A Guide To Archiving Of Electronic Records
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A Guide To Archiving Of Electronic Records
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Author : Tim Stiles
language : en
Publisher: Lulu.com
Release Date : 2014
A Guide To Archiving Of Electronic Records written by Tim Stiles and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014 with Language Arts & Disciplines categories.
The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with both Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The maintenance and retention of such records provides the means by which a study, trial, process or procedure can be reconstructed and thus enabling the information and results generated to be verified. Requirements for the operation of an archive and the archiving process for electronic records are no different to the requirement of physical records which are required to be retained for regulatory or business requirements. However, due to the variety and fragility of electronic records some additional features are required. The purpose of this document is to identify and discuss these features and provide guidance on how these challenges can be met.
Gcp A Guide To Archiving
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Author : Chris Jones
language : en
Publisher: Lulu.com
Release Date : 2014-07-16
Gcp A Guide To Archiving written by Chris Jones and has been published by Lulu.com this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-16 with Science categories.
This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).
Ensuring The Integrity Of Electronic Health Records
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Author : Orlando López
language : en
Publisher: CRC Press
Release Date : 2020-12-21
Ensuring The Integrity Of Electronic Health Records written by Orlando López and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-21 with Business & Economics categories.
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.
Guide For Managing Electronic Records From An Archival Perspective
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Author :
language : en
Publisher:
Release Date : 1997
Guide For Managing Electronic Records From An Archival Perspective written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Archival materials categories.
Electronic Records In The Manuscript Repository
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Author : Elizabeth H. Dow
language : en
Publisher: Bloomsbury Publishing USA
Release Date : 2009-04-13
Electronic Records In The Manuscript Repository written by Elizabeth H. Dow and has been published by Bloomsbury Publishing USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-04-13 with Language Arts & Disciplines categories.
Electronic Records in the Manuscript Repository defines the problems related to electronic records and digital documents, describes the steps the curator should take to manage those electronic records and digital documents, and suggests ways to learn the specific skills and perspectives needed to do the job well. It provides an introduction to vocabulary, basic concepts, and best practices to date by collecting and contextualizing data from several real-world projects, and it contains almost 30 pages of references to resources that the curator can consult for information on specific topics. Dow starts with a review of archival concepts, including a look at archival practices, and then discusses the problems created by electronic materials in that context, as well as the research in progress to tackle these problems.
Building An Electronic Records Archive At The National Archives And Records Administration
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2005-07-28
Building An Electronic Records Archive At The National Archives And Records Administration written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-07-28 with Computers categories.
The federal government generates and increasingly saves a large and growing fraction of its records in electronic form. In 1998, the National Archives and Record Administration (NARA) launched its Electronic Archives (ERA) program to create a system to preserve and provide access to federal electronic records. To assist in this project, NARA asked the NRC to conduct a two-phase study to provide advice as it develops the ERA program. The first two reports (phase one) provided recommendations on design, engineering, and related issues facing the program. This report (phase two) focuses on longer term, more strategic issues including technology trends that will shape the ERA system, archival processes of the ERA, and future evolution of the system. It also provides an assessment of technical and design issues associated with record integrity and authenticity.
The Digital Archives Handbook
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Author : Aaron D. Purcell
language : en
Publisher: Bloomsbury Publishing PLC
Release Date : 2019-02-08
The Digital Archives Handbook written by Aaron D. Purcell and has been published by Bloomsbury Publishing PLC this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-02-08 with Language Arts & Disciplines categories.
The Digital Archives Handbook provides archivists a roadmap to create and care for digital archives. Written by archival experts and practitioners, Purcell brings together theoretical and practical approaches to creating, managing, and preserving digital archives. The first section is focused on processes and practices, including chapters on acquisitions, appraisal, arrangement, description, delivery, preservation, forensics, curation, and intellectual property. The second section is focused on digital collections and specific environments where archivists are managing digital collections. These chapters review digital collections in categories including performing arts, oral history, architectural and design records, congressional collections, and email. The book discuss the core components of digital archives—the technological infrastructure that provides storage, access, and long-term preservation; the people or organizations that create or donate digital material to archives programs, as well as the researchers use them; and the digital collections themselves, full of significant research content in a variety of formats with a multitude of research possibilities. The chapters emphasize that the people and the collections that make up digital archives are just as important as the technology. Also highlighted are the importance of donors and creators of digital archives. Building digital archives parallels the cycle of donor work—planning, cultivation, and stewardship. During each stage, archivists work with donors to ensure that the digital collections will be arranged, described, preserved, and made accessible for years to come. Archivists must take proactive and informed actions to build valuable digital collections. Knowing where digital materials come from, how those materials were created, what materials are important, what formats or topical areas are included, and how to serve those collections to researchers in the long term is central to archival work. This handbook is designed to generate new discussions about how archivists of the twenty-first century can overcome current challenges and chart paths that anticipate, rather than merely react to, future donations of digital archives.
Handbook Of Research On Records And Information Management Strategies For Enhanced Knowledge Coordination
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Author : Chisita, Collence Takaingenhamo
language : en
Publisher: IGI Global
Release Date : 2021-01-15
Handbook Of Research On Records And Information Management Strategies For Enhanced Knowledge Coordination written by Chisita, Collence Takaingenhamo and has been published by IGI Global this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-15 with Language Arts & Disciplines categories.
The convergence of technologies and emergence of interdisciplinary and transdisciplinary modus of knowledge production justify the need for research that explores the disinterestedness or interconnectivity of the information science disciplines. The quantum leap in knowledge production, increasing demand for information and knowledge, changing information needs, information governance, and proliferation of digital technologies in the era of ubiquitous digital technologies justify research that employs a holistic approach in x-raying the challenges of managing information in an increasingly knowledge- and technology-driven dispensation. The changing nature of knowledge production for sustainable development, along with trends and theory for enhanced knowledge coordination, deserve focus in current times. The Handbook of Research on Records and Information Management Strategies for Enhanced Knowledge Coordination draws input from experts involved in records management, information science, library science, memory, and digital technology, creating a vanguard compendium of novel trends and praxis. While highlighting a vast array of topics under the scope of library science, information science, knowledge transfer, records management, and more, this book is ideally designed for knowledge and information managers, library and information science schools, policymakers, practitioners, stakeholders, administrators, researchers, academicians, and students interested in records and information management.
Proceedings Of The 6th Annual Federal Depository Library Conference April 14 17 1997 Washington National Airport Hilton Arlington Va
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Author :
language : en
Publisher:
Release Date : 1997
Proceedings Of The 6th Annual Federal Depository Library Conference April 14 17 1997 Washington National Airport Hilton Arlington Va written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Depository libraries categories.
Proceedings Of The Annual Federal Depository Library Conference
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Author :
language : en
Publisher:
Release Date : 1997
Proceedings Of The Annual Federal Depository Library Conference written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Depository libraries categories.