Ensuring Data Integrity for GXP Compliance

Ensuring Data Integrity for GXP Compliance

Sep 13, 2018 2:49 pm EDT

This digital book on data integrity provides multiple perspectives from experts in the industry, with solutions to common challenges. This compilation of previously published material on the IVT Network website is excellent for the beginner or the experienced professional working for data integrity compliance, with papers geared towards a general understanding, as well as papers dealing with more complex issues.

You will uncover the latest regulations and guidances in the pages of the book, making this a timely source of information that can be put right to work. Whether you work in quality, operations, or are in the regulatory or validation industry, this book will be your new go-to. 

Titles and Authorship:

What is Data Integrity and Why is it Important?     

John Lincoln


The Data Quality Equation—A Pragmatic Approach to Data Integrity                 

Christopher H. White and Lizzandra Rivera González


Building a Quality Culture that Supports Data Integrity in the Pharmaceutical Industry            

Aris Koumandaros


MHRA Data Integrity Guidance: Implementation Approach  

Ivan Soto


Data Integrity Strategies for Quality Control Laboratories                      

Ivan Soto


Automated, Digital Colony Counting: Qualification and Data Integrity   

Tim Sandle


Conducting Data Integrity Self Inspections by Quality Assurance          

Siegfried Schmitt


Computer System Validation & Data Integrity  

Eileen Cortes


Data Integrity Strategies for Migrating Data from Legacy Systems 

Ivan Soto


The Effective Use of CAPA When Things Go Wrong with Data Integrity 

Ivan Soto


Ensuring Data Integrity During Validation  

Ivan Soto

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