![eQMS Implementation Steps, Tips, and Real-World Success]()
One thing we’ve learned here at Greenlight Guru is that there are a lot of MedTech companies that want to get a new eQMS. Maybe they’ve reached the limits of their paper-based quality system. Or maybe their current eQMS just isn’t everything they were sold on. They’d like to make a change, but when they start looking into everything that goes into an eQMS implementation, they worry about how difficult it will be to switch.
If that sounds familiar, I can assure you that you’re not alone in worrying about implementing a new eQMS. But I can also assure you that a successful implementation is not just possible—it’s the outcome you should expect.
At Greenlight Guru, our Onboarding and Implementation team has helped more than 1,000 customers implement our eQMS. The medical device experts on our team have worked with MedTech companies of all shapes and sizes, and we’ve learned a thing or two about successful implementations along the way. “First value” is a term we like to use in customer success, and it’s exactly what it sounds like. Your first value is that “aha moment”—the moment when you start seeing value from your new software.
So, regardless of whether a company decides to use Greenlight Guru, here’s what we’d recommend to make the eQMS implementation process go smoothly.
BONUS CONTENT: Use this QMS Implementation Checklist to build your task force and keep track of all key dates and critical events during the project!
How to implement a quality management system: navigating the 4 key steps
The best way to start implementation on the right foot is by looking ahead—seeing what you’ll need to do and planning for it. While your specific implementation should be tailored to your business needs, the broad strokes of what you need to prepare for are generally the same.
Here’s how I’d go about navigating your implementation:
1. Create a dedicated eQMS implementation task force
The first step in your eQMS journey is establishing an implementation task force. Some companies will designate a single person to implement their eQMS, but frankly, a team of one is not enough to get the job done.
For a project of this size and scope—one that involves multiple departments—you need a truly cross-functional task force.
Keep in mind that the size of the team will vary depending on the size of the company. In smaller companies, one person may wear multiple hats, while in larger companies there may be more stakeholders that need to be involved.
In practice, the task force should include:
When I say “eQMS Owner”, I’m talking about the project manager for your QMS implementation. Each process (CAPA, training, risk, etc.) may have its own designated owner, but the eQMS owner runs point for the entire project. Their job is to coordinate everyone, unblock people who are having issues, communicate with the eQMS supplier, and ultimately own the success of the project.
We include the executive sponsor on this list because executive buy-in and participation is critical. An executive sponsor can not only help get you the resources you need, but they’re also there because an eQMS is a big purchase, and the executive team needs to see it’s a successful use of the budget.
2. Evaluate your current QMS and begin planning activities
No two implementations are exactly alike, and your current level of documentation will determine the path your eQMS implementation takes. For instance, the eQMS implementation for a company starting from scratch (with no documents or records to transfer) will look very different from the implementation for a company with an existing eQMS that wants to switch software solutions.
The onboarding and implementation team at Greenlight Guru frequently works with customers in both these situations—and everything in between. Sometimes a customer will have a few QMS procedures in place and some early design documents and records. Other times they may be archiving an entire legacy QMS and creating all new QMS procedures using our templates (what we call ‘rip and replace’).
That’s why at Greenlight Guru, we have several different implementation pathways, so you can choose the implementation plan that makes the most sense for your business.
3. Decide which documents and records need to be prioritized
Whether you’re creating your QMS from scratch or migrating documents from a legacy eQMS solution, the same general rule applies: start with the most important elements. This is because you don’t have to wait until you're “done” with implementation to use the system; implementation is a rolling process.
So if you’re starting from scratch, you’ll want to think about what you need right now to get you to your next milestone, and what could wait a little longer. For instance, if you’re in early stage product development, establishing QMS elements that are applicable to production and post-production may not be the best use of your time. Instead, focus your efforts on elements of your QMS that apply to the stage your company is currently in, like document control, training, design controls, and risk management.
If you’re migrating from an existing system, you probably have an enormous amount of documentation and records in your system. So prioritize what really needs to get into the system first. For example, your work instructions on inspecting product (that you’ll need to use right away) should take priority over your CAPA records from 2017.
We also recommend identifying categories for existing documents and records. Some documents will be significantly impacted by the transition to your new eQMS, some may require only minor updates, and some won’t need any update at all. Some may need to be archived, and some may be obsolesced by your use in the new system. This evaluation exercise is a great time to clean up your documentation. Why bring garbage in, just to throw it out later on?
4. Measure and improve
The ultimate goal of your QMS is to ensure that your products are of the highest quality and are safe and effective for their end users. And with so much riding on the effectiveness of your quality system, it’s important you continue to evaluate and improve it through frequent internal audits and management reviews.
Listen to our own Sara Adams talk about the importance of internal audits on this episode of the Global Medical Device Podcast, and you’ll get a sense of just how critical it is to build a culture of quality where continuous improvement is a core value.
3 Tips for a smooth eQMS implementation
Implementing an eQMS may be easier said than done, but there are some things you can do before and during the process that will dramatically increase the chances that implementation goes smoothly and you see high rates of adoption from your team.
