Validation and qualification in analytical laboratories Ludwig Huber.
Material type:
TextPublication details: New York : Informa Healthcare, 2007..Edition: 2nd edDescription: v, 303 p. : ill. ; 24 cmISBN: - 9780849382673 (hbk. : alk. paper)
- 543.0685 HUB
| Item type | Current library | Call number | Status | Date due | Barcode |
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Central Library General Section | 543.0685 HUB (Browse shelf(Opens below)) | Available | 025687 |
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.
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