The Regulatory Tab
The Regulatory tab contains the Regulatory Submission Summary table. You can add this table to a new tab from multiple locations:
In the customer experience information page, navigate to Customize > Related Objects > Regulatory Submission Summary — Displays all regulatory submissions and regulatory report decisions that are assigned as subjects or drivers of a customer experience or its regulatory report decision.
In the part information page, navigate to Customize > Quality > Regulatory Submission Summary — Displays all regulatory submissions that are assigned as subjects of parts. A regulatory submission is displayed for all the previous revisions and the current revision of a part. The following actions are available from the table toolbar:
Create regulatory submission—Enables you to create a regulatory submission for a part.
Copy—Enables you to create a copy of the object type.
The following table describes the columns of a Regulatory Submission Summary table:
Name
Description
Opens the regulatory submission information page. For more information, see Non-Revisable Regulatory Submission Information Page and Revisable Regulatory Submission Information Page.
Object Type
Indicates the regulatory submission type.
Identity
Specifies the number, organization, and version of the regulatory submission.
Name
Specifies the name of the regulatory submission.
State
Indicates the life cycle state of a regulatory submission.
Subject
Specifies the subject for the regulatory submission. Some regulatory submissions can have multiple subjects.
Submitted To
Specifies the regulatory agency to which a submission is made.
Submission ID
Specifies the ID of the regulatory submission on the customer experience information page.
Submitted Date
Specifies the date when the regulatory submission was submitted to the regulatory agency.
Approval Date
Specifies the date on which the regulatory submission was approved by the regulatory agency.
Certificate Number
Specifies the unique identifier of the regulatory submission that is assigned by the agency when it is approved.
Expiration Date
Specifies the expiration date of the regulatory submission.
Expired
Specifies if the regulatory submission has expired.
Submission Stage
Specifies the stage of the regulatory submission in the overall submission process.
Content
Specifies the primary content of the regulatory submission.
Remote URL
Specifies the URL of the regulatory submission available in the system hosted by the regulatory agency.
Context
Specifies the context and the organization to which the context belongs.
The following actions are available from the right-click actions menu:
Action
Description
Check In
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.
Check Out
Enables you to check out the revisable regulatory submission to prevent conflicts that might occur when multiple people are simultaneously editing the submission.
Undo Checkout
Enables you to release the lock so that the revisable regulatory submission is available for checkout.
Rename
Enables you to rename a regulatory submission.
Edit
Enables you to open the Edit window where you can modify the attributes and related details of a regulatory submission.
New > New Change Notice
Enables you to create a change notice.
New > New Change Request
Enables you to create a change request.
New > New Problem Report
Enables you to create a problem report to document a problem or request a product enhancement.
New > New Variance
Enables you to create a variance in the folder.
New > New Review
Enables you to create a review task to validate the requirement.
New > New Promotion Request
Enables you to create a promotion request.
Copy
Enables you to create a copy of the object type.
Set State
Enables you to change the life cycle state of the submission. For more information, see Setting the State of an Object.
Delete
Enables you to delete the regulatory submission.
Reassign Life Cycles
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.
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. You can change the view to Expired in the part information page only. This view displays the regulatory submission in the Expired submission stage. For more information on managing table views, see Table and Table View Overview. To specify a table view, see Customizing Table Views.
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