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Data Integrity and Data Governance
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.
Site Reliability Engineering
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.
Data Integrity and Quality
Data integrity is the quality, reliability, trustworthiness, and completeness of a data set, providing accuracy, consistency, and context. Data quality refers to the state of qualitative or quantitative pieces of information. Over five sections, this book discusses data integrity and data quality as well as their applications in various fields.
Data Integrity and Compliance
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.
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations
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.
Digital Data Integrity
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 ...
Asset Data Integrity is Serious Business
Asset data integrity is a critical aspect of every business, yet it is often overlooked. This book will not only provide an appreciation of this fact, it will also provide a road map to achieving value out of something most CEOs, managers, and workers often overlook. The authors bring many years of experience and hands-on expertise that cannot be obtained elsewhere. An assessment tool is provided so once the problem is recognized by the reader, areas of improvement can be easily recognized. A detailed appendix provides further clarity.
Data Integrity Solutions
A Delusional Technology Syndrome (Chapter 1) has facilitated the manifestation of Digital Data Disorders (Chapter 2) that are impacting our lives in very negative ways and thus driving the need for an Information Integrity Imperative for the twenty first century (Chapter 3). There is a new way forward and a new day to prosper that I will cover in the Road to Recovery (Chapter 4). I hope you will gain insight from reading this book and will share your insights with others. I am also confident we the people will establish the appropriate levels of commitment to ensure the information stored and manipulated in thousands of technology systems, that have a high degree of control over the quality ...
Validation of Chromatography Data Systems
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.
Data Integrity and Gxp
This concise pocket book is a perfect introduction to Data Integrity in a GxP environment. It summarises key definitions and concepts from FDA and Eudralex regulatory requirements. Data Integriy and Data Reliability are increasingly seen as a critical aspect in ensuring patient health and safety. This book clearly outlines the fundamentals of Data Integrity, required to be Accurate, Attributable, legible, contemporaneously recorded, original or a true copy(ALCOA). In addition, the requirements of Computerised systems are summarised through a lifecycle approach. All-in-all a concise guide for any Engineering or Science professional. (Size 5" x 8" Paperback)
