Data Integrity and Data Governance (eBook)

Practical Implementation in Regulated Laboratories

R D McDowall (Autor)

eBook Download: PDF

2018
598 Seiten
Royal Society of Chemistry (Verlag)
978-1-78801-327-7 (ISBN)

Infos

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.

Inhalt

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

Produkt-Details

• Erscheint lt. Verlag: 6.11.2018
• Sprache: englisch
• Themenwelt: Naturwissenschaften ► Chemie ► Analytische Chemie
• Themenwelt: Technik
• ISBN-10: 1-78801-327-1 / 1788013271
• ISBN-13: 978-1-78801-327-7 / 9781788013277