The WinKQCL 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 WinKQCL 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).