The regulation requires us to validate computer systems for intended use.
I am a bit confused about the scope of this term "intended use".
For example:
We develop a complaint handling system in house. So it's CAT 5. We have a software development process to ensure the quality of the product by documenting software use case, business requirements, unit test, System integrity test, User acceptance test. We thought all of these activities will form the validation of the system. We have a validation plan and a validation report to summarize all these activities and the deliverables.
This system is then deployed to different users in different locations (US, Europe, Asia, etc) with a user manual.
The regions heads signed the original project plan. Whenever there is an update to the system, the regions heads will again sign the approval.
We have already completed the validation at the end of UAT, before deployment. So do we have to validate this system for its intended use in different regions?
I hope I can be clear on this issue, because we do have a lot of global applications.
Thanks,
Natalie
"Intended use" to me is an owner interpretation of an application.
I don't know whether you are a supplier or an intrenal department of a multinational depoying the system in its different affiliates.
Although you do a preliminary validation and provide a detailed manual, I think it is very adviseable that the owner (together or not with the supplier) will run over the manual and see how he wants to put the system to his use. This can result in additional testing.
So the above is really intresting when it comes to suppliers saying 'PART 11 COMPLIANT'. It is the company's (= user) interpration of the predicate rules that need to be followed and not the developper's interpretation. I would prefer that a supplier added a phrase like: built to bepart11 compliant. In this way they show consideration of the user, and leave an opening for the intended use of the user.
Hello Natalie, no matter how redundant it sounds validation cannot be same as quality testing. The unit testing,system integrity test etc form the QA testing.
Validation can be a subset of the testing done previously but will be done in production environment only .thru IQ OQ PQ. at the users site.
'Intended use' would mean the final usage. The actual business process that will handle the complaints. This can be specifically tested in PQ.
Edited by Jagram on 06-29-09 03:53 AM. Reason for edit: No reason given.
