Schaumburg, Ill.-based Hermann Ultrasonics' FDA System Component (FSC), an add-on software package, allows only authorized personnel to operate the system and creates an audit trail, an electronic record. These features meet FDA CFR 21 part 11 standards for login and traceability.

Operators such as administrators, supervisors, or users can be enabled or prohibited from changing different features of the DIALOG touch-weld process controller. An audit trail of electronic signatures is created, showing all changes made and which user made them.