Regulatory Submissions Table Page
As a Quality System Manager, when you create a non-revisable or revisable regulatory submission, a record of that submission is added to the Regulatory Submissions table.
This table is available from multiple locations:
Quality > Regulatory Submissions.
On the Details tab of a regulatory agency.
Some of the default information displayed on the Regulatory Submissions table are as follows:
Name
Description
Opens regulatory submission information table. For more information, see Regulatory Submission Information Page.
Object Type
Specifies regulatory submission type.
Name
Specifies the name of the regulatory submission.
Number
Specifies the unique number of the submission.
Identity
Specifies the number and version of the regulatory submission.
Subject
Specifies a part, a place, or a regulatory decision for which the regulatory submission is created. Some regulatory submissions can have multiple subjects.
Submitted To
Specifies the regulatory agency against which a submission is done.
Certificate Number
Specifies certificate number of a submission.
Expiration Date
Specifies date of expiration of a submission.
Expired
Specifies the expiry status of a submission.
Version
Specifies the latest iteration of the submission.
State
Specifies the lifecycle state of a submission.
Content
Specifies the content attached with a submission.
Remote
Specifies remote URL.
To customize or personalize the table, see Personalizing Tables and Customizing Table Views.
The most frequently used actions from the menu also appear as icons in the table toolbar.
Icon
Action
Description
New Regulatory Submission
Click this icon to create a new regulatory submission. For more information, see Creating a Regulatory Submission.
Copy Selected Object
Copy a part to the clipboard to be used in a subsequent paste operation.
New > New Change Notice
Create a new change notice. The change notice includes an implementation plan detailing the tasks required to make the change. For more information, see Creating a Change Notice.
New > New Review
Create a new review to validate the requirement.
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This action is available only for Products, Libraries, and Quality.
New > New Change Request
Create a new change request.
A change request details and quantifies the impact of the proposed changes and is created in response to one or more problem reports or without any reference to a problem report. For more information, see Creating a Change Request.
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This action is available only for Products, Libraries, and Quality.
New > New Problem Report
Create a new problem report to document a problem or request a product enhancement. For more information, see Creating a Problem Report.
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This action is available only for Products, Libraries, and Quality.
New > New Variance
Create a new variance in the folder. For more information, see Creating a Variance.
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This action is available only for Products, Libraries, and Quality.
Promotion request.
New > New Promotion Request
Create a promotion request for regulatory submissions. For more information, see Create a Promotion Request.
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This action is available only for Products, Libraries, and Quality.
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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 will get added in the affected objects table.
You can create change objects (change notice, change request, problem report, promotion request, variance, and review) only for the revisable regulatory submission and its subtypes such as adverse event regulatory submission, establishment registration submission, regulatory product submission, and unique device identifier submission.
Right-Click Actions
The following actions are applicable for a non-revisable regulatory submission except for the Revise, Check In, Check Out, and Undo Checkout action. Editing a revisable regulatory submission requires a checkout and a checkin.
Action
Description
Edit
Opens the Edit wizard where you can edit regulatory submission attributes and related details.
Check Out
Enables you to check out the revisable regulatory submission and prevent conflicts that might occur when multiple people are simultaneously editing the same submission at the same time.
Undo Checkout
Enables you to release the lock so that the revisable regulatory submission is available for checkout.
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.
Revise
Enables you to revise the regulatory submission. For more information, see Creating Revision Tasks for a Revisable Regulatory Submission.
Create Followup
Enables you to create a follow-up on a regulatory submission. For more information, see Creating Follow-up Tasks for a Regulatory Submission.
Set State
Enables you to change the lifecycle state of the submission. For more information, see Setting the State of an Object.
Undo Reservation
When this action is enabled, it indicates that another user has the object reserved for modification. You can use this action to manually revoke their reservation and allow another user to modify the object. This action is available only for the non-revisable regulatory submission.
A confirmation message appears with details about the user and the action they are performing.
Delete
Enables you to delete the regulatory submission.
Reassign Life Cycles
Enables you to reassign the lifecycle state to the regulatory submission.
Rename
Enables you to rename a regulatory submission.
New > New Change Notice
Create a change notice.
New > New Review
Create a review to validate the requirement.
New > New Problem Report
Create a problem report to document a problem or request a product enhancement.
New > New Variance
Create a variance in the folder.
New > New Change Request
Create a change request.
New > New Promotion Request
Create a promotion request.
Create a Regulatory Submission
Click the Actions menu to create a New Regulatory Submission. For more information, see Create a Regulatory Submission.
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