Agilent to roll out first-in-class QA/QC software

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Related tags: Chemistry, Chemical compound, Agilent technologies

Agilent Technologies has launched a software package to help drug
companies keep a close eye on the quality of chemical compounds.
The firm says the product is the first of its kind, allowing a more
than seven-fold increase in the number analytical instruments that
can be monitored from a single PC.

Agilent says that the Cerity Networked Data System for Pharmaceutical QA/QC provides automated 3-D analysis, generic instrument control and a spreadsheet-style custom calculator in one package.

This should provide significant improvements in productivity, cost reduction and compliance support for laboratory managers, claims the firm, as it will enable them to evaluate and track the quality of raw and manufactured chemical compounds more efficiently.

Chris van Ingen, senior vice president and general manager of Agilent's Life Sciences and Chemical Analysis business, said that other packages on the market can typically only monitor four analytical instruments, but its new product can handle 30. The package can also monitor non-Agilent instruments, including those made by Waters Alliance, the leading analysis machine vendor.

Also, 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,"​ he said.

The custom calculator - which Agilent believes is a unique feature of its product - automatically performs the calculations required in standard operating procedures.

This should make it easier for companies to comply with the 21 CFR Part 11 regulations developed by the US Food and Drug Administration (FDA) on electronic record keeping.

21 CFR Part 11 requires validation of every software package used in the quality control process, with error checking and cross-validation needed whenever manual data entry or data copying is used. The calculator provides a calculation audit trail and eliminates the need for data copying and subsequent, extensive data validation.

More information on the new product is available at www.agilent.com/chem/nds​.

Related topics: Contract Manufacturing & Logistics, QA/QC

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