Validation Of Computerized Analytical 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.
Computer Systems Validation
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2003-12-18
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 2003-12-18 with Medical categories.
Both pervasive and ubiquitous, computerized systems are now an integral component of every corporate strategy in pharmaceutical and healthcare companies. However, when technology is combined with high-risk public safety projects or the production and control of life-saving medicines or devices, it is necessary to ensure that it is reliable, quality
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.
Validating Corporate Computer Systems
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Author : Guy Wingate
language : en
Publisher: CRC Press
Release Date : 2000-05-31
Validating Corporate Computer Systems 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 2000-05-31 with Medical categories.
One of the biggest computer validation challenges facing pharmaceutical manufacturers is the large corporate system. This book provides practical information and advice on good IT practice and validation principles. Written by experts, it includes case studies on EDMSs, EAM systems, LIMSs, and MRP II systems.
Analytical Method Validation And Instrument Performance Verification
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Author : Chung Chow Chan
language : en
Publisher: John Wiley & Sons
Release Date : 2004-04-09
Analytical Method Validation And Instrument Performance Verification written by Chung Chow Chan 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 2004-04-09 with Science categories.
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
Encyclopedia Of Chromatography 2004 Update Supplement
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Author : Jack Cazes
language : en
Publisher: CRC Press
Release Date : 2004-08-11
Encyclopedia Of Chromatography 2004 Update Supplement written by Jack Cazes and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-08-11 with Science categories.
In step with novel technologies and methodologies that have reshaped chromatography in recent years, this supplement reviews developments in HPLC, TLC, SFC, CCC, and other areas-presenting 50 authoritative entries filled with practical information vital to applications from biotechnology to environmental science to clinical pathology.
A Laboratory Quality Handbook Of Best Practices
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Author : Donald C. Singer
language : en
Publisher: Quality Press
Release Date : 2001-09-25
A Laboratory Quality Handbook Of Best Practices written by Donald C. Singer and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-09-25 with Business & Economics categories.
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation
Plastics Additives
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Author : J.C.J. Bart
language : en
Publisher: IOS Press
Release Date : 2006-03-15
Plastics Additives written by J.C.J. Bart and has been published by IOS Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-03-15 with Science categories.
"Cover-to-cover reading of Plastics Additives, Advanced Industrial Analysis, is recommended for both professional analysts and plastics technologists. Professor Bart’s prose style is easy to read. A professional background in analytical chemistry is not assumed. Particularly valuable is the trove of good advice as to which approach might be best in a given situation. Every department with a serious interest in additive / property relations should invest in a copy.” -- PMAD Newsletter. This industrially relevant and up-to-date resource deals with all established and emerging analytical methods for in-polymer additive analysis of plastics formulations. Quality assurance and industrial troubleshooting all benefit from direct analysis modes. Plastics Additives comprises detailed coverage of solid-state spectroscopy, thermal analysis and pyrolysis, laser techniques, surface studies and microanalysis along with process analytics, quantitative analysis and modern method development and validation applied to additives in polymers. The book is organised for quick and easy reference and is extensively illustrated with over 200 figures, 300 flow diagrams and tables to facilitate rapid understanding of this topic, and it contains 4000 references. Emphasis is on understanding (principles and characteristics) and industrial applicability.
Artificial Crime Analysis Systems Using Computer Simulations And Geographic Information Systems
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Author : Liu, Lin
language : en
Publisher: IGI Global
Release Date : 2008-01-31
Artificial Crime Analysis Systems Using Computer Simulations And Geographic Information Systems written by Liu, Lin and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-01-31 with Business & Economics categories.
In the last decade there has been a phenomenal growth in interest in crime pattern analysis. Geographic information systems are now widely used in urban police agencies throughout industrial nations. With this, scholarly interest in understanding crime patterns has grown considerably. Artificial Crime Analysis Systems: Using Computer Simulations and Geographic Information Systems discusses leading research on the use of computer simulation of crime patterns to reveal hidden processes of urban crimes, taking an interdisciplinary approach by combining criminology, computer simulation, and geographic information systems into one comprehensive resource.