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Pharma & Biotech

WinKQCLTM 5 Validation Package

Catalog #: 25-505
WinKQCLTM 5 Validation Package
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Product Overview

Our WinKQCLTM 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 WinKQCLTM Endotoxin Detection Software includes the essential components to satisfy data integrity requirements:

 

  • meta data
  • audit trail and audit trail review
  • trending
  • user management
  • archiving

 

Support materials that focus on data integrity are accessible via our QC InsiderTM Toolbox, a suite of online, comprehensive tools designed to support QC professionals who perform the bacterial endotoxins test (BET).

 

  • Data Integrity FAQs Tech Tip
  • On-demand webinar: 'The Importance of Data Integrity for Endotoxin Testing'

 

Subscription is required to access the QC InsiderTM Toolbox and is free.

 

Interested to learn more?

We invite you to get a closer look to see how our WinKQCLTM Software works, how it can optimize your QC processes, lean out your workflow and help you ensure compliance in your endotoxin testing.

 

Request a Demo

 

 

WinKQCLTM Software: Technical Features

  • Integration of Molecular Devices® SpectraMax®, GeminiTM and VersaMaxTM readers; BioTekTM ELx808TM, FLx800TM, EonTM and SynergyTM 2 readers; and the Tecan® SunriseTM reader
  • Introduction of Kinetic SmartStopTM 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 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 InsiderTM 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.

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