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Book Cover
E-book
Author Huber, Ludwig, 1948-

Title Validation of computerized analytical and networked systems / Ludwig Huber
Published Englewood, CO : Interpharm Press, [2002]
©2002
Online access available from:
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Description 1 online resource (viii, 228 pages) : illustrations
Contents Regulations and standards -- Terminology -- Design qualification -- Vendor assessment -- Validation during development -- Installation qualification -- Operational qualification -- Maintenance and ongoing performance qualification -- Validation of macros and spreadsheet programs -- Validation of networked systems -- Compliance with electronic records and signatures (21 cfr part 11) -- Operational compliance of legacy systems -- Audits
Bibliography Includes bibliographical references (pages 201-210) and index
Notes Print version record
Subject Pharmaceutical industry -- Data processing -- Quality control.
Pharmaceutical technology -- Automation -- Quality control.
Software Validation.
Computer-Aided Design -- standards.
Drug Industry -- standards.
Laboratories -- standards.
Quality Control.
Form Electronic book
ISBN 1420025910 (electronic bk.)
9781420025910 (electronic bk.)