Validation of Computerized Analytical Systems
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- 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.
- Copyright:
- 1995
Book Details
- Book Quality:
- Publisher Quality
- Book Size:
- 268 Pages
- ISBN-13:
- 9781000948226
- Related ISBNs:
- 9781003419297, 9780367401726, 9780935184754
- Publisher:
- CRC Press
- Date of Addition:
- 04/28/23
- Copyrighted By:
- Taylor & Francis Group, LLC. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including pho
- Adult content:
- No
- Language:
- English
- Has Image Descriptions:
- No
- Categories:
- Nonfiction, Science, Medicine
- Submitted By:
- Bookshare Staff
- Usage Restrictions:
- This is a copyrighted book.