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Pharma & Biotech

WinKQCL™ 6 Qualification Manual

Catalog #: 25-614

WinKQCLTM Software Version 6 Qualification Manual for Installation, Operation, and Performance Qualification, Disc version

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Product Overview

The WinKQCLTM Software Qualification manual describes the IQOQPQ protocols needed for proper qualification of the Lonza Endotoxin Detection system. The Lonza Endotoxin Detection system consists of a combination of compatible microplate readers, liquid handling systems, computer systems, the WinKQCLTM Software, and endotoxin testing reagents. The system is used for the measurement of endotoxin in liquid samples. Lonza IQOQPQ protocols define the suggested procedures and documentation needed for proper qualification of the Lonza Endotoxin Detection system. The end user must ultimately decide if these procedures are acceptable to their internal regulatory and compliance department(s).
Three types of qualification are recommended for proper system performance. They are:
1) Installation Qualification (IQ) - used to ensure that the hardware and software are installed and configured properly in preparation for further testing.
2) Operational Qualification (OQ) - used to determine that the hardware and software components are in proper working order and meet the manufacturer’s recommended specifications.
3) Performance Qualification (PQ) - used to evaluate the overall functional performance of the system using Lonza endotoxin testing reagents by performing actual endotoxin tests. Please note this is not a product validation of specific samples, rather a system performance qualification.
These protocols are designed for qualifying the WinKQCLTM Software and compatible instruments, and should be completed at the time the system is installed.   HARD COPY DISC

Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

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