European Commission

Eudralex V4 Annex 11: Computerised Systems, 1/11

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In January 2011, the European Commission published a new version of Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Annex 11, Computerised Systems.ᅠThis version was in effect as ofᅠJune 30, 2011.

The Annex wasᅠupdated in response to the increased use of computerised systems and the increased complexity of these systems.ᅠᅠ

Highlights of the new document include the addition of risk management practices, expanded requirements for system suppliers and service providers, and additional documentation requirements.

Issuing Body

European Commission

SKU: 300017. Category: .