Data integrity is fundamental in a pharmaceutical and medical devices quality system. This book provides practical information to enable compliance with data integrity, while highlighting and efficiently integrating worldwide regulation into the subject. The ideas presented in this book are based on many years’ experience in regulated industries in various computer systems development, maintenance, and quality functions. In addition to case studies, a practical approach will be presented to increase efficiency and to ensure that the design and testing of the data integrity controls are correctly achieved.
Preface
Introduction
Chapter 1 : Inspection Trends
Chapter 2 : Electronic Records Life Cycle
Chapter 3 : MHRA DefinitionsElectronic Records Governance
Chapter 4 : Relevant Electronic Records Management Procedural Controls
Chapter 5 : Electronic Records Controls - Supporting Processes
Chapter 6 : Electronic Records Controls - In Storage
Chapter 7 : Electronic Records Controls - During Processing
Chapter 8 : Electronic Records Controls - While in Transit
Chapter 9 : Trustworthy Computer Systems
Chapter 10 : Electronic Records and Service Providers
Chapter 11 : Relevant Worldwide GMP Regulations and Guidelines
Chapter 12 : MHRA GuidanceElectronic Records Management - 21 CFR Part 211
Chapter 13 : Electronic Records Management - EMA Annex 11
Chapter 14 : Self Inspection
Summary
Appendices : Glossary of Terms
Abbreviations and Acronyms
Regulatory Cross Match
MHRA GMP Data Integrity Definitions and Guidance for Industry March 2015
Relevant Worldwide GCP and GLP Regulations and Guidelines
Electronic Records Integrity in Non-Clinical Laboratories
Electronic Records Integrity in Clinical Systems
Electronic Integrity in a Data Warehouse and Business Intelligence