How Ender Diagnostics' quality manager built an in vitro medical device QMS with Qualio
Ender Diagnostics is a Swiss developer and manufacturer of rapid molecular diagnostic kits for the detection of SARS-CoV-2.
Ender sits on the frontlines of the worldwide battle against COVID-19, offering rapid, high-accuracy on-site and laboratory testing.
As a producer of COVID-19 PCR tests, Ender's quality management system falls under in vitro diagnostic medical device standards and regulations, including the EU IVDD (transitioning to the IVDR) and ISO 13485.
Dr Ender isch dr Gschwinder.
The organization was founded in 2020 and expanded rapidly, buoyed by the explosive demand for COVID-19 testing as the pandemic raged.
But Ender's manual, paper-based QMS couldn't keep pace with this expansion and lacked audit-ready traceability and control. The system also didn't support remote and home working.
With the majority of Ender's workforce formed of scientists and graduates, there were only small pockets of specific quality management experience - and no patience for time-consuming admin tasks which distracted from scientific work.
Mohamad El Zein interviewed for the position of Ender Diagnostics' quality manager in April 2021. One of his interview questions was:
"What would be your approach for implementing a document and training management system for Ender Diagnostics?"
That was my interview task. But I presented something totally different.
I said I wouldn't do it like this. I would implement an entire eQMS because it makes much more sense.
I got the job and started immediately!
Mohamad got to work with his eQMS search straight away, first turning to Google and then honing in on Capterra to find a reputable and trusted vendor.
Mohamad's search priorities were:
1. An easy-to-use eQMS software system, with...
2. Rapid set-up time and no need for hours of training
3. Cloud-based access for an international, remotely distributed team
I've used other systems before. Some require about 100 clicks to assign and complete tasks.
And I found out that most of the time, people weren't doing it because it was too complicated.
An eQMS should help you and you shouldn't have to spend time on the system itself.
As the sole quality resource, Mohamad decided to implement Qualio and was impressed by the speed and ease of the implementation and validation.
With ISO 13485 compliance as the primary objective, Mohamad began to construct his eQMS around the requirements of the standard with help from the Qualio team.
As a Qualio customer, Mohamad could request dedicated QA support and pre-built compliant document templates to accelerate his ISO 13485 preparations.
We got set up very quickly.
I was alone as quality manager, so I really appreciated the support by Qualio and especially Sumatha.
Sometimes I didn't have time to create a process from scratch, so I asked if she could produce a template.
And that's what she did. The support was great.
Ender Diagnostics' manufacturing sites, as well as its testing laboratories in Bern and Zurich, now access Qualio as the company's dedicated electronic quality management system.
Ender faced its ISO 13485 audits in February and April 2022 and passed with flying colors, unlocking new regulated markets to Ender for the first time.
With digitally enforced compliance, the organization can now focus on further market expansion and has begun work on territory-specific requirements.
The headcount of Ender Diagnostics has already tripled to over 180 employees since Mohamad joined, making a cloud-based single source of truth vital for continued compliance and quality improvement.
Ender now has ambitious plans for bringing fresh products to market, with 3 more in the pipeline and an SaMD project in the works too.
Above all, Mohamad has embedded the control, consistency and traceability he felt was impossible in a paper-based quality framework - and has made his own life easier in a hybrid working world.
By using Qualio’s DMS we were able to eliminate all non-conformities related to our document control.
The office is 3 hours from my house so I do lots of work at home and on the train, and you can imagine my backpack full of paper before Qualio.
Forget it! COVID showed us you must have the possibility to work from anywhere.
Ender Diagnostics now has a complete cloud-based eQMS comprising:
Document control (SOPs, work instructions and forms)
Training management
Quality event management
Mohamad has seen a noticeable uptick in engagement with the quality system, with more Ender employees comfortably accessing and completing quality tasks within Qualio than the previous system.
In terms of time - and time being money - Qualio has definitely been worth it.
It's been outstanding.
