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The ‘Why’ of validation and the need for critical thinking

Validation is more than just a compliance requirement; it plays a vital role in ensuring patient safety, product quality, and data integrity. Applying critical thinking helps eliminate biases, refine processes, and remove inefficiencies. A continuous improvement mindset, supported by industry insights and AI-driven automation, can enhance validation efforts, ensuring system reliability and business continuity. In this episode of Regulatory Risk Insight, Arun and Carolyn explore the ‘Why’ of validation and the need for critical thinking.

Key Takeaways from the Episode

  • Validation should prioritize real risks over compliance checklists.
  • Critical thinking helps challenge biases and improve validation strategies.
  • Continuous improvement and industry insights drive more effective validation.
  • AI can automate routine tasks, enabling smarter risk management.
  • A well-structured validation process ensures long-term system reliability.

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