Calyx RIM 6.1 CHF 5 Data Migration

The Calyx RIM 6.1 CHF 4 database migration provides the following set of changes:

Calyx RIM Data Administration Changes for CH eCTD Module 1 Version 1.4

  • For Data Administration Changes to CH eCTD Module 1 Version1.4, if the CH region already exists in the Application Maintenance - Region Values section in Data Administration, it will be updated to have the code value CH in the database. Otherwise, an error message will appear and the script will exit.
  • Switzerland country will be updated to belong to the Switzerland region if it does not belong to it already.
  • If the CH-1-4 Assembly DTD /Schema type already exists in the Assembly > Assembly DTD/Schema Types section in Data Administration, it will be activated (if inactive) and updated to have the code value CH-1-4. Otherwise, the CH-1-4 Assembly DTD /Schema will be added.
  • Filing Type Values will be added to the Sequence Maintenance > Filing Type Values section in Data Administration, if they do not already exist. If they already exist, they will be updated with an eCTD Code for CH-1-4 DTD/Schema.

PDS: Local Route of Administration

The field named Local Route of Administration has been added to the product detail set (PDS) entity. This field is Hidden out-of-the-box (OOTB), is multi-select, and is non-required, with values from the Data Administration > Route of Administration values list.
The rules for migrating the 'extraText20' field on a PDS entity configured to capture Route of Administration values starting from Calyx RIM 6.1 CHF 4 should be as follows:
  • Values that are recognized as existing in the Data Administration > Route of Administration Values list should migrate as is to the new field Local Route of Administration on the PDS entity.
  • Values that are not recognized as existing in the Data Administration > Route of Administration Values list should not migrate to the PDS Comments field on PDS entity.