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WinKQCL™ 5 Qualification Manual

Catalog #: 25-504

WinKQCLTM 5 Software Qualification Manual for Installation, Operation, and Performance Qualification 


Product Overview


WinKQCLTM Installation, Operational, Performance Qualification  (IOPQ) Manual


The WinKQCLTM Endotoxin Detection Qualification Manual includes the essential components to satisfy requirements when performing an installation, operational, and performance qualification of Lonza approved instruments to quantitate the endotoxin assay using Lonza reagents.


Features the IOPQ Manual qualify include:


  • Integration of Molecular Devices® SpectraMax®, GeminiTM and VersaMaxTM readers; BioTekTM ELx808TM, FLx800TM, EonTM and SynergyTM 2 readers; and the Tecan® SunriseTM reader
  • 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 MODATM 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 PyroTecTM 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 SpeedFillTM 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 WinKQCLTM 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  
  • WinKQCLTM Version 5.3.1 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.





Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

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QC Insider™ Toolbox

Endotoxin Expertise At Your FingertipsTM

QC InsiderTM Toolbox is packed with comprehensive support tools that will help you perform the bacterial endotoxins test. It has been created by QC experts who face many of the same regulated manufacturing challenges as you do.