This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
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
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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