How can I validate a patch?

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
1

Hello all;

I am close to do an OQ qualification for a patch to our already validated data collection software.

The OQ doc template that I am using seems that all the info it requires is like to requalify the software again.

So I feel that I am qualifying the software again which that is not the intend. The intention is just to do an OQ for the patch only.

My questions are:

Do I have to drive the OQ over the software again or over the patch only?
Does anyone know where (site) to find any sample of patch OQ/validation report documentation?

2

First question you need to ask is, what is the function of the patch.

When you know this you should be able to generate a risk assessment which will direct you to the level of testing that is required.

Get the main stakeholders involved and iron out what the patch is required for, and what impact it will have on other aspects of the system.

Regards

3

Yes:

The patch is from the vendor itself and it was tested by them.
Also they sent all the docs with all the patch details.

Also I already knows what the patch does.

My doubt is on the documentation.

4

After you have performed the Risk Assessment, I assume the next course of action you will take is to generate a change control with the proposed change.

To this change control I would then, attach a test script with the specific tests that need to be carried out in order to test the patch.

It really depends on what your Master Plan advises you to do.

1 Like
5

Graham is, as usual, quite correct. Iā€™d just like to add a little more.

In the risk assessment / test scoping effort, I recommend you include tests of areas immediately around the patch. That is often sometimes difficult to visualize but is pretty common for regression testing. Clearly the directly impacted areas need to be tested but often patch consequences are only seen in other areas. So if you picture the patch as a bulls-eye in the target, test that as well as the adjacent ring. I hope that makes sense.

1 Like
6

Hi,

Yes, the consequence testing also to be evaluated as a better practice. Valuable contribution Mr. Yodon, Greetings !