European Union Regulations

European Union Regulations

EU Annex 11

The European Union’s (EU) Annex 11 defines the EU’s regulations for using computerized systems in Good Manufacturing Practice (GMP) for life sciences products. Annex 11 is a checklist that enables European regulatory agencies to establish the requirements for automated systems related to pharmaceutical products and medical devices. The guidelines set forth by the Commission of the European Committees are not too distant from their US counterpart created by the FDA (21 CFR Part 11). EU Annex 11 is the EU’s equivalent to Title 21 CFR Part 11, although it has different guidelines and regulatory practices than the latter. Annex 11 suggests that risk assessment is the beginning of compliance for all computerized systems, while the FDA guideline focuses exclusively on electronic signatures and records within those systems.

In addition, Annex 11 defines the criteria under which electronic records and signatures are managed.

It’s important to note that Annex 11 is not a regulation like the FDA 21 CFR Part 11 rule. Annex 11 is a guideline critical to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products.

EU Annex 11CFR Part 11
Scope All computerized systems as part of Good Manufacturing Practice; applications should be validated and IT infrastructure qualified.Electronic records and signatures that are used for any FDA-regulated activities by life sciences and other organizations.
FocusQuality management of computerized systems from a risk-based standpoint.The use of electronic signatures and records in open or closed computer systems
ObjectiveThe use of a computerized system should result in the same quality assurance and product quality as manual systems with no risk increase.The electronic records and signatures captured and stored should be as reliable and trusted as paper documents and wet signatures.
Relevance and ValidationRelevant to GMP but referenced in other areas as well. Relevant to and based on validation according to GMP, GDP, GLP, GCP, and medical devices.