The Validation Handbook For Engineers

Author : Priscilla Browne
Publisher : Createspace Independent Publishing Platform
ISBN 13 : 9781548341442
Total Pages : 232 pages
Book Rating : 4.44/5 ( download)

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Download or read book The Validation Handbook for Engineers written by Priscilla Browne and published by Createspace Independent Publishing Platform. This book was released on 2017-06-23 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation is a regulatory and legal requirement for the manufacture of medical devices and medicinal products. Validation is concerned with ensuring design requirements are fulfilled and that products are safely and consistently manufactured. It is a systematic and logical process. This book provides a concise overview and reference for engineers. It includes chapters on equipment and process validation and test method validation. Ancillary services and facilities are also reviewed in terms of typical deliverables.

Author : Mourad Debbabi
Publisher : Springer Science & Business Media
ISBN 13 : 3642152287
Total Pages : 261 pages
Book Rating : 4.83/5 ( download)

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Download or read book Verification and Validation in Systems Engineering written by Mourad Debbabi and published by Springer Science & Business Media. This book was released on 2010-11-16 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: At the dawn of the 21st century and the information age, communication and c- puting power are becoming ever increasingly available, virtually pervading almost every aspect of modern socio-economical interactions. Consequently, the potential for realizing a signi?cantly greater number of technology-mediated activities has emerged. Indeed, many of our modern activity ?elds are heavily dependant upon various underlying systems and software-intensive platforms. Such technologies are commonly used in everyday activities such as commuting, traf?c control and m- agement, mobile computing, navigation, mobile communication. Thus, the correct function of the forenamed computing systems becomes a major concern. This is all the more important since, in spite of the numerous updates, patches and ?rmware revisions being constantly issued, newly discovered logical bugs in a wide range of modern software platforms (e. g. , operating systems) and software-intensive systems (e. g. , embedded systems) are just as frequently being reported. In addition, many of today’s products and services are presently being deployed in a highly competitive environment wherein a product or service is succeeding in most of the cases thanks to its quality to price ratio for a given set of features. Accordingly, a number of critical aspects have to be considered, such as the ab- ity to pack as many features as needed in a given product or service while c- currently maintaining high quality, reasonable price, and short time -to- market.

Author : Avner Engel
Publisher : John Wiley & Sons
ISBN 13 : 1118029313
Total Pages : 712 pages
Book Rating : 4.12/5 ( download)

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Download or read book Verification, Validation, and Testing of Engineered Systems written by Avner Engel and published by John Wiley & Sons. This book was released on 2010-11-19 with total page 712 pages. Available in PDF, EPUB and Kindle. Book excerpt: Systems' Verification Validation and Testing (VVT) are carried out throughout systems' lifetimes. Notably, quality-cost expended on performing VVT activities and correcting system defects consumes about half of the overall engineering cost. Verification, Validation and Testing of Engineered Systems provides a comprehensive compendium of VVT activities and corresponding VVT methods for implementation throughout the entire lifecycle of an engineered system. In addition, the book strives to alleviate the fundamental testing conundrum, namely: What should be tested? How should one test? When should one test? And, when should one stop testing? In other words, how should one select a VVT strategy and how it be optimized? The book is organized in three parts: The first part provides introductory material about systems and VVT concepts. This part presents a comprehensive explanation of the role of VVT in the process of engineered systems (Chapter-1). The second part describes 40 systems' development VVT activities (Chapter-2) and 27 systems' post-development activities (Chapter-3). Corresponding to these activities, this part also describes 17 non-testing systems' VVT methods (Chapter-4) and 33 testing systems' methods (Chapter-5). The third part of the book describes ways to model systems’ quality cost, time and risk (Chapter-6), as well as ways to acquire quality data and optimize the VVT strategy in the face of funding, time and other resource limitations as well as different business objectives (Chapter-7). Finally, this part describes the methodology used to validate the quality model along with a case study describing a system’s quality improvements (Chapter-8). Fundamentally, this book is written with two categories of audience in mind. The first category is composed of VVT practitioners, including Systems, Test, Production and Maintenance engineers as well as first and second line managers. The second category is composed of students and faculties of Systems, Electrical, Aerospace, Mechanical and Industrial Engineering schools. This book may be fully covered in two to three graduate level semesters; although parts of the book may be covered in one semester. University instructors will most likely use the book to provide engineering students with knowledge about VVT, as well as to give students an introduction to formal modeling and optimization of VVT strategy.

Author : Jeffrey O. Grady
Publisher : CRC Press
ISBN 13 : 9780849378386
Total Pages : 356 pages
Book Rating : 4.89/5 ( download)

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Download or read book System Validation and Verification written by Jeffrey O. Grady and published by CRC Press. This book was released on 1997-11-25 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: Historically, the terms validation and verification have been very loosely defined in the system engineering world, with predictable confusion. Few hardware or software testing texts even touch upon validation and verification, despite the fact that, properly employed, these test tools offer system and test engineers powerful techniques for identifying and solving problems early in the design process. Together, validation and verification encompass testing, analysis, demonstration, and examination methods used to determine whether a proposed design will satisfy system requirements. System Validation and Verification clear definitions of the terms and detailed information on using these fundamental tools for problem solving. It smoothes the transition between requirements and design by providing methods for evaluating the ability of a given approach to satisfy demanding technical requirements. With this book, system and test engineers and project managers gain confidence in their designs and lessen the likelihood of serious problems cropping up late in the program. In addition to explanations of the theories behind the concepts, the book includes practical methods for each step of the process, examples from the author's considerable experience, and illustrations and tables to support the ideas. Although not primarily a textbook, System Validation and Verification is based in part on validation and verification courses taught by the author and is an excellent supplemental reference for engineering students. In addition to its usefulness to system engineers, the book will be valuable to a wider audience including manufacturing, design, software , and risk management project engineers - anyone involved in large systems design projects.

