Pharmaceutical Computer Systems Validation: Quality, Assurance, Risk Management and Regulatory Compliance

From The Critics

Reviewer: Michael R Jacobs, BS, PharmD(Temple University School of Pharmacy)
Description: This is a comprehensive resource for the development, use, and validation of computer systems in all aspects of the pharmaceutical industry. The first section details the multitude of ways that computers are used in drug development and what is necessary to meet the requirements of regulatory agencies, while the second section consists of 20 case studies that focus on specific uses of computers in areas such as document management, the analytical laboratory, clinical research, and marketing. This is the second edition of a book first published in 2004.
Purpose: The book aims to provide insight into the complexities of integrating computer applications throughout all aspects of the pharmaceutical industry. The concepts discussed in the first section are pulled together in the second section with case studies that demonstrate how they interrelate to aid compliance with regulatory standards. Understanding these concepts and applications are critical to the success of a pharmaceutical company. The book achieves this goal.
Audience: The foreword to the first edition mentions that the "book will be welcomed by novices and experts, suppliers, developers, purchasers, and regulators alike." On the surface, it appears to be written more for software systems engineers or information technology specialists, but it quickly becomes apparent that anyone who works in the pharmaceutical industry and uses a computer will find this information useful in better understanding and completing a variety of jobs. This is largely accomplished by drawing on the experience of experts well established in this area.
Features: Computers, or better stated, computer systems, play an increasingly important role in managing the enormous volume of data generated across all phases of the drug development process. They are essential in maximizing efficiency, facilitating regulatory compliance, and enhancing quality and risk management activities. This book provides a thorough discussion of how and why some computer systems fail to achieve these goals. Among the topics in the first section are an overview of what can be expected from a well-designed computer system, considerations in the selection of vendors for hardware and software solutions, approaches for system validation, and the essentials of user training and obtaining end-user input. The case studies in the second section detail how computer systems can be used in specific phases of the drug development process including laboratory information management, clinical systems, control and monitoring instrumentation, document management, and marketing and supply applications. Inspection report findings are included in most chapters and provide a connection to the expectations of regulatory authorities. As might be expected, abbreviations are used throughout the book and some might not be understood by readers. The nine pages of abbreviations toward the beginning of the book will be useful to these readers. The index also is helpful, providing page numbers for most entries, thus avoiding the irritation of looking up a topic only to be redirected to a different section of the index.
Assessment: This is an outstanding resource for anyone responsible for the building, use, or maintenance of computer systems in the pharmaceutical industry. Though technical, it is easy to read. It is, to my knowledge, the most comprehensive book available on this topic. The second edition is a needed update, given the enhanced capabilities of computer systems and increased regulatory oversight of their use.

Doody Reviews

Reviewer: Michael R Jacobs, BS, PharmD (Temple University School of Pharmacy)
Description: This is a comprehensive resource for the development, use, and validation of computer systems in all aspects of the pharmaceutical industry. The first section details the multitude of ways that computers are used in drug development and what is necessary to meet the requirements of regulatory agencies, while the second section consists of 20 case studies that focus on specific uses of computers in areas such as document management, the analytical laboratory, clinical research, and marketing. This is the second edition of a book first published in 2004.
Purpose: The book aims to provide insight into the complexities of integrating computer applications throughout all aspects of the pharmaceutical industry. The concepts discussed in the first section are pulled together in the second section with case studies that demonstrate how they interrelate to aid compliance with regulatory standards. Understanding these concepts and applications are critical to the success of a pharmaceutical company. The book achieves this goal.
Audience: The foreword to the first edition mentions that the "book will be welcomed by novices and experts, suppliers, developers, purchasers, and regulators alike." On the surface, it appears to be written more for software systems engineers or information technology specialists, but it quickly becomes apparent that anyone who works in the pharmaceutical industry and uses a computer will find this information useful in better understanding and completing a variety of jobs. This is largely accomplished by drawing on the experience of experts well established in this area.
Features: Computers, or better stated, computer systems, play an increasingly important role in managing the enormous volume of data generated across all phases of the drug development process. They are essential in maximizing efficiency, facilitating regulatory compliance, and enhancing quality and risk management activities. This book provides a thorough discussion of how and why some computer systems fail to achieve these goals. Among the topics in the first section are an overview of what can be expected from a well-designed computer system, considerations in the selection of vendors for hardware and software solutions, approaches for system validation, and the essentials of user training and obtaining end-user input. The case studies in the second section detail how computer systems can be used in specific phases of the drug development process including laboratory information management, clinical systems, control and monitoring instrumentation, document management, and marketing and supply applications. Inspection report findings are included in most chapters and provide a connection to the expectations of regulatory authorities. As might be expected, abbreviations are used throughout the book and some might not be understood by readers. The nine pages of abbreviations toward the beginning of the book will be useful to these readers. The index also is helpful, providing page numbers for most entries, thus avoiding the irritation of looking up a topic only to be redirected to a different section of the index.
Assessment: This is an outstanding resource for anyone responsible for the building, use, or maintenance of computer systems in the pharmaceutical industry. Though technical, it is easy to read. It is, to my knowledge, the most comprehensive book available on this topic. The second edition is a needed update, given the enhanced capabilities of computer systems and increased regulatory oversight of their use.