case study:

Fast implementation

Reapplix is a regenerative medicine company that help people who suffer from hard to heal diabetic foot ulcers, which may result in amputation. The patients are treated with 3C Patch®, a biological patch manufactured using only the patient’s own blood and placed directly on the foot ulcer.

The company is in the initial commercialization phase in the US and selected European markets and was looking for a way to get rid of inefficient paper-based documentation and processes.

“Our main concern was that it would take too long and require a lot of internal resources to digitize our QMS and DHF. However, we were up and running after about one month, which was much faster than expected.” says Niels Erik Holm, COO at Reapplix.

Avoid a 'big bang' project

To harvest efficiency benefits early and not ‘overwhelm’ the organization with a new system, SimplerQMS was implemented in three phases. Instead of going for the typical ‘big-bang’ launch, which is riskier and often puts too much pressure on a busy organization, Reapplix choose a  gradual 3-step roll out:

Step 1

  • SOPs
  • Work Instructions
  • Templates

Step 2

  • Design Control
  • Equipment Management
  • Supplier Management

Step 3

  • Non-Conformances
  • CAPAs
  • Complaints
  • Audits

“It was critical for us to choose an eQMS that could support all the relevant processes in our medical device company – not only now - but also in the future. We found this in SimplerQMS. Furthermore, the system is developed and designed by people who are very knowledgeable about medical device regulation and processes" says Niels Erik Holm.

The first digital audit

Reapplix recently went through their first ISO13485/MDD audit after digitizing their QMS. 

“The notified-body auditor was especially interested in our eQMS validation documentation, which is a requirement in ISO13485:2016. SimplerQMS had helped us with the validation and provided critical documents like the risk analysis, regulatory criticality assessment, validation plan, OQ & PQ, validation report and certificate. The auditor was very impressed with this work. We were able to find and show procedures, instructions, reports, meeting minutes etc. very fast by searching in the system” says Ulla Tedaldi, QA Manager at Reapplix.

“The collaboration with SimplerQMS has lived up to our expectations. Their service has been superb and very supportive”

Niels Erik Holm, COO at Reapplix

Making the decision

Many startup’s fear that going from a paper-based QMS to an electronic eQMS is an unfeasible task. Therefore, SimplerQMS has set of tools that will help move the historic documentation. To save time for the customer, SimplerQMS also comes with ready-to-use procedures for Document Control, Identity Management, Electronic Signature Agreement etc.  

“I can seem scary before you start and of course there is some work getting from paper to and electronic system. However, when you start to see the benefits, you realize that it was the right decision. So just go for it!” says Ulla Tedaldi, QA Manager at Reapplix.

Reapplix case facts

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