McDowall R.D. Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories

London, UK: The Royal Society of Chemistry, 2019. — 660 p. — ISBN: 178801281X.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.How to Use This Book and an Introduction to Data Integrity
How Did We Get Here?
The Regulators’ Responses
What Is Data Governance?
A Data Integrity Model
Roles and Responsibilities in a Data Governance Programme
Data Integrity Policies, Procedures and Training
Establishing and Maintaining an Open Culture for Data Integrity
An Analytical Data Life Cycle
Assessment and Remediation of Laboratory Processes and Systems
Data Integrity and Paper Records: Blank Forms and Instrument Log Books
The Hybrid System Problem
Get Rid of Paper: Why Electronic Processes are Better for Data Integrity
Data Integrity Centric Analytical Instrument Qualification and Computerised System Validation
Validating Analytical Procedures
Performing an Analysis
Second Person Review
Record Retention
Quality Metrics for Data Integrity
Raising Data Integrity Concerns
Quality Assurance Oversight for Data Integrity
How to Conduct a Data Integrity Investigation
Data Integrity and Outsourcing
Data Integrity Audit Aide Memoire