Yes, as recommended by GAMP 5, users can rely on the supplier file to establish the validated status of their system.
However, it is important to specify that it is the users who make the decision on the validated status or not of the system and it is in no way the supplier who can do so.
Assistance from suppliers is an element that makes it possible to capitalize on the checkpoints already verified at the supplier. But this cannot be done without first checking a certain number of prerequisites, in particular:
- How is the supplier organized via a supplier audit?
- In which environments are the tests carried out?
- What is the content of the checks already carried out in relation to my identified risks?
Validation being to provide proof of conformity and control of the system in its environment, the supplier cannot in any case provide proof of the organizational control points to be covered in particular by the implementation of procedures, etc.
