Join this channel to get access to perks: / @hitendrakumarshah3718 The news in UK can be accessed through the below link; www.standard.c... This video will help you to learn how to control and validate excel spreadsheets.
Spreadsheets are not under GAMP category. We need to validate the functionality and controls of spreadsheets in line with the guideline expectations. Please refer the session on CSV for GAMP categorisation.
I have a doubt, we revised the one of the CQA specification, it is notifiable change. Should we do Process validation before getting NRA approval or after getting approval. Please let me know
What exactly changed? CQA is changed means whether limit or test or method of test is changed? That needs to be evaluated. Based on this I can guide you.
