Title Validation of computerized analytical and networked systems / Ludwig Huber

Published Englewood, CO : Interpharm Press, [2002] ©2002

Online access available from: ProQuest Ebook Central (owned titles)    View Resource Record

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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.)

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