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Pharma & Biotech

eDelivered WinKQCLTM 6 Software Package

Catalog #: 25-611E

WinKQCLTM 6 Endotoxin Detection and Analysis Software Package  fully-integrated, 21CFR part 11 compliant solution for quantitative endotoxin detection analysis, data management, reporting, and trending. (E-delivery)

 

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Product Overview

Lonza WinKQCLTM Software is a fully integrated client-server software that is designed and developed specifically for the purpose of endotoxin testing. WinKQCLTM 6 Software includes the essential components to meet the latest data integrity requirements for metadata, searchable logs and audit trails, trending,  fine grain user management, and archiving.
WinKQCLTM Software guides the user through the process of setting up a microplate template and running an assay to determine the amount of endotoxin in a sample solution. WinKQCLTM Software can be used with a compatible microplate reader to run the template and perform common endotoxin tests such as initial qualification, routine tests, inhibition/enhancement tests and an RSE/CSE test. The WinKQCLTM Software uses the run data to calculate the results for the sample solutions and their associated positive product controls. All data will be displayed in an easy to read, configurable report and can be electronically reviewed and signed. Since WinKQCLTM Software stores all template and test information in a single Microsoft® SQL Server® database, all sample data, including linked standard, accessory, reader, and user information, can be trended and recalled for review from any WinKQCLTM Software client.
In addition to endotoxin tests, WinKQCLTM Software allows reader-specific validation tests to be performed to ensure the instrument is operating properly. WinKQCLTM Software p/n 25-611E includes one “instrument” license and one “workgroup” license.  Additional WinKQCLTM Software reader licenses must be purchased to connect more than one instrument (p/n 25-613E). Additional WinKQCLTM Software Workgroup licenses must be purchased for each additional workgroup configured on the central WinKQCLTM Software database within a company (p/n 25-612E). E-DELIVERY ONLY

Certificate of Analysis (CoA)

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