Description
Book SynopsisGood 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 functi
Table 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.
