Hello everybody, I need to know the proper methodology related to URS.
Are these the steps to follow with the URS?
Is correct:
1-The user sends an e-mail requering a new software.
2-The sector of validations assesses the order (e-mail).
3-The sector of validations runs an Impact assessment to see the implications GxP and GAMP category.
My main questions is:
“The URS should always be generated despite of the software would be validated or not?”
Tks Carlos