According to the US Food and Drug Administration’s Quality System Regulation (Code of Federal Regulations Title 21 Part 820), 820.3(z) Validation means establishing by objective evidence that the particular requirements for a specific intended use can be consistently fulfilled and 820.3(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. So, even though it appears to be validation maynot be needed as verification is done, human factor evaluation plays considerable role in detrimining the critical elements.