Systematic Software Testing For Microcomputer Systems

Gain an in-depth understanding of software testing management and process issues that are critical for delivering high-quality software on time and within budget. Written by leading experts in the field, this book offers those involved in building and maintaining complex, mission-critical software systems a flexible, risk-based process to improve their software testing capabilities. Whether your organization currently has a well-defined testing process or almost no process, Systematic Software Testing provides unique insights into better ways to test your software.This book describes how to use a preventive method of testing, which parallels the software development lifecycle, and explains how to create and subsequently use test plans, test design, and test metrics. Detailed instructions are presented to help you decide what to test, how to prioritize tests, and when testing is complete. Learn how to conduct risk analysis and measure test effectiveness to maximize the efficiency of your testing efforts. Because organizational structure, the right people, and management are keys to better software testing, Systematic Software Testing explains these issues with the insight of the authorsOCO more than 25 years of experience."

SAFECOMP '92 advances the state-of-the-art, reviews experiences of the past years, considers the guidance now available and identifies the skills, methods, tools and techniques required for the safety of computer control systems.

Inexperienced software developers - such as fresh graduates - shape the future of software engineering as a practice. Supporting these novice developers in becoming high quality engineers is a key objective of our engineering community. Yet, inexperienced developers have considerable trouble in applying the fundamentals of systematic software testing in industrial settings. Gaps in testing skills arise from inherent attributes of systematic testing itself and environmental attributes, such as the educational setting in universities. Frustrated, practitioners have long since devised cost intensive workarounds. In this thesis, this problem situation is qualitatively analyzed in great detail, leveraging insights from three Grounded Theory studies. Employing Everett M. Rogers' 'Theory of the Diffusion of Innovation', strategic improvements to the onboarding situation are presented. Lastly, tool support for the strategies developed in this thesis is presented and evaluated.

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Software Testing presents one of the first comprehensive guides to testing activities, ranging from test planning through test completion for every phase of software under development, and software under revision. Real life case studies are provided to enhance understanding as well as a companion website with tools and examples.