Software Validation Verification Testing And Documentation

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.

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."

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.

“The main thrust of the book is to describe verification and validation approaches that have been used successfully on contemporary large—scale software projects” -- Preface.

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.