Agilent Technologies’ MassHunter Workstation Software Now Supports FDA’s 21 CFR Part 11
Product News Jun 08, 2007
Agilent Technologies Inc. has announced new FDA-compliance features for MassHunter Workstation.
MassHunter is the high-productivity software that provides 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;
• 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.