FDA Electronic system audit

foreverblue80

This is an interesting request and its the first time I heard about it even with my prior job with Nav vendor. A little background, the company I work for is medical equipment suppler and we are ISO compliant and under FDA rules. We got audit by one of our customers. Based on the Electronic system audit checklist from FDA, we need to provide a report or documentation to on validate computer software for its intended use. Has anyone seen this type of request? I contacted our 3rd party vendor and they are not able to help us. This is first time they heard about it. Do we have any documentation or report, maybe with Microsoft?


Thank you in advance.

txeriff

This is not a development issue. I think this is more an audit issue and by that sentence I can't tell much. You will need to ask them what needs to be audited and reported.

foreverblue80

I know. When I asked the auditor, everything he came back is like open end question... Like what report do you have and test to insure permission is working.. or what type of test do you perform to make sure the functionality of the system is working properly....

KTA8

It's quite normal. They're asking you how to do deal with changes, if you've test of the development and so on.

vaprog

I don't know about initial system validation, but for changes to the system you need to have predefined rules/procedures, including quality control management, and you need to document that you followed these rules and that quality is assured. Just as for ISO 9000 ff.

foreverblue80

We have ISO 9000 certification. During the audit, they don't ask anything about the system. The auditor is focus on department process. The FDA audit is forcing us to get ISO 13485. The 8 years at my prior job as business consultant/developer, I never had this request. Event with a client is under FDA regulation.

The stuff they are asking is like install Windows or Office and asking how are you able to test it to make sure software perform as expected.

Always learn something new and this one give me a headache.