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Author :
Publisher : ASTM International
ISBN 13 :
Total Pages : 271 pages
Book Rating : 4./5 ( download)
Download or read book Computerized Laboratory Systems written by and published by ASTM International. This book was released on with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : ASTM International
ISBN 13 : 9780803102682
Total Pages : 274 pages
Book Rating : 4.1/5 (26 download)
Download or read book Computerized Laboratory Systems written by and published by ASTM International. This book was released on 1975 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879392
Total Pages : pages
Book Rating : 4.8/5 (793 download)
Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ludwig Huber
Publisher : CRC Press
ISBN 13 : 1000948226
Total Pages : 268 pages
Book Rating : 4.0/5 (9 download)
Download or read book Validation of Computerized Analytical Systems written by Ludwig Huber and published by CRC Press. This book was released on 2023-04-28 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Parenteral Drug Association
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.:/5 (254 download)
Download or read book Validation and qualification of computerized laboratory data acquisition systems written by Parenteral Drug Association and published by . This book was released on 1999 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : S. P. Maj
Publisher :
ISBN 13 :
Total Pages : 388 pages
Book Rating : 4.:/5 (51 download)
Download or read book The Use of Computers for Laboratory Automation written by S. P. Maj and published by . This book was released on 1993 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Use of Computers for Laboratory Automation gives readers sufficient knowledge of computer systems and automation to enable them to read, and evaluate critically, technical literature and system specifications, thereby allowing the active participation in the selection, implementation, use and maintenance of computer systems in laboratories. The Use of Computers for Laboratory Automation addresses the fundamental concepts in computer engineering, software engineering and automation. It places the emphasis on principles of operation rather than on `product specific' details, which makes it independent and to a large degree `future-proof'. Particular attention is given to Laboratory Information Management Systems (LIMS) and the associated verification and valuation of computers in regulated (GLP) environments. The book is written in an approachable style, using simple technical language, making it easily accessible to scientists at all professional levels (licentiate, graduate, practising professional) and capacities (technician, analyst, technical manager etc.), and from many different disciplines.
Author : Sion Wyn
Publisher :
ISBN 13 : 9781931879613
Total Pages : 0 pages
Book Rating : 4.8/5 (796 download)
Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Author : Mary Ann Worthington
Publisher : ASTM International
ISBN 13 : 080310975X
Total Pages : 113 pages
Book Rating : 4.8/5 (31 download)
Download or read book Computerization and Data Management in the Metals Analysis Laboratory written by Mary Ann Worthington and published by ASTM International. This book was released on 1988 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : ASTM Committee E-31 on Computerized Systems
Publisher :
ISBN 13 :
Total Pages : 114 pages
Book Rating : 4.0/5 ( download)
Download or read book ASTM Standards on Computerized Systems written by ASTM Committee E-31 on Computerized Systems and published by . This book was released on 1983 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781931879415
Total Pages : pages
Book Rating : 4.8/5 (794 download)
Download or read book ISPE GAMP® Good Practice Guide: Validation of Laboratory Computerized Systems written by Ispe and published by . This book was released on 2007-04-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Pieter Kubben
Publisher : Springer
ISBN 13 : 3319997130
Total Pages : 219 pages
Book Rating : 4.3/5 (199 download)
Download or read book Fundamentals of Clinical Data Science written by Pieter Kubben and published by Springer. This book was released on 2018-12-21 with total page 219 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book comprehensively covers the fundamentals of clinical data science, focusing on data collection, modelling and clinical applications. Topics covered in the first section on data collection include: data sources, data at scale (big data), data stewardship (FAIR data) and related privacy concerns. Aspects of predictive modelling using techniques such as classification, regression or clustering, and prediction model validation will be covered in the second section. The third section covers aspects of (mobile) clinical decision support systems, operational excellence and value-based healthcare. Fundamentals of Clinical Data Science is an essential resource for healthcare professionals and IT consultants intending to develop and refine their skills in personalized medicine, using solutions based on large datasets from electronic health records or telemonitoring programmes. The book’s promise is “no math, no code”and will explain the topics in a style that is optimized for a healthcare audience.
