Validation of EEprom/Software on Automated lines

COMPUTER SYSTEM VALIDATION (CSV) COMPLIANCE SOFTWARE
1

Hi Everyone,

We have an older system that is ran off an EEprom. We recently updated it and performed a complete validation. This EEprom controls a lot of different functions, as this is an automated process line, and these were all tested extensively in the original validation. Now we want to make a minor change to one of the functions. As any updates however minor, mean a new EEprom has to be loaded, I think this drives us to have to re-execute the entire validation, or can we just validated the changes to this EEprom?

thanks uys, much appreciated

2

Hello N-H,

I think that doing the entire validation again is certainly overkill in this scenario. I would first of all carry out an impact assessment with the relevant stakeholders to find out what impact this change will have on the system.

Based on the results of this impact assessment I would then carry out whatever revalidation on that specific part that has had the update and any related areas that could be affected.

Hope that helps.