Read and Download eBook Full
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:
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: 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: Alex R. Rodriguez
Publisher: Springer Science & Business Media
Published: 2013-11-09
Total Pages: 503
ISBN-13: 1468452363
DOWNLOAD EBOOKprofessional-standards-review organizations (PSRO) in defining quality of care for the Medicare program; it is a "shared responsibility of health professionals and government to provide a reasonable basis for confidence that action will be taken, both to assess whether services meet professionally recognized standards and to correct any deficiencies that may be found" (p. 14). Similar pronouncements have been made for the quality assurance activities of the Department of Defense's CHAMPUS program and of the 1980s successor to the PSROs, the federally designated peer-review organizations (PROs), established to ensure quality and utilization-efficient care for Medicare. Links between the federal and state gov ernments and between professional associations and private review entities have been developed to make this "shared responsibility" manifest in the delivery and reimbursement of health services. This responsibility is seen in light of both pro fessional and legal accountability, a view noted by Gibson and Singhas (1978) and Alger (1980). Accountability, then, becomes a concentric concept that elaborates on the pure view of quality and reflects the federal government's consumer protection activities during the 1970s. The Joint Commission on Accreditation of Hospitals (JCAH), which has pro vided another primary historical leadership role in defining quality assurance, has promoted the evolution of the concept of resource limitations as a part of the defini tion of quality assurance.
Author: Prof. Kakasaheb. J. Kore , Mr. P.S Minhas , Dr. Sudhahar Dharmalingam , Dr. Panikumar Durga Anumolu , Dr. Kella Alekhya
Publisher: Shashwat Publication
Published: 2024-05-16
Total Pages: 257
ISBN-13: 8119908562
DOWNLOAD EBOOKThe Pharmacy Council of India's (PCI) revised B. Pharmacy syllabus is followed in this state-of-the-art book. The broader topics of pharmaceutical quality assurance that undergrads, postgrads, industry professionals, researchers, and students getting ready for different competitive tests need to be covered in this book's encompassing content. The writing style of this book is clear, straightforward, and uncomplicated, which sets it apart from others. For the self-evlution of learning, the book is complemented by questions in the formats of multiple choice, fill in the blank, true-false, short answer, and long answer. Additionally included are the solutions to the True-False, Fill in the Blank, and Multiple Choice problems. Links to websites and recommended reading are provided to assist readers in staying up to date on the most recent advancements in the field of pharmaceutical quality assurance. The book can be used as the main source of instruction or as supplementary material by academicians and teachers at universities and colleges for undergraduate and graduate pharmacy courses.
