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Validation of Computerized Analytical Systems, Paperback by Huber, Ludwig, Li...

Description: Validation of Computerized Analytical Systems, Paperback by Huber, Ludwig, ISBN 036740172X, ISBN-13 9780367401726, Like New Used, Free shipping in the US Validation of Computerized Analytical and Networked Systems provides the definitive rationales, logic, and methodology for validation of computerized analytical systems. Whether you are involved with formulation or analytical development laboratories, chemical or microbiological quality control laboratories, LIMS installations, or any aspect of robotic in a healthcare laboratory, this book furnishes complete validation details.

International and FDA regulations and requirements are discussed and juxtaposed with numerous practical examples that show you how to cost-effectively and efficiently accomplish validation acceptable to FDA GCP/GLP/GMP, NAMAS, and EN45001 standards. The templates included provide documentation examples and the many checklists found throughout th assure that all aspects of covered in a logical sequence. The chapters describe and explain such topics as the Product Life Cycle revalidation, change control, documentation requirements, qualifications, testing, data validation and traceability, inspection, SOPs, and many other that help streamline the validation process.

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Validation of Computerized Analytical Systems, Paperback by Huber, Ludwig, Li...

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Book Title: Validation of Computerized Analytical Systems

Number of Pages: 268 Pages

Language: English

Publication Name: Validation of Computerized Analytical Systems

Publisher: CRC Press LLC

Publication Year: 2019

Subject: Pharmacy, Pharmacology, Chemistry / General

Item Weight: 16 Oz

Type: Textbook

Item Length: 10 in

Subject Area: Science, Medical

Author: Ludwig Huber

Item Width: 7 in

Format: Trade Paperback

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