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.

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.

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.

The management of clinical data, from its collection during a trial to its extraction for analysis, has become critical in preparing a regulatory submission and obtaining approval to market a treatment. Groundbreaking on its initial publication nearly 14 years ago, and evolving with the field in each iteration since then, this latest volume includes revisions to all chapters to reflect the recent updates to ICH E6, good clinical practices, electronic data capture, and interactive response technologies. Keeping the coverage practical, the author focuses on the most critical information that impacts clinical trial conduct, providing a full end-to-end overview for clinical data managers. Features: Provides an introduction and background information for the spectrum of clinical data management tasks. Outstanding text in the industry and has been used by the Society for Clinical Data Management in creating its certification exam. Explains the high-level flow of a clinical trial from creation of the protocol through study lock. Reflects electronic data capture and interactive response technologies. Discusses using the concept of three phases in the clinical data management of a study: study startup, study conduct, and study closeout, to write procedures and train staff.

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.

Develop an understanding of FDA and global regulatory agency requirements for Laboratory Control System (LCS) operations In Laboratory Control System Operations in a GMP Environment, readers are given the guidance they need to implement a CGMP compliant Laboratory Control System (LCS) that fits within Global Regulatory guidelines. Using the Quality Systems Approach, regulatory agencies like the FDA and the European Medicine Agency have developed a scheme of systems for auditing pharmaceutical manufacturing facilities which includes evaluating the LCS. In this guide, readers learn the fundamental rules for operating a CGMP compliant Laboratory Control System. Designed to help leaders meet regulatory standards and operate more efficiently, the text includes chapters that cover Laboratory Equipment Qualification and Calibration, Laboratory Facilities, Method Validation and Method Transfer, Laboratory Computer Systems, Laboratory Investigations as well as Data Governance and Data Integrity. The text also includes chapters related to Laboratory Managerial and Administrative Systems, Laboratory Documentation Practices and Standard Operating Procedures and General Laboratory Compliance Practices. Additionally, a chapter outlining Stability Program operations is included in the text. In addition to these topics, it includes LCS information and tools such as: ● End of chapter templates, checklists, and LCS guidance to help you follow the required standards ● Electronic versions of each tool so users can use them outside of the text ● An In-depth understanding of what is required by the FDA and other globally significant regulatory authorities for GMP compliant systems For quality assurance professionals working within the pharmaceutical or biopharma industries, this text provides the insight and tools necessary to implement government-defined regulations.

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.