![image (3) image (3)](https://apotechconsulting.com/wp-content/uploads/bb-plugin/cache/image-3-circle-3f60d2fc389527990d597a195eebd143-hs52cfmijo9p.webp)
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 Frame 1000005946](https://apotechconsulting.com/wp-content/uploads/Frame-1000005946.png)
Scope of work
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
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 Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Gantt Chart to manage and plan the validation
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Validation report drafted
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Training of the stakeholders to ensure they will be self-sufficient on CSV at the end of the project
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Risk assessment for each softwares in use at ID SOLUTIONS
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Draft of a validation procedure and all related working documents (test protocols, tests templates, validation report, …)
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Validation with technicians to conduct the tests
![Have a project in mind_ Let’s work together! Have a project in mind_ Let’s work together!](https://apotechconsulting.com/wp-content/uploads/Have-a-project-in-mind_-Lets-work-together.png)
Key numbers
![Management Management](https://apotechconsulting.com/wp-content/uploads/Management.png)
Team
1 consultant
![Charity Charity](https://apotechconsulting.com/wp-content/uploads/Charity.png)
Location
France and remote
![Combo Chart Combo Chart](https://apotechconsulting.com/wp-content/uploads/Combo-Chart.png)
Length
8 months
![WeChat WeChat](https://apotechconsulting.com/wp-content/uploads/WeChat.png)
Type
TM2