Expert Support At Your Fingertips for the Bacterial Endotoxins Test

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QC Insider - Endotoxin Expertise at Your Fingertips™


Data Integrity is not a new regulatory requirement, but important throughout your entire endotoxin testing process. “Data integrity is the degree to which a collection of data is complete, consistent and accurate through the data lifecycle,” (WHO).


Our new White Paper, added to our QC Insider™ Library, provides a risk-based approach using FMEA (Failure Mode and Effect Analysis), and helps identify risks that may be inherent in your current workflow in the Bacterial Endotoxins Test (BET).  


Other topics covered: 


  • How to document your data flow
  • How to build an audit trail and data review process
  • WinKQCL™ Software: an example of data integrity principles applied to develop, test and verify a system that helps ensure proof of data integrity   


Already a Subscriber to the QC Insider™ Toolbox?    Not a QC Insider™ Expert Yet? 
After clicking on White Paper:  Ensuring Data Integrity in the BET, input your user name and password on the login page. You will then be directed to the White Paper page where you can access the latest tool.   Register and you will be directed to a Registration Page. After you have successfully registered, you will be able to navigate through the QC Insider™ Toolbox and access the new White Paper.


Delivered to you from the QC experts who face many of the same regulated manufacturing challenges as you do, the QC Insider™ Toolbox is packed with comprehensive support tools that will help you perform the bacterial endotoxins test.


Become a QC Insider™ expert and Register Now.




Explore Our Resources


QC Insider™ Support: direct access to one-on-one guidance and detailed information about software support, recertification & testing services, reader install & maintenance and workflow optimization.


QC Insider™ Training: self-directed training resources that will help you build on your bacterial endotoxins test expertise.


QC Insider™ Library: technical resources that will help ensure your success with the bacterial endotoxins test. You will have access to a collection of package inserts, quick guides, technical tips and more.


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Data Integrity FAQs Tech Tip                                                                                        

Learn about the requirements of data integrity, what they mean, and how they relate to in-process and endotoxin release testing.  


Topics include:            
  • Is gel clot testing affected by data integrity?
  • Qualitative vs. quantitative systems
  • How WinKQCL™ Software can help ensure compliance               



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