21 CFR Part 11 2024 pdf epub mobi 电子书

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发表于2024-12-11

21 CFR Part 11 2024 pdf epub mobi 电子书

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出版者:Informa Healthcare

作者:Orlando Lopez

出品人:

页数:243

译者:

出版时间:2004-01-15

价格:USD 229.95

装帧:Hardcover

isbn号码:9780849322433

丛书系列:

图书标签: 美国法律参考资料 Signatures IT Electronic

21 CFR Part 11 2024 pdf epub mobi 电子书图书描述

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 2024 pdf epub mobi 电子书

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