Data Integrity and Compliance

Data Integrity and Compliance PDF

Author: José Rodríguez-Pérez

Publisher: Quality Press

Published: 2019-05-08

Total Pages: 143

ISBN-13: 0873899873

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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.

Ensuring the Integrity of Electronic Health Records

Ensuring the Integrity of Electronic Health Records PDF

Author: Orlando López

Publisher: Productivity Press

Published: 2020-12-22

Total Pages: 320

ISBN-13: 9780367616038

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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.

Data Integrity and Data Governance

Data Integrity and Data Governance PDF

Author: R. D. McDowall

Publisher: Royal Society of Chemistry

Published: 2018-11-09

Total Pages: 660

ISBN-13: 178801281X

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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.

Data Integrity in the Pharmaceutical Industry

Data Integrity in the Pharmaceutical Industry PDF

Author: Sarah Tanksley

Publisher: CRC Press

Published: 2017-09-30

Total Pages:

ISBN-13: 9781138731936

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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.

Digital Data Integrity

Digital Data Integrity PDF

Author: David B Little

Publisher: John Wiley & Sons

Published: 2007-04-04

Total Pages: 256

ISBN-13: 9780470035191

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How to plan your future strategy for efficient, cost-saving data management Businesses have historically treated data protection as an afterthought, as simply making an occasional copy of data that could be used in the future. Today, this attitude is changing rapidly. The ever-increasing amount of data, along with the emphasis on continuous availability, necessitates changes in the approach to data integrity, which results in management and protection becoming much more closely aligned. Digital Data Integrity throws light on the data integrity landscape of the future. It provides the reader with a brief overview of the historical methods and subsequent evolution of data protection. The text shows how the whole subject of data integrity is changing and describes and positions many of the new, enhanced, more intelligent protection technologies and methods. Digital Data Integrity: Takes a unique, forward look at data protection and management, highlighting the paradigm shift from simple backup and recovery to total data management. Details recent developments in compliance regulations in an accessible manner. Covers enhanced protection technologies such as advanced intelligent synthetic backups, data reduction methods, and data growth – online protection using continuous data protection. Explains data life cycle management and data storage, using management, quality of service products and tools to achieve better data management, intelligent allocation of storage, and compliance with regulations. Contains information on quality control, looking at SLA (Service Level Agreements), protection by business unit and billing/charge back. Unique insight into hot topics such as next generation bare metal recovery and true system provisioning. This invaluable text will provide system administrators, and database administrators, as well as senior IT managers and decision makers with a thorough understanding of data management and protection. With contributions from Ray Schafer and Paul Mayer.

Site Reliability Engineering

Site Reliability Engineering PDF

Author: Niall Richard Murphy

Publisher: "O'Reilly Media, Inc."

Published: 2016-03-23

Total Pages: 552

ISBN-13: 1491951176

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The overwhelming majority of a software system’s lifespan is spent in use, not in design or implementation. So, why does conventional wisdom insist that software engineers focus primarily on the design and development of large-scale computing systems? In this collection of essays and articles, key members of Google’s Site Reliability Team explain how and why their commitment to the entire lifecycle has enabled the company to successfully build, deploy, monitor, and maintain some of the largest software systems in the world. You’ll learn the principles and practices that enable Google engineers to make systems more scalable, reliable, and efficient—lessons directly applicable to your organization. This book is divided into four sections: Introduction—Learn what site reliability engineering is and why it differs from conventional IT industry practices Principles—Examine the patterns, behaviors, and areas of concern that influence the work of a site reliability engineer (SRE) Practices—Understand the theory and practice of an SRE’s day-to-day work: building and operating large distributed computing systems Management—Explore Google's best practices for training, communication, and meetings that your organization can use

Data Integrity and Data Governance

Data Integrity and Data Governance PDF

Author: B. Santhosh Kumar

Publisher: Intechopen

Published: 2023-04

Total Pages: 0

ISBN-13: 9781839688621

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Data integrity is the overall accuracy, completeness, and consistency of data. Data integrity also refers to the safety of data regarding regulatory compliance, such as GDPR compliance, and security. It is maintained by a collection of processes, rules, and standards implemented during the design phase. Data governance is the process of managing the availability, usability, integrity, and security of the data in enterprise systems, based on internal data standards and policies that also control data usage. Effective data governance ensures that data is consistent and trustworthy and does not get misused. This book provides a comprehensive overview of data integrity and data governance and their myriad applications.

Validation of Chromatography Data Systems

Validation of Chromatography Data Systems PDF

Author: Robert D. McDowall

Publisher: Royal Society of Chemistry

Published: 2016-11-25

Total Pages: 778

ISBN-13: 1849736626

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Guiding chromatographers working in regulated industries and helping them to validate their chromatography data systems to meet data integrity, business and regulatory needs. This book is a detailed look at the life cycle and documented evidence required to ensure a system is fit for purpose throughout the lifecycle. Initially providing the regulatory, data integrity and system life cycle requirements for computerised system validation, the book then develops into a guide on planning, specifying, managing risk, configuring and testing a chromatography data system before release. This is followed by operational aspects such as training, integration and IT support and finally retirement. All areas are discussed in detail with case studies and practical examples provided as appropriate. The book has been carefully written and is right up to date including recently released FDA data integrity guidance. It provides detailed guidance on good practice and expands on the first edition making it an invaluable addition to a chromatographer’s book shelf.

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