Validation and qualification in analytical laboratories
by
Huber, Ludwig, 1948-
Title
:
Validation and qualification in analytical laboratories
Author
:
Huber, Ludwig, 1948-
ISBN
:
9780849382680
Edition
:
2nd ed.
Publication Information
:
New York : Informa Healthcare, c2007.
Physical Description
:
v, 303 p. : ill.
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.
Subject Term
:
Chemistry, Analytic -- Quality control.
Chemical laboratories -- Standards.
Electronic Access
:
Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
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Online Library | E-Book | 284781-1001 | ONLINE | | Elektronik Kütüphane |