Tag: GAMP 5

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Software Validation in GMP: Continuous, Risk-Based Control Across the Lifecycle

Explore risk-based software validation in GMP, from CSV to continuous assurance, ensuring compliance, data integrity, and efficiency....
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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....
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Computer System Validation (CSV) in the Pharmaceutical Industry

Practical guide to CSV in pharma: lifecycle validation, Annex 11 updates, GAMP 5 methods, CSA approach, and real-world compliance practices....
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How to Write a GMP-Compliant User Requirement Specification (URS)

Learn how to write a GMP-compliant User Requirement Specification (URS) with regulatory guidance, risk-based principles, and its role in the...

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