Agilent Technologies’ New MassHunter Workstation Software Now Supports FDA’s 21 CFR Part 11

Agilent Technologies Inc. (NYSE: A) today announced new FDA-compliance features for MassHunter Workstation. MassHunter is the high-productivity software that provides intuitive instrument control, data acquisition, qualitative and quantitative data analysis and reporting for the Agilent 6410 Triple Quadrupole liquid chromatography/mass spectrometer (LC/MS) system. Customers in regulated environments can now count on MassHunter software to help them comply with 21CFR 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.

The new features include:

security measures ensuring the integrity of acquired data, analysis results and report results;
comprehensive audit-trail features for quantitative analysis, using a flexible and configurable audit-trail map; and
customizable user roles and groups that allow an administrator to individualize user access to processing tasks.
“Earlier this year, Agilent introduced installation and operational qualification (IQ/OQ) services for the Agilent 6410 triple quad mass spectrometer in regulated markets,” said Agilent’s Frank Kuhlmann, software product marketing manager, LC/MS. “The MassHunter Workstation software compliance features announced today take that a significant step further, supporting the electronic signature, audit trail and data security requirements in the 21 CFR Part 11 regulations, all crucial for customers working in the pharmaceutical industry.”

In addition, Agilent offers software IQ/OQ services to achieve instrument qualification. For further details, visit Agilent in ASMS Booth #85 or online at www.chem.agilent.com/Scripts/PCol.asp?lPage=38192.