By Christian Kelley

Following along in the Medical Device compliance stream, the FDA is planning a new revision of 21 CFR Part 11, which is a regulation governing electronic signatures and records. It’s my understanding that future versions of Teamcenter (Unified) will support biometric authentication.

Biometric authentication appears to be slated as a requirement in an update to 21 CFR Part 11 (see the side by side comparison of the current 20 year old version of Part 11 and the new, revised proposal).

Apparently, biometric support was supposed to be included in the original Part 11, but due to the technology and cost barrier of biometrics 20 years ago, that requirement was killed. Today, biometrics are common and, in fact, most computer manufacturers, including Siemens PLM Conference sponsors HP, Dell and Lenovo sell business and consumer products with biometric support.

Leave a Reply

This article first appeared on the Siemens Digital Industries Software blog at