Introduction to the Rotronic Monitoring System > RMS Software Compliance

EU Annex 11: Computerized systems within GMP-regulated activities

EU: European Union

GMP: Good Manufacturing Practice

GLP: Good Laboratory Practice

GCP: Good Clinical Practice

What was to become the Annex 11 was released in 1991 and updated in January 2011. The Annex 11 can be found with the EudraLex (the rules governing Medicinal products in the European Union) volume 4 (good manufacturing practice). The guidelines state that, where a computerized system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process. The Annex 11 is also a requirement for GLP and GCP in Europe; unifying the requirements for the management of electronic records and electronic signatures in regulated companies.

FDA CFR 21 Part 11 & EU Annex 11 Requirements

Both the FDA CFR 21 Part 11 and the EU Annex 11 share the mutual goal of safe, validated computer systems for drug manufacturing (GMP). Whereas the Part 11 is a regulation, the Annex 11 is only a guideline to comply with GMP principles within the EU. The FDA CFR 21 Part 11 has an international reach whereas the EU Annex 11 is focused on Europe.

Here are some of the industry standards when it comes to complying with the two titles:

•Access limited to authorized individuals using roles; privileges are assigned to role not individuals.

•Specific password security

•Unique user name

•Audit trail for all changes

Request the RMS-WP-Vxxx-EN to find out how Rotronic comply to the FDA requirements and the EU guidelines.