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Covering the initial writing of the validation plan through implementation, testing, and installation qualification, through ongoing calibration, performance qualification, and change control, Validation of Computerized Analytical and Networked Systems provides guidance throughout the entire validation process. The book contains everything readers require to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies. It includes a discussion of 21 CFR Part 11-Electronic Records; Electronic Signatures, as well as a chapter on bringing legacy systems into compliance with 21 CFR Part 11 regulations. Tags: validation computerized analytical and networked systems |
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