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Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Handbook of Computer and Computerized System Validation for the Pharmaceutical Industry

Paperback (16 May 2003)

  • $36.46
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    Publisher's Synopsis

    This handbook details methods for sustainable compliance with GxPs and 21 CFR Part 11 validation requirements regarding computerized systems in the pharmaceutical, biotechnology, and medical device industry. The handbook follows FDA guidelines and best industry practices in defining roles, responsibilities, and requirements of system validation. Ch

    Book information

    ISBN: 9781410737441
    Publisher: 1stBooks
    Imprint: 1stBooks
    Pub date:
    DEWEY: 615.190285
    DEWEY edition: 22
    Language: English
    Number of pages: 459
    Weight: 1188g
    Height: 278mm
    Width: 212mm
    Spine width: 25mm

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