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Software facilitates FDA 21 CFR Part 11 compliance.

Press Release Summary:



E-Sig software, for GENESIS X-ray Microanalysis System, provides electronic signatures as required by 21 CFR Part 11 and satisfies US FDA security and audit trail requirements. Spectra collected can be electronically archived with date and time stamp. Primary data cannot be altered. Any changes are tagged and tracked, and levels of data processing are restricted based on permissions set by supervisor.



Original Press Release:


EDAX Releases E-Sig, FDA 21CFR Part 11 Compliant Software for the GENESIS X-ray Microanalysis Systems


Mahwah, NJ - EDAX Inc., a leader in X-ray microanalysis, X-ray fluorescence and electron diffraction instrumentation, has released E-Sig, a U.S. FDA 21 CFR Part 11 compliant software application for the GENESIS X-ray Microanalysis System (XMS).

"E-Sig is the first X-ray microanalysis software package that provides electronic signatures as required by 21 CFR Part 11 and is able to satisfy US FDA security and audit trail requirements," notes Del Redfern, Micro Characterization Tools Product Manager for EDAX.

"The new E-Sig application provides users with the ability to electronically archive spectra collected using the GENESIS software along with the user information and a date and time stamp that are added to the files saved within the user-defined projects," he adds.

"There are three main features of the new application concerning data integrity," Redfern explains. They are: 1) the primary data cannot be altered, 2) any changes to the data are tagged and tracked and 3) the levels of data processing are restricted based on permissions set by the supervisor."

"In instances where the user changes parameters within the spectra to improve peak identification or the quantification routine, the E-Sig application will save the data, including the project name and a sequence number, to maintain the audit trails. In addition, when a user prints out any data, the application looks at the parameters being printed and automatically saves the data with a new sequence number, if the parameters are different from those last saved," offers Redfern.

EDAX is the acknowledged leader in Energy Dispersive Microanalysis, X-ray Fluorescence and Electron BackScatter Diffraction instrumentation. It designs, manufactures, installs and services high-quality products and systems for leading
companies in semiconductors, metals, geological, biological, material and ceramics market. Since it's founding in 1962, EDAX has used its knowledge and experience to develop ultra-sensitive silicon radiation sensors, digital electronics and specialized
application software that facilitate solutions to research, development and industrial requirements.

EDAX is a unit of AMETEK Process & Analytical Instruments. AMETEK, Inc., is a leading global manufacturer of electronic instruments and electric motors with annual sales of more than $1 billion.

For further information about EDAX, contact:

EDAX Inc.

91 McKee Drive, Mahwah, NJ 07430

Tel: (201) 529-4880 Fax: (201) 529-3156

E-mail: edax.info-americas@ametek.com

edax.info-international@ametek.com

Website: www.edax.com

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