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Data Integrity: The Science, The Regulations, The Use

Your go-to guide on specific data integrity requirements for GCP, GLP, GMP, GVP, and other areas in regulated science.

This practical handbook written by Quality Assurance professionals for Quality Assurance professionals provides best practices you can apply regardless of your system's format or the regulatory mandates of your area. It dives into:

📉  Data integrity and data quality within the context of the QA profession

🔎  Practical and specific auditing tips

💡  Training requirements across organizational units

💼  Data integrity challenges and differences in company policies

📊  And more!

 

70% of sales benefit the SQA Learning Foundation!

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Praise for this comprehensive Handbook

"Data Integrity: The Science, The Regulations, The Use is a great guide written by Society of Quality Assurance professionals which truly stands out in the realm of data integrity informational resources. This book is a treasure trove for all GMP/GCP/GLP professionals including quality assurance professionals, auditors, data governance managers, and scientists who wish to navigate the intricate landscape of data integrity in a regulated environment." —Eric S. Pittman, MBA, Former Division Director, Bioresearch Monitoring, US FDA; Former US Delegate to the OECD Working Party on GLPs, US FDA

"A thorough primer on responsibly handling the information that makes the biotech world tick.... The book is designed to guide the reader in understanding the importance of good, traceable data in an industry full of rules and regulations, which come from agencies like the FDA.” — Kirkus Reviews
Read the full Kirkus review.

 
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