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How to Find and Fix ProblemsA FDAnews publication
1st edition 2016
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Is your data too good to be true? Are your procedures overly complex? If so, your data integrity may be at risk. The Top Ten Data Integrity Traps report shows you where most data integrity problems occur and helps you create a plan to weed them out - and keep them out. You'll learn about 10 areas to watch for data integrity violations: 1. Quality culture 2. Batch records 3. Manufacturing floor 4. Raw vs. recorded data 5. Lab equipment 6. Analytical documentation 7. Document control 8. Lab control procedures 9. Material management 10. Personnel This FDAnews Brief walks you through the 10 major areas of vulnerability and teaches you how to spot trouble in each. You'll learn how to:
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