Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies by Sarah Tanksley - PDF and EPUB eBook

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Many articles describe the history and theory behind data integrity. However, few offer practical advice and solutions. Written...

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Details of Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies

Exact title of the book
Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies
Book author
Sarah Tanksley
Book edition
Hardcover
Number of pages
550 pages
File size (in PDF)
2200 kB
Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies

Some brief overview of book

Many articles describe the history and theory behind data integrity. However, few offer practical advice and solutions. Written by an author with a vast amount of experience in the industry, Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies serves as a hands-on guide to the current regulatory expectations for generating and handling data.

This unique text presents techniques for tracing the life cycle of data, as well as identification and avoidance of common blind spots in the data collection and review process, examples of lapses in data integrity, and strategies for remediation of data integrity breaches. It also discusses requirements and advice for communicating data integrity breaches to health authorities. As international government bodies have shifted their point of interest to focus on data integrity as part of their routine operations, this book is a must read for anyone working in a GMP (good manufacturing practices) regulated environment, whether the job involves supporting, generating, reviewing, or archiving data.