9781420088946

Pharmaceutical Computer Systems Validation: Quality Assurance, Risk Management and Regulatory Compliance

by ;
  • ISBN13:

    9781420088946

  • ISBN10:

    1420088947

  • Edition: 2nd
  • Format: Hardcover
  • Copyright: 2010-02-23
  • Publisher: CRC Press

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Supplemental Materials

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  • The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
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Summary

Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

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