ChecK List for Software Validation

COMPUTER SYSTEM VALIDATION (CSV)
1

Dear Forum Members,

Can anyone provide me the check list for software validation? Do let me know if any guidance documents if available.

Thanking You & Regards,

kvkiran

2

Do you mean the documents assocaited with the validation or what the documents contain?

3

Depending on your goal, there’s the FDA guidance on Software Validation:

http://www.fda.gov/cdrh/comp/guidance/938.html

4

Dear Forum Members,

Thank you for your information.

Mr.Gokeeffe,

its nothing but the summary sheet to check which system is eligible for software validation and what to be checked for software valdiation.

I hope that this may be clear for you.

Do reply!

Thanking You & Regards,

kvkiran

5

Hi kvkiran,

I think you need an Intended Use and Base Risk document.

This document will walk you through what equipments need to be validated and to what extent, ie what GAMP cateogory it falls into.

If you would like to purchase a copy of this doument from our company Premier Validation, please contact me at the contact details below.

Regards