It’s one of the most frequent questions we hear when talking to prospective clients: “How long will it take to implement an electronic quality management system (eQMS)?” If you asked ten vendors, chances are, you’d get ten different answers. That’s because there are so many variables at play, and each regulated company’s needs are different.
At ZenQMS, we like to say, ‘Our team works at the speed of you.’ So, our answer is: “Your eQMS implementation should take the length of time that works best for your organization.”
Now you’re probably thinking, “How do I determine that?” Well, here are a few things you’ll need to consider:
Urgency
eQMS implementation always has some level of urgency. After all, it’s a powerful tool to help Quality teams keep their GxP regulated companies compliant and to mitigate risk – and nobody wants to wait a year to use it.
But how urgent depends on your current state of quality. If you already have a strong quality foundation and are simply switching to a new, better fitting eQMS, it may not be necessary to implement the software at hyperspeed. Or maybe your first regulatory audit is years away, and you want to build a solid foundation for tracking SOPs, training records, CAPAs, etc.
However, if you’re finding it difficult to keep your documents in a state of control, are struggling with a manual paper-based system, or most concerningly, you received a warning letter after a regulatory audit, you’ll want to implement your eQMS right. Now.
When compliancy (or the future of the business) is at stake, the last thing you want is a lengthy QMS implementation process. Make sure your eQMS vendor understands your level of urgency and make sure they’re capable of meeting your required speed before you sign on the dotted line.
Modules
It seems pretty obvious, but implementing an entire suite of quality modules takes longer than just setting up one or two. For regulated companies, knowing which modules they want to prioritize can really speed up the implementation timeline.
If you need your eQMS up and running ASAP, start with a standard implementation of Documents and Training. This ensures your quality documents are in a state of control and your team is meeting training compliance standards, baseline requirements for any GxP organization. Once your foundation is set, turn your attention to modules like Issues, Change Controls, and Audits. But be careful – you’ll want to double check the pricing structure of your eQMS before switching on additional modules. At ZenQMS, you get access to all modules from day one, however some vendors charge for each module you use with an a la carte pricing model.
Data Migration
This one is also pretty clear: More migrated documents means a longer implementation. For companies transitioning from paper/manual systems to an eQMS, it’s our recommendation that they bring over only the most recent, most effective documents and archive the rest. Not only does this reduce implementation time (and costs), it keeps your QMS clutter free and makes it easier to find exactly what you need when you need it.
Speaking of extra costs, watch out for hidden fees if you’re switching from one eQMS to another. Some QMS vendors charge to extract a company’s own data from their account. (We think this is… not great.) Because this could alter the budget and the timeline, be sure to investigate each vendors’ policies on cancellation and data retrieval ahead of time. For some suggestions on what to ask when vetting a new eQMS, check out this section of our eQMS 101 guide.
Flexibility
Some eQMS platforms call themselves “out-of-the-box” QMS software, offering set templates and predefined quality workflows. Quality teams assume this means a quick and easy implementation. But imagine having to change every single quality process you have in order to match the rigid templates and workflows of your new eQMS. That slows down the process a lot.
On the flipside, a configurable, flexible eQMS allows Quality leaders the freedom to design workflows in ways they already understand, which removes any delays. If an admin wants to take paper workflows and duplicate them in digital form, they can! If they want to upgrade those workflows to make them more intuitive and accessible, they can do that too! Familiarity and flexibility are some of the many reasons why a configurable eQMS is such an advantage for Quality professionals, especially when it comes to getting up and running quickly.
Support
In the end, there’s nothing more pivotal to the success of an eQMS implementation than the vendor’s Support team. That’s because they’re the ones who work with the client to establish a reasonable timeline, answer questions in a timely manner, and keep things on track with weekly check-ins. Clients need to know their Support team cares about your organization’s compliance as much as you do.
Once again, it pays to do the research, ask questions, and understand the vendor support policies and fees ahead of time, so implementation can go as smoothly and as quickly as possible.
Okay, but what’s a normal eQMS implementation timeline?
We get it, “it depends” isn’t really an answer.
We can’t speak for other QMS platforms, but we typically complete standard eQMS implementation, including full validation and user acceptance testing (UAT) of the software, in 3 months or less. Depending on the situation and the experience of a company’s quality team, implementation can even be completed in as little as 23 days. Remember, your level of urgency, module use, and data migration amount can all impact the timeline, but one thing we can promise is that our team moves at your speed.
If your life sciences company is stuck on a paper system or your Quality team is struggling with an existing eQMS, check out this free eQMS Buyers Guide for more information about finding a better solution for your quality management needs.