The European Medicines Agency has released a new Annex 11-Computerized Systems 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 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).
The updated Annex will take effect June 30, 2011.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.