Data Integrity in Pharmaceutical and Medical Devices Regulation Operations:Best Practices Guide to Electronic Records Compliance

图书简介

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. Inspection Trends. Electronic Records Life Cycle. MHRA Definitions. Electronic Records Governance. Relevant Electronic Records Management Procedural Controls. Electronic Records Controls - Supporting Processes. Electronic Records Controls - In Storage. Electronic Records Controls - During Processing. Electronic Records Controls - While in Transit. Trustworthy Computer Systems. Electronic Records and Service Providers. Relevant Worldwide GMP Regulations and Guidelines. MHRA Guidance. Electronic Records Management - 21 CFR Part 211. Electronic Records Management - EMA Annex 11. 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.

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Data Integrity in Pharmaceutical and Medical Devices Regulation Operations:Best Practices Guide to Electronic Records Compliance 药物和医疗器械管理操作中的数据完整性：电子记录合规的最佳操作指南 药物化学

Data Integrity in Pharmaceutical and Medical Devices Regulation Operations:Best Practices Guide to Electronic Records Compliance

药物和医疗器械管理操作中的数据完整性：电子记录合规的最佳操作指南
药物化学