Validation Of Computerized Analytical And Networked Systems
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Validation Of Computerized Analytical Systems
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Author : Ludwig Huber
language : en
Publisher: CRC Press
Release Date : 2023-04-28
Validation Of Computerized Analytical Systems written by Ludwig Huber and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-28 with Medical categories.
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.
Validation Of Computerized Analytical And Networked Systems
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Author : Ludwig Huber
language : en
Publisher: CRC Press
Release Date : 2001-10-01
Validation Of Computerized Analytical And Networked Systems written by Ludwig Huber and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-10-01 with Medical categories.
You cannot afford to be in the dark when it comes to validating your analytical systems and lab software. Written by international laboratory and compliance expert Dr. Ludwig Huber, Validation of Computerized Analytical and Networked Systems is an invaluable validation tool. Covering the initial writing of the validation plan through implementation, testing, and installation qualification, through ongoing calibration, performance qualification, and change control, the book provides guidance throughout the entire validation process. Huber pays special attention to 21CFR Part 11 electronic records and signatures compliance, including recommendations for implementation and the scope of Part 11 for chromatographic systems. He discusses vendor assessment, covers the criteria and procedures for vendor audits, and includes vendor assessment checklists. He also explores the validation of complex networked systems and "office software" such as Macros, spreadsheets, and databases, and the operational compliance of legacy systems. The book contains everything you need to perform computer systems validation cost-effectively and in a manner acceptable to national and international regulatory agencies.
High Performance Liquid Chromatography
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Author : Omar Al Sayed Omar
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2022-02-21
High Performance Liquid Chromatography written by Omar Al Sayed Omar and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-02-21 with Science categories.
During the past decade, modern high-performance liquid chromatography (HPLC) utilization has expanded greatly, especially in the quality control of pharmaceutical products in drug quality control laboratories. This book provides an extensive collection of technical information about HPLC-Columns (physicochemical properties and chromatographic characteristics), from various manufacturers, and helps analysts to decide on the ideal approach for their analysis according to the requirements of drug manufacturers specifi cations and the desired Pharmacopeia. In addition, the authors give practical advice on how to prepare mobile phases, choose a suitable detector, and set up an HPLC analysis. This book is comprehensive for the average professional or technician who plans to work with modern HPLC. This book is useful for most Drug Quality Control Laboratories where modern HPLC is utilized. Following a hands-on approach, the book gives key insights into the pharmaceutical applications of HPLC and the latest requirements of the major regulatory agencies such as ICH, FDA, or USP.
Nbs Special Publication
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Author :
language : en
Publisher:
Release Date : 1968
Nbs Special Publication written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1968 with Weights and measures categories.
Modern Hplc For Practicing Scientists
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Author : Michael W. Dong
language : en
Publisher: John Wiley & Sons
Release Date : 2016-04-06
Modern Hplc For Practicing Scientists written by Michael W. Dong and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-06 with Science categories.
A comprehesive yet concise guide to Modern HPLC Written for practitioners by a practitioner, Modern HPLC for Practicing Scientists is a concise text which presents the most important High-Performance Liquid Chromatography (HPLC) fundamentals, applications, and developments. It describes basic theory and terminology for the novice, and reviews relevant concepts, best practices, and modern trends for the experienced practitioner. Moreover, the book serves well as an updated reference guide for busy laboratory analysts and researchers. Topics covered include: HPLC operation Method development Maintenance and troubleshooting Modern trends in HPLC such as quick-turnaround and "greener" methods Regulatory aspects While broad in scope, this book focuses particularly on reversed-phase HPLC, the most common separation mode, and on applications for the pharmaceutical industry, the largest user segment. Accessible to both novice and intermedate HPLC users, information is delivered in a straightforward manner illustrated with an abundance of diagrams, chromatograms, tables, and case studies, and supported with selected key references and Web resources. With intuitive explanations and clear figures, Modern HPLC for Practicing Scientists is an essential resource for practitioners of all levels who need to understand and utilize this versatile analytical technology.
Preparing For Fda Pre Approval Inspections
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Author : Martin D. Hynes
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Preparing For Fda Pre Approval Inspections written by Martin D. Hynes and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th
Pharmaceutical Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Pharmaceutical Computer Systems Validation written by Guy Wingate and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
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.
Endotoxins
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Author : Kevin L. Williams
language : en
Publisher: CRC Press
Release Date : 2007-02-23
Endotoxins written by Kevin L. Williams and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-02-23 with Medical categories.
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
Secure Computer And Network Systems
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Author : Nong Ye
language : en
Publisher: John Wiley & Sons
Release Date : 2008-04-15
Secure Computer And Network Systems written by Nong Ye and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-04-15 with Computers categories.
Computer and network systems have given us unlimited opportunities of reducing cost, improving efficiency, and increasing revenues, as demonstrated by an increasing number of computer and network applications. Yet, our dependence on computer and network systems has also exposed us to new risks, which threaten the security of, and present new challenges for protecting our assets and information on computer and network systems. The reliability of computer and network systems ultimately depends on security and quality of service (QoS) performance. This book presents quantitative modeling and analysis techniques to address these numerous challenges in cyber attack prevention and detection for security and QoS, including: the latest research on computer and network behavior under attack and normal use conditions; new design principles and algorithms, which can be used by engineers and practitioners to build secure computer and network systems, enhance security practice and move to providing QoS assurance on the Internet; mathematical and statistical methods for achieving the accuracy and timeliness of cyber attack detection with the lowest computational overhead; guidance on managing admission control, scheduling, reservation and service of computer and network jobs to assure the service stability and end-to-end delay of those jobs even under Denial of Service attacks or abrupt demands. Secure Computer and Network Systems: Modeling, Analysis and Design is an up-to-date resource for practising engineers and researchers involved in security, reliability and quality management of computer and network systems. It is also a must-read for postgraduate students developing advanced technologies for improving computer network dependability.
Simulation In Computer Network Design And Modeling Use And Analysis
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Author : Al-Bahadili, Hussein
language : en
Publisher: IGI Global
Release Date : 2012-02-29
Simulation In Computer Network Design And Modeling Use And Analysis written by Al-Bahadili, Hussein and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-02-29 with Computers categories.
"This book reviews methodologies in computer network simulation and modeling, illustrates the benefits of simulation in computer networks design, modeling, and analysis, and identifies the main issues that face efficient and effective computer network simulation"--Provided by publisher.