EU GMP Annex 11 Concept Paper
- kalexander29
- Dec 30, 2022
- 1 min read
The European Medicines Agency (EMA) has published a concept paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice (GMP) for medicinal products - Computer Systems. The proposed guidelines will replace Eudralex Volume 4: Annex 11 Computerised Systems.