Ennov InSight 7.2 Release Notes (Cumulative)

Data Administration Tables Updated: Ennov InSight 7.2

Data Administration tables, sections, or fields updated in Ennov InSight 7.2 release. These include the tables modified to support IDMP data capture.

Data Administration Section: Product Family Maintenance

Entity Affected Column/Field Name Value List Description
N/A
  • RMS Term ID
  • RMS Modified On
  • RMS Status
The following values now include the respective columns:
  • ATC Values
  • Domain Type Values
Table 1. Substance Values
Entity Affected Field Name Value List Description
Substance
  • Term ID
  • Substance Name
  • Data Classification
  • Category
  • Domain
  • Last User Updated
  • Last Changed Date
  • Active Flag
The Substance Values attributes page is updated with SMS tab, including the columns to associate and display the data from SPOR Master Lists > Substance.
Substance
  • Type
  • Substance Name
  • INN
  • CAS Number
  • Molecular Formula
  • Compound Number
  • XEVMPD Development Substance
  • Substance Level Class
  • CBD
  • Development Sponsor
  • Compendial Designation/Source
  • Keywords
  • Description
  • Comments
  • Last Changed Date
  • Alias Name
  • Compendial Designation/Source:
With the implementation of the new SMS tab, the Substance Alias tab under Substance Values is now hidden.
Substance
  • Type
  • Substance Name
  • INN
  • CAS Number
  • Molecular Formula
  • Compound Number
  • XEVMPD Development Substance
  • Substance Level Class
  • CBD
  • Development Sponsor
  • Compendial Designation/Source
  • Keywords
  • Description
  • Comments
  • Last User Updated
  • Last Changed Date
  • Language
  • Translation Term
With the implementation of the new SMS tab, the Substance Translations tab under Substance Values is now hidden.
Substance SMS Term ID This column is added to Data Administration > Substance Values grid view and displays the data from SPOR Master Lists > Substance.
Substance XEVMPD Standard Term This column is added to Data Administration > Substance Values grid view and displays the data from Substance XEVMPD Information > EV Code.
Substance Substance Name This column is updated to display the data from SPOR Master Lists > Substance in the grid view.
N/A Type The Type column in the Substance Values page is updated to pre-populate the following values:
  • CMR Substance
  • Endocrine Substance
  • Uncategorized
N/A Type The Type field in the Substance Values (Create and Edit) page is updated to display the following values from the Data Administration > Substance Subtype Type Values grid:
  • Uncategorized (inactive by default)
  • CMR Substance
  • Endocrine Substance
  • Strain
  • Human Product Substance
  • Placeholder
  • Substance
N/A Category of CMR Type The Substance Values (Create/Edit) pages are updated with a new Category of CMR Type field. This field appears only when you select the CMR Substance value in the Type field.
Table 2. EURD ID Values
Entity Affected Column/Field Name Value List Description
N/A Family Identifier/Active Substances The EURD Procedure Identifier field and column is renamed to Family Identifier/Active Substances on the EURD ID Values.

Data Administration Section: Other

Entity Affected Column/Field Name Value List Description
N/A
  • RMS Term ID
  • RMS Modified On
  • RMS Status
The following values now include the respective columns:
  • 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
Table 3. MAH /Development Sponsor /Organisation Values
Entity Affected Column/Field Name Value List Description
N/A xEVMPD In OMS Term Search widget, this field is updated to pre-populate the existing XEVMPD code if it exists for Organization. If the XEVMPD Code (MAH Code EV Code) exists on the MAH/Development Sponsor XEVMPD Information tab for MAH/Development Sponsor/Organisation Values, it is pre-populated in the Code search field on the OMS Term Search widget.

Data Administration Section: Product Detail Set Maintenance

Entity Affected Column/Field Name Value List Description
N/A
  • RMS Term ID
  • RMS Modified On
  • RMS Status
The following values now include the respective columns:
  • 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
Table 4. Manufacturer Values
Entity Affected Column/Field Name Value List Description
N/A Confidentiality Indicator This flag is now available on the Global Detail Sets page (Manufacturer Values > Global Product Details ) when you select Packaging or Substance option for the Detail Type field.

The Confidentiality Indicator flag displays values from the Product Detail Set Maintenance > Data Classification Type values.

N/A
  • Country
  • Regulatory Agency
The Manufacturing Authorisation Reference Number page and tab of the Manufacturer Values table is updated to include the respective fields and columns.
N/A
  • Labeler DUNS Number/Legal Manufacturer Single Registration Number(SRN)
  • Authorized Representative Name
The Manufacturer (View/Create/Edit) pages are updated with the following new fields:
  • Labeler DUNS Number/Legal Manufacturer Single Registration Number(SRN)
  • Authorized Representative Name
Table 5. Packaging Category Values
Entity Affected Column/Field Name Value List Description
N/A IDMP Package Level The Packaging Category Values page now includes the respective field.
Table 6. Time Unit Values
Entity Affected Column/Field Name Value List Description
N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
The Time Unit Values table is updated with a new RMS tab to associate the SPOR Units of Measurement values. The RMS tab grid view includes the respective columns and displays the data from SPOR Master Lists > Unit of Measurement.
Table 7. Package Component Values
Entity Affected Column/Field Name Value List Description
N/A Product Material The Product Material drop-down field type is updated to an optional multi-select field type. This includes Available and Selected boxes. You can move values from the Product Material Available box to the Selected box and vice-versa.

Data Administration Section: Registration Maintenance

Entity Affected Column/Field Name Value List Description
N/A
  • RMS Term ID
  • RMS Modified On
  • RMS Status
The following values now include the respective columns:
  • 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
Table 8. Risk of Shortage of Supply Reason Values
Entity Affected Column/Field Name Value List Description
N/A N/A The Marketing Status Reason Values is renamed to be Risk of Shortage of Supply Reason Values.
Table 9. Registration Status Values
Entity Affected Column/Field Name Value List Description
N/A
  • Term ID
  • Term Name
  • Description
  • Last User Updated
  • Last Changed Date
  • Active Flag
The Registration Status Values table is updated with a new RMS tab to associate the SPOR Regulatory Entitlement Status values. The RMS tab grid view includes the respective columns and displays the data from SPOR Master Lists > Regulatory Entitlement Status.

Data Administration Section: Application Maintenance

Entity Affected Column/Field Name Value List Description
N/A
  • RMS Term ID
  • RMS Modified On
  • RMS Status
The following values now include the respective columns:
  • Country Values
  • Legal Status Values
  • Orphan Status Values
  • Procedure Type Values
  • Product Information Document Type Values
  • Regulatory Entitlement Type Values

Data Administration Section: Product Maintenance

Entity Affected Column/Field Name Value List Description
N/A
  • RMS Term ID
  • RMS Modified On
  • RMS Status
The following values now include the respective columns:
  • Dosage/Pharmaceutical Form Values
  • Medical Device Values
  • Product Category Values
  • Product Cross Reference Type Values
  • Routes of Administration Values