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Author: Richard C. Fries
Publisher: CRC Press
Published: 1998-08-11
Total Pages: 497
ISBN-13: 148227003X
DOWNLOAD EBOOK"Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."
Author: Guy Wingate
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 773
ISBN-13: 1420088955
DOWNLOAD EBOOKThoroughly 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.
Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
Published: 2014-04-01
Total Pages: 385
ISBN-13: 1587634333
DOWNLOAD EBOOKThis User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author: G. Gordon Schulmeyer
Publisher: Artech House Publishers
Published: 2008
Total Pages: 0
ISBN-13: 9781596931862
DOWNLOAD EBOOKProvides the latest details on current best practices and explains how SQA can be implemented in organizations large and small. Also helps readers understand the requirements of the ASQ's CSQE examination.
Author: Ivan Mistrik
Publisher: Morgan Kaufmann
Published: 2015-10-12
Total Pages: 417
ISBN-13: 0128025417
DOWNLOAD EBOOKSoftware Quality Assurance in Large Scale and Complex Software-intensive Systems presents novel and high-quality research related approaches that relate the quality of software architecture to system requirements, system architecture and enterprise-architecture, or software testing. Modern software has become complex and adaptable due to the emergence of globalization and new software technologies, devices and networks. These changes challenge both traditional software quality assurance techniques and software engineers to ensure software quality when building today (and tomorrow's) adaptive, context-sensitive, and highly diverse applications. This edited volume presents state of the art techniques, methodologies, tools, best practices and guidelines for software quality assurance and offers guidance for future software engineering research and practice. Each contributed chapter considers the practical application of the topic through case studies, experiments, empirical validation, or systematic comparisons with other approaches already in practice. Topics of interest include, but are not limited, to: quality attributes of system/software architectures; aligning enterprise, system, and software architecture from the point of view of total quality; design decisions and their influence on the quality of system/software architecture; methods and processes for evaluating architecture quality; quality assessment of legacy systems and third party applications; lessons learned and empirical validation of theories and frameworks on architectural quality; empirical validation and testing for assessing architecture quality. - Focused on quality assurance at all levels of software design and development - Covers domain-specific software quality assurance issues e.g. for cloud, mobile, security, context-sensitive, mash-up and autonomic systems - Explains likely trade-offs from design decisions in the context of complex software system engineering and quality assurance - Includes practical case studies of software quality assurance for complex, adaptive and context-critical systems
Author: Boyd L. Summers
Publisher: CRC Press
Published: 2019-04-05
Total Pages: 153
ISBN-13: 0429508387
DOWNLOAD EBOOKDriving innovation can reduce costs for companies, institutions, military programs, and successful businesses. Quality is key to successful innovation. Delivery of complex products must have high quality to reduce customer problems and defects. This book explains how to integrate Quality Assurance processes to produce compliant product management and gap analysis. It shows how Quality Assurance provides a common operating framework in which best practices, improvements, and cost avoidance activities can be shared. Effective Processes for Quality Assurance emphasizes improving process execution and reducing operational costs. It also focuses on how Quality Assurance personnel must support companies, institutions, military programs, and successful businesses by encouraging a cooperative, proactive approach and ensure compliance through management and team member participation. Lean and Agile can provide a competitive advantage, and this practical reference explains how to implement these two principles to deliver products that have fewer defects. It also explains: Quality Assurance methods Measuring benefits of Quality Assurance process improvement Quality Assurance performance and improvement Risk management Quality Assurance improvement with metrics Effective processes for Quality Assurance Quantitative process performance and commitments Quality Assurance plans Quality Assurance for customers and suppliers Supporting software configuration Effective Processes for Quality Assurance covers the critical issues for implementing Quality Assurance processes that can deliver high-quality products successfully.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 1986-02-01
Total Pages: 432
ISBN-13: 0309036461
DOWNLOAD EBOOKAs more people live longer, the need for quality long-term care for the elderly will increase dramatically. This volume examines the current system of nursing home regulations, and proposes an overhaul to better provide for those confined to such facilities. It determines the need for regulations, and concludes that the present regulatory system is inadequate, stating that what is needed is not more regulation, but better regulation. This long-anticipated study provides a wealth of useful background information, in-depth study, and discussion for nursing home administrators, students, and teachers in the health care field; professionals involved in caring for the elderly; and geriatric specialists.
Author: United States Government Accountability Office
Publisher: Lulu.com
Published: 2019-03-24
Total Pages: 234
ISBN-13: 0359536395
DOWNLOAD EBOOKAudits provide essential accountability and transparency over government programs. Given the current challenges facing governments and their programs, the oversight provided through auditing is more critical than ever. Government auditing provides the objective analysis and information needed to make the decisions necessary to help create a better future. The professional standards presented in this 2018 revision of Government Auditing Standards (known as the Yellow Book) provide a framework for performing high-quality audit work with competence, integrity, objectivity, and independence to provide accountability and to help improve government operations and services. These standards, commonly referred to as generally accepted government auditing standards (GAGAS), provide the foundation for government auditors to lead by example in the areas of independence, transparency, accountability, and quality through the audit process. This revision contains major changes from, and supersedes, the 2011 revision.
Author:
Publisher: BoD – Books on Demand
Published: 2024-05-29
Total Pages: 312
ISBN-13: 0850140242
DOWNLOAD EBOOKIn any engineering field (including manufacturing, construction, transportation, aerospace, food and agriculture, oil and gas, etc.), ensuring product quality is fundamental to achieving success. Quality assurance (QA) and quality control (QC) are integral components of managing quality. According to the American Society for Quality (ASQ), QA is defined as the part of quality management that focuses on instilling confidence in meeting quality requirements, while QC is concerned with fulfilling those requirements. QA instills confidence internally within the engineering organization’s management and externally with customers, government agencies, regulators, certifiers, and other stakeholders. QA primarily examines how processes are carried out or how products are made, while QC concentrates on product inspection. When QA and QC collaborate effectively, organizational efficiency is enhanced, resulting in superior products. Quality Control and Quality Assurance - Techniques and Applications explores various aspects of quality, including quality planning, QC, QA, and quality enhancement. It covers topics related to QA such as total quality management (TQM), failure testing, process and product quality assurance (PPQA), and statistical process control (SPC). QC includes chapters describing process control, control charts, acceptance sampling, and product quality assessment. For meaningful and easy traceability, the chapters are divided into four sections: “Basics of QA/QC”; “Applications of QA/QC in Industry”; “Applications of QA/QC in Healthcare”; and “Applications of QA/QC in Education”. Covering the latest practices, techniques, and applications in QC and QA, this book is a valuable resource for engineering and business students, practicing engineers, engineering managers, and third-party agencies.
Author: United States. Department of Education
Publisher:
Published: 1996
Total Pages: 244
ISBN-13:
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