The release of the Organisational Management Service (OMS) and Referential Management Service (RMS), the first components of EMA’s SPOR Master Data Management roadmap, is in sight. With the User Acceptance Testing (UAT) ongoing, the first actual use of the system gives more information on how to prepare as a company.
Before the go-live of the systems, there are several activities you should do to prepare:
- Decide who will have Super and normal user rights in these systems and set up internal processes
- Map your MAH, manufacturer and MA applicant data and decide on how to maintain these in OMS
- Standardize free text package descriptions with the Containers list
- Map the lists required for CESSP MAA
- Prepare your xEVMPD processes to switch to OMS/RMS usage
- Prepare the documentation required to request user access and organisation updates
- Assess the impact on other regulatory processes, such as the eAF, Clinical Trial portal and EudraCT
An optimal implementation of OMS/RMS within a company will not only pave the way for IDMP, but will contribute to improve regulatory submissions and interdepartmental harmonization.
If you require any assistance in the preparation, please contact us.