CSV in Pharma | GAMP 5, FDA, EU & WHO Guidelines + ALCOA+ | Data Integrity Explained!
Автор: Pharmalytics
Загружено: 20 апр. 2025 г.
Просмотров: 151 просмотр
CSV in Pharma | GAMP 5, FDA, EU & WHO Guidelines + ALCOA+ | Data Integrity Explained!
Welcome to @Pharmalytics – your trusted guide for pharmaceutical quality and compliance!
In this video • CSV in Pharma | GAMP 5, FDA, EU & WHO... , we dive deep into Computer System Validation (CSV) and how it's applied in the pharmaceutical industry in alignment with GAMP 5, US FDA (21 CFR Part 11), EU Annex 11, and WHO guidelines.
✅ Learn the V-Model lifecycle
✅ Understand how CSV supports Data Integrity
✅ Explore real-world examples that connect CSV with the ALCOA+ principles
✅ Discover how a risk-based approach enhances compliance and inspection readiness
Whether you're a quality professional, CSV specialist, auditor, or pharma techie, this video is your step-by-step guide to mastering CSV compliance in GxP systems.
🔔 Subscribe to @Pharmalytics for more pharma industry insights on GxP, GMP, regulatory guidelines, and quality systems!
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#CSV #GAMP5 #PharmaCompliance #FDA #EUAnnex11 #DataIntegrity #ALCOAplus #PharmaceuticalIndustry #CSVExplained #PharmaValidation #Pharmalytics

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