Ennov InSight 7.2 Data Migration Documentation

Data Administration Updates for Ennov InSight 7.2

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

Application Maintenance

For the Country Values, Legal Status Values, Orphan Status Values, Procedure Type Values, Product Information Document Type Values, Regulatory Entitlement Type Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.

Medical Device Maintenance

To capture the data of Class III High Risk Medical Device products for UDI FDA and UDI MDR submissions, the new Medical Device Maintenance section is added to the Data Administration and includes the following sub sections:
  • EU Device Nomenclature Category Values .
  • EU Device Nomenclature Values .
  • FDA GMDN In-Vitro Term Type Values
  • Global Medical Device Nomenclature (GMDN) Code Values is moved from the Product Maintenance section.

Other

To support IDMP specification, the Certificate Master File Values and File Identifier Type Values sections are added to the Other section.

For the Application Submission Type Values, Concentration Measure Type Values, Indications/Intended Use Values, Language Values, Legal Basis Values, Units of Measurement Values,Unit of Presentation Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.

Product Detail Set Maintenance

To support IDMP specification, the Origin of Substance Values list is added to the Product Detail Set Maintenance section.

The Packaging Category Values list now includes the IDMP Package Level field.

To define more than one material for a package component, the following changes are implemented for Package Component Values:
  • the Product Material field type is changed to multiple selection.
  • the Product Material field is not required.
The following changes are implemented for Manufacturer Values:
  • The Confidentiality Indicator is available on the Manufacturer Values > Global Product Details when you select the Packaging or Substance option for the Detail Type field.
  • The Manufacturing Authorization Reference Number tab now includes the Country that approved the manufacturing site and the Regulatory Agency in the country that approved the manufacturer.
  • The Regulatory Agency is populated from the Country Values > Health Authority tab.
  • The Labeler DUNS Number/Legal Manufacturer Single Registration Number(SRN) and Authorised Representative Name are added to the Manufacturer page
For the Data Classification Type Values, Manufacturing Functions Values, Medical Device Values, Packaging Type Values, Product Material Values , Shelf Life Type Values, Storage Condition Values,Substance Role Values , Time Unit Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.

Product Family Maintenance

The EURD Procedure Identifier) field and column are renamed to Family Identifier / Active Substances on the EURD ID Values page.

For the ATC Values and Domain Type Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.

Product Maintenance

For the Dosage/Pharmaceutical Form Values, Medical Device Values, Product Category Values, Product Cross Reference Type Values, Routes of Administration Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.

Registration Maintenance

The Registration Status Values list is now mapped to the Regulatory Entitlement Status from the SPOR Master Lists section. The RMS tab is added and mapping is done using the RMS search widget to associate RMS term to RIM value.

The Marketing Status Reason Values is renamed to Risk of Shortage of Supply Reason Values

For the Marketing Status Values, Master File Type Values, Medicinal Product Name Part Type Values, Medicinal Product Type Values, Provenance Reason Values, Qualified Person Responsible for Pharmacovigilance (QPPV) Values, Registration Status Values, Risk of Shortage of Supply Reason Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.

SPOR Master Lists

The Reason of Marketing Unavailability list is added to the the SPOR Master Lists section and mapped to the Risk of Shortage of Supply Reason Values list from the Registration Maintenance section.

For the Data Classification Type Values, Manufacturing Functions Values, Medical Device UID Values, Packaging Type Values, Product Material Values , Shelf Life Type Values, Storage Condition Values,Substance Role Values , Time Unit Values, the Data Administration lists that are associated with SPOR RMS now display the following columns in the grid/list view if there is an associated RMS Term for the value(s):
  • RMS Term ID - the term ID from the SPOR Master List.
  • RMS Modified On - the modified data from the operational attributes of the SPOR Master List.
  • RMS Status - the status of the term from the SPOR Master List.