Assembly Maintenance: 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 | Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Defines when the Data Administration value was created/updated. 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 Attributes
To define an assembly DTD/Schema value, enter values for the following attributes:
| Attribute | Description |
|---|---|
| DTD Code | Name of the zip file supplied for the DTD. Example: CA-1-0. |
| URL | Name of the zip file supplied for the DTD. Example: ca-1-0. |
| Region | All active values of Regulatory Region type from the Region Values. |
| Countries | All countries for the selected regions. |
| Last User Updated | Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Defines when the Data Administration value was created/updated. 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 | Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Defines when the Data Administration value was created/updated. 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:
| Attribute | Description |
|---|---|
| Category | The subcategory given for the Assembly. |
| Name | Subcategory name. |
| Last User Updated | Defines by whom the Data Administration value was created/updated. By default, this option is read-only. It is populated automatically when updates were made to the table. |
| Last Changed Date | Defines when the Data Administration value was created/updated. 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. |