Author : Hugh W. Coleman
Publisher : John Wiley & Sons
ISBN 13 : 1119417708
Total Pages : 420 pages
Book Rating : 4.05/5 ( download)

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Download or read book Experimentation, Validation, and Uncertainty Analysis for Engineers written by Hugh W. Coleman and published by John Wiley & Sons. This book was released on 2018-04-09 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Helps engineers and scientists assess and manage uncertainty at all stages of experimentation and validation of simulations Fully updated from its previous edition, Experimentation, Validation, and Uncertainty Analysis for Engineers, Fourth Edition includes expanded coverage and new examples of applying the Monte Carlo Method (MCM) in performing uncertainty analyses. Presenting the current, internationally accepted methodology from ISO, ANSI, and ASME standards for propagating uncertainties using both the MCM and the Taylor Series Method (TSM), it provides a logical approach to experimentation and validation through the application of uncertainty analysis in the planning, design, construction, debugging, execution, data analysis, and reporting phases of experimental and validation programs. It also illustrates how to use a spreadsheet approach to apply the MCM and the TSM, based on the authors’ experience in applying uncertainty analysis in complex, large-scale testing of real engineering systems. Experimentation, Validation, and Uncertainty Analysis for Engineers, Fourth Edition includes examples throughout, contains end of chapter problems, and is accompanied by the authors’ website www.uncertainty-analysis.com. Guides readers through all aspects of experimentation, validation, and uncertainty analysis Emphasizes the use of the Monte Carlo Method in performing uncertainty analysis Includes complete new examples throughout Features workable problems at the end of chapters Experimentation, Validation, and Uncertainty Analysis for Engineers, Fourth Edition is an ideal text and guide for researchers, engineers, and graduate and senior undergraduate students in engineering and science disciplines. Knowledge of the material in this Fourth Edition is a must for those involved in executing or managing experimental programs or validating models and simulations.

Author : William L. Oberkampf
Publisher : Cambridge University Press
ISBN 13 : 1139491768
Total Pages : 782 pages
Book Rating : 4.61/5 ( download)

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Download or read book Verification and Validation in Scientific Computing written by William L. Oberkampf and published by Cambridge University Press. This book was released on 2010-10-14 with total page 782 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in scientific computing have made modelling and simulation an important part of the decision-making process in engineering, science, and public policy. This book provides a comprehensive and systematic development of the basic concepts, principles, and procedures for verification and validation of models and simulations. The emphasis is placed on models that are described by partial differential and integral equations and the simulations that result from their numerical solution. The methods described can be applied to a wide range of technical fields, from the physical sciences, engineering and technology and industry, through to environmental regulations and safety, product and plant safety, financial investing, and governmental regulations. This book will be genuinely welcomed by researchers, practitioners, and decision makers in a broad range of fields, who seek to improve the credibility and reliability of simulation results. It will also be appropriate either for university courses or for independent study.

Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1000436012
Total Pages : 1062 pages
Book Rating : 4.13/5 ( download)

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Download or read book Handbook of Validation in Pharmaceutical Processes, Fourth Edition written by James Agalloco and published by CRC Press. This book was released on 2021-10-28 with total page 1062 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture

Author : Aristides Dasso
Publisher : IGI Global
ISBN 13 : 1591408512
Total Pages : 443 pages
Book Rating : 4.12/5 ( download)

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Download or read book Verification, Validation and Testing in Software Engineering written by Aristides Dasso and published by IGI Global. This book was released on 2007-01-01 with total page 443 pages. Available in PDF, EPUB and Kindle. Book excerpt: "This book explores different applications in V & V that spawn many areas of software development -including real time applications- where V & V techniques are required, providing in all cases examples of the applications"--Provided by publisher.

Author : David A. Vogel
Publisher : Artech House
ISBN 13 : 1596934239
Total Pages : 445 pages
Book Rating : 4.38/5 ( download)

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Download or read book Medical Device Software Verification, Validation and Compliance written by David A. Vogel and published by Artech House. This book was released on 2011 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: HereOCOs the first book written specifically to help medical device and software engineers, QA and compliance professionals, and corporate business managers better understand and implement critical verification and validation processes for medical device software.Offering you a much broader, higher-level picture than other books in this field, this book helps you think critically about software validation -- to build confidence in your softwareOCOs safety and effectiveness. The book presents validation activities for each phase of the development lifecycle and shows: why these activities are important and add value; how to undertake them; and what outputs need to be created to document the validation process.From software embedded within medical devices, to software that performs as a medical device itself, this comprehensive book explains how properly handled validation throughout the development lifecycle can help bring medical devices to completion sooner, at higher quality, in compliance with regulations."

Author : Robert O. Lewis
Publisher : John Wiley & Sons
ISBN 13 : 9780471570110
Total Pages : 388 pages
Book Rating : 4.17/5 ( download)

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Download or read book Independent Verification and Validation written by Robert O. Lewis and published by John Wiley & Sons. This book was released on 1992-11-11 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Comprehensive and up-to-date, it covers the most vital part of software development, independent verification and validation. Presents a variety of methods that will ensure better quality, performance, cost and reliability of technical products and systems. Features numerous hints, tips and instructions for better interaction between verification and validation personnel, development engineers and managers. Includes 8 case histories ranging from major engineering systems through information systems. Many of the principles involved also apply to computer hardware as well as the fields of science and engineering.