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" Validation of computerized analytical and networked systems / "


Document Type : BL
Record Number : 569259
Doc. No : b398478
Main Entry : Huber, Ludwig,1948-
Title & Author : Validation of computerized analytical and networked systems /\ Ludwig Huber.
Publication Statement : Englewood, CO :: Interpharm Press,, c2002.
Page. NO : viii, 228 p. :: ill. ;; 26 cm.
ISBN : 1574911333
Bibliographies/Indexes : Includes bibliographical references (p. 201-210) and index.
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.
Subject : Pharmaceutical technology-- Automation-- Quality control.
Subject : Pharmaceutical industry-- Data processing-- Quality control.
Subject : Software Validation.
Subject : Computer-Aided Design-- standards.
Subject : Drug Industry-- standards.
Subject : Laboratories-- standards.
Subject : Quality Control.
copyhttps://lib.clisel.com/site/catalogue/569259
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