It is the manufacturer's responsibility to investigate and manage alerts in accordance with applicable procedures and regulations.
The EAMS does not assess or validate the quality of the investigation performed by users. Its purpose is to provide a common platform that enables connected stakeholders to manage and process alerts efficiently.
All actions performed within EAMS are recorded and remain traceable through the system audit trail of investigations/actions.
For further clarification on this article please feel free to contact the EMVO Helpdesk.
Email: helpdesk@emvo-medicines.eu
Phone no: +32 2 657 00 08