1st Edition
Data Integrity in Pharmaceutical and Medical Devices Regulation Operations Best Practices Guide to Electronic Records Compliance
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.
Biography
Orlando Lopez
E-records Integrity SME
Durham North Carolina USA
Orlando Lopez has significant understanding and experience with worldwide regulatory authorities regarding CSV, e-records integrity, and related requirements/guidelines related to Production Manufacturing Systems, IT Systems, Analytics, and Business Intelligence.
He has knowledge and experience in the development of governance and SLC deliverables. Wrote and deployed CSV methodology to computer infrastructure J&J worldwide. Several times he had re-engineered the computer validation methodology to regulated companies.
Orlando Lopez has experience with direct participation in FDA agency remedial action plans, regulatory inspections, response activities, and consent decree remediation related verifications.
He is published in the Encyclopedia of Pharmaceutical Science and Technology, 4th Edition - Chapter 56 Computer Systems Validation (Taylor & Francis Group, LLC) and had written 25+ publications, including 9 computer compliance related books - amazon.com/author/orlandolopez/
Familiar with gap assessment, remediation planning and remediation execution activities.
