EDX-7000/8000 Energy Dispersive X-Ray Fluorescence Spectrometers Now Compliant with the US FDA 21 CFR Part 11 Electronic Records; Electronic Signatures

Shimadzu announces its EDX-7000/8000 energy dispersive X-ray fluorescence spectrometers are now compliant with the 21 CFR Part 11 Electronic Records; Electronic Signatures, which is designated by the U.S. Food and Drug Administration (FDA).

Demand for impurity inspection for drugs by X-ray fluorescence analysis has been growing. With this trend, the market for energy dispersive X-ray fluorescence spectrometers will expand in the pharmaceutical industry. Making the EDX-7000 and EDX-8000 compliant with the U.S. regulation for electronic records and electronic signatures addresses this new requirement. Shimadzu plans to actively market these instruments in the pharmaceutical industry, with sales targets of at least 20 units of these two models in FY 2015 and at least 40 units in FY 2016 and after.

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. The regulation defines that records and signatures must not be altered and changes need to be recorded to make the electronic records and signatures trustworthy.

Features of EDX-7000/8000 in measurement of pharmaceutical products

These spectrometers analyze residues such as residual metal catalysts, hazardous metals, and metal impurities contained in active pharmaceutical ingredients easily and non-destructively without requiring any pretreatment. They allow users to start analysis of a powder, solid, or liquid sample by simply placing the sample in the special assembled container and setting the container in the instrument. As compared to chemical analysis procedures that require significant work and time, the EDX-7000/8000 offers simplified operation in any pharmaceutical production process.

Shimadzu also offers the LabSolutions CS network system for data management of a number of analytical instruments. LabSolutions CS enables management of analytical data obtained by all compatible instruments, including the EDX series instruments, in a database on the server computer. Use of the network system enables integrated data management where data can be loaded on any computer on the network.

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