CASE STUDY:

REAPPLIX

Who is Reapplix?

Reapplix is a regenerative medicine company that helps 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.

 

 

Product: 3C Patch System

Industry: Medical Device

Company Size: 20 employees

Development Stage: Initial commercialization

Goal: Easier regulatory compliance and higher work efficiency

 

 

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.

Niels Erik Holm

COO, Reapplix

Reapplix Video Testemonial

eQMS Implementation

Preparing for Implementation

Implementation of a new software towards established processes is always a sensitive task. The stakes are even higher when the documents in question are essential to the success of a medical device or pharmaceutical product.

To ensure a smooth and fast transition to a new system we met up with Niels. We started by discussing their current QMS solution and their essential processes. When we completely understood how is their QMS wired we needed to consider the needs of the team and the company. Over the course of several sessions, we thoroughly got to know the processes, and goals of ReApplix so that we could offer a suitable set-up.

Implementation Process

We agreed on a 3 step implementation process. This process offers a steadier transition but also requires more time. Compared to a “big bang” launch, which transitions all processes in one step, 3 step implementation is paced out and doesn’t put too much pressure on a busy organization.

We agreed on the following implementation phases:

STEP 1

  • SOPs
  • Work Instructions
  • Templates

STEP 2

  • Design Control
  • Equipment Management
  • Supplier Management

STEP 3

  • Non-Conformances
  • CAPAs
  • Complaints
  • Audits

The implementation of phase 1 took approximately 1 month. In the end, ReApplix transitioned their QMS to the following SimplerQMS modules:

  • Document Control
  • Design Control
  • Equipment Management
  • Supplier Management
  • Customer Management
  • Training Management
  • Post-Market Surveillance

It can seem scary before you start and of course, there is some work getting from paper to an electronic system. However, when you start to see the benefits, you realize that it was the right decision. So just go for it!

Ulla Tedaldi

QA Manager, Reapplix

Training and Support

Training

Part of a gradual implementation process is also a progressive introduction to the functionings of the SimplerQMS software. After the implementation of the 1st phase, we started a hands-on training session with the team members. We gradually introduced Reapplix to different features of our software. Employees were able to experiment with different use cases while a training instructor provided feedback and guidance. The training session was finalized when all crucial employees confidently used SimplerQMS to complete their daily tasks.

Support

Even though the training was finished and the team understood the new software very well, there were times when they needed help with a specific process or feature. Part of the SimplerQMS package is also a 9-17 customer support which allows for easy and fast resolution of troubles. 

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

Niels Erik Holm

COO, Reapplix

Results

Successful Digital Audit

The Reapplix team mainly appreciated the fast integration of the software to their existing processes. Thanks to SimplerQMS, the team started to rely on notifications, which allowed them to better focus on their work and communicate requests more efficiently. When it was time for their first digital audit, Reapplix passed with flying colors. The auditor was impressed with the efficient search functions and the team’s ability to provide crucial documents in no time.

Reapplix appreciated:

✓ Fast Implementation

✓ Ready-To-Use Procedures

✓ Reliable Customer Support

✓ Notifications and Reminders

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

Ulla Tedaldi

QA Manager, Reapplix