EMA Releases Revised Computerized Systems Annex to GMP Guide

The European Medicines Agency released Annex 11–Computerized Systems, a supplement to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community. The annex applies to all forms of computerized systems that are used as part of GMP-regulated activities.

Some key points in the new Annex note that computer applications should be validated and that information-technology structures should be qualified. The document also states that when moving from manual operation to computerized operation, it is important to ensure that product quality and process control assurance do not decrease. In the same regard, the overall risk to the process should not be affected when such a change takes place.

The Annex addresses risk management as a tool that should be applied throughout the life cycle of the computerized system, taking into account factors such as patient safety and data integrity. Agreements and working relationships among personnel and third parties are addressed as well. Finally, the revised Annex reviews project and operational phases of drug manufacturing and how computerized systems can play a role in these stages (e.g., by documenting validation, checking for accuracy, and maintaining audit trails).