Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories

Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories

by R D McDowall

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Product Details

ISBN-13: 9781788012812
Publisher: Royal Society of Chemistry, The
Publication date: 11/09/2018
Pages: 598
Product dimensions: 6.14(w) x 9.21(h) x (d)

Table 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

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