Download or read book The Computer System Risk Management and Validation Life Cycle written by R. Timothy Stein and published by Paton Professional. This book was released on 2006 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Risk based Software Validation written by David Nettleton and published by . This book was released on 2006-08-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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."
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.
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.
Download or read book Risk based E business Testing written by Paul Gerrard and published by Artech House. This book was released on 2002 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: This hands-on guide for business, project and test managers and test practitioners presents an effective approach for using risk to construct test strategies for e-business systems. Using an easily-learned risk-analysis technique, it teaches you how to use risk to select and prioritize test methods for e-business projects. This innovative resource shows you how to select test techniques to address business risks and integrate them into a coherent test process. The book presents twenty-four test techniques that address failure modes found in web applications. Grouped into seven categories, they are organized to make test strategy development easy. Each chapter has a comprehensive list of references to papers, books and web resources. The book provides you with guidelines for post-deployment monitoring of availability, performance, security and site integrity. It includes an overview of eight most important tool types with guidelines for selection and implementation. What?
Download or read book Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2003-12-18 with total page 1032 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 assured, and validated. The most comprehensive guide on computer validation currently available, containing more than 200 illustrations and more than 100 tables, Computer Systems Validation helps you see the big picture. The author reviews regulations and their development, organization responsibilities, validation life cycle based on GAMP4 Guide, strategic approaches to validation, electronic records and signatures, handling regulatory inspections, metrics, and opportunities for performance improvement. He presents practical examples and checklists throughout the book and explores the role of quality assurance and risk management as key components of pragmatic regulatory compliance. Covering methods that help you avoid duplicating effort among departments and business functions, the book demonstrates how you can use your investment in technology to improve business efficiency and gain the competitive edge.
Download or read book An Assessment of Space Shuttle Flight Software Development Processes written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 207 pages. Available in PDF, EPUB and Kindle. Book excerpt: Effective software is essential to the success and safety of the Space Shuttle, including its crew and its payloads. The on-board software continually monitors and controls critical systems throughout a Space Shuttle flight. At NASA's request, the committee convened to review the agency's flight software development processes and to recommend a number of ways those processes could be improved. This book, the result of the committee's study, evaluates the safety, oversight, and management functions that are implemented currently in the Space Shuttle program to ensure that the software is of the highest quality possible. Numerous recommendations are made regarding safety and management procedures, and a rationale is offered for continuing the Independent Verification and Validation effort that was instituted after the Challenger Accident.
Download or read book DESIGN CONTROLS RISK MANAGEMENT PROCESS VALIDATION FOR MEDICAL DEVICE PROFESSIONALS written by Vernon Geckler and published by Wasatch Consulting Resources LLC. This book was released on 2017-02-11 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook provides the most up to date resource currently available for interpreting and understanding design controls. This handbook is the most exhaustive resource ever written about FDA & ISO 13485 design controls for medical devices with a collection of all applicable regulations and real-world examples. Four-hundred & forty, 8.5" X 11" pages provides an extensive evaluation of FDA 21 CFR 820 and is cross-referenced with ISO 13485 to provide readers with a broad and in-depth review of practical design control implementation techniques. This handbook also covers basic, intermediate and advanced design control topics and is an ideal resource for implementing new design control processes or upgrading an existing process into medical device quality systems. This critical resource also specifically outlines key topics which will allow quality managers and medical device developers to improve compliance quickly to pass internal and external audits and FDA inspections. The author breaks down the regulation line by line and provides a detailed interpretation by using supportive evidence from the FDA design control guidance and the quality systems preamble. Numerous examples, case studies, best practices, 70+ figures and 45+ tables provide practical implementation techniques which are based on the author's extensive experience launching numerous medical device products and by integrating industry consultant expertise. In addition, bonus chapters include: explanation of medical device classification, compliance to design controls, risk management, and the design control quality system preamble. 20-40 pages are dedicated to each of the major design control topics: Design and Development Planning, Design Input, Design Output, Design Transfer, Design Verification, Design Validation, Design Change and Design History File.
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.
Download or read book Computer System Validation and GAMP 5 written by Vonlynx Solutions LLC and published by Independently Published. This book was released on 2020-12-19 with total page 120 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to help you understand how computerized systems are validated using the GAMP5framework. The information will be presented in a project life cycle format. This will give you a solid idea howComputerized System Validation projects are conducted. This book is suited for anyone new to Computer SystemsValidation. It is written in a simple manner and can serve as starter guide which includes many high-level sample templates and illustration.
