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Workstation Software Supports FDA’s 21 CFR Part 11
MassHunter is the high-productivity software that provides instrument control, data acquisition, qualitative and quantitative data analysis, and reporting for the proprietary 6410 Triple Quadrupole liquid chromatography/mass spectrometer (LC-MS) system. Users in regulated environments can now count on the software to help comply with 21 CFR Part 11, an FDA regulation that defines parameters by which pharmaceutical companies can author, approve, store, and distribute records electronically. In addition, the new MassHunter Workstation helps customers meet requirements for current Good Manufacturing Practice, or cGMP—the basic principles, procedures and resources required to ensure an environment suitable for manufacturing products of an acceptable quality. Additional features include security measures to ensure the integrity of acquired data, as well as audit trail features for quantitative analysis.
Agilent Technologies, Inc.
5301 Stevens Creek Blvd.
Santa Clara, CA, 95051-7201
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