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Customer Story REPERIO

Medtech startup Reperio able to focus on innovation while freeing up resources with Scilife

  • Being fully digital from the very start empowered remote working, saved labor hours and minimized errors
  • Starting off with basic functionality opened up growth yet respected limited startup budget
  • Full ISO 13485 compliance, prevalidation and clear audit trail saved time-intensive regulatory headaches
Image that represents Eyetracking from Reperio | Scilife

 

About REPERIO

The Dutch medtech startup Reperio is on a mission to save our eyes. The company specializes in developing cutting edge and non-invasive medical tech to help early detection of conditions such as Glaucoma, that, if undetected, can lead to severe visual impairment or even total sight loss. The software and products Reperio develops have the potential to improve the quality-of-life of millions of people around the world. 

Annemarie Booijenga, QA lead at Reperio, shares her Scilife story with our Customer Success Manager, Trine Michelsen.

 

 

The Challenges

Reperio is a young company, founded not long before the pandemic in 2019. Annemarie explains that she entered the company in 2021 with the task of setting up a complete quality management system from scratch. Since Reperio is a European medical device company, a compliant QMS was essential to meet ISO 13485 regulations

Annemarie describes that her first challenge, considering the conditions at the time, was that Reperio’s QMS had to be set up entirely remotely. To Annemarie it was clear, she definitely wasn’t starting anything requiring paper!

Reperio’s second challenge, shared by most young startups, was budget constraints. Annemarie explains that financial resources were definitely a limiting factor in the early days.

 

The Search

From the word go, Annemarie set her sights upon searching for only electronic QMS (eQMS) solutions. Not only for remote-compatible reasons, but from her experience of paper-based QMS being notoriously high maintenance. She also had to take into consideration Reperio’s initial financial limitations. Since Reperio was so small, Annemarie decided a full-blown eQMS with all the enterprise bells and whistles wasn’t necessary. What Annemarie was looking for was a modular eQMS, something simple but effective with the possibility to grow.

 

‘When you just start, you just need to put your documents somewhere. So what we really needed was something to manage our documentation, that didn’t involve paper. What was really a big advantage of Scilife is that we just started with the document module and that when we grow, Scilife can grow with us.’

Annemarie Booijenga, QA lead at Reperio

 

Another important search criteria for Annemarie was that she wanted flexibility and freedom in her eQMS. 

 

‘What I don't like, for example, is that other eQMS solutions completely dictate the way you work. We didn't want an eQMS to tie our hands, but we did need a system to be compliant, to make everything available, to be paperless and to be modular. So well, that’s how we ended up with Scilife!’

Annemarie Booijenga, QA lead at Reperio

 

The Set up

When asked about onboarding and implementation, Annemerie remembers that it was a smooth process for her team of software engineers - all she had to do was grant them login access!

 

‘Maybe they are not representative of all users, because they have a lot of affinity with computers and applications and stuff like that, but they were able to use Scilife without problems, without any training.’

Annemarie Booijenga, QA lead at Reperio

 

Annemarie herself followed a training led by Trine, but she mentions that even without that session she would have been able to find her way with the platform, thanks to Scilife’s extensive knowledge base

 

‘Before I started, I already had the work instruction on how to use Scilife ready based on your knowledge database, because just by reading your knowledge database that's available online, you can get so much. It's already a full manual of how the system works. also if you have questions it's just very easy to reach out to Scilife’s help desk and get an answer very fast’

Annemarie Booijenga, QA lead at Reperio

 

Annemarie also adds that Scilife’s onboarding support was excellent, and helped everything start off smoothly for Reperio.

 

Favorite features

 

1. Live editing & multiple authors

Scilife makes real-time editing directly within the platform easy. Annemarie mentions that her favorite feature is that documents don’t need to be constantly uploaded and downloaded in order to make edits. Everything is stored digitally and edited digitally in one central place. This ensures documents don’t get lost.

 

‘That's what I really like about Scilife. You don't need to do the uploads and downloads, all the changes are there. If you make a change it's immediately there. You just get a new version and that’s just really good because otherwise, if you have it locally on your computer, sometimes computers crash, things are lost, or you don't know where you saved it - because you have a number of files or even two people working on the same document offline.’

