Data Migration Documentation

Calyx RIM 6.2 Data Administration Tables

Data Administration Updates: Organisation Management System (OMS) Integration

The following Data Administration values have been updated with an Organisation Identifier attribute for the purpose of mapping Organisation in Calyx RIM for Registrations to Organisation in the Organisation Management System (OMS):
  • Other > MAH/Development Sponsor/Organisation Values
  • Application Maintenance > Country Values > Health Authority Values
  • Product Detail Set Maintenance > Manufacturer Values
The Organisation Identifier attribute for all Data Administration tables is not updated with a value post migration. This value needs to be updated manually or via Data Exchange.
Note: The Health Authority values are not Data Exchange aware.
Additional fields to support the OMS Integration have been added to the MAH/Development Sponsor/Organisation Values:
  • Location Identifier
  • Location Status

Data Administration Updates: Referentials management service (RMS) Integration

An additional Data Administration section named SPOR Maintenance has been added to support the Referentials management service (RMS) integration. This section contains the following tables:
  • ATC RMS Values
  • Compendial Designation/Source RMS Values
  • Concentration Measure Type RMS Values
  • Country RMS Values
  • Denominator/Numerator Unit RMS Values
  • Dosage/Pharmaceutical Form RMS Values
  • EMA Authorisation Status RMS Values
  • Language RMS Values
  • Legal Basis RMS Values
  • Medical Device RMS Values
  • Medicinal product Type RMS Values
  • Procedure Type RMS Values
  • Route of Administration RMS Values
  • Unit of Measure Prefix RMS Values

The SPOR Maintenance section is based on the custom lists in database.

The following Data Administration values have been updated with RMS Term Name attribute for the purpose of mapping Calyx RIM for Registrations values to value in the SPOR Maintenance section:
  • Application Maintenance > Country Values
  • Application Maintenance > Procedure Type Values
  • Other > Concentration Measure Type Values
  • Other > Denominator Unit Values
  • Other > Language Values
  • Other > Legal Basis Values
  • Other > Numerator Values
  • Other > Unit of Measure Prefix
  • Product Family Maintenance > ATC Values
  • Product Maintenance > Compendial Designation/Source Values
  • Product Maintenance > Dosage/Pharmaceutical Form Values
  • Product Maintenance > Medical Device Values
  • Product Maintenance > Route of Administration
  • Registration Maintenance > EMA Authorisation Status Values
  • Registration Maintenance > Medicinal Product Type Values

The RMS Term Name attribute for all Data Administration tables is not updated with a value post-migration. This value needs to be updated manually or via Data Exchange.

Data Administration Updates: Procedure Type Values

An additional field named IDMP Internal Procedure Code has been added to the Procedure Type Values. The field will be empty after the migration.

Data Administration Updates: Region Values

The Region Values table in the Application Maintenance section has been updated with a new region named IDMP Integration.

Data Administration Updates: Region Type Values

The Region Type Values table in the Application Maintenance section has been updated with a new default region type named IDMP.

Data Administration Updates: Manufacturer Values

The following changes to the Data Administration section are introduced:
  • Country text field has been deleted.
  • Country Code drop-down field has been updated with a Country label and changed to be displayed as Country instead of Country Code.

The migration rules are described in the Calyx RIM 6.2 Data Migration Document.

Data Administration Updates: Country Specific Detail Type Values

Within Data Administration, the following Country Specific Detail Type Values will be created with the following types:
  • US FDA Regulation Number
  • FDA Device Class
  • EU Device Class

Data Administration Updates: Country Specific Detail Values

All existing values on Product for the entity named FDA Regulatory Number will be migrated under the Data Administration entity named Country Specific Detail Values with a parent Country Specific Detail Type of US FDA Regulatory Number with Country United States.

All existing values on Product for the entity named FDA Device Class will be migrated under the Data Administration entity named Country Specific Detail Values with a parent Country Specific Detail Type of FDA Device Class with Country United States.

All existing values on Product for the entity named EU Class will be migrated under the Data Administration entity named Country Specific Detail Values with a parent Country Specific Detail Type of EU Device Class with all countries in European Union region including European Union country.

Data Administration Updates: Global Medical Device Nomenclature (GMDN) Code Values

All existing values on Product for the entity named Global Medical Device Nomenclature (GMDN) Code (where the Product Family type is Medical Device or Pharmaceutical-Medical Device) will be added to the Global Medical Device Nomenclature (GMDN) Code Values table in Data Administration.

Data Administration Updates: UMDNS Code Values

All existing values on Product for the entity named UMDNS Code (where the Product Family type is Medical Device or Pharmaceutical-Medical Device) will be added to the UMDNS Code Values table in Data Administration.

Data Administration Updates: Applicable Standards Values

The Version of Standard field for the Applicable Standards Values tables will be blank after migration.