To set-up a new organization in EudraVigilance (EV) Production or XCOMP (test) system, the following series of steps need to be followed:
1. EMA EudraVigilance Registration Documents
2. New Organization First User QPPV/RP or Change of EU QPPV/RP
3. Vendor registration in the EudraVigilance external compliance testing environment (XCOMP)
4. EMA EudraVigilance Registration Manual
EMA Registration Documents New Organization First User Vendor Registration EMA Registration Manual