Focus Topic: Data Integrity and Validation

May’s session focused on rising enforcement around data integrity violations and validation failures. With increasing regulatory scrutiny on digital systems, teams must prioritize readiness.

Covered in the session:

• FDA expectations on data controls and audit trails
• Best practices for computer system validation (CSV)
• Examples from recent FDA Warning Letters
• Strategies to improve inspection readiness

Presented as part of our monthly Warning Letter Wednesday series on FDA regulatory trends and compliance strategy.