21 CFR Part 11 pdf epub mobi txt 電子書下載 2024

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Orlando Lopez

Informa Healthcare

2004-01-15

243

USD 229.95

Hardcover

9780849322433

圖書標籤: 美國法律參考資料 Signatures IT Electronic

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发表于2024-05-21

21 CFR Part 11 epub 下載 mobi 下載 pdf 下載 txt 電子書下載 2024

21 CFR Part 11 pdf epub mobi txt 電子書下載 2024

圖書描述

Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places regulatory compliance within the context of quality assurance. He demonstrates the importance of integrating validation activities into the system lifecycle using a structured top-down approach. He covers practical applications of quality assurance and engineering techniques as they relate to the development of systems fit to meet user and regulatory requirements.

21 CFR Part 11 下載 mobi epub pdf txt 電子書