Validation Center™

In April 2008, the European Commission published a new, draft version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11, Computerised Systems.  The Annex was updated in response to the increased use of computerised systems and the increased complexity of these systems. Corresponding amendments are also proposed for Chapter 4 of the GMP Guide (Documentation).  Highlights of the new document include the addition of risk management practices, expanded requirements for purchased systems, and additional documentation requirements.