Revised EU GMP Computerized Systems Annex 11

The EU Medicinal Products GMP contains an Annex (11) on use of computerized systems. This annex identifies requirements for validation, electronic records, and use of third party software.  In some instances it is more specific than FDA requirements.  The new version at the link provided obsoletes the Dec 1998 version when it becomes effective June 30, 2011.

This version requires risk management throughout the lifecycle taking into account patient safety, data integrity and product quality.  It also has a section on the operational phase similar topics related 21 CFR 11 for electronic records and signatures among other requirements.

View the annex at this link:  annex11_01-2011_en

“Being Agile & Compliant”

2-day Public Training Course
Tampa, Florida USA
Feb 18-19, 2019

Come meet John F. Murray, Jr., who recently retired from FDA and joined SoftwareCPR®, at the course!

Hurry to get latest discounts … submit form below:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.