Reference Information For The Software Verification And Validation Process
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Reference Information For The Software Verification And Validation Process
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Author : Dolores R. Wallace
language : en
Publisher: DIANE Publishing
Release Date : 1996
Reference Information For The Software Verification And Validation Process written by Dolores R. Wallace and has been published by DIANE Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996 with Computers categories.
Computing systems are employed in the health care environment in efforts to increase reliability of care and reduce costs. Software verification and validation (V&V) is an aid in determining that the software requirements are implemented correctly and completely and are traceable to system requirements. It helps to ensure that those system functions controlled by software are secure, reliable, and maintainable. Software V&V is conducted throughout the planning, development and maintenance of software systems, including knowledge based systems, and may assist in assuring appropriate reuse of software.
Reference Information For The Software Verification And Validation Process
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Author : Gordon Press Publishers
language : en
Publisher:
Release Date : 1997-06
Reference Information For The Software Verification And Validation Process written by Gordon Press Publishers and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997-06 with categories.
Pharmaceutical Computer Validation Introduction Guidebook
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Author : Daniel Farb
language : en
Publisher: UniversityOfHealthCare
Release Date : 2005
Pharmaceutical Computer Validation Introduction Guidebook written by Daniel Farb and has been published by UniversityOfHealthCare this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Business & Economics categories.
Pharmaceutical Computer Validation Introduction gives you a comprehensive introduction to computer systems validation as the computers come to life while the head of computer systems at a pharmaceutical company has to prepare for an FDA inspection. You will learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and so on. It is also relevant for the medical device, food, and cosmetic industries. 86 pages in the guide include a handy printout of several relevant FDA documents. Those readers who wish to have an accompanying program with video and interactivity should also purchase the CD version.
Publications Of The National Institute Of Standards And Technology Catalog
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Author : National Institute of Standards and Technology (U.S.)
language : en
Publisher:
Release Date : 1994
Publications Of The National Institute Of Standards And Technology Catalog written by National Institute of Standards and Technology (U.S.) and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with categories.
Part 11 And Computer Validation Guidebook
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Author : Daniel Farb
language : en
Publisher: UniversityOfHealthCare
Release Date : 2005
Part 11 And Computer Validation Guidebook written by Daniel Farb and has been published by UniversityOfHealthCare this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005 with Business & Economics categories.
Gives an introduction to computer issues in the pharmaceutical industry, as well as to computer systems validation. This work helps you learn about regulations, the personnel responsible for computer validation, how to accomplish validation, examples of regulatory problems, and more. It is useful for research personnel in FDA-regulated industries.
Handbook Of Bioequivalence Testing
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2007-08-22
Handbook Of Bioequivalence Testing written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-08-22 with Medical categories.
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made
Handbook Of Bioequivalence Testing Second Edition
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Author : Sarfaraz K. Niazi
language : en
Publisher: CRC Press
Release Date : 2014-10-29
Handbook Of Bioequivalence Testing Second Edition written by Sarfaraz K. Niazi and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-29 with Medical categories.
As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have made bioequivalence testing more complex. The second edition of Handbook of Bioequivalence Testing has been completely updated to include the most current information available, including new findings in drug delivery and dosage form design and revised worldwide regulatory requirements. New topics include: A historical perspective on generic pharmaceuticals New guidelines governing submissions related to bioequivalency studies, along with therapeutic code classifications Models of noninferiority Biosimilarity of large molecule drugs Bioequivalence of complementary and alternate medicines Bioequivalence of biosimilar therapeutic proteins and monoclonal antibodies New FDA guidelines for bioanalytical method validation Outsourcing and monitoring of bioequivalence studies The cost of generic drugs is rising much faster than in the past, partly because of the increased costs required for approval—including those for bioequivalence testing. There is a dire need to re-examine the science behind this type of testing to reduce the burden of development costs—allowing companies to develop generic drugs faster and at a lower expense. The final chapter explores the future of bioequivalence testing and proposes radical changes in the process of biowaivers. It suggests how the cost of demonstrating bioequivalence can be reduced through intensive analytical investigation and proposes that regulatory agencies reduce the need for bioequivalence studies in humans. Backed by science and updated with the latest research, this book is destined to spark continued debate on the efficacy of the current bioequivalence testing paradigm.
Software Quality Assurance
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Author : Claude Y. Laporte
language : en
Publisher: John Wiley & Sons
Release Date : 2018-01-04
Software Quality Assurance written by Claude Y. Laporte 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 2018-01-04 with Technology & Engineering categories.
This book introduces Software Quality Assurance (SQA) and provides an overview of standards used to implement SQA. It defines ways to assess the effectiveness of how one approaches software quality across key industry sectors such as telecommunications, transport, defense, and aerospace. Includes supplementary website with an instructor’s guide and solutions Applies IEEE software standards as well as the Capability Maturity Model Integration for Development (CMMI) Illustrates the application of software quality assurance practices through the use of practical examples, quotes from experts, and tips from the authors
Reliability Engineering
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Author : Hoang Pham
language : en
Publisher: World Scientific
Release Date : 2025-05-27
Reliability Engineering written by Hoang Pham and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-05-27 with Technology & Engineering categories.
Most products that influence our daily lives are becoming increasingly complex. Reliability and statistical analytics play a vital role in business, finance, and industry. On one hand, these tools enable organizations to achieve better results and make fact-based decisions across various domains. On the other hand, modern business is becoming more competitive and challenging due to global competition and the inherent complexity of business operations.This book features 18 articles selected from the International Journal of Reliability, Quality and Safety Engineering (IJRQSE) over the past 30 years. These articles represent the major themes of the journal, focusing on reliability, quality, and safety engineering. They are among the most cited articles in the last three years.
Verification Validation And Testing In Software Engineering
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Author : Aristides Dasso
language : en
Publisher: IGI Global
Release Date : 2007-01-01
Verification Validation And Testing In Software Engineering written by Aristides Dasso and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-01-01 with Computers categories.
"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.