Quality Q&A: What's the real ROI of an eQMS?

Forget theoretical. We wanted to hear about the actual ROI of an eQMS. We chatted with Sandy Hedberg, Vice President of Quality and Regulatory Affairs at ARC-One Solutions, an esteemed GxP Software organization, to learn more about the impact QMS software can have on quality and beyond in this latest Quality Q&A.

Q: It’s easy to understand how the right quality management tools can improve the day-to-day of the Quality team, but we’ve found it’s sometimes harder for leadership to grasp the larger impact. Based on your experience, why is having an eQMS such a necessity not just for the sake of the Quality team, but for the success of life sciences organizations? 

Sandy Hedberg: One of the biggest things is that it lets you see that you’re actually improving what needs to be improved. How do you really know you're correcting and fixing what you need to if you're not documenting it in an easily trackable and searchable way? You just can't. Somebody's going to forget something, and then you're going to get ready to release a product and say, 'Oh shoot, we don't have this.' A good eQMS helps you avoid any delay from noncompliance.

Q: When is the right time to start budgeting for a QMS software? 

Sandy: Generally, it’s about finding the point at which it’s going to become too cumbersome to keep doing quality management on paper or with spreadsheets. But the key is learning when that moment will be before you hit it.

Once you get to the point where you really need an eQMS, if you haven't already started researching it, you're going to be in trouble. In fact, you may already be noncompliant by the time you start trying to budget for a system. When I was a consultant, I would let people know the time to start looking at better quality management tools is now, because if you wait, you’re not going to be able to get an eQMS implemented in time.  

Q: How do you prove the ROI of an eQMS to leadership when trying to make the case for the QMS software you need?

Sandy: I found that most of the time, particularly with bigger organizations, it's one of two things: You're either going to get budget for an eQMS because it's going to help make you more compliant, or it's going to cost less dollars.

And by “less dollars” I mean not just the cost of the system, but also maybe you’ll be spending less time doing something the eQMS will be able to handle automatically for you. Or maybe you can get rid of another redundant system or hold off on hiring for now.

You have to look at what the cost to the company would be if you don’t implement an eQMS. What's the cost for implementing one? What are the advantages? What are the disadvantages? Does it affect your need for other applications?

Q: With your experience in quality, you know that an eQMS can be a game changer – as long as it’s functioning the way you need it to. At ARC-One, the quality team was utilizing a different eQMS platform before switching to ZenQMS. When did you realize your previous eQMS wasn’t the right fit?

Sandy: A major problem was the experience for the users. Nothing was very intuitive and it was difficult to find documents. For example, if we got a CAPA or nonconformance to approve, I had to call my staff to figure out how to find it – and I’m not bad with technology. I even had trouble getting dashboards or reports out of it that were reasonable and that I knew were correct. It was frustrating.

We were also behind on upgrades because the validation was difficult, which meant Support couldn’t do much to help us with configurations. 

Q: What stood out to you about ZenQMS? How did you know it was going to work better for your team?

Sandy: I was doing consulting before I joined ARC-One, and had used ZenQMS previously. When I came in, I already had my mind made up. I suggested ZenQMS because it's intuitive, and also because it’s easy to see what the cost is for the first five years without having to deal with seat licenses.

It’s easy to navigate, easy to update, easy to see everything that I need to see. The team loves the dashboard and you can figure the system out without having a big training session. We went from a cumbersome eQMS to a streamlined system. 

Q: Are you seeing a tangible ROI from ZenQMS? 

Sandy: Yes, we have time to focus on other projects that we didn’t have time for before. Now that the application sends automatic notifications to the person in charge of the next step, we’re not spending time chasing a lot of that down anymore. That’s freeing us up to do more auditing to make sure that we're more compliant with our development activities.

One of the biggest things for me is that we’re no longer constantly chasing people to get their training done. That’s saving a lot of time on my part, and a lot of time for the team as a whole, because the dashboard makes it all much easier to track.

And with the staff being able to find things better, we’re ensuring we’re compliant. If they don’t remember what a procedure says, they can go look it up really easily in ZenQMS. On other systems, you might get people deciding not to look it up or double check the procedure because it’s too hard to find. From a compliance perspective, that’s huge. 

Hear more from Sandy in the eQMS University Webinar: Metrics and KPI Best Practices to Showcase the Value of Quality.