Spectrometers Comply with FDA Electronic Signature Regulation

August 28, 2015
Pharmaceutical Technology Editors

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-09-02-2015, Volume 11, Issue 9

Shimadzu Scientific Instruments reports its EDX-7000/8000 spectrometers are compliant with electronic signature regulations.

Shimadzu Scientific Instruments (SSI) has announced its EDX-7000/8000 energy dispersive x-ray fluorescence spectrometers are compliant with the 21 CFR Part 11 electronic signature regulation designated by FDA.

The compliancy confirms that the electronic records produced by the spectrometers 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 company reports in a press release.

The instrument 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 output audit trail logs, including instrument setting change history and user operation history.

Source: Shimadzu Scientific Instruments