Additions to networked data system software for pharmaceutical quality assurance/quality control are said to increase efficiency and lower costs for IT and laboratory managers
Agilent Technologies has introduced what it says is a breakthrough version of software for the pharmaceutical quality assurance/quality control (QA/QC) environment.
The Agilent Cerity networked data system for pharmaceutical QA/QC is the first system of its kind to provide automated 3D analysis, generic instrument control and a spreadsheet-style custom calculator. This functionality, combined with Cerity's advanced architecture, provides significant improvements in productivity, cost reduction and compliance support for IT and laboratory managers.
"The new Cerity enables pharmaceutical companies to evaluate and track the quality of raw and manufactured chemical compounds with the highest efficiency and productivity," said Chris van Ingen, senior vice president and general manager of Agilent's life sciences and chemical analysis business.
"We have coupled key analytical functionality with our compliance expertise and an industry-leading architecture to resolve many traditional problems for both the pharmaceutical IT and laboratory manager. "For example, customers can use one computer with Cerity software to acquire and track data from up to 30 analytical instruments, a tremendous increase in efficiency from the usual 1:4 ratio".
Automated 3D analysis.
The new automated 3D analysis feature enables an automated compound purity evaluation and confirmation of compound identity based on retention time, response and wavelength.
Automation of this process, performed daily in the analytical laboratory, reduces compound confirmation workflow time from hours to minutes.
Custom calculator.
The unique custom calculator automatically performs all integral and mathematic calculations required in standard operating procedures (often done in Microsoft Excel).
This is important because FDA 21 CFR Part 11 regulations require validation of every software package used, with error checking and cross-validation needed whenever manual data entry or data copying is used.
This new feature provides a calculation audit trail, eliminating the need for data copying and subsequent, extensive data validation. Generic instrument control.
Cerity's new generic instrument control module enables laboratories to control non-Agilent chromatographic instrumentation with level-3 instrument control. For each instrument type, an instrument-specific driver or adapter is needed, which can be provided by Agilent or an Agilent alliance partner upon request.
Because the driver is provided by or in cooperation with the instrument manufacturer, Cerity can uniquely provide verifiably compliant instrument control.
All actions are tracked in Cerity's instrument logbook.
Cerity also provides full instrument control of GPIB-based instrumentation such as Waters Alliance systems.
Cerity provides level-4 instrument control of Agilent's market-leading networked instrumentation, including the Agilent 1100 Series liquid chromatographs, the Agilent 6890 and 6850 gas chromatographs, and the Agilent 35900E dual-channel interfaces. The new release supports additional Agilent 1100 Series high-performance liquid chromatography modules, including the well-plate autosampler, and the diode-array, fluorescence and refractive-index detectors.
