Calyx RIM 6.2 CHF 5 Data Migration

Running the migration script results in multiple changes to the Data Administration data. The changes must be reviewed, and updated if necessary.

Changes related to CH-1-5 implementation:
  • Associates Switzerland country with Switzerland region in the Application Maintenance - Region Values if it is not associated already.
  • Adds the CH-1-5 assembly DTD type in the Assembly - Assembly DTD/Schema Types section in Data Administration, if it does not already exist.
  • Adds the following values to the Sequence Maintenance – Filing type Values section in Data Administration if they do not already exist:
    • Corrigendum Filing
    • DMF Filing
    • Follow-Up Measures
    • Known Active Substance
    • New Active Substance
    • Orphan Fast Track Filing
    • Periodic Safety Update Report
    • Plasma Master File
    • Reformat Filing
    • Renewal Filing
    • Supplement Filing
    • Transfer MA Filing
    • Withdrawal Filing
    • Used for meeting
    • Co-Marketing Medicinal Product
    • Parallel Import
    • Variation 1A Filing
    • Variation 1AIN Filing
    • Variation 1B Filing
    • Variation 2 Filing
    • Extension Filing
Changes related to Data Administration grids and values:
  • Adds the Last User Updated and Last Changed Date fields to the user interface (UI) for every Data Administration Value.
  • Adds the Created By and Created Date fields to each value of the SPOR Maintenance table.
  • Adds a new flag with Yes/No values, named System Process Default Flag that indicates which status Name mapped to the same Internal System Status will be shown by default in Calyx RIM after an Event is closed manually or using a wizard. The field will be present in these Data Administration Values:
    • Application Status Values
    • Event-Change Detail Status Values
    • Product Status Values
    • Product Detail Set Status Values
    • Sequence Status Values
Changes related to entities:
  • Adds a new flag with Yes/No values, XEVMPD Submission Required? to the Full Product Presentation entity (before the Use Reference Active Ingredient field).
  • Adds the Optimize Fonts in Paper Output flag when the assembly publishing settings library or the publishing settings library template are migrated.