Enhancements to Regulatory Submissions (Med Device)
Windchill 12.1.2.9
Description
The Regulatory Hub solution supports non-revisable as well as revisable regulatory submissions that can co-exist and can be executed through their submission processes. These regulatory submissions provide a configurable Subject and Driver link that can reference relevant information for the regulatory submission.
You can initiate, manage, and maintain the revision-controlled regulatory submissions. The revisable regulatory submissions can also be managed in the following ways using the Change Management processes.
• Adding revisable regulatory submissions in the Affected Objects and Resulting Objects tables of the Problem Report, Variance, Change Request, Change Notice, and Review.
• Creating promotion requests for revisable regulatory submissions. You can add quality as the context and regulatory submission types as objects while creating a promotion request.
• Applying the relationship constraint rules for revisable regulatory submission objects in the Type Manager hierarchy.
• Recognizing revisable regulatory submission objects as changeable in the Type Manager hierarchy.
• Using the Business Rule and Mapping Rule configurations like any other changeable objects.
You can create, edit, and delete table data from the Edit Regulatory Submission window table data while editing a regulatory submission.
The Acknowledgement Messages table on the information page of the regulatory submission displays the acknowledgement messages from the regulatory agencies. You can configure this table on a native workflow task template.
The Regulatory Submission Type attribute allows you to define the type of regulatory submission that you want to create for a type of Customer Experience Regulatory Report Decision. You can specify customer experience as the subject of a regulatory submission.
You can use the latest set of sample workflows as a best practice to build your workflows.
The Regulatory Submission Processor Interface enables you to customize the behavior of regulatory submissions. It includes the following methods for:
• Populating attributes
• Generating the human-readable report
• Generating the submission payloads
• Processing acknowledgements
• Switching to an alternate editing user interface
• Adding methods for submitting the regulatory submissions based on the type of regulatory submission
• Processing the expired regulatory submissions
• Configuring the type of content to be sent to a regulatory agency
• Cancelling the terminated regulatory submissions
The Regulatory Transmission Delegate Interface enables you to customize the transmission of regulatory submissions to regulatory agencies. The simulate communication method enables you to test the transmission process during development. The Azure file drop communication method enables you to store the payloads in Azure Blob Storage. New properties have been added for regulatory submissions.
The Regulatory Submission Summary table in the customer experience information page displays all the regulatory submissions with customer experiences or its regulatory report decisions assigned as the subject. It is visible only to the users in specific roles and those who are members of the View CEM Regulatory Submissions license profile. The Related Tasks table is enhanced to display tasks for the regulatory submissions.
The method for generating the human-readable report has been enhanced to specify that a draft report can be generated. The human-readable report also uses a dedicated Report Screen layout for its format.
Related Information
For more information, see
Folder Table Actions,
Regulatory Submissions Table Page,
Affected Objects, Review Objects, Affected End Items, and Resulting Objects,
Managing Table Data for a Regulatory Submission,
Create a Promotion Request,
Acknowledgement Messages Table,
Configuring the Submitted To Attribute,
Regulatory Submission Processor Interface,
Regulatory Transmission Delegate Interface,
Developing a Submission Processor,
Developing an Expiration Processor,
Developing a Cancellation Processor,
Developing a Completion Processor,
Developing an Acknowledgement Interpreter,
Developing a Clean Transmission Content Processor,
Configuring the Submitted To Attribute,
Creating a Regulatory Submission,
Setting up Subjects for a Regulatory Submission,
Using the Simulate Transmission Delegate,
Using the Azure File Drop Transmission Delegate,
Regulatory Master Properties,
The Regulatory Tab,
About the Regulatory Submission Process, and
Developing a Report.