Ennov InSight 7.2 Release Notes (Cumulative)

Data Administration Tables Added: Ennov InSight 7.2

The following Data Administration tables, sections, or fields were added for Ennov InSight 7.2. These include the tables added to support IDMP data capture.

Data Administration Section: Other

Table 1. Certificate Master File Values
Entity Affected Field Name Value List Description
Application, Substance, Manufacturer
  • Master File Name
  • Master File Type
  • Master File Version
  • Master Identifier
  • Certificate Type
  • Certificate Number
  • Submission Date
  • Date of Last Update
  • Substance Reference
  • Related Application
  • Manufacturer
  • Content Link
  • Local Identifier
  • Last User Updated
  • Last Changed Date
  • Status
  • Version
To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the Certificate Master File Values table is introduced.
Table 2. File Identifier Type Values
Entity Affected Field Name Value List Description
Application, Substance
  • Filе Identifier Type
  • Last User Updated
  • Last Changed Date
To maintain a standardized and structured method of collecting, reporting, coding, and evaluating authorized medicinal product data, the File Identifier Type Values table is introduced.

Data Administration Section: Product Family Maintenance

Table 3. Substance Subtype Type
Entity Affected Field Name Value List Description
Application, Substance Name Subtypes of substance. The following values pre-populate in the grid. You cannot activate/modify the values below. For configuration assistance, contact our support representatives.
  • Uncategorized (inactive by default)
  • CMR Substance
  • Endocrine Substance
  • Strain
  • Human Product Substance
  • Placeholder
  • Substance

Data Administration Section: Product Detail Set Maintenance

Table 4. Origin of Substance Values
Entity Affected Column/Field Name Value List Description
Product Detail Set Origin of Substance For additional medicinal product data, the Origin of Substance Values table is introduced. The value for Origin of Substance can be entered in the respective field.

Data Administration Section: SPOR Master Lists

Table 5. Substance
Entity Affected Column/Field Name Value List Description
Substance
  • Identifier
  • Name
  • Data Classification
  • Category
  • Domain
  • Code
To display the associated existing substance data to uniquely identify the ingredients and materials of a medicinal product Substance table is introduced.
Table 6. Reason for Marketing Unavailability Values
Entity Affected Column/Field Name Value List Description
N/A
  • List ID
  • List Name
  • List Owner
  • Term Id
  • Term Name
  • Short Name
  • Status
  • Domain
  • Modified On
  • Source Id
  • Source Term Id
  • Default Flag
  • Active Flag
  • XEVMPD Code
  • Description
  • Comments
  • Version Number
  • ISO Code
  • Creation Date
  • Modification Date
Indicates the reason for the drug unavailability in the market. You cannot create/modify the respective value and its attributes.

Data Administration Section: Medical Device Maintenance

Table 7. Global Medical Device Nomenclature (GMDN) Code Values
Entity Affected Field Name Value List Description
Product Component Device Details
  • GMDN Code
  • GMDN Term Name
  • GMDN Term Definition
  • Term is IVD
Global Medical Device Nomenclature (GMDN) Code used to identify medical devices.
Table 8. EU Device Nomenclature Values
Entity Affected Field Name Value List Description
Product Component Device Details
  • Device Nomenclature Category
  • Device Nomenclature Code
  • Device Nomenclature Code Name/Description
A set or system of names used by manufacturers when registering their medical devices in the EUDAMED database.
Table 9. EU Device Nomenclature Category Values
Entity Affected Field Name Value List Description
Product Component Device Details
  • Device Nomenclature Category Name
  • Device Nomenclature Code Value
They type of the nomenclature used by the manufacturers to register medical devices in EUDAMED.
Table 10. FDA GMDN In-Vitro Term Type Values
Entity Affected Field Name Value List Description
Product Component Device Details GMDN In-Vitro Term Type The GMDN type used to identify Vitro diagnostic devices for the FDA submission.
Table 11. EU Category of CMR Type Values
Entity Affected Field Name Value List Description
Product Component Device Details Category of CMR Type Different categories of the medications that are required to prepare for medical issues of a patient.