Summary
This article covers the features of the regulatory requirements manager including the storage and tracking of standard requirement sets.
Table of Contents
- Access Regulatory Requirements Manager
- Available Columns and Filter Types
- Actions
- Choose an Action – Press Go
The Regulatory Requirements Manager allows for the storage and tracking of Standard Requirement Sets that have been stored in the system. From this screen each requirement set that has been added to a regulatory body in the Regulatory Manager can be seen alongside their associated regulatory bodies, categories and contacts.
Access Regulatory Requirements Manager
From within the CTMS platform, click the expandable menu to the left of the screen. Expand the Regulatory option and select Regulatory Requirements.
Available Columns and Filter Types
The Regulatory Requirements Manager has many columns that can be dragged and dropped between the manager and filters menu. The values of the requirement set, regulatory bodies, regulatory categories, and the contacts columns serve as links to the records they represent. For more information see the article on CTMS Managers.
The following table defines each column, the actions made available through the column value and the filters and sorts available.
| Name | Value | Action | Sortable | Filters |
|---|---|---|---|---|
| Requirement Status | Indicates if the requirement set is active or deleted. | (none) | Yes | Choice |
| Requirement Set | Displays the name of the requirement set in the table. | Links to the Standard Requirement Set Screen containing the Requirement Set Form. | Yes | Text |
| Regulatory Bodies | Displays a list of the regulatory bodies the requirement set has been associated with. | Each entry links to the Regulatory Body Form it represents. | Yes | Choice |
| Regulatory Categories | Displays the regulatory categories the requirement set has been added to. | Each entry links to the Regulatory Category Form it represents. | Yes | Choice |
| Countries | Displays the countries in which the requirement set’s associated Regulatory Bodies operate. | (none) | Yes | Choice |
Actions
The Actions Menu can be expanded by clicking and contains the following options:
Add Regulatory Body
By clicking the Add Regulatory Body Action, you will be directed to a new Regulatory Body form that can be saved to add a new record to the Regulatory Bodies Manager.
Add Requirement Set
By clicking the Add Requirement Set Action, you will be directed to a new Standard Requirements Set form that can be saved to add a new record to the Regulatory Requirements Manager.
Exports
By clicking the options Excel or CSV, the system will provide an export of the information currently displayed in the Manager table in the chosen format. The content of this export will be based on the filters applied to the table at the time of export.
Choose an Action – Press Go
The Choose an Action – Press Go dropdown can be expanded by clicking and contains the following options.
Deletion
A regulatory requirement set can be deleted and restored through the Regulatory Requirements Manager. If a regulatory requirement set is used/referenced for a regulatory body the connection between the set and the body will be removed upon the deletion of the requirements.
To Delete
To delete a regulatory requirement, the Requirements Status must be set to Active Only.
- Select the checkbox by the Regulatory Requirement record.
- Select Delete Checked in the Choose An Action Press-Go dropdown.
- Select Delete button on the Confirmation Page.
To Restore
To restore a deleted regulatory requirement, the Requirements Status must be set to Deleted Only.
- Select the checkbox by the Regulatory Requirement record.
- Select Restore Checked in the Choose an Action Press-Go dropdown.
- Select Restore button on the Confirmation Page.
Need more help?
Please visit the Fountayn Contact Information page.