Data Integrity and Data Governance - Practical Implementation in Regulated Laboratories

List of contents

Preface; Glossary, Abbreviations and Data Integrity Terms;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; Subject Index

Product details

• Authors: R D McDowall, R D (Director Mcdowall, Robert D McDowall, Robert D (Director Mcdowall
• Publisher: Royal Society Of Chemistry
• Languages: English
• Product format: Hardback
• Released: 09.11.2018
• EAN: 9781788012812
• ISBN: 978-1-78801-281-2
• No. of pages: 672
• Subject: Natural sciences, medicine, IT, technology > Natural sciences (general)