The report aims to bridge the gap between high-level regulatory requirements (like ALCOA+) and practical shop-floor implementation. It emphasizes that data integrity is not just an IT issue, but a fundamental pillar of patient safety and product quality. 🛡️ Risk-Based Approaches
A unique strength of TR 90 is its focus on the "human element." It suggests that even the best technical controls will fail if the corporate culture encourages shortcuts. pda technical report 90