Hi Viraj,

it really depends on the equipment or the process you are trying to validate. There are some, for instance if you purchase equipment from a vendor, there are cases were you can validate this equipment as an COTS ( Commercially Off the Shelf) often times a validation package may be purchased and you may just have to bridge the gaps of validation between the manufacturer and your company. If lets say you bought a customized piece of equipment that utilized software, then a computer system validation (CSV) may be needed. I know I have seen CSV’s to be very lenghty and tedious, one particular one that I saw was over 100 pages long and it took the individual a few weeks to complete. Based on my experience I have done DQs,IQs,OQs, and PQs. I have not personally done a CSV yet.

Chris