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:
• > .
• On the Details tab of a regulatory agency.
Some of the default information displayed on the Regulatory Submissions table are as follows:
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Name
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Description
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Opens regulatory submission information table. For more information, see Regulatory Submission Information Page.
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Object Type
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Specifies regulatory submission type.
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Name
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Specifies the name of the regulatory submission.
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Number
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Specifies the unique number of the submission.
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Identity
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Specifies the number and version of the regulatory submission.
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Subject
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Specifies a part, a place, or a regulatory decision for which the regulatory submission is created. Some regulatory submissions can have multiple subjects.
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Submitted To
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Specifies the regulatory agency against which a submission is done.
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Certificate Number
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Specifies certificate number of a submission.
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Expiration Date
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Specifies date of expiration of a submission.
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Expired
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Specifies the expiry status of a submission.
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Version
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Specifies the latest iteration of the submission.
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State
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Specifies the lifecycle state of a submission.
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Content
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Specifies the content attached with a submission.
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Remote
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Specifies remote URL.
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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.
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Icon
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Action
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Description
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New Regulatory Submission
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Click this icon to create a new regulatory submission. For more information, see Creating a Regulatory Submission.
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Copy Selected Object
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Copy a part to the clipboard to be used in a subsequent paste operation.
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>
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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.
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Create a new review to validate the requirement.
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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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>
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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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Create a new variance in the folder. For more information, see Creating a Variance.
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Create a promotion request for regulatory submissions. For more information, see Create a Promotion Request.
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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.
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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.
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Action
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Description
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Edit
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Opens the Edit wizard where you can edit regulatory submission attributes and related details.
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Check Out
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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.
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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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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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Revise
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Enables you to revise the regulatory submission. For more information, see Creating Revision Tasks for a Revisable Regulatory Submission.
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Create Followup
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Enables you to create a follow-up on a regulatory submission. For more information, see Creating Follow-up Tasks for a Regulatory Submission.
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Set State
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Enables you to change the lifecycle state of the submission. For more information, see Setting the State of an Object.
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Undo Reservation
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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.
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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 lifecycle state to the regulatory submission.
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Rename
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Enables you to rename a regulatory submission.
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>
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Create a change notice.
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>
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Create a review to validate the requirement.
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>
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Create a problem report to document a problem or request a product enhancement.
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Create a variance in the folder.
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Create a change request.
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Create a promotion request.
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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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