Data Integrity and Data Governance. Dieser Artikel ist nicht verfügbar.Data Integrity and Data Governance

Data integrity is the hottest topic in the pharmaceutical industry at the moment. Global regulatory agencies have issued six guidance documents in the past couple of years, however all documents are vague and to not contain detailed examples or advice to help regulated laboratories to implement policies, procedures and processes to ensure integrity. The aim of this book is to provide practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries. It is designed for analytical chemists and scientists working in regulated laboratories, management and senior management roles, primarily in the pharmaceutical industry and consultants who will benefit from the practical guidance provided.

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.