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Author: Ludwig Huber
Publisher: CRC Press
ISBN: 1000948226
Category : Science
Languages : en
Pages : 268
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Book Description
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.
Author: Ludwig Huber
Publisher: CRC Press
ISBN: 1000948226
Category : Science
Languages : en
Pages : 268
Get Book
Book Description
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.
Author: LUDWIG HUBER.
Publisher:
ISBN: 9780429135927
Category :
Languages : en
Pages :
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Book Description
Author: Guy Wingate
Publisher: CRC Press
ISBN: 1420088955
Category : Medical
Languages : en
Pages : 773
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Book Description
Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
Author:
Publisher:
ISBN:
Category : Physical measurements
Languages : en
Pages : 452
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Book Description
Author: Kevin L. Williams
Publisher: CRC Press
ISBN: 1420020595
Category : Medical
Languages : en
Pages : 441
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Book Description
This source expertly examines the discovery, biological structure, control, and continued clarification of endotoxin from a parenteral manufacturing perspective, with in-depth discussion of state-of-the-art technologies involving Limulus amebocyte lysate (LAL) such as assay development, automation, depyrogenation. Completely revised and exp
Author: Martin L. Shooman
Publisher: John Wiley & Sons
ISBN: 0471464066
Category : Technology & Engineering
Languages : en
Pages : 552
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Book Description
With computers becoming embedded as controllers in everything from network servers to the routing of subway schedules to NASA missions, there is a critical need to ensure that systems continue to function even when a component fails. In this book, bestselling author Martin Shooman draws on his expertise in reliability engineering and software engineering to provide a complete and authoritative look at fault tolerant computing. He clearly explains all fundamentals, including how to use redundant elements in system design to ensure the reliability of computer systems and networks. Market: Systems and Networking Engineers, Computer Programmers, IT Professionals.
Author: G. G. Leininger
Publisher: Elsevier
ISBN: 148314688X
Category : Computers
Languages : en
Pages : 715
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Book Description
Computer Aided Design of Multivariable Technological Systems covers the proceedings of the Second International Federation of Automatic Control (IFAC). The book reviews papers that discuss topics about the use of Computer Aided Design (CAD) in designing multivariable system, such as theoretical issues, applications, and implementations. The book tackles several topics relevant to the use of CAD in designing multivariable systems. Topics include quasi-classical approach to multivariable feedback system designs; fuzzy control for multivariable systems; root loci with multiple gain parameters; multivariable frequency domain stability criteria; and computational algorithms for pole assignment in linear multivariable systems. The text will be of great use to professionals whose work involves designing and implementing multivariable systems.
Author:
Publisher:
ISBN:
Category :
Languages : en
Pages : 52
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Book Description
For more than 20 years, Network World has been the premier provider of information, intelligence and insight for network and IT executives responsible for the digital nervous systems of large organizations. Readers are responsible for designing, implementing and managing the voice, data and video systems their companies use to support everything from business critical applications to employee collaboration and electronic commerce.
Author:
Publisher:
ISBN:
Category : Fossil fuels
Languages : en
Pages : 980
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Book Description
Author: Stênio Fernandes
Publisher: Springer
ISBN: 3319545213
Category : Computers
Languages : en
Pages : 185
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Book Description
This book provides a comprehensive view of the methods and approaches for performance evaluation of computer networks. It offers a clear and logical introduction to the topic, covering both fundamental concepts and practical aspects. It enables the reader to answer a series of questions regarding performance evaluation in modern computer networking scenarios, such as ‘What, where, and when to measure?’, ‘Which time scale is more appropriate for a particular measurement and analysis?’, 'Experimentation, simulation or emulation? Why?’, and ‘How do I best design a sound performance evaluation plan?’. The book includes concrete examples and applications in the important aspects of experimentation, simulation and emulation, and analytical modeling, with strong support from the scientific literature. It enables the identification of common shortcomings and highlights where students, researchers, and engineers should focus to conduct sound performance evaluation. This book is a useful guide to advanced undergraduates and graduate students, network engineers, and researchers who plan and design proper performance evaluation of computer networks and services. Previous knowledge of computer networks concepts, mechanisms, and protocols is assumed. Although the book provides a quick review on applied statistics in computer networking, familiarity with basic statistics is an asset. It is suitable for advanced courses on computer networking as well as for more specific courses as a secondary textbook.
