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Data Integrity In Pharmaceutical And Medical Devices Regulation Operations
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Book Synopsis Data Integrity in Pharmaceutical and Medical Devices Regulation Operations by : Orlando Lopez
Download or read book Data Integrity in Pharmaceutical and Medical Devices Regulation Operations written by Orlando Lopez and published by CRC Press. This book was released on 2016-11-03 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Book Synopsis Data Integrity and Compliance by : José Rodríguez-Pérez
Download or read book Data Integrity and Compliance written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2019-05-08 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectation-it's a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sources-including the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agency-into a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies' position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.
Book Synopsis Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation by : Orlando Lopez
Download or read book Pharmaceutical and Medical Devices Manufacturing Computer Systems Validation written by Orlando Lopez and published by Taylor & Francis. This book was released on 2018-10-02 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: Validation of computer systems is the process that assures the formal assessment and report of quality and performance measures for all the life-cycle stages of software and system development, its implementation, qualification and acceptance, operation, modification, requalification, maintenance and retirement (PICS CSV PI 011-3). It is a process that demonstrates the compliance of computer systems functional and non-functional requirements, data integrity, regulated company procedures and safety requirements, industry standards, and applicable regulatory authority’s requirements. Compliance is a state of being in adherence to application-related standards or conventions or regulations in laws and similar prescriptions. This book, which is relevant to the pharmaceutical and medical devices regulated operations, provides practical information to assist in the computer validation to production systems, while highlighting and efficiently integrating worldwide regulation into the subject. A practical approach is presented to increase efficiency and to ensure that the validation of computer systems is correctly achieved.
Book Synopsis Data Integrity and Data Governance by : R. D. McDowall
Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Book Synopsis Ensuring the Integrity of Electronic Health Records by : Orlando López
Download or read book Ensuring the Integrity of Electronic Health Records written by Orlando López and published by CRC Press. This book was released on 2020-12-21 with total page 203 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a critical aspect to the design, implementation, and usage of any system which stores, processes, or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and, upon later retrieval, ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls, and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA, Medicines and Healthcare Products Regulatory Agency (UK); FDA, Food and Drug Administration (US); National Medical Products Association (China); TGA, Therapeutic Goods Administration (Australia); SIMGP, Russia State Institute of Medicines and Good Practices; and the World Health Organization, to name a few.
Book Synopsis Data Integrity in the Pharmaceutical Industry by : Sarah Tanksley
Download or read book Data Integrity in the Pharmaceutical Industry written by Sarah Tanksley and published by CRC Press. This book was released on 2017-09-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Many articles describe the history and theory behind data integrity. However, few offer practical advice and solutions. Written by an author with a vast amount of experience in the industry, Data Integrity in the Pharmaceutical Industry: Current Topics and Effective Strategies serves as a hands-on guide to the current regulatory expectations for generating and handling data. This unique text presents techniques for tracing the life cycle of data, as well as identification and avoidance of common blind spots in the data collection and review process, examples of lapses in data integrity, and strategies for remediation of data integrity breaches. It also discusses requirements and advice for communicating data integrity breaches to health authorities. As international government bodies have shifted their point of interest to focus on data integrity as part of their routine operations, this book is a must read for anyone working in a GMP (good manufacturing practices) regulated environment, whether the job involves supporting, generating, reviewing, or archiving data.
Book Synopsis Data Integrity and Compliance by : José Rodríguez-Pérez
Download or read book Data Integrity and Compliance written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2019-05-08 with total page 143 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data integrity is a global mandatory requirement for the regulated healthcare industry. It is more than a mere expectationits a basic element of good documentation practices, one of the most fundamental pillars of a quality management system. Robustness and accuracy of the data submitted by manufacturers to regulatory authorities when bringing a medical product to market are crucial. The purpose of this book is to consolidate existing data integrity principles and expectations from several regulatory sourcesincluding the U.S. Food and Drug Administration, World Health Organization, and European Medicines Agencyinto a single and handy document that provides detailed, illustrative implementation guidance. It serves as a means of understanding regulatory agencies position on good data management and the minimum expectation for how medical product manufacturers can achieve compliance.
