do life sciences companies deserve a great quality tool, they also deserve excellent customer support to go with it.  

“The response times were unbelievable. Especially coming from my most recent experience with a different eQMS where we’d never get that type of service, the whole process was seamless.” - Theresa Sheehan, Senior Director of Quality Assurance and Compliance at Uniquity Bio (Read the customer story here.)

Whether it’s not enough flexibility, too much complexity, or not enough support, it’s time life sciences companies broke free from the limitations that affect their current quality solution. Interested in learning how to get the control and support you’re looking for? Schedule a call with ZenQMS and find out how we do eQMS differently.