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, Chapter 4, Documentation.  The draft updates were written to correspond to changes in EU GMP Annex 11, Computerised Systems.  See sections 4.1, 4.3, 4.7, and 4.9 for new requirements for electronic documentation and records.