ABSTRACT

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

chapter 1|6 pages

Introduction

chapter 2|6 pages

SLC, Computer Validation, and Annex 11

chapter 3|6 pages

Annex 11 Principles

chapter 4|10 pages

Risk Management

chapter 5|4 pages

Personnel

chapter 6|6 pages

Suppliers and Service Providers

chapter 7|12 pages

Validation

chapter 8|10 pages

Data

chapter 9|4 pages

Accuracy Checks

chapter 10|6 pages

Data Storage

chapter 11|4 pages

Printouts

chapter 13|8 pages

Change and Configuration Management

chapter 15|10 pages

Security

chapter 16|6 pages

Incident Management

chapter 18|10 pages

Batch Certification and Release

chapter 19|4 pages

Business Continuity

chapter 20|4 pages

Archiving

chapter 21|10 pages

SLC Documentation

chapter 22|4 pages

Relevant Procedural Controls

chapter 26|24 pages

Annex 11 and Electronic Records Integrity