FDA and Peachtree Quantum question

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

our company has just bought Peachtree Quantum 2011 and were wondering what steps, if any, we needed to go through to validate the software (even while installing) to please the FDA.

we’re new to the validation process in general so any info on the lengths we need to go to with documenting everything would be appreciated

2

Hi,

Isn’t Peachtree some sort of accounting software? Is it used in support of any GxP process? If not, and it is not being installed on GMP-build PC’s/Servers, the FDA really won’t care what you do with it. Otherwise you’ll need to treat it as any other bit of GxP software and produce a full qualification/validation set of docs.

Cheers

Monkey

3

Hi Monkey,

Thanks for the reply. If we use this accounting software to record where product was shipped, and then use that information for recalls, could it be reasonably argued that it falls under GMP?

Thanks, have a great weekend!