The importance of data integrity in the endotoxin test

Data Integrity can be broken down into a simple definition:

The maintenance of…
The assurance of…
The accuracy and consistency of…

….data over its entire life cycle.

For Lonza customer’s purposes, it is a critical aspect to the design, implementation and usage of any system, which stores, processes, or retrieves data.

Recently, several Lonza experts contributed to the Kevin Williams book, “Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems” regarding Data Integrity. In Chapter 11, they dive into the importance of Data Integrity in the endotoxin test. Topics include a discussion on Metadata, the ALCOA model, and Data Integrity risks.

In addition to the general discussion on Data Integrity and the BET assay, WinKQCL^® Software is highlighted in the chapter as an endotoxin software system that assures data integrity and 21 CFR Part 11 compliance. Automating the endotoxin test by reducing workflow to improve Data Integrity is another important subject addressed in Chapter 11. Lonza’s PyroTec Pro robotic platform is a complete automated endotoxin testing system will improve data integrity organically with the capture of new metadata into the growing analytical capabilities of WinKQCL^® Software.

You can learn more about Kevin’s book
Learn more about Data Integrity
We also offer a technical tip at our QC Insider^® Toolbox
The FDA provides a guidance document on "Data integrity and compliance with drug CGMP questions and answers guidance for industry"

Written by Travis

Scientific Support Specialist

Back to blog page