Eudralex V4 Chapter 4: Documentation, 1/11

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In January 2011, the European Commission published a new version of EudraLex Volume 4, EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4, Documentation.ﾠThe updates were written to correspond with changes in EU GMP Annex 11, Computerised Systems.ﾠThis version went into effect on June 30, 2011.ﾠ

See sections 4.1 requirements specifically for electronic documentation and records.