Validation of Computerized Analytical Systems
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Product Details
Author:
Ludwig Huber
Format:
Paperback
Pages:
268
Publisher:
CRC Press (October 7, 2019)
Language:
English
ISBN-13:
9780367401726
Weight:
16oz
Dimensions:
7" x 10"
File:
TAYLORFRANCIS-TayFran_260123055423600-20260123.xml
Folder:
TAYLORFRANCIS
List Price:
$62.99
Case Pack:
1
As low as:
$59.84
Publisher Identifier:
P-CRC
Discount Code:
H
Audience:
Professional and scholarly
Pub Discount:
30
Country of Origin:
United States
Imprint:
CRC Press
Overview
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.
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.
