Tag: ICH Q9(R1)

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Quality Risk Management in Computer System Validation (CSV) featured image with digital compliance and validation icons.

Quality Risk Management in Computer System Validation (CSV)

Explore how risk management in CSV optimizes validation by focusing on critical functions, ensuring compliance and efficient use of resources....
Draft Revisions to EudraLex GMP Guide Chapter 1 – Pharmaceutical Quality System

Draft Revisions to EudraLex GMP Guide Chapter 1 – Pharmaceutical Quality System

Draft revisions to GMP Chapter 1 focus on risk-based oversight, early warning systems, supply chain risks, and improved Product Quality...

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