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 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 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.

Integrity and Internal Control in Information Systems is a state-of-the-art book that establishes the basis for an ongoing dialogue between the IT security specialists and the internal control specialists so that both may work more effectively together to assist in creating effective business systems in the future. Building on the issues presented in the preceding volume of this series, this book seeks further answers to the following questions: What precisely do business managers need in order to have confidence in the integrity of their information systems and their data? What is the status quo of research and development in this area? Where are the gaps between business needs on the one hand and research/development on the other; what needs to be done to bridge these gaps? Integrity and Internal Control in Information Systems contains the selected proceedings of the Second Working Conference on Integrity and Internal Control in Information Systems, sponsored by the International Federation for Information Processing (IFIP) and held in Warrenton, Virginia, USA, in November 1998. It will be essential reading for academics and practitioners in computer science, information technology, business informatics, accountancy and edp-auditing.

The development and integration of integrity and internal control mechanisms into information system infrastructures is a challenge for researchers, IT personnel and auditors. Since its beginning in 1997, the IICIS international working conference has focused on the following questions: what precisely do business managers need in order to have confidence in the integrity of their information systems and their data and what are the challenges IT industry is facing in ensuring this integrity; what are the status and directions of research and development in the area of integrity and internal control; where are the gaps between business needs on the one hand and research / development on the other; what needs to be done to bridge these gaps. This sixth volume of IICIS papers, like the previous ones, contains interesting and valuable contributions to finding the answers to the above questions. We want to recommend this book to security specialists, IT auditors and researchers who want to learn more about the business concerns related to integrity. Those same security specialists, IT auditors and researchers will also value this book for the papers presenting research into new techniques and methods for obtaining the desired level of integrity.

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.

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.

Information Technology/Database Management "...the definitive source for understanding modern data architecture. Other books have bits and pieces of architecture described, but nowhere else is there a single source that has all the components of modern data architecture in one place in an organized and readable manner." -From the Foreword by William H. Inmon The technology for compiling data has evolved to the point where most organizations now amass information faster than they can use it. The bad news is that most of that data is disparate, scattered across different databases and platforms. The time has come to tame the data chaos, and this invaluable resource shows you how. Michael H. Brackett schools you in a variety of techniques for creating a cohesive data structure that everyone in your organization can use. Step-by-step, he guides you through the entire process of planning, building, and programming a data warehouse tailored to your organization's needs. You learn how to: * Prepare and evaluate existing data for a data warehouse * Cross reference data so it's easy to find in all corporate locations * Prepare data for client/server systems * Improve the consistency and quality of existing and future data * Manage a data warehouse The Data Warehouse Challenge is an indispensable tool for database administrators and developers, systems programmers and analysts, and all those involved with helping their organizations rise to the challenge of taming data chaos.

Data Sharing Using a Common Data Architecture Wouldn’t it be a pleasure to know and understand all the data in your organization? Wouldn’t it be great to easily identify and readily share those data to develop information that supports business strategies? Wouldn’t it be wonderful to have a formal data resource that provides just-in-time data for developing just-in-time information to support just-in-time decision making? Data Sharing Using a Common Data Architecture shows you how by: Defining a common data architecture, its contents, and its uses Refining data to a common data architecture Discussing disparate data, its structure, quality, and how to identify it Describing how Data Sharing Reality is achieved Focusing on the importance of people and creating a win-win situation Providing a data lexicon and extensive glossary Data Sharing Using a Common Data Architecture is must reading for data administrators, database administrators, MIS project leaders, application programmers, systems analysts, MIS trainers and instructors, and graduate students.