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.
As you move data to the cloud, you need to consider a comprehensive approach to data governance, along with well-defined and agreed-upon policies to ensure your organization meets compliance requirements. Data governance incorporates the ways people, processes, and technology work together to ensure data is trustworthy and can be used effectively. This practical guide shows you how to effectively implement and scale data governance throughout your organization. Chief information, data, and security officers and their teams will learn strategy and tooling to support democratizing data and unlocking its value while enforcing security, privacy, and other governance standards. Through good data governance, you can inspire customer trust, enable your organization to identify business efficiencies, generate more competitive offerings, and improve customer experience. This book shows you how. You'll learn: Data governance strategies addressing people, processes, and tools Benefits and challenges of a cloud-based data governance approach How data governance is conducted from ingest to preparation and use How to handle the ongoing improvement of data quality Challenges and techniques in governing streaming data Data protection for authentication, security, backup, and monitoring How to build a data culture in your organization
Data integrity is the hottest topic in the pharmaceutical industry. Global regulatory agencies have issued guidance, after guidance after guidance in the past few years, most of which does not offer practical advice on how to implement policies, procedures and processes to ensure integrity. These guidances state what but not how. Additionally, key stages of analysis that impact data integrity are omitted entirely. The aim of this book is to provide practical and detailed help on how to implement data integrity and data governance for regulated analytical laboratories working in or for the pharmaceutical industry. It provides clarification of the regulatory issues and trends, and gives practical methods for meeting regulatory requirements and guidance. Using a data integrity model as a basis, the principles of data integrity and data governance are expanded into practical steps for regulated laboratories to implement. The author uses case study examples to illustrate his points and provides instructions for applying the principles of data integrity and data governance to individual laboratory needs. This book is a useful reference for analytical chemists and scientists, management and senior management working in regulated laboratories requiring either an understanding about data integrity or help in implementing practical solutions. Consultants will also benefit from the practical guidance provided.
Data governance looks simple on paper, but in reality it is a complex issue facing organizations. In this practical guide, data experts Uma Gupta and San Cannon look to demystify data governance through pragmatic advice based on real-world experience and cutting-edge academic research.
Data-governance programs focus on authority and accountability for the management of data as a valued organizational asset. Data Governance should not be about command-and-control, yet at times could become invasive or threatening to the work, people and culture of an organization. Non-Invasive Data Governance™ focuses on formalizing existing accountability for the management of data and improving formal communications, protection, and quality efforts through effective stewarding of data resources. Non-Invasive Data Governance will provide you with a complete set of tools to help you deliver a successful data governance program. Learn how: • Steward responsibilities can be identified and recognized, formalized, and engaged according to their existing responsibility rather than being assigned or handed to people as more work. • Governance of information can be applied to existing policies, standard operating procedures, practices, and methodologies, rather than being introduced or emphasized as new processes or methods. • Governance of information can support all data integration, risk management, business intelligence and master data management activities rather than imposing inconsistent rigor to these initiatives. • A practical and non-threatening approach can be applied to governing information and promoting stewardship of data as a cross-organization asset. • Best practices and key concepts of this non-threatening approach can be communicated effectively to leverage strengths and address opportunities to improve.
As organizations deploy business intelligence and analytic systems to harness business value from their data assets, data governance programs are quickly gaining prominence. And, although data management issues have traditionally been addressed by IT departments, organizational issues critical to successful data management require the implementation of enterprise-wide accountabilities and responsibilities. Data Governance: Creating Value from Information Assets examines the processes of using data governance to manage data effectively. Addressing the complete life cycle of effective data governance—from metadata management to privacy and compliance—it provides business managers, IT professionals, and students with an integrated approach to designing, developing, and sustaining an effective data governance strategy. Explains how to align data governance with business goals Describes how to build successful data stewardship with a governance framework Outlines strategies for integrating IT and data governance frameworks Supplies business-driven and technical perspectives on data quality management, metadata management, data access and security, and data lifecycle The book summarizes the experiences of global experts in the field and addresses critical areas of interest to the information systems and management community. Case studies from healthcare and financial sectors, two industries that have successfully leveraged the potential of data-driven strategies, provide further insights into real-time practice. Facilitating a comprehensive understanding of data governance, the book addresses the burning issue of aligning data assets to both IT assets and organizational strategic goals. With a focus on the organizational, operational, and strategic aspects of data governance, the text provides you with the understanding required to leverage, derive, and sustain maximum value from the informational assets housed in your IT infrastructure.
The world is witnessing the growth of a global movement facilitated by technology and social media. Fueled by information, this movement contains enormous potential to create more accountable, efficient, responsive, and effective governments and businesses, as well as spurring economic growth. Big Data Governance and Perspectives in Knowledge Management is a collection of innovative research on the methods and applications of applying robust processes around data, and aligning organizations and skillsets around those processes. Highlighting a range of topics including data analytics, prediction analysis, and software development, this book is ideally designed for academicians, researchers, information science professionals, software developers, computer engineers, graduate-level computer science students, policymakers, and managers seeking current research on the convergence of big data and information governance as two major trends in information management.
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.
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.