The Computer System Risk Management And Validation Life Cycle
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The Computer System Risk Management And Validation Life Cycle
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Author : R. Timothy Stein
language : en
Publisher: Paton Professional
Release Date : 2006
The Computer System Risk Management And Validation Life Cycle written by R. Timothy Stein and has been published by Paton Professional this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Business & Economics categories.
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.
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
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.
Eu Annex 11 Guide To Computer Validation Compliance For The Worldwide Health Agency Gmp
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Author : Orlando Lopez
language : en
Publisher: CRC Press
Release Date : 2015-04-06
Eu Annex 11 Guide To Computer Validation Compliance For The Worldwide Health Agency Gmp written by Orlando Lopez and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-06 with Business & Economics categories.
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is
Validating Pharmaceutical Systems
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Author : John Andrews
language : en
Publisher: CRC Press
Release Date : 2005-08-03
Validating Pharmaceutical Systems written by John Andrews and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-08-03 with Medical categories.
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
Validation Of Chromatography Data Systems
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Author : Robert D McDowall
language : en
Publisher: Royal Society of Chemistry
Release Date : 2016-11-23
Validation Of Chromatography Data Systems written by Robert D McDowall and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-23 with Science categories.
Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.
Practical Approaches To Method Validation And Essential Instrument Qualification
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Author : Chung Chow Chan
language : en
Publisher: John Wiley & Sons
Release Date : 2011-03-01
Practical Approaches To Method Validation And Essential Instrument Qualification 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 2011-03-01 with Science categories.
Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.
Handbook Of Research On Emerging Technologies For Effective Project Management
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Author : Jamil, George Leal
language : en
Publisher: IGI Global
Release Date : 2019-09-13
Handbook Of Research On Emerging Technologies For Effective Project Management written by Jamil, George Leal and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-09-13 with Business & Economics categories.
Driven by such tools as big data, cognitive computing, new business models, and the internet of things, the overall demand for innovation is becoming more critical for competitiveness and emerging technologies. These technologies have become real alternatives for the market and offer new perspectives for modern project management applications. The Handbook of Research on Emerging Technologies for Effective Project Management is an essential research publication that proposes innovations for firms and markets through the exploration of project management principles and methods and the effective integration of knowledge and innovation. It encompasses academic and scientific propositions, reviews for conceptual bases, applications of theories in new market solutions, and cases of successful insertion of disruptive technologies and business models in new competitive market offers. Featuring a range of topics such as innovation management, business administration, and marketing, this book is ideal for project managers, IT specialists, software developers, executives, practitioners, managers, marketers, researchers, and industry professionals.
Software Development Patterns And Antipatterns
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Author : Capers Jones
language : en
Publisher: CRC Press
Release Date : 2021-08-26
Software Development Patterns And Antipatterns written by Capers Jones and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-26 with Computers categories.
Software development has been a troubling since it first started. There are seven chronic problems that have plagued it from the beginning: Incomplete and ambiguous user requirements that grow by >2% per month. Major cost and schedule overruns for large applications > 35% higher than planned. Low defect removal efficiency (DRE) Cancelled projects that are not completed: > 30% above 10,000 function points. Poor quality and low reliability after the software is delivered: > 5 bugs per FP. Breach of contract litigation against software outsource vendors. Expensive maintenance and enhancement costs after delivery. These are endemic problems for software executives, software engineers and software customers but they are not insurmountable. In Software Development Patterns and Antipatterns, software engineering and metrics pioneer Capers Jones presents technical solutions for all seven. The solutions involve moving from harmful patterns of software development to effective patterns of software development. The first section of the book examines common software development problems that have been observed in many companies and government agencies. The data on the problems comes from consulting studies, breach of contract lawsuits, and the literature on major software failures. This section considers the factors involved with cost overruns, schedule delays, canceled projects, poor quality, and expensive maintenance after deployment. The second section shows patterns that lead to software success. The data comes from actual companies. The section’s first chapter on Corporate Software Risk Reduction in a Fortune 500 company was based on a major telecom company whose CEO was troubled by repeated software failures. The other chapters in this section deal with methods of achieving excellence, as well as measures that can prove excellence to C-level executives, and with continuing excellence through the maintenance cycle as well as for software development.