-
alexandrabuga replied to the topic Maintenance & validation in the forum Process Validation and Process Risk 7 years, 3 months ago
I agree with what most of said that determining the main cause of the equipment failure and to add to the discussion, I would say based on this week’s Simulation, the importance of logging these incidences. In case there is a pattern and something else on the factory floor may be playing a role or other environmental causes. I think running a verification test would satisfy this particular case, but as @neb 2 mentions a CAPA might need to be initiated if the failure is considered a product risk and this might include process changes which could require revalidation.