LivAssured links all quality processes, ensures traceability, and keeps improving their unique medical device  

About LivAssured

Nocturnal epileptic seizures can be frightening. If caregivers can’t be on site quickly, this can be dangerous and very stressful for the epilepsy patient and the caregiver. But now, there is a solution: NightWatch.

For many years, Dutch epilepsy centers SEIN and Kempenhaeghe have been carrying out scientific research into reliable nocturnal epilepsy detection. As part of the LivAssured group, this collaboration culminated in NightWatch - a unique medical aid that accurately detects nocturnal epileptic seizures and instantly alerts remote caregivers. 

As an organization, LivAssured consists of experienced entrepreneurs from the technical and medical arena and motivated engineers with a passion for high-quality medical technology. LivAssured collaborates with a network of leading partners to be able to safeguard the required quality level and to keep improving NightWatch based on user experience.

A year ago, Jolanda Oorthuizen was brought in as Quality Assurance and Regulatory Affairs (QARA) Manager. One of the first things she did was implement Scilife. 

Twelve months on, Jolanda talked to our Customer Success Manager, Trine Michelsen and Customer Success Representative, Laura Gilbert. They found out how Scilife helped LivAssured make compliance easier and created a traceability matrix for major quality improvements…

The Search

As an organization, LivAssured had a shared file server and was already working digitally. But it wasn’t specific software that fit their quality needs. They wanted to continuously improve their medical device, NightWatch. So, with Jolanda brought in as QARA Manager, she set out to upgrade their quality management system:

“In my first month, I was looking for an eQMS and I found Scilife. I’d worked with multiple eQMS systems before and I was looking for a system that I could configure myself.”

With her experience, Jolanda knew what kind of system she wanted. And for LivAssured’s needs, it was also important that it was an all-in-one system. As Jolanda explained:

“We didn’t only want a document management system. We wanted to be able to add a CAPA system and Change Control.”

Jolanda knew that an eQMS solution that could link all quality processes would be hugely beneficial for LivAssured. And she knew this from past experience:

“In previous companies, we always had these huge excel sheets with all the people and their competences and their roles and functions… It was a monstrous document!”

So, with her choice made, Jolanda started setting up Scilife…

The Set Up

Before rolling out Scilife’s eQMS to be used within LivAssured, Jolanda tried out some of the trainings herself. For her, Scilife was easy to start using:

“It was pretty quick. It’s not difficult and is user-friendly. The software itself is intuitive. You just click wherever you need to be.”

Jolanda also praised the customer success team, saying that she’s always had support when she needed it:

“The onboarding was really smooth. And every question I asked got answered.”

With the Scilife eQMS set up, Jolanda was ready to use various features so that LivAssured could really see the benefits.

Favourite Features

As many organizations do, LivAssured started with document management. And then Jolanda started adding other elements of the Scilife eQMS. As she did so, being able to connect everything is what stood out for her:

“I really like that you can create a matrix and that it’s all linked together. The combination of training, CAPAs and Change Control - the whole package is nice.”

This meant there was no need for manual tracking of who was doing what, or trying to find out if documents had been signed and reviewed. For example, Jolanda didn’t need to spend time investigating what people should be doing after trainings were complete:

“When people finish trainings, competences are automatically linked to the new version. I haven’t seen that in another system before.”

Expert Advice

With her experience using different eQMS solutions, including Scilife, we asked Jolanda what advice she’d give to other organizations. Her reply was this:  

“I actually recommended Scilife to our manufacturing partner. Of course, you need to see which system works for you - being a manufacturer is different from a production facility. But Scilife has a lot of features for everyone.”

The Results

So, a year on from implementing Scilife, we wanted to know what the biggest impact was for LivAssured. This is what Jolanda said: 

“Before Scilife, we couldn’t really be sure who completed a task. Scilife tracks everything so we can see who does things, who signs off tasks and who reviews them. That’s a really big improvement.”

As LivAssured continues to improve its NightWatch product, they need to continually ensure quality. With Scilife, they’ve got it covered.

Are you on the lookout for an eQMS that links
all quality processes, ensures full traceability and
sets you up for success? 

Then get in touch and see how Scilife can support you!