Regulatory Master Preferences

Additional Capabilities > Windchill Quality Management Solutions > Windchill Regulatory Submissions > Regulatory Master Administration > Defining the Types of Regulatory Submissions > General Information about Regulatory Submission > Regulatory Master Preferences

The Regulatory Master preference group determines the behavior of a variety of regulatory submission objects.

All preferences are set at the quality, organizations, or site level by an administrator. To set or update a preference, navigate to Site > Utilities > Business Administration > Preference Management > Regulatory Master. For more information, see Preference Management and Setting a Preference.

The following sections describe the preferences available in the Regulatory Master preference subcategories.

Preferences for Regulatory Product Submission (RPS)

The Regulatory Master preferences that control the configuration of the regulatory product submission types are organized in the Regulatory Product Submission folder.

Preference	Description	Default Value
Remove RPS Regulatory Content for Revisions	Provides the ability to remove specific regulatory content from all types of RPS regulatory submissions when a new revision is created. You can select one or more regulatory content categories in the Value field.	Not set
Reset RPS Tracking Attributes for Revisions	Provides the ability to reset specific tracking attributes from all types of RPS regulatory submissions when a new a revision is created. Select one of the following values: • Reset All Submission Tracking Attributes to reset Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired. • Preserve Certificate Information Only to preserve Certificate Number, Expiration Date, and Expired. This assumes that a new electronic submission will be filed with each revision. • Do Not Reset Any Submission Tracking Attributes to preserve Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired.	Do Not Reset Any Submission Tracking Attributes

Preferences for Unique Device Identifier Submission (UDI)

The Regulatory Master preferences that control the configuration of the unique device identifier submissions are organized in the Unique Device Identifier Submission folder.

Preference	Description	Default Value
Remove UDI Regulatory Content for Revisions	Provides the ability to remove specific regulatory content from all types of UDI regulatory submissions when a new revision is created. You can select one or more regulatory content categories in the Value field.	Not set
Reset UDI Tracking Attributes for Revisions	Provides the ability to reset specific tracking attributes from all types of UDI regulatory submissions when a new a revision is created. Select one of the following values: • Reset All Submission Tracking Attributes to reset Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired. • Preserve Certificate Information Only to preserve Certificate Number, Expiration Date, and Expired. This assumes that a new electronic submission will be filed with each revision. • Do Not Reset Any Submission Tracking Attributes to preserve Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired.	Do Not Reset Any Submission Tracking Attributes

Preferences for Adverse Event Regulatory Submission (AER)

The Regulatory Master preferences that control the configuration of the adverse event report submission types are organized in the Adverse Event Regulatory Submission folder.

Preference	Description	Default Value
Remove AER Regulatory Content for Revisions	Provides the ability to remove specific regulatory content from all types of AER regulatory submissions when a new revision is created. You can select one or more regulatory content categories in the Value field.	Not set
Reset AER Tracking Attributes for Revisions	Provides the ability to reset specific tracking attributes from all types of AER regulatory submissions when a new a revision is created. Select one of the following values: • Reset All Submission Tracking Attributes to reset Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired. • Preserve Certificate Information Only to preserve Certificate Number, Expiration Date, and Expired. This assumes that a new electronic submission will be filed with each revision. • Do Not Reset Any Submission Tracking Attributes to preserve Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired.	Do Not Reset Any Submission Tracking Attributes

Preferences for Establishment Registration Submission (ER)

The Regulatory Master preferences that control the configuration of the establishment registration submission types are organized in the Establishment Registration Submission folder.

Preference	Description	Default Value
Remove ER Regulatory Content for Revisions	Provides the ability to remove specific regulatory content from all types of ER regulatory submissions when a new revision is created. You can select one or more regulatory content categories in the Value field.	Not set
Reset ER Tracking Attributes for Revisions	Provides the ability to reset specific tracking attributes from all types of ER regulatory submissions when a new a revision is created. Select one of the following values: • Reset All Submission Tracking Attributes to reset Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired. • Preserve Certificate Information Only to preserve Certificate Number, Expiration Date, and Expired. This assumes that a new electronic submission will be filed with each revision. • Do Not Reset Any Submission Tracking Attributes to preserve Submitted Date, Submission ID, Approval Date, Certificate Number, Expiration Date, and Expired.	Do Not Reset Any Submission Tracking Attributes