Shimadzu's EDX Spectrometers Now Compliant with US FDA Electronic Signature Regulation
Product News Aug 05, 2015
Shimadzu Scientific Instruments (SSI) has announced 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 these 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.
The U.S. FDA put into effect 21 CFR Part 11 in 1997. This regulation defines the criteria under which electronic records and electronic signatures are considered to be equivalent to records and signatures on paper.
It applies to pharmaceutical and food companies that perform business activities in the U.S., companies that supply products or raw materials to these companies, (including exporting) and laboratories that receive contracted analysis from these companies.