Shimadzu's Fluorescence Spectrometers Now Compliant with FDA's Electronic Signature Regulation
Shimadzu Scientific Instruments announces that its EDX-7000/8000 energy dispersive x-ray fluorescence spectrometers are now compliant with the 21 CFR Part 11 electronic signature regulation designated by the U.S. Food and Drug Administration (FDA). The Part 11 compliancy confirms that the electronic records produced by Shimadzu’s EDX-7000/8000 are trustworthy and reliable for use in the pharmaceutical and food industries. It also confirms the reliability of other key instrument features needed for industries--including security, user’s rights management, validation, and operation and audit trail output.
The EDX-7000/8000 features a secure user authentication and screen lock function that allows only authorized users access to the system. Login information is also recorded in a secure operational history log. The instrument’s audit trail log function allows users to quickly and easily output audit trail logs, including instrument setting change history and user operation history.