Data Migration Documentation

Calyx RIM 6.2 CHF 5 Data Administration Tables

Requirements for the standard migration of Calyx RIM 6.2 Certified Hotfix (CHF) 4 to Calyx RIM 6.2CHF 5 are provided in this topic.

Data Administration Updates: Audit Fields

Two fields, Last User Updated and Last Changed Date, are added to the user interface (UI) for every Data Administration Value, including sub-tables. After migrating from a previous Calyx RIM version to Calyx RIM 6.2 CHF 5, these fields are present in the grids with data from the database, similar to the other windows for the value.

Another two fields, Created By and Created Date, are added to each value of the SPOR Maintenance table. After migrating from a previous Calyx RIM version to Calyx RIM6.2 CHF 5, these fields are present with data from the database in the grids, similar to the other windows for the value.

Data Administration Updates: Default Flag for Statuses

The System Process Default Flag (Yes/No values) provides the ability to assign several external statuses to the same Internal System Status in Data Administration for Application, Product, Event, or Sequence. You can see the assigned status after running the wizard or when the Event is closed manually. Before, the system randomly selected the first status that was mapped to the Internal System Status and you could not define which statuses would show after the updates. The field is added to the these Data Administration Values:
  • Application Status Values
  • Event-Change Detail Status Values
  • Product Status Values
  • Product Detail Set Status Values
  • Sequence Status Values

Data Administration Updates: Region

If the CH region already exists in the Application Maintenance - Region Values section in Data Administration, it will be updated to include the code value CH in the database. If the CH region does not exist in the Application Maintenance - Region Values section in Data Administration, an error message is shown and the script will exit.

The country value 'Switzerland' will be updated to belong to Switzerland region, if it does not belong to it already.

Data Administration Updates: Assembly DTD/Schema Type

If the CH-1-5 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-1-5. Otherwise, CH-1-5 Assembly DTD /Schema will be added.

Data Administration Updates: Filing Type Values

Filing Type Values are 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. Following are the list of Filing Types added with their eCTD Codes:
  • Corrigendum Filing: corrigendum
  • DMF Filing: dmf
  • Follow-Up Measures: fum
  • Known Active Substance: na-bws
  • New Active Substance: na-nas
  • Orphan Fast Track Filing: orphan-fasttrack
  • Periodic Safety Update Report: psur
  • Plasma Master File: pmf
  • Reformat Filing: reformat
  • Renewal Filing: renewal
  • Supplement Filing: supplemental-info
  • Transfer MA Filing: transfer
  • Withdrawal Filing: withdrawal
  • Used for meeting: advice
  • Co-Marketing Medicinal Product: na-co-marketing
  • Parallel Import: na-pi
  • Variation 1A Filing: var-type1a
  • Variation 1AIN Filing: var-type1ain
  • Variation 1B Filing: var-type1b
  • Variation 2 Filing: var-type2
  • Extension Filing: extension

Entities Updates

A new flag XEVMPD Submission Required? with Yes/No values, is added to the Full Product Presentation entity (before the Use Reference Active Ingredient field) to indicate that an XEVMPD Submission for a current Full Product Presentation is ready to be submitted to the EMA authority. The default flag value is Yes.

After migration from a previous Calyx RIM version to Calyx RIM 6.2 CHF 5, the new flag will be Yes if Full Product Presentation does not have an EV Code value and No if there is an EV Code value for the entity.

In addition, this new field is available as a column on the Full Product Presentations tabs on the Registration Attributes and Home page windows, and in the Notifications when a Value Changed flow as an option for selection.

When the assembly publishing settings library or the publishing settings library template are migrated, the Optimize Fonts in Paper Output flag is added and set to No by default.