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RobertP45
I am creating a new process to cover “extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results”, which is from FDA CFR 820.50-Purchasing Controls. The last FDA visit we were asked how do you define and use Tightened Controls over a supplier or contracted vendor. I am trying to locate a definition of “extent of control” or “tightened controls” either on guidance documents from the FDA site or by Googling the terms. We have processes in place, but an FDA acceptable definition of these for the FDA, needs to be more comprehensive than what I presently have. Thank you!