Author : Mindy Allport-Settle
Publisher : PharmaLogika Books
ISBN 13 : 9781937258252
Total Pages : 0 pages
Book Rating : 4.2/5 (582 download)
Download or read book Computer System Validation written by Mindy Allport-Settle and published by PharmaLogika Books. This book was released on 2021-03-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ata Elahi
Publisher : Springer
ISBN 13 : 3319667750
Total Pages : 272 pages
Book Rating : 4.3/5 (196 download)
Download or read book Computer Systems written by Ata Elahi and published by Springer. This book was released on 2017-11-08 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook covers digital design, fundamentals of computer architecture, and assembly language. The book starts by introducing basic number systems, character coding, basic knowledge in digital design, and components of a computer. The book goes on to discuss information representation in computing; Boolean algebra and logic gates; sequential logic; input/output; and CPU performance. The author also covers ARM architecture, ARM instructions and ARM assembly language which is used in a variety of devices such as cell phones, digital TV, automobiles, routers, and switches. The book contains a set of laboratory experiments related to digital design using Logisim software; in addition, each chapter features objectives, summaries, key terms, review questions and problems. The book is targeted to students majoring Computer Science, Information System and IT and follows the ACM/IEEE 2013 guidelines. • Comprehensive textbook covering digital design, computer architecture, and ARM architecture and assembly • Covers basic number system and coding, basic knowledge in digital design, and components of a computer • Features laboratory exercises in addition to objectives, summaries, key terms, review questions, and problems in each chapter
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309183618
Total Pages : 261 pages
Book Rating : 4.3/5 (91 download)
Download or read book Medicare Laboratory Payment Policy written by Institute of Medicine and published by National Academies Press. This book was released on 2000-12-04 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical laboratory tests play an integral role in helping physicians diagnose and treat patients. New developments in laboratory technology offer the prospect of improvements in diagnosis and care, but will place an increased burden on the payment system. Medicare, the federal program providing coverage of health-care services for the elderly and disabled, is the largest payer of clinical laboratory services. Originally designed in the early 1980s, Medicare's payment policy methodology for outpatient laboratory services has not evolved to take into account technology, market, and regulatory changes, and is now outdated. This report examines the current Medicare payment methodology for outpatient clinical laboratory services in the context of environmental and technological trends, evaluates payment policy alternatives, and makes recommendations to improve the system.
Author : John Andrews
Publisher : CRC Press
ISBN 13 : 9780367392383
Total Pages : 576 pages
Book Rating : 4.3/5 (923 download)
Download or read book Validating Pharmaceutical Systems written by John Andrews and published by CRC Press. This book was released on 2019-08-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems. Sprinkled with case studies and real-life examples, the book offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification. The first section examines the different levels of automated systems used throughout the drug development, manufacture, and delivery lifecycle, using the GAMP 4 lifecycle approach to their validation. The second section uncovers some real-life applications of GAMP 4 to different areas of the regulations such as GLP, GCP, GMP, and GDP. The book explores some of the latest thinking on computer validation and reflects changes that have occurred in the industry since the early days of validation. The contributors are a deliberate blend of those who have faced the problems of the 1990s and the Y2K controversies and those who have more recently arrived on the scene and made an impact on the perception of validation of automated systems across the field of GxP. They do more than show you how to do the right thing; they show you how to do the right thing in compliance with regulations.
Author : Daniel Cowan
Publisher : Springer Science & Business Media
ISBN 13 : 038722629X
Total Pages : 331 pages
Book Rating : 4.3/5 (872 download)
Download or read book Informatics for the Clinical Laboratory written by Daniel Cowan and published by Springer Science & Business Media. This book was released on 2007-06-02 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This series is directed to healthcare professionals who are leading the tra- formation of health care by using information and knowledge. Launched in 1988 as Computers in Health Care, the series offers a broad range of titles: some addressed to specific professions such as nursing, medicine, and health administration; others to special areas of practice such as trauma and radi- ogy. Still other books in the series focus on interdisciplinary issues, such as the computer-based patient record, electronic health records, and networked healthcare systems. Renamed Health Informatics in 1998 to reflect the rapid evolution in the discipline now known as health informatics, the series will continue to add titles that contribute to the evolution of the field. In the series, eminent - perts, serving as editors or authors, offer their accounts of innovations in health informatics. Increasingly, these accounts go beyond hardware and so- ware to address the role of information in influencing the transformation of healthcare delivery systems around the world. The series also increasingly focuses on “peopleware” and the organizational, behavioral, and societal changes that accompany the diffusion of information technology in health services environments.
