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What is Risk Management in Computer System Validation about?

This document summarizes regulatory requirements and guidance for effective and practical risk management in computer system validation. It reviews GXP regulations and guidance documents regarding risk assessment and management. It focuses on the ISO 14971 risk management process and discusses several risk analysis methodologies and their applicability to computer system validation. Finally, it presents a risk management process flow and discusses validation approaches based on risk, including a single inte

Author

baluchakp

Language

EN