Idevax is a Belgian-based medical device company that develops, produces, and commercializes innovative drug delivery medical devices used for prophylactic and therapeutic vaccination as well as lymphatic applications.
As Quality Assurance and regulatory affairs manager, Daniele Scalco Vasconcelos’s role is to ensure high quality standards for development, production and cultural QA, plus compliance with regulations.
Daniele talked to Scilife Customer Success Manager, Trine Michelsen about how Scilife has been used since the start, integrating different processes, managing audits, paper-based versus digital systems, and her enjoyment of working with Trine!
From the very beginning, Idevax knew they wanted a QMS in place. And they were also sure that it should be an eQMS, that they wanted to be digital from the start. As Daniele explained:
“We were founded in December 2020 and we’ve been using Scilife since the beginning.”
So, why did they choose Scilife? The reason was quite simple:
“We chose Scilife because of our CEO’s previous experience of Scilife, which was a very positive experience.”
With the decision made so easily, the next step was for Idevax and Scilife to work together in setting up the eQMS.
The first module Idevax started with was Document Control, then very soon after that, they added Event Control, Change Control and Training. So, for Daniele, it was a smooth, step-by-step set-up process.
“The support was really great. I remember the demo at the beginning, which I could rewatch whenever I needed.”
And the support continued after the initial set-up, with Daniele able to access it in various forms:
“I also use the Knowledge Base a lot and periodic meetings with customer success is really great as it gives us the chance to talk about tools or things to improve.”
When it comes to Daniele's favorite aspects of using Scilfe, she has several - ranging from how it helps with compliance and risk management to particular features and modules, as well as promoting collaboration. Here is what she had to say about compliance:
“Traceability is the most important thing for compliance and with Scilife it’s really easy to retrieve information. In an audit for example, if you take paper based records and start going through it all, it would be a mess.”
With risk management, Daniele finds that using an eQMS helps identify deviations and leads to improvement.
“When we find a deviation, we have to prevent it from occurring again, so adding impact and risk is really helpful. And that is linked to improvement.”
In terms of particular modules, Daniele's favorite feature is the workflow in Document Control, as it lets her see the root cause of any issue and she loves that it is automatic
“I also really like the Training module because you don’t need to keep track of what is updated and by who. And the linked documents function is also very useful.”
For Daniele, it is not just about features and functions, it is also how using Scilife impacts her daily working life and of her whole team.
“I have Scilife open every second of my day. For collaboration it's really important. It’s very easy to work in a collaborative way when you have a platform where everyone can access and add to the same document.”
So, would Daniele recommend Scilife? “Absolutely” was her response. And what advice would she give to other organizations looking for an eQMS?
“Find one that is easy to use, that's the most important thing. It should be intuitive, so that people can easily access documentation.”
She also advised that QA managers should look deeply into their processes and think how they will integrate it, to take a step back and understand how their workflows will fit into the eQMS.
“One thing that is always a challenge is integrating operations. To create a process that integrates operations into the system is the most challenging thing.”
But for Daniele, taking the time to integrate existing workflows into an eQMS is completely worth it and leads to much more efficient operations.
Using Scilife from the very start has helped Idevax identify quality issues at an early stage. This leads to improved efficiency, which in turn makes compliance easy.
“Scilife has made our life easier in so many ways. One of the things I like the most is how it integrates different processes. It gives a bigger picture of everything and allows us to keep track of deviations and see opportunities for improvement.”
Being an eQMS also has huge advantages, as a digital system allows Daniele and the QA team at Idevax to investigate issues deeply.
“I wouldn’t have enough time to deep root cause investigation and analysis if it was paper based.”
And the results of all this? During audits, Idevax not only received compliments regarding the use of Scilife’s platform, it helped them obtain their ISO certification within a year and a half.
Are you looking for an eQMS that ensures compliance, increases efficiency, and promotes collaboration?
Then contact us and see how Scilife can support you.