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Validation of Computerized Analytical Systems
Author: Ludwig Huber
Publisher: CRC / Interpharm Press, Inc.
Copyright: 1995
ISBN: 0-935184-75-9
Price: $178.50 (US dollars)
Page Count: 275

A Product Manager for LC Products at Hewlett-Packard, Huber is the author of numerous articles and books, and is a frequent speaker at international seminars on regulatory compliance and quality assurance in analytical laboratories.

The book is touted as the definitive text on validation of computer controlled analytical systems. It includes information on what to validate, when to validate, and how to validate all aspect of computers for laboratory equipment, from programmable HPLC equipment to chromatographic data handling to standalone computers to software, including LIMS. The text provides the rationale, logic and methodology to perform the validation in an acceptable manner t the regulatory agencies and accreditation bodies (FDA GCP/GLP/GMP, ISO Guide 25, ISO 9001/EN 45001, and NAMAS).

The book is for laboratory managers and analytical scientists, validation teams, and information management and quality assurance professionals who need to come to grips with the complex issues and concerns regarding computer controlled analytical equipment validation. It is designed to assist a variety of laboratories, including those involved in formulation or analytical development, environmental or food testing, chemical or microbiological quality control, LIMS installations, or any aspect of robotics in a healthcare laboratory setting where the computer portions of the systems must be validated.


To order, or for more information, contact:
CRC Press LLC
2000 NW Corporate Blvd
Boca Raton, FL 34431 USA
Telephone: +1 800-272-7737 or +1 561-994-0555
Facsimile: +1 800-374-3401 or +1 561-989-9732
   
 
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