Agilent Technologies introduces industry-first features in pharmaceutical software for drug quality assurance and control
Additions to Cerity Networked Data System increase efficiency, lower costs for IT and laboratory managers
PALO ALTO, Calif., Jan 29, 2004
Agilent Technologies Inc. (NYSE: A) today introduced 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 3-D 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 3-D Analysis
The new automated 3-D 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.
The unique custom calculator automatically performs all integral and mathematic calculations required in standard operating procedures (often done in Microsoft(r) 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.
Cerity NDS for Pharmaceutical QA/QC has been designed specifically for labs in pharmaceutical QA/QC, implementing the strict technical controls required by 21 CFR Part 11 (the FDA regulation on electronic record keeping, data tracking and security) and other regulations and quality standards such as GMP, cGMP, GAMP, and ISO 17025.
Cerity has an industry-leading architecture that is enterprise-wide, open-standard, secure, flexible and scalable. It is the first completely network-based data system for automated instrumentation control and data acquisition, management and evaluation. Cerity uses industry standards, employing a scalable client-server architecture, LAN communication with standard COM and TCP/IP protocols, a modern Oracle(r)-based database, and XML format for data exchange. It supports failover clustering and automated acquisition buffering for seamless 24 x 7 system operation. The Cerity architecture is of significant benefit to IT managers in that it requires less hardware, less cost, and lower maintenance while providing high up-time and facilitating network qualification. Network qualification services are also available from Agilent.
Pricing and Availability
The Agilent Cerity NDS for Pharmaceutical QA/QC can be ordered through any Agilent sales office. Prices vary depending on laboratory requirements. The newest revision is available free of charge to all customers with a valid software update contract. Existing customers without a contract can purchase an upgrade. More information is available at www.agilent.com/chem/nds.
About Agilent Technologies
Agilent Technologies Inc. (NYSE: A) is a global technology leader in communications, electronics, life sciences and chemical analysis. The company's 28,000 employees serve customers in more than 110 countries. Agilent had net revenue of $6.1 billion in fiscal year 2003. Information about Agilent is available on the Web at www.agilent.com.
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