Audit trails

I have a new custom designed software system that has no audit trails.
I want to validate the software but can I validate the software if there is no audit trail. ?

Hello Gersiobhan,

Yes you can certainly validate the software but if you want to ensure compliance with 21 CFR Part 11 without an audit trail then that’s a different matter.


Thanks - yes want to ensure compliance with 21 Part 11 as the software is being used to make a quality decision - back to the drawing board!!

Here is a link to a presentation on Audit Trails for compliance software…it may help you with this: