IQMS Enterprise Resource Planning Software Validation

Hi,

I've been assign the project that validates our newly installed IQMS Enterprise Resource Planning Software. Can anyone offer some suggestions or advice on how to get started?

Thanx!

Roger

You may want to check first if the software developer may have already done the validation

Thanks for your response-always appreciated! The vendor does offer a qualification package, however my client decided that they will not be using all the functionality and so they do not want to spend the "dinero".

Besides, I really want to be able to add this to my CV! I enjoy project like this. Sad huh? I guess I need to get a life!

I agree with Arios. IQMS wants to keep their customers happy like many software developers run extensive testing. Granted, this does not always catch all of the bugs, but IQMS has a user group, blog, and support service so it would be good to contact them.

If they do not have evidence of testing, then you can input known error conditions to verify if the software 'catches' them similar to the renegade or 'red-rabbit' testing done to verify manufacturing error-proofing is effective and operational.

Good luck!

You're right-it never hurts to ask. I will take you suggestion and contact them...

Well, after spending 5 days training with the rep, I have found out: they do internal testing and even "validation". But they can provide no documentation. As we know, for the FDA, if there is no documentation it did not happen!

It is as I suspected. This is typical. Even though a company may do internal testing, their documentation of the testing is usually poor or non-existent. That is job security for me though!