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Medical device CSV

Introduction

IVD manufacturer

The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France.

Apotech consultant:

Apotech’s consultant coordinated 5 technicians, acting as project manager and technical consultant and reporting to the QA and site directors.

Types of Audits 

  • GAMP5
  • 21 CFR PART 11
  • GMP Annex 11

Locations

  • France ​
Frame 1000005946

Scope of work

Done

Assessment of the initial situation (who will be the stakeholders, the project owner, what is the level of maturity and importance of the topics for them, is IT Infrastructure within the scope)

Done

Gantt Chart to manage and plan the validation

Done

Validation report drafted

Done

Training of the stakeholders to ensure they will be self-sufficient on CSV at the end of the project

Done

Risk assessment for each softwares in use at ID SOLUTIONS

Done

Draft of a validation procedure and all related working documents (test protocols, tests templates, validation report, …)

Done

Validation with technicians to conduct the tests

Have a project in mind_ Let’s work together!
Client quote

This CSV project required some technical skills that we didn’t have in house. Our Apotech consultant has been extremely supportive, not only by managing the project but also by sharing their knowledge and training the team. We are now compliant and feel capable of maintaining our softwares validated, as expected by the regulation!

Key numbers

Management

Team

1 consultant

Charity

Location

France and remote

Combo Chart

Length

8 months

WeChat

Type

TM2

Excited to work together on your next project?

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