Digital Filling System - What do I need to Validate Here?

Hi All,

I have a query in relation to the following issue.

I currently have a client that needs a Digital Filling System fully validated.

The following departments are going to use this system:

o Regulatory
o Manufacturing
o Supply Chain
o Human Resources
o Finance
o Travel
o Other Projects


I assume the system will have to be validated for regulatory,Manufacturing,Supply Chain.

But what about Human Resources, Finance, Travel and other projects?

Do I need to validate these sections of the system aswell.

Any help would be greatly appreciated.

Regards

Did you mean a digital filing system (a system to organize digital files)? Otherwise, I can't see what Travel would have to do with a filling machine.

If this is the case, then you need to see how the system impacts the quality aspects of your regulated business. Chances are that there won't be any impact for, say, Travel.

I would expect that there would be considerable impact in the Regulatory department. If regulated by FDA, then likely Part 11 is relevant.

Is this on the right track for your question?