Annex 11: The EU's New Expectations For Regulated Computerized Systems

By Martin Browning

Annex 11 is one of several guidance documents that supplement the EU’s GMP rules (EUDRALEX Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice). It applies to all human and veterinary medicinal products made or sold in the EU.

Here’s how the EU summarizes the overall purpose of Annex 11 (boldface added for emphasis):

“...the introduction of computerized systems into systems of manufacturing — including storage, distribution and quality control—does not alter the need to
observe the relevant principles given elsewhere in the [GMP] Guide. Where a computerized system replaces a manual operation, there should be no resultant decrease in product quality or quality assurance.”

In plain English, Annex 11 wants to ensure the computerized systems you use to manufacture medicinal products have no adverse impact on product quality, product efficacy, or patient safety. In addition, when a computerized system replaces a manual operation, Annex 11 wants to ensure there are no increased risks.

The Annex 11 Guidance is for the lifecycle of computerized systems to reflect the increased use and complexity of automated systems in the pharmaceutical industry. In this paper we cover the Scope of Annex 11, it's impact on medical device companies and its role in inspection readiness.