Regulatory Content
All regulatory submissions submitted electronically to a regulatory agency require specific information or regulatory content prepared according to the regulatory standards. Examples of regulatory content include the regulatory submission payload and the regulatory submission acknowledgements. You can create and attach the regulatory content to a revisable and non-revisable regulatory submission. Currently the ability to create, update, and delete Regulatory Content can only be done using supported Windchill APIs and ODATA REST Services. For information on creating, and managing the regulatory content, see the Windchill Rest Services Help Center.
The Regulatory Content table provides details of the regulatory content attached to the regulatory submission. You can view the Regulatory Content table from the regulatory submission information page.
The following information is contained in the Regulatory Content table:
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Column Heading
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Description
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Category
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Category of the regulatory content.
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Label or File Name
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The name of the uploaded document.
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Opens the regulatory content information page.
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Format
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The file type of content used as the regulatory content.
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Last Modified
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The date and time when the regulatory content was last checked in or edited.
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Modified By
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The user who last performed a check in or edit for the regulatory content.
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The following actions are available from the table toolbar or from the table rows.
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Icon
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Description
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Download multiple files.
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Download the local file attachment
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Consider the following points about regulatory content:
• You can attach only one regulatory content of each category to a regulatory submission.
• The regulatory content is carried forward when a new iteration or revision is created for a revisable regulatory submission.
• The regulatory content is carried forward when a follow-up is created for a non-revisable regulatory submission.
Configure Regulatory Content Categories
The Customize Modeled Enumerations panel in the Type and Attribute Management utility allows you to add and customize the regulatory content categories. The out-of-the-box categories available are:
• Acknowledgement1
• Acknowledgement2
• Acknowledgement3
• Certificate of Registration
• Regulatory Submission Payload
For more information on customizing enumerations, see Customize Modeled Enumerations Utility.