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Validation of Computerized Analytical Systems
 
 
Validation of Computerized Analytical Systems (Hardcover)
by Ludwig Huber (Author) "When Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations were first introduced, computers were not widely used in laboratories and so no special..." (more)
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Product Description
Synopsis
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 the book 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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First Sentence
When Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulations were first introduced, computers were not widely used in laboratories and so no special attention was paid to the use of computer hardware and software. Read the first page
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Front Cover | Copyright | Table of Contents | Excerpt | Index | Back Cover
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