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Jonah Krakow10/10/234 min read

It’s not you, it’s your eQMS: 5 ways to determine whether it’s time to switch

Quality at your life sciences organization is now safer, more efficient, and more organized thanks to the electronic quality management system (eQMS) you have in place. Compared to those still relying on spreadsheets and manual systems, you’re in great shape. 

 

But…you might have a nagging feeling that after paying a hefty sum, working through a lengthy implementation, and sitting through multiple training sessions, your eQMS should be working better than it does. 

Are your frustrations just minor hiccups or symptoms of an eQMS that’s not quite fit-for-purpose? Sure, ripping out and replacing your existing eQMS means more time and effort, but in many cases, the long-term benefits of a system that suits your needs outweigh the short-term inconveniences of getting rid of the old one. 

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Here are 5 questions to think about before deciding what to do with your current eQMS:

1. Are you still storing data in multiple locations? 

One of the biggest advantages of an eQMS over manual systems is organization. Data can be accessed, analyzed, and automatically updated across your company within seconds. But only if that data is actually connected.

If you’ve invested in an enterprise system but are still storing critical data outside your eQMS, (in a learning management system, Excel, filing cabinets, etc.) you’re losing out on an important benefit, not to mention additional security. You need to ask yourself why?

  • Is configuring the system’s workflows to match your preferred processes too complicated and not worth the effort? 
  • Does the system make it difficult to access important documents? 
  • Are the tools or modules to solve the problem too expensive, or not available at all?

If you investigate other eQMS options, make sure to look for an all-in-one solution that keeps your data connected, in a way that meets you where you are.

2. Do you have complete visibility into your training and workflow processes?

How easy is it to see who’s coming up on their training and who is past due? Or what stage a workflow is in and who’s holding things up? Or what the latest version of an SOP is and its effective date? 

It’s never a good time to realize that you can’t find the answers within your enterprise eQMS, but it’s especially rough when you can’t find them at an audit’s notice. 

The right eQMS will provide instant visibility across your entire company, allowing you to pull documents and training reports without pulling teeth. And you’ll find future audits will put less of a strain on your resources and your mental health.

3. Are additional fees hurting your eQMS’ effectiveness and creating more work?

Extra charges for updates, seat licenses, validation materials, and additional software can add up, slowing productivity down to a crawl. Are they preventing you from getting the most out of your system? See if any of these scenarios sound familiar:

  • Your team continues to run older, less functional versions of their eQMS software because the cost of the update is just too high. 
  • Training compliance for the entire company falls on the quality team, rather than each department being held responsible for its own records, because purchasing additional seat licenses to delegate the work is too expensive. 
  • Validation materials are an extra cost, or not even available at all. That leaves little support or direction to make sure your system is validated, fit-for-purpose, and can hold up to audit scrutiny. 
  • Your team continues to rely on external software programs to fill the gaps that the eQMS was expected to fix in the first place, and those programs aren’t free.

If you’re doing more work than you thought, including frequently asking your CFO for more money, you might want to consider an eQMS where separate fees for seat licenses, validation, and software updates aren’t part of the contract.

4. How easy is it to change your workflows?

Some eQMS solutions feel like they were created by software designers who aren’t familiar with how quality teams really work. Their systems follow a different logic. Workflows don’t always, uh, flow. And they’re filled with lots of bells and whistles that look nice, but don’t really add functionality. As a result, day-to-day operations can turn into overly-complicated headaches. 

  • Are you configuring your workflows around the rigid templates of the eQMS and not your own preferences? 
  • Do the smallest tasks require submitting a ticket to their support team, or your IT department? 
  • Is the system scalable?

If your eQMS makes the easy stuff complicated, consider one with common-sense functionality that allows you to make changes that fit your preferences, and your schedule.

5. How do your colleagues feel about your existing eQMS? 

If your colleagues love the current system, find it easy to navigate, and rarely need refreshers on how to use it, your eQMS might be doing fine. But if they struggle to complete tasks and training, complain about how long it takes to get things done, and are generally reluctant to adopt it, that could be a sign your eQMS isn't intuitive.

An easy-to-use eQMS with a simple interface allows general users to quickly get in, complete their assignments, and move on with their day. It also reduces the need to constantly nag co-workers about signatures and training compliance. If that sounds like a better use of everyone’s time, investigating other eQMS solutions is worth it.

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