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
Scope of work
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)
Gantt Chart to manage and plan the validation
Validation report drafted
Training of the stakeholders to ensure they will be self-sufficient on CSV at the end of the project
Risk assessment for each softwares in use at ID SOLUTIONS
Draft of a validation procedure and all related working documents (test protocols, tests templates, validation report, …)
Validation with technicians to conduct the tests
Key numbers
Team
1 consultant
Location
France and remote
Length
8 months
Type
TM2