How To Prevent Data Integrity Warning Letters

Failures in data governance and data integrity continue to be addressed in approximately 80% of FDA warning letters issued to domestic and foreign sites. This ebook explores insights and strategies from experts in the field, including:

• An Analysis of FDA Warning Letters
• Is GMP Quality System Auditing Fundamentally Flawed?
• Managing GxP Environmental Systems To Ensure Data Integrity
• 5 Steps To Build A Quality Culture That Supports Data Integrity
• The 5 Basic Tenets of Data Integrity - And How Failures Occur