Change Control

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Hi All,

Can a change control be generated prior to validation report approval? i.e. report doc is being drafted when software version gets upgraded - in this scenario can I generate a change control documenting the upgrade prior to having the report singed off? The best practice is to wait but incase of time contraint I am wondering if this is acceptable.

Any input is appreciated.

Thanks!

2

The way I see it wouldn’t you want to have the change approved before generating a protocol for it? So, the way I see it is that you want to document and approve the change before you make a change and test it.