Скачать или смотреть 21 CFR Part 11 vs EU Annex 11 Key Differences Explained

Unlock the secrets to maintaining data integrity in the pharmaceutical and life sciences industries! In this video, we delve into the critical importance of accurate data and the foundational regulations governing electronic records and signatures—Title 21 CFR Part 11 in the US and EU Annex 11 in Europe. Learn about their roles in fostering trust with regulatory bodies and patients, and why compliance is key for electronic systems. We'll explore the differences, from specific technical controls to principle-based approaches, and the importance of risk management and periodic reviews. Stay compliant, stay informed—your guide to harmonizing US and EU regulations starts here!

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OUTLINE:

00:00:00 Introduction to Electronic Record Regulations
00:00:56 US and EU
00:01:56 A Detailed Look
00:02:40 Risk Management and Periodic Review
00:03:33 Similarities and Differences
00:04:13 Harmonized Compliance for Global Operations