Toximaster® QC8 Software

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The Toximaster® QC8 software supports data processing based on the protocols complying with three types of pharmacopeia (USP, EP, JP) for bacterial endotoxin testing. This software is compliant with FDA 21 CFR Part 11 ERES (electronic records/electronic signature), which requires the proper information from all parties involved in the testing of the sample. Toximaster® QC8 offers excellent audit trail capabilities, can provide statistical processing of means, standard deviations, and has robust data processing functions. The data processing functions can be performed by defining sample types such as standards, controls and test samples.

Key Features

• FDA 21 Part 11 ERES compliant
• Endotoxin determination in compliance with pharmacopoeias (USP/EP/JP) for BET
• Capable of creating three types of curves: internal standard curve, manual input curve and a measured curve
• Product endotoxin limit and MVD generation
• Allows trending of product results over time and early detection of potential product failures
• Generates hard copy printouts with all pertinent information for routine audits through three unique audit trails
• Creation of a standard workflow to be reviewed, confirmed and approved prior to operating
• Security functions to lock the application, disable an account and lock out the system
• Backup of the user management database and automatic backup of the system information database
• Improved precision and accuracy over the traditional gel clot method
• Ideal software for comparative testing and validating most LAL

Toximaster® QC8 Software

Q: What type of audit trail capabilities are available with this system?

A: The Toximaster® QC8 software is capable of various types of audit trails:

• Audit trail that directly affects a test plan document/test record
• Audit trail of each registered test information in separate groups (lysate, standard reagent, test sample, test group, accessory information saved standard curve, test group)
• Audit trail of user management information that shows registration and change of users, results of authentication, and registration and change of authorized group

Q: Can the protocols and standard curves be saved for later use?

A: Yes, the Toximaster® QC8 software can save and archiving information for later use.

Q: Will each user have their own unique identification (username and password) to access the software?

A: Yes, the Toximaster® QC8 software can save each user with unique identifier and password access, specific to their role in your lab. The system administrator can customize user privileges in the system.