Data system for gas chromatography/mass spectrometry provides productivity and compliance support features to address the requirements of FDA 21 CFR Part 11
Agilent Technologies has introduced the Agilent MSD Security ChemStation, the first data system for gas chromatography/mass spectrometry (GC/MS) from Agilent that addresses all requirements of FDA 21 CFR Part 11 for a closed system.
The new software facilitates the compliant use of GC/MS in pharmaceutical environments.
With the introduction of this new ChemStation software, Agilent has compliance solutions for all its major analytical platforms used in the pharmaceutical industry, including GC, GC/MS, liquid chromatography (LC), LC/MS, capillary electrophoresis (CE), CE/MS, and UV/Vis spectroscopy.
The new MSD Security ChemStation provides productivity and compliance support features to address the data security, integrity and traceability requirements of FDA 21 CFR Part 11.
The software offers result versioning and version management; user-independent, automatic audit trails; and electronic signing capabilities for electronic records.
Access to the application is protected by mandatory logon with a user identification code and password.
Electronic records generated by the application are always stored with all related raw, meta and result data.
The software includes interactive and automatic library searching for additional result confirmation.
Data can be stored to durable media by using the built-in data archival tool.
The integrated archival function is a convenient way to archive electronic data, while ensuring data integrity and retaining full traceability.
The Agilent MSD Security ChemStation supports all Agilent 6890 series GCs and 5973 series MSDs.
The new software is compatible with Microsoft Windows 2000 and Windows XP and smoothly integrates into existing IT environments.
It makes use of standard Windows user administration with direct leverage of Windows security and auditing policies.
Agilent GC/MS qualification services have been expanded to include the new software into their scope.
IQ (Installation Qualification) and OQ/PV (Operational Qualification/Performance Validation) help customers to validate the correct installation and operation of their Agilent GC/MS systems.
The Agilent MSD Security ChemStation is available worldwide.
For customers who already have an Agilent MSD Productivity ChemStation, Agilent offers a one-time upgrade to the MSD Security ChemStation at a reduced price.
