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This book provides practical information to enable compliance with computer systems requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program. The ideas presented in this book are based on the author's twenty five years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. A practical approach is presented to increase efficiency and to ensure that software development and maintenance is achieved correctly.
List of contents
Introduction. SLC, Computer Validation, and Annex 11. Annex 11 Principles. Risk Management. Personnel. Suppliers and Service Providers. Validation. Data. Accuracy Checks. Data Storage. Printouts. Audit Trails—Ensuring Data Integrity. Change and Configuration Management. Periodic Evaluation: Independent Review to Ensure Continued Validation of Computerized Systems. Security. Incident Management. Electronic Signatures: Electronic Signing Requirements. Batch Certification and Release. Business Continuity. Archiving. SLC Documentation. Relevant Procedural Controls. Maintaining the Validated State in Computer Systems. Annex 11 and the Cloud. EU GMP Chapter 4–Documentation and Annex 11. Annex 11 and Electronic Records Integrity. Annex 11 and 21 CFR Part 11: Comparisons for International Compliance.
About the author
Orlando López 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.
Summary
Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.
The purpose of Annex 11 is to provide the EMA healthcare industry with consistent criteria for effective implementation, control, and use of computer systems. EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP supplies practical information to facilitate compliance with computer system GMP requirements, while highlighting and integrating the Annex 11 guidelines into the computer compliance program.
The ideas presented in this book are based on the author’s 25 years of experience with computer validation in the healthcare industry with various computer systems development, maintenance, and quality functions. The book details a practical approach to increase efficiency and to ensure that software development and maintenance are achieved correctly.
Examining the implementation of the computer systems validation entirely based on EU Annex 11, the book includes examples from laboratory, clinical, and manufacturing computer systems. It also discusses electronic record integrity associated with stored information.
