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Validation and qualification in analytical laboratories / Ludwig Huber.

By: Material type: TextTextPublication details: New York : Informa Healthcare, c2007.Edition: 2nd edDescription: v, 303 p. : ill. ; 24 cmISBN:
  • 9780849382673 (hbk. : alk. paper)
  • 084938267X (hbk. : alk. paper)
Subject(s): LOC classification:
  • QD75.4.Q34.H83-2007
Online resources:
Contents:
Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits.
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Includes bibliographical references (p. 281-297) and index.

Introduction -- Regulations, standards, and guidelines -- Terminology and validation overview -- Risk-based validation and qualification -- Master and project planning for equipment and computer systems -- Design qualification -- Installation qualification -- Operational qualification -- Performance qualification and maintenance -- Special considerations for software and computer systems -- Validation of analytical methods -- Data review and validation and evaluation of uncertainty -- Handling out-of-specification situations -- (Certified) reference standards -- People -- Proficiency testing for external laboratory qualification -- Audits.