Here’s the advice I’d give anyone who’s about to implement a new QMS solution:
1. Be transparent about your QMS implementation from the very beginning
Over the years, I’ve noticed that Quality departments often hoard information about the new QMS until it’s ready for everyone to start using. That delay usually comes from a good place. The Quality team doesn’t want to spring a new software solution on their colleagues if it isn’t completely ready.
But that’s not the best way to operate. Gatekeeping information about a new eQMS leaves people in the dark and doesn’t give them time to prepare, ask questions, and feel comfortable with the change. You need everyone on board with this, and you can’t get that buy-in if people don’t know what’s going on.
Instead, bring up the new QMS early and often. Educate everyone about what’s happening, why it’s happening, and what success with this new platform will look like.
One of the most interesting things we’ve seen at Greenlight Guru is that the success rate of QMS implementation skyrockets when both Quality and Product Development are involved from the very beginning (rather than just Quality).
And it makes sense, though. How likely were you to quickly start using something that was given to you without any warning or preparation? Most people like to have some say in how a tool they will use every day is chosen and implemented.
So keep the information flowing and share as much as you can about the project, including the timing of the roll-out, to the broader team.
2. Focus on getting to your first value as quickly as possible
At Greenlight Guru, we ask all our new customers about their first value because we know from experience that the faster we can get them to it, the easier the rest of the implementation and onboarding will be.
For most MedTech companies, that first value is publishing documents in the platform. But you can go deeper than that. What kind of documents? Your supplier SOPs and forms? Your quality manual? What would you love to have in this platform as soon as possible?
Because if we can do that together—if you can show your team the value of this tool ASAP—it’s going to give them confidence and build trust early on, when it’s needed most. Plus, achieving your first value gives us something to celebrate with you!
3. Keep the ball rolling by hitting your milestones
Once we’ve built some momentum together by achieving your first value, we can start looking forward to the key milestones that will keep implementation moving at a steady pace.
Not sure what those milestones should be? Not to worry. Our onboarding and implementation team at Greenlight Guru has proven plans and execution documents we can adjust to your team’s needs. For instance, if you have an audit coming up in X number of months, we can tailor your implementation schedule and work together in our meetings to ensure that you’re ready to use our eQMS for that audit.
Once you have critical events identified (like audits or submissions) and milestones established (like getting parts of the software up and running or releasing training to the team), you have a roadmap to success. From there, success is a matter of following the roadmap and working together to make sure you and your team have everything they need to achieve their goals.
How Greenlight Guru helped Canterbury Scientific with a flawless QMS implementation
Canterbury Scientific was established in 1985 in Christchurch, New Zealand and is a leading global OEM supplier of high-quality, stable IVD Controls and Calibrators for diabetes and hemoglobinopathy assays.
Prior to implementing Greenlight Guru, the team at Canterbury was using a paper-based QMS that worked, but made it difficult to check on progress and manage timelines for nonconformances and change controls. Canterbury CEO Clive Seymour said, “We had the realization that a professional quality management system was our foundation for success and that ultimately, we needed to go with an electronic solution.”
Clive said he had anticipated it would be challenging to migrate to a new QMS, but was pleasantly surprised at how smooth the process was with Greenlight Guru. He credited their onboarding and implementation Guru for listening to their needs and creating an implementation plan that would fit their business objectives and timelines.
Canterbury Scientific took a two-phase approach, moving SOPs, work instructions, and relevant documents from their QMS to Greenlight Guru’s eQMS in the first phase. The second phase focused on enhancing internal audits to systematically improve documentation and embed the system throughout all functions in the company. (That’s step four, if you’re counting!)
Though they were initially worried about document migration, the team found that uploading documents was seamless and version control was in place immediately. They quickly established automated processes for their quality events and change orders, but what really won the team over was seeing for themselves how easy the system was to use for everyday tasks.
“There’s a visceral satisfaction to getting things done and having them removed from your dashboard,” said Clive. “People like to see and feel that they’re making progress.”
Ultimately, cultivating that sense of progress is one of the most important parts of any eQMS implementation. And for Clive and his team, it was a signal that they’d made the right decision in choosing Greenlight Guru for their eQMS.
BONUS CONTENT: Use this QMS Implementation Checklist to build your task force and keep track of all key dates and critical events during the project!
Greenlight Guru gives you the customized path you need for a successful QMS implementation
At Greenlight Guru, our dedicated onboarding and implementation team is made up of seasoned medical device professionals—just like you. We know the pitfalls and the paths around them because we’ve been in your shoes.
Whether you’re bringing decades of documents to our QMS platform or starting from scratch, we’ll work with you to understand your first value and get you there fast. Every MedTech company is different, which is why we customize your onboarding path to your unique needs. We also have 80+ templates to help get you started and our onboarding and implementation team will be with you every step of the way.
Implementing a new QMS platform doesn’t have to be overwhelming. If you’re ready for an implementation experience that’s built just for you, then get your free demo of Greenlight Guru today!
