Assembly Maintenance
Assembly values appear in drop-down lists on the Assembly Attributes page and are designated when an assembly is created. Data administration enables you to add and modify drop-down list values, and set the status of a value to active or inactive.
When you select a value under Assembly, a page opens with a table of all values that have been defined. You can sort these values by column. The default view is sorted in ascending, alphanumeric order.
The proper data administration access privileges are required to view and modify assembly values.
Assembly Maintenance: Assembly Values
You can create and maintain the following assembly values:
| Value | Description |
| Assembly Category | Clinical, non-clinical, submissions, etc. |
| Assembly DTD/Schema Type | us-2-01, ich-3-2, stf-2-2, etc. |
| Note: When creating or modifying the Assembly DTD/Schema Type value, regions available for selection in the Region field are limited by those of a Regulatory Region type only. | |
| Assembly Status | In draft, approved, suspended |
| Assembly Subcategory | Summary of clinical efficacy, clinical study report, drug master file, etc. |
Assembly Category Attributes
To define an assembly category value, enter values for the following attributes:
| Attribute | Description |
| Name | Category of assembly. |
| Last User Updated | Indicates the name of the user who last created/updated the assembly category. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Active | Indicates if the entity is active or inactive. |
Assembly DTD/Schema Type Attributes
To define an assembly DTD/Schema value, enter values for the following attributes:
Ennov InSight Administration 7.3 Assembly Maintenance
| Attribute | Description |
| DTD Code | Name of the zip file supplied for the DTD. Example: CA-1-0. |
| URL | Hyperlink to the source DTD or XML Schema Definition (XSD) file, if available. |
| Region | All active Region values of the Regulatory Region type. |
| Countries | All countries for the selected regions. |
| eCTD 4.0 Template Mapping |
Indicates the name of the eCTD 4.0 assembly template. You can select only one assembly template. The deleted eCTD 4.0 assembly template is automatically unassigned from all the Assembly DTD/Schema Type instances in Data Administration. |
| Last User Updated | Indicates the name of the user who last created/updated the assembly DTD/Schema. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Active | Indicates if the entity is active or inactive. |
Assembly Status Attributes
To define an assembly status value, enter values for the following attributes:
| Attribute | Description |
| Name | The name given for the Assembly status. |
| Default Flag | Flag to indicate if the product status is the default.Yes and No values are available for selection. |
| Effective Status | Effective Status. Yes and No values are available for selection. |
| Last User Updated | Indicates the name of the user who last created/updated the assembly status. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Active | Indicates if the entity is active or inactive. |
Assembly Subcategory Attributes
To define an assembly subcategory value, enter values for the following attributes:
Ennov InSight Administration 7.3 Assembly Maintenance
| Attribute | Description |
| Category | The subcategory given for the Assembly. |
| Name | Subcategory name. |
| Last User Updated | Indicates the name of the user who last created/updated the assembly subcategory. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Indicates the date when the last change was made. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Active | Indicates if the entity is active or inactive. |