Calyx RIM 7.0 Entities Updates
The migration performs multiple changes to the Calyx RIM entities.
Product Family
A new field Show in Tree with Yes/No is added to the Product Family entity, applicable for all the Product Family Types.
All entities migrated from previous application versions will migrate with ‘Yes’ selected, and will be shown in the Product Family Tree.
Full Product Presentation
A new flag with Yes/No values, XEVMPD Submission Required?, is added to the Full Product Presentation entity before the Use Reference Active Ingredient field to indicate that XEVMPD Submission for current Full Product Presentation is ready to be submitted to EMA authority. By default, the flag value is Yes.
After migrating to Calyx RIM 7.0, the new flag value will be Yes if Full Product Presentation does not have an EV Code value. If there is an EV Code value for the entity, the flag value will be No.
In addition, this new field as a column should be available on the Full Product Presentation tabs on the Registration Attributes window and on the Home page navigation pane respectively, and in the flow as an option for selection.
Queries
- XEVMPD Submissions - QC Verification and Audit
- XEVMPD Submissions and Acknowledgement
To view new reports, you must have at least Read permission for the XEVMPD component. Reports appear in the Registration Planning and Tracking tab.
Leafs
For every leaf that has Actuate populated, the Actuate value must be changed as follows:
| Actuate Value | Change to |
|---|---|
| onLoad | L |
| onRequest | R |
| other | O |
| none | N |