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?
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 guys, much appreciated[/quote]
Do a risk assessment - if minor change points to being low risk to quality, then just run the IQ and then PQ (relevant parts). - if it throws up loads of problems, your strategy was still correct and you need to perform some more regression testing thats all. As long as you have shown due diligence in your test approach and documented this in the change control forms, you will be fine. You can always monitor it closely for a few production runs after to make extra sure.