TestStand 21 CFR Part 11 compliance

[mjbrooks07]

Hello,

I'm evaluating the use of TestStand in conjunction with LabView for a new family of test systems. Our facility produces FDA Class III Medical Devices, is there any literature on achieving 21 CFR Part 11 compliance (Electronic records and electronic signatures) with use of TestStand?

Thanks,

[WireWeaver]

While i'm not familiar with the details of it, CertTech makes a Tool Qualification Kit for TestStand. They'd probably be a good contact for more info.

Hope this helps!

Trent

[Nrojas]

NI is not the final equipment manufacturer, but many equipments developed with software of NI LabVIEW and TestStand has passed FDA. http://www.ni.com/white-paper/7150/zhs