What are the FDA and ISO saying in reference to process validation where :

“inspection” ≈ “monitoring”

and

“test” ≈ “measurement”

Would IS ultimately still require “full” verification for a process that supposedly did not need validation?

What are your views on this? Do you believe their approval processes that allow a company not to validate would actually vary? If you have any examples of products that have been required to be validated by one organization and not the other please list them.