Book Synopsis Guideline on General Principles of Process Validation by :
Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Medical Devices by : World Health Organization
Download or read book Medical Devices written by World Health Organization and published by World Health Organization. This book was released on 2010 with total page 147 pages. Available in PDF, EPUB and Kindle. Book excerpt: Background papers 1 to 9 published as technical documents. Available in separate records from WHO/HSS/EHT/DIM/10.1 to WHO/HSS/EHT/DIM/10.9
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :396 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: This 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.
Download or read book Integrity written by Barbara Killinger and published by McGill-Queen's Press - MQUP. This book was released on 2010 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt: How to restore integrity so that social values can be upheld and family welfare strengthened.
Book Synopsis Safe Medical Devices for Children by : Institute of Medicine
Download or read book Safe Medical Devices for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2006-01-20 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative medical devices have helped reduce the burden of illness and injury and improve the quality of life for countless children. Mechanical ventilators and other respiratory support devices rescue thousands of fragile newborns every year. Children who once would have died of congenital heart conditions survive with the aid of implanted pacemakers, mechanical heart valves, and devices that close holes in the heart. Responding to a Congressional request, the Institute of Medicine assesses the system for postmarket surveillance of medical devices used with children. The book specifically examines: The Food and Drug Administration's monitoring and use of adverse event reports The agency's monitoring of manufacturers' fulfillment of commitments for postmarket studies ordered at the time of a device's approval for marketing The adequacy of postmarket studies of implanted devices to evaluate the effects of children's active lifestyles and their growth and development on device performance Postmarket surveillance of medical devices used with children is a little investigated topic, in part because the market for most medical products is concentrated among older adults. Yet children differ from adults, and their special characteristics have implications for evaluation and monitoring of the short- and long-term safety and effectiveness of medical devices used with young patients.
Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Book Synopsis Cybersecurity for Industry 4.0 by : Lane Thames
Download or read book Cybersecurity for Industry 4.0 written by Lane Thames and published by Springer. This book was released on 2017-04-03 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces readers to cybersecurity and its impact on the realization of the Industry 4.0 vision. It covers the technological foundations of cybersecurity within the scope of the Industry 4.0 landscape and details the existing cybersecurity threats faced by Industry 4.0, as well as state-of-the-art solutions with regard to both academic research and practical implementations. Industry 4.0 and its associated technologies, such as the Industrial Internet of Things and cloud-based design and manufacturing systems are examined, along with their disruptive innovations. Further, the book analyzes how these phenomena capitalize on the economies of scale provided by the Internet. The book offers a valuable resource for practicing engineers and decision makers in industry, as well as researchers in the design and manufacturing communities and all those interested in Industry 4.0 and cybersecurity.
Book Synopsis Sterile Manufacturing by : Sam A. Hout
Download or read book Sterile Manufacturing written by Sam A. Hout and published by CRC Press. This book was released on 2021-07-05 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products. Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning. The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.
Book Synopsis Water Supply and Water Scarcity by : Vasileios A. Tzanakakis
Download or read book Water Supply and Water Scarcity written by Vasileios A. Tzanakakis and published by MDPI. This book was released on 2020-11-04 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Book includes selected papers that has been published in the Water journal Special Issue (SI) on Water Supply and Water Scarcity. Moreover, an overview of the SI is included. The papers selected for publication in the SI include review and research papers on water history, on water management issues under water scarcity regimes, on rainwater harvesting, on water quality and degradation, and on climatic variability impacts on water resources. Overall, the issue identify and highlight the main challenges in water sector, and particularly in management and protection of water resources and in use of alternative (non-conventional) water resources, especially in areas with demographic change and climate vulnerability in order to achieve sustainable and secure water supply. Furthermore, general guidelines and possible solutions for an improved and sophisticated water management system are proposed and discussed, such as the adoption of advanced technological solutions and practices that improve water-use efficiency and the use of alternative water resources, to address the growing environmental and health issues and to reduce the emerging conflicts among water users.
Download or read book 21 CFR Part 11 written by Orlando López and published by CRC Press. This book was released on 2004-01-15 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering regulatory requirements stipulated by the FDA, this book delineates the organization, planning, verification, and documentation activities and procedural controls required for compliance with worldwide computer systems validation regulations. The author introduces supporting technologies such as encryption and digital signatures and places
