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21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

Orlando López




[PDF.zz26] 21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry

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 | #3964151 in Books |  2004-01-15 | Original language:English | PDF # 1 |  10.28 x.79 x7.22l,1.41 | File type: PDF | 243 pages

||0 of 0 people found the following review helpful.| Two Stars|By Miguel|If you are new to 21 CFR Part 11, this is no the book for you.|0 of 1 people found the following review helpful.| Two Stars|By Kiran S.|It is more of a summary and very less details.|14 of 16 people found the following review helpful.| Great overview of 21 CFR Part 11|

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 acti...

You easily download any file type for your device.21 CFR Part 11: Complete Guide to International Computer Validation Compliance for the Pharmaceutical Industry   |  Orlando López. Just read it with an open mind because none of us really know.

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