Next, we will leave the Infission corporation to talk to some colleagues who manage manufacturing at a medical instruments company—Lilean Brosh. We will interview them on what they consider to be their most urgent compliance issue. We will dive into the details of CFR 21, and show how the audit procedures of this standard fit into GRC Manager. We will also show how some of the records management requirement of CFR 21 Part 11 are managed through digital signature aspects of Oracle Workflow.
This regulation relates to the Food and Drug Administration's primary jurisdiction for the premarket review and regulation of products that comprises any combination of a drug and a device; a device and a biological product; a biological product and a drug; or a drug, a device, and a biological product. An example of a biological product is a vaccine.
The thrust of CFR 21 is good manufacturing practices to protect...