Download or read book Software Verification and Validation written by Marcus S. Fisher and published by Springer Science & Business Media. This book was released on 2007-12-03 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book fills the critical need for an in-depth technical reference providing the methods and techniques for building and maintaining confidence in many varities of system software. The intent is to help develop reliable answers to such critical questions as: 1) Are we building the right software for the need? and 2) Are we building the software right? Software Verification and Validation: An Engineering and Scientific Approach is structured for research scientists and practitioners in industry. The book is also suitable as a secondary textbook for advanced-level students in computer science and engineering.
Download or read book Managing the Documentation Maze written by Janet Gough and published by John Wiley & Sons. This book was released on 2010-03-16 with total page 486 pages. Available in PDF, EPUB and Kindle. Book excerpt: The accessible, easy-to-follow guide that demystifies documentation management When it comes to receiving documentation to confirm good science, U.S. and international regulators place high demands on the healthcare industry. As a result, companies developing and manufacturing therapeutic products must implement a strategy that allows them to properly manage their records and documents, since they must comply with rigorous standards and be available for regulatory review or inspection at a moment’s notice. Written in a user-friendly Q&A style for quick reference, Managing the Documentation Maze provides answers to 750 questions the authors encounter frequently in their roles as consultants and trainers. In simple terms, this handy guide breaks down the key components that facilitate successful document management, and shows why it needs to be a core discipline in the industry with information on: Compliance with regulations in pharmaceutical, biological, and device record keeping Electronic systems, hybrid systems, and the entire scope of documentation that companies must manage How to write and edit documents that meet regulatory compliance Making the transition to an electronic system, including how to validate and document the process Anyone responsible for managing documents in the health field will find this book to be a trusted partner in unraveling the bureaucratic web of confusion, while it initiates a plan on how to put an effective, lasting system in place—one that will stand up to any type of scrutiny.
Download or read book The Basics of FMEA written by Raymond J. Mikulak and published by CRC Press. This book was released on 2017-08-09 with total page 90 pages. Available in PDF, EPUB and Kindle. Book excerpt: Demonstrates How To Perform FMEAs Step-by-StepOriginally designed to address safety concerns, Failure Mode and Effect Analysis (FMEA) is now used throughout the industry to prevent a wide range of process and product problems. Useful in both product design and manufacturing, FMEA can identify improvements early when product and process changes are
Download or read book Quality Risk Management in the FDA Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
Download or read book Diagnostic Radiology Physics with MATLAB written by Johan Helmenkamp and published by CRC Press. This book was released on 2020-11-23 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Imaging modalities in radiology produce ever-increasing amounts of data which need to be displayed, optimized, analyzed and archived: a "big data" as well as an "image processing" problem. Computer programming skills are rarely emphasized during the education and training of medical physicists, meaning that many individuals enter the workplace without the ability to efficiently solve many real-world clinical problems. This book provides a foundation for the teaching and learning of programming for medical physicists and other professions in the field of Radiology and offers valuable content for novices and more experienced readers alike. It focuses on providing readers with practical skills on how to implement MATLAB® as an everyday tool, rather than on solving academic and abstract physics problems. Further, it recognizes that MATLAB is only one tool in a medical physicist’s toolkit and shows how it can be used as the "glue" to integrate other software and processes together. Yet, with great power comes great responsibility. The pitfalls to deploying your own software in a clinical environment are also clearly explained. This book is an ideal companion for all medical physicists and medical professionals looking to learn how to utilize MATLAB in their work. Features Encompasses a wide range of medical physics applications in diagnostic and interventional radiology Advances the skill of the reader by taking them through real-world practical examples and solutions with access to an online resource of example code The diverse examples of varying difficulty make the book suitable for readers from a variety of backgrounds and with different levels of programming experience.
Download or read book Leveraging Applications of Formal Methods Verification and Validation Specialized Techniques and Applications written by Tiziana Margaria and published by Springer. This book was released on 2014-09-26 with total page 661 pages. Available in PDF, EPUB and Kindle. Book excerpt: The two-volume set LNCS 8802 and LNCS 8803 constitutes the refereed proceedings of the 6th International Symposium on Leveraging Applications of Formal Methods, Verification and Validation, ISoLA 2014, held in Imperial, Corfu, Greece, in October 2014. The total of 67 full papers was carefully reviewed and selected for inclusion in the proceedings. Featuring a track introduction to each section, the papers are organized in topical sections named: evolving critical systems; rigorous engineering of autonomic ensembles; automata learning; formal methods and analysis in software product line engineering; model-based code generators and compilers; engineering virtualized systems; statistical model checking; risk-based testing; medical cyber-physical systems; scientific workflows; evaluation and reproducibility of program analysis; processes and data integration in the networked healthcare; semantic heterogeneity in the formal development of complex systems. In addition, part I contains a tutorial on automata learning in practice; as well as the preliminary manifesto to the LNCS Transactions on the Foundations for Mastering Change with several position papers. Part II contains information on the industrial track and the doctoral symposium and poster session.
