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FOR IMMEDIATE RELEASE December 11, 2003 Guava Technologies: CFR Part 11 Compliant Cell Culture Monitoring. Guava Technologies has announced that using their ViaCount assay, bioprocessing facilities can now determine cell numbers and viability with greater speed, accuracy and reliability than ever before while still complying with 21 CFR Part 11 requirements. The Guava ViaCount assay has been demonstrated to count multiple samples in a fraction of the time needed for manual hemacytometer cell counts while substantially improving assay precision and greater accuracy. The ViaCount assay also provides more accurate viability assessments than traditional Trypan Blue-based methods since the ViaCount assay can easily distinguish apoptotic cells from healthy live cells and dead cells. New versions of Guava Technologies' CytoSoft Software, version 2.1 for the Guava PCA system and version 2.5 for the Guava PCA-96 system, include enhanced support for 21 CFR Part 11 compliance. To help manage increasing volumes of data, results are automatically summarised in spreadsheet files, which users can put directly into the laboratory record, eliminating data transcription errors. Moreover, the Guava CytoSoft software includes features that support compliance with FDA 21 CFR Part 11 regulations. A new applications note describing strategies that customers can employ for validating the Guava ViaCount assay and adopting the Guava PCA into their GMP environments is now available from the Guava Technologies website at www.guavatechnologies.com in the online library section.
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