Ultrasonic Welding of Medical Parts
Add-On Software for the Electronic Audit Trail
In the medical sector, process reliability and tracking are important requirements. The first manufacturer to produce ultrasonic welding machines for joining thermoplastics, Herrmann Ultraschall GmbH & Co. KG, Karlsbad, Germany, offers an integrated software module, FSC, which records changes in system parameters and user actions in electronic audit trails.
In combination with the DataRecorder software module, which permits the process results to be permanently stored on a PC directly from the ultrasound generator, it allows welding work as well as user actions, such as parameter changes, to be continuously recorded in the form of a comprehensive production log book.
The FSC software is integrated into the user interface of the HiQ Dialog ultrasonic welding machine as an add-on. It offers
- user authentication with password and picture,
- user management,
- control of user rights, and
- audit trail
In the event of a change of process parameters, previous values can be easily restored, since both the previous value and the value after the change are stored. The software can also identify unauthorized manipulation and corrupt data records.
It thus fulfills CFR 21 Part 11 of the US FDA for the production process in the pharmaceutical and medical sectors, which is also important in Europe.
Translated from Kunststoffe 4/2015, p. 12.
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