Description: Data Integrity and Data GovernancePractical Implementation in Regulated Laboratories Author(s): R D McDowall Format: Hardback Publisher: Royal Society of Chemistry, United Kingdom Imprint: Royal Society of Chemistry ISBN-13: 9781788012812, 978-1788012812 Synopsis 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.
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Book Title: Data Integrity and Data Governance
Number of Pages: 598 Pages
Language: English
Publication Name: Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories
Publisher: Royal Society of Real Chemistry
Publication Year: 2018
Subject: Engineering & Technology, Chemistry, Science
Item Height: 234 mm
Item Weight: 1122 g
Type: Textbook
Author: R D Mcdowall
Item Width: 156 mm
Format: Hardcover
