Hi All,

I believe that both require full verification of the process, but at different times. The FDA definition seems to be requiring full verification of the process by inspection and test, or 100% testing of a process. However taking: inspection ≈ monitoring and test ≈ measurement, we can see the ISO definition is extremely similar, but does not say fully verified. However, ISO also has the statement that, “Validate any process…Including the times when deficiencies become apparent after the product has been delivered”. This shows that although a process may not be fully verified before the product is delivered, if it is found to not be fully verified, then validation is needed.

http://www.mastercontrol.com/newsletter/medical_device/process-validation-medical-device-0610.html

-Andrew Nashed