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Annex 11 Draft Revision: What’s New in Qualification & Validation
9:00
YouTubeHema Sharma
Annex 11 Draft Revision: What’s New in Qualification & Validation
This video explores the key updates in the draft revision of EU GMP Annex 11, focusing on qualification and validation requirements for computerized systems. Learn how the new guidance aligns with data integrity, risk-based approaches, and modern technologies like cloud and SaaS. We’ll break down critical expectations for system lifecycle ...
9 views2 days ago
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What is Computer System Validation (CSV) in the Pharmaceutical Industry?
What is Computer System Validation (CSV) in the Pharmaceutical Industry?
getreskilled.comAug 28, 2024
Complete guide to computer system validation in 2025
Complete guide to computer system validation in 2025
qualio.comOct 5, 2022
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Computer System Validation and, Good Documentation Practices for GxP Systems - SlideServe
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