I agree with @asimbana that ISO provides more flexibility with their definition “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of “results of a process cannot be fully verified by subsequent inspection and test”. As discussed in lecture the word “fully” makes it harder. Although by the language it would be possible to not require validation, FDA and ISO would require full verification. As described in lecture there are problems however because; 1. Verification test may be destructive 2. 100% inspection might be costly and 3. 100% inspection might not pick up the defects for example human error. Overall I believe that it is important and smarter to Validate. As Dr. Simon said, “When in doubt, Validate!”