Accuracy Verification Methods

The importance of accuracy verification methods was understood at the very beginning of the development of numerical analysis. Recent decades have seen a rapid growth of results related to adaptive numerical methods and a posteriori estimates. However, in this important area there often exists a noticeable gap between mathematicians creating the theory and researchers developing applied algorithms that could be used in engineering and scientific computations for guaranteed and efficient error control. The goals of the book are to (1) give a transparent explanation of the underlying mathematical theory in a style accessible not only to advanced numerical analysts but also to engineers and students; (2) present detailed step-by-step algorithms that follow from a theory; (3) discuss their advantages and drawbacks, areas of applicability, give recommendations and examples.

This book seeks to introduce the reader to current methodologies in analytical calibration and validation. This collection of contributed research articles and reviews addresses current developments in the calibration of analytical methods and techniques and their subsequent validation. Section 1, "Introduction," contains the Introductory Chapter, a broad overview of analytical calibration and validation, and a brief synopsis of the following chapters. Section 2 "Calibration Approaches" presents five chapters covering calibration schemes for some modern analytical methods and techniques. The last chapter in this section provides a segue into Section 3, "Validation Approaches," which contains two chapters on validation procedures and parameters. This book is a valuable source of scientific information for anyone interested in analytical calibration and validation.

Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

With increasing urbanization and development of society, advancement in geotechnical technologies is essential to the construction of infrastructures. Geotechnical Investigation is the first step of applying scientific methods and engineering principles to obtain solutions to civil engineering problems. The studies presented in this volume deal with the attempts made by scholars and engineers to address the latest development in geotechnical engineering such as characterization of geomaterials, slope stability, tunneling, mitigation of geohazards, and some other geotechnical issues that are quite relevant in today's world. This volume is based on contributions to the the GeoChina International Conference on Civil & Transportation Infrastructures: From Engineering to Smart & Green Life Cycle Solutions -- Nanchang, China, 2021.

The fourth book of a four-part series, Design Theory and Methods using CAD/CAE integrates discussion of modern engineering design principles, advanced design tools, and industrial design practices throughout the design process. This is the first book to integrate discussion of computer design tools throughout the design process. Through this book series, the reader will: Understand basic design principles and all digital modern engineering design paradigms Understand CAD/CAE/CAM tools available for various design related tasks Understand how to put an integrated system together to conduct All Digital Design (ADD) product design using the paradigms and tools Understand industrial practices in employing ADD virtual engineering design and tools for product development The first book to integrate discussion of computer design tools throughout the design process Demonstrates how to define a meaningful design problem and conduct systematic design using computer-based tools that will lead to a better, improved design Fosters confidence and competency to compete in industry, especially in high-tech companies and design departments

Practical approaches to ensure that analytical methods and instruments meet GMP standards and requirements Complementing the authors' first book, Analytical Method Validation and Instrument Performance Verification, this new volume provides coverage of more advanced topics, focusing on additional and supplemental methods, instruments, and electronic systems that are used in pharmaceutical, biopharmaceutical, and clinical testing. Readers will gain new and valuable insights that enable them to avoid common pitfalls in order to seamlessly conduct analytical method validation as well as instrument operation qualification and performance verification. Part 1, Method Validation, begins with an overview of the book's risk-based approach to phase appropriate validation and instrument qualification; it then focuses on the strategies and requirements for early phase drug development, including validation of specific techniques and functions such as process analytical technology, cleaning validation, and validation of laboratory information management systems Part 2, Instrument Performance Verification, explores the underlying principles and techniques for verifying instrument performance—coverage includes analytical instruments that are increasingly important to the pharmaceutical industry, such as NIR spectrometers and particle size analyzers—and offers readers a variety of alternative approaches for the successful verification of instrument performance based on the needs of their labs At the end of each chapter, the authors examine important practical problems and share their solutions. All the methods covered in this book follow Good Analytical Practices (GAP) to ensure that reliable data are generated in compliance with current Good Manufacturing Practices (cGMP). Analysts, scientists, engineers, technologists, and technical managers should turn to this book to ensure that analytical methods and instruments are accurate and meet GMP standards and requirements.

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.