Annemarie Booijenga, QA lead at Reperio

 

Not only does a central digital document control mean files are safer and easily accessible, it also makes it possible for multiple authors from multiple departments to work in tandem on the same document. That collaborative feature is Annemarie’s firm favorite.

 

‘In a previous multinational company I worked for, we had the situation quite a lot that multiple people were working on one update, but because you needed to upload, you needed to find a way to share files if you want to have two or more people working on the same update. Sometimes it was someone from R&D that needed to add a new product, and another one was from operations that just needed to improve workflow or something in the documents, but there was no way to just have both people working on the same document. With Scilife, you don’t have to find a way to share files.’

Annemarie Booijenga, QA lead at Reperio

 

2. Document control

Annemarie highlights that the Search and Tags features within Document Control are really handy for Reperio. Rather than just being an electronic document storage solution, Scilife’s Document Control has complete document management capabilities. She explains that she likes that the platform allows her to make custom document types, which means Reperio is able to really put everything into Scilife.

 

3. Central Dashboard

Annemarie adds that it’s useful as a manager to have an overview of everyone's action list in the central dashboard. At a glance, she knows which of her team needs to be followed up.

 

4. Audit-readiness

Annemarie mentions that it’s far easier to demonstrate everything during an audit with Scilife, because it’s all in the system; in one place and easy to track. 

 

5. Validation

Scilife takes care of the bulk of validation work, which Annemarie says also saves any Life Sciences company a lot of time.

 

Expert Advice

When asked to share her top tips for other Life Sciences professionals searching for an eQMS, Annemarie gets straight to the point:

 

‘Before buying an eQMS, really think about what you want from it. How do you want to use it? What do I want my eQMS to help me with, what do I want it to do? And well, then really look at a system that can really help you with that.’

Annemarie Booijenga, QA lead at Reperio

 

She explains that despite that advice sounding quite obvious, too many times she sees other companies diving in headfirst without much thought about their specific company QMS needs. This means their chosen QMS, however great it may work for another company, ends up making things even more difficult than before.

When it comes to implementing Scilife, Annemarie has the following excellent advice:

 

‘You really have to think about how you want to do your implementation. Ask yourself: what groups do you need? What document types do you need? What users do you need? Make a structure before even opening Scilife to just have a plan on paper, an implementation plan. If you have that clear, if you know what tags you need, what folders you need, what document types you need, then it's just sitting behind your computer and just filling it out and then you're ready to go. If you have that, then implementation is very easy, but it takes some pre work’

Annemarie Booijenga, QA lead at Reperio

 

She also makes an interesting point:

 

If you plan ahead, you can get management approval upfront before you work in the system, because as soon as you have something in the system, well then it's also in the database, and it becomes far more difficult to change things. So you need to delete everything or mark for deletion and start over again, and that makes it just far more complicated.’

Annemarie Booijenga, QA lead at Reperio

 

The Results

Annemarie is really happy with the Scilife platform. For Reperio, she says, Scilife has been a great ally in saving resources which has helped Reperio to focus on what matters, innovating sight-saving tech to help improve lives. 

 

‘Scilife really helps you to be compliant and it saves you a lot of money and time that you can then spend on other things. If you are in a small startup company, money is not unlimited, you need to be careful with it.’

Annemarie Booijenga, QA lead at Reperio

 

Annemarie highlights that although some QA professionals from big companies find eQMS solutions expensive, it’s worth the cost to go paperless

 

‘I think in the end, it's cheaper to have an eQMS that arranges everything well, because doing everything with paper, it's very labor intensive. It takes a lot of hours that the system can do for you.  In addition, it will be far easier to demonstrate everything during an audit because you have it all in the system, it’s just much more easy to track. Also, if you have a big team then training them through Scilife will certainly save you resources and time.  Paper document distribution and keeping track of trainings is often a full-time job in a big company. But it’s just moving paper around.’

Annemarie Booijenga, QA lead at Reperio

 

We hope to be Reperio’s allies in improving lives for many more years to come!

 

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