Archive News Story
(Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
Ultrasonic Welder features FDA-compliant design.
August 9, 2005 -
Ultrasonic welder is available with FDA System Component (FSC) add-on software package that meets FDA CFR 21 part 11 standards for login and traceability. Login screens only let authorized personnel operate system. Operators, defined as Administrator, Supervisor, Setup, or User, can be enabled or prohibited from changing different features of DIALOG touch weld process controller. Audit trail is created, showing all changes made and electronic signatures.
Archive Press Release
(Products mentioned in this Archive Press Release may or may not be available from the manufacturer.)
Release date: August 3, 2005
Ultrasonic Welder Now Fully Compliant to FDA Standard CFR 21 Part 11
Herrmann Ultrasonics, Schaumburg IL, introduces the world's first and only FDA compliant ultrasonic welder. The FDA System Component, (FSC), an add-on software package, meets FDA CFR 21 part 11 standards for login and traceability.
Login in screens let only authorized personnel operate the system. Operators can be defined as an Administrator, Supervisor, Setup, or User(s) and can be enabled or prohibited from changing the different features of the DIALOG touch weld process controller. An Audit Trail (electronic record) is created, showing all changes made and the user that made the changes (electronic signatures).
Herrmann Ultrasonics has been setting industry standards with features such as true Windows®-based touch screen controllers, most rigid machine design, built in calibration, and on-screen weld process graphing capabilities. The FSC software continues the pioneering path of the recognized technology leader in ultrasonic welding.
For further information, please contact Vasko Naumovski via E-mail to Vasko.Naumovski@HerrmannUltrasonics.com.
Contacts:
General Information:
Vasko Naumovski Product Manager PLASTICS
USA
Phone: 224-805-6343 E-mail this person Company Information: Name: Herrmann Ultrasonics, Inc. Address: 1261 Hardt Circle City: Bartlett State: IL ZIP: 60103 Country: USA Phone: 630-626-1626 FAX: 630-626-1627 http://www.herrmannultrasonics.com
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