You may have the most thoroughly validated systems but if your IT infrastructure doesn’t support a robust backup and restore process, you’re a ticking time-bomb!

Why is this being brought up in a computer system validation discussion?

Well, effectively, a backup PROGRAM is a software application.

Data Integrity

You may also recall in the data integrity discussion (and give yourself a pat on the back if you did!) that backup data are exact, complete, and secure.

This just screams validation, right?

While it falls under the ‘Infrastructure’ type category, it’s critical to business integrity as well as to stability of your application and the data gathered and maintained by your applications so it deserves some attention.


A backup AND restore system should be validated.

Requirements may not be all that interesting – backup everything!

But think about it a bit: where IS all your data?


There may be some on a dedicated PC that holds all the label templates.

Some may reside on local user’s PCs that, while on the network, have chosen to store data locally (which likely isn’t backed up).

Also, don’t forget that in many cases, there is also metadata stored with the data (e.g., all audit trail information).


This absolutely needs to be included in backup and the ability to restore needs to be validated.

Your requirements may well be just an inventory of where things reside that need to be backed up.