|
|
|||
|
||||
OverviewData 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. Full Product DetailsAuthor: R D McDowall (Director, R.D.McDowall Ltd)Publisher: Royal Society of Chemistry Imprint: Royal Society of Chemistry Weight: 1.122kg ISBN: 9781788012812ISBN 10: 178801281 Pages: 598 Publication Date: 09 November 2018 Audience: General/trade , General Format: Hardback Publisher's Status: Active Availability: In Print This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us. Table of ContentsReviewsThe management of regulated industry needs to read all 600 pages in the book in order to set the standard for how every single person in their organization needs to work, themselves included. -- Siri H. Segalstad, Segalstad Consulting AS, Norway Author InformationTab Content 6Author Website:Countries AvailableAll regions |