I have been asked to provide a recommended strategy for validation of an MES system.
The scope of the project includes the plant control systems and their interface with the MES. There are 100 - 200 items in the list of equipment for the site. I do not know the validation status of those control systems, but part of the strategy I develop should address those systems.
I have GAMP4, GAMP5, and am familiar with their contents, I’m trying to develop a strategy specific to MES, its interface with plant floor equipment, and the individual control systems.
Thanks for any insight/recommendations. Also, if any of you know any good articles or sites, I’d appreciate the info.