WinKQCL^TM 5 Endotoxin Detection & Analysis Software Package

Product Overview

Our WinKQCL^TM 5 Software offers a fully integrated solution for your quantitative endotoxin detection testing, data management and reporting needs. It can be installed as a simple standalone system, or it can interface with multiple robots and readers in multiple labs around the world, all storing data in a single database.

Our endotoxin detection and analysis software has been one of the first CFR 21 Part 11 solutions, built with the robust framework to satisfy all data integrity needs and requirements in mind. As experts in digital control systems, Lonza has always embraced data integrity by providing quantitative endotoxin detection systems that are easy to use and help ensure reliable, reproducible, and accurate electronic results upon the strictest regulatory standards.The WinKQCL^TM Endotoxin Detection Software includes the essential components to satisfy 21 CFR Part 11 technical and data integrity requirements for the following:

• electronic records and signatures
• audit trail and audit trail review
• trending toolsuser management
• database archiving    

Support materials that focus on data integrity are accessible via our QC Insider^TM Toolbox, a suite of online, comprehensive tools designed to support QC professionals who perform the Bacterial Endotoxins Test (BET).

• White Paper: "Ensuring Data Integrity in the Bacterial Endotoxins Test"
• Data Integrity FAQs Tech Tip
• On-demand webinar: "The Importance of Data Integrity for Endotoxin Testing"

Subscription is required to access the QC Insider^TM Toolbox and is free

• WinKQCL^TM Software: Technical Features and Applications include:
• Integration of Molecular Devices^® SpectraMax^®, Gemini^TM and VersaMax^TM readers; BioTek^TM ELx808^TM, FLx800^TM, Eon^TM and Synergy^TM 2 readers; and the Tecan^® Sunrise^TM reader
• Introduction of Kinetic SmartStop^TM monitoring feature to address split pair, and other reaction conditions, without sacrificing time waiting for a fixed number of reads
• Enterprise level IT features including wide area network support, ability to work across time zones, application virtualization, Active Directory^® integration and data segregation by lab
• Bi-directional interface with 3rd party database systems, such as Lonza’s MODA^TM Environmental Monitoring Software, or an LIS or LIMS system. Data can be pushed directly into the template and data can be exported out to 3rd party systems
• Tecan^® EVOware^® interface integration for PyroTec^TM Liquid Handling System
• Multi-user control:  multiple users can control multiple readers from one workstation
• Customizable endotoxin test reports
• Fine grain user permissions control
• Rapid data entry via barcode compatible windows
• Edit assay feature which allows for the correction of template layout mistakes
• Template customization with a click of a mouse using the SpeedFill^TM and Drag n’ Drop features
• Interactive trending tools provide actionable results on demand, helping you easily detect drift and enabling you to make proactive decisions. Trending is included in the WinKQCL^TM Software. No need to purchase a separate trending application.
• Built-in database backup and maintenance scheduler
• Meets 21 CFR Part 11 technical requirements for electronic records and signatures, audit trails and database archiving
• Multi-language support for installation, user interface, reports and user help and manual: English, French, German, Italian, Japanese, Spanish, Portuguese, Simplified Chinese and Traditional Chinese
• WinKQCL^TM Version 5.3.3 is now available. Please contact our Scientific Support Team for download and trial of our latest release

Active Directory is a trademark of Microsoft Corporation. Molecular Devices, SpectraMax, VersaMax and Gemini are trademarks of Molecular Devices, LLC. BioTek, Synergy, ELx808, Eon and FLx800 are trademarks of BioTek Instruments, Inc. Tecan, EVOware and Sunrise are trademarks of Tecan Group Ltd.