Interesting Validation Question

COMPUTER SYSTEM VALIDATION (CSV)
1

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

2

We have this fun thing in the states now called Sarbanes-Oxley (SOX for short).

SOX recommends some fundamental computer testing is required. Really it is just good practice to make sure that your software functions correctly before use. So typically, you wouldn’t have to “validate” other sections but SOX rules can call for testing.

We are struggling with how to merge the two. Validation being a dirty word and a meaning that the cost to implement is much higher. So how to justify validation or testing when the software module is not GMP

3

I assume that

o Human Resources
o Finance
o Travel
o Other Projects

do not have to be tested, but I would perform a Risk/GxP assement to ensure that these areas are not regulatory

4

As you thought HR can not be ignore.
HR should be validated in the peoples qualification aspect which will come under Training management . We have to consider as QMS governance .

This has been clearly mentioned in GXP .