V- model of CSV

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

I am doing ME in Pharmaceutical process and automation. I never had any experience in pharma… I got an assignment to write about computer system validation of an computer system. Not sure where to start. Need help and please help with links. I need to write atleast 4 pages about the computer validation using V-model
Thanks,
Paddy

2

Hi Paddy75,

Try a search for “v model” and you’ll see some good threads. Take a look at this one, in particular:

http://www.askaboutvalidation.com/forum/showthread.php?t=1696&highlight=model

Come back if you have specific questions.

3

Thank you very much yadon

4

There are many articles at

ISPE publishes Pharmaceutical Engineering and the issues and articles are located online. There have been many articles on the GAMP V model over the past 12 years.