The Regulatory Tab
The Regulatory tab contains the Regulatory Submission Summary table. If this table is not available, you can add this table to a new tab by navigating to > > .
The Regulatory Submission Summary table displays all regulatory submissions and regulatory report decisions that are assigned as subjects or drivers of a customer experience or its regulatory report decision.
The following table describes the columns of a Regulatory Submission Summary table:
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Name
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Description
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Opens the regulatory submission information page. For more information, see Non-Revisable Regulatory Submission Information Page and Revisable Regulatory Submission Information Page.
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Object Type
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Indicates the regulatory submission type.
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Identity
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Specifies the number, organization, and version of the regulatory submission.
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Name
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Specifies the name of the regulatory submission.
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State
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Indicates the life cycle state of a regulatory submission.
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Subject
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Specifies the subject for the regulatory submission. Some regulatory submissions can have multiple subjects.
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Submitted To
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Specifies the regulatory agency to which a submission is made.
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Submission ID
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Specifies the ID of the regulatory submission on the customer experience information page.
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Submitted Date
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Specifies the date when the regulatory submission was submitted to the regulatory agency.
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Approval Date
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Specifies the date on which the regulatory submission was approved by the regulatory agency.
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Certificate Number
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Specifies the unique identifier of the regulatory submission that is assigned by the agency when it is approved.
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Expiration Date
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Specifies the expiration date of the regulatory submission.
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Expired
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Specifies if the regulatory submission has expired.
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Submission Stage
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Specifies the stage of the regulatory submission in the overall submission process.
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Content
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Specifies the primary content of the regulatory submission.
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Remote URL
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Specifies the URL of the regulatory submission available in the system hosted by the regulatory agency.
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Context
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Specifies the context and the organization to which the context belongs.
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The following actions are available from the right-click actions menu:
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Action
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Description
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Check In
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Enables you to submit your modification to the revisable regulatory submission as a new iteration and releases the lock to make it available for checkout.
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Check Out
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Enables you to check out the revisable regulatory submission to prevent conflicts that might occur when multiple people are simultaneously editing the submission.
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Undo Checkout
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Enables you to release the lock so that the revisable regulatory submission is available for checkout.
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Rename
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Enables you to rename a regulatory submission.
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Edit
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Enables you to open the Edit window where you can modify the attributes and related details of a regulatory submission.
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>
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Enables you to create a change notice.
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>
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Enables you to create a change request.
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>
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Enables you to create a problem report to document a problem or request a product enhancement.
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>
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Enables you to create a variance in the folder.
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>
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Enables you to create a review task to validate the requirement.
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>
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Enables you to create a promotion request.
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Copy
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Enables you to create a copy of the object type.
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Set State
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Enables you to change the life cycle state of the submission. For more information, see Setting the State of an Object.
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Delete
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Enables you to delete the regulatory submission.
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Reassign Life Cycles
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Enables you to reassign the life cycle state to the regulatory submission.
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• The non-revisable Regulatory Submission is not a changeable object. If you select multiple regulatory submissions including revisable and non-revisable, for creating a change object, then only revisable regulatory submission is added to the Affected Objects table.
• You can create change objects (change notice, change request, problem report, promotion request, variance, and review) only for a revisable regulatory submission and its subtypes such as adverse event regulatory submission, establishment registration submission, regulatory product submission, and unique device identifier submission.
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By default, the table view is set to All. You can change the view to Work in Process. This view displays the regulatory submission in the Submitted or In Progress submission stage. For more information on managing table views, see Table and Table View Overview. To specify a table view, see Customizing Table Views.