Windchill Regulatory Submissions
Most companies are required to provide a qualification submission to gain authorization to sell their products in the markets of a given geography. Market authorization typically requires a submission of the product information in a country or region-specific format, for every country or region where it is sold. Typically, market authorizations must be renewed annually or updated when the product changes. For example, Food and Drug Administration requires clinical submissions like New Drug Application, Pre-Market Authorization or 510K submission, electronics industries require to get their products UL certified, and so on. The Regulatory Submission feature provides a centralized mechanism to track, manage and maintain artifacts that are submitted to regulatory agencies. It helps organizations with a process to document their compliance and submissions to regulatory agencies.
This feature provides customization capabilities that you can leverage to create and automate the submission process to meet business requirements.
License
The Windchill Regulatory Master module is a licensed feature. The Regulatory Master license usage is recorded for following user actions:
• Create Regulatory Submission
• Edit Regulatory Submission
• Delete Regulatory Submission
• View Regulatory Submission
• Create Follow-up of a Regulatory Submission
• Complete a Regulatory Submission task
For license related details, see Out-of-the-Box Profiles and Managing User License Entitlements.
Process Flow
A Quality System Manager can create a new submission, that will mature into a regulatory submission. You can view the life cycle states for a regulatory submission by clicking the life cycle state displayed on the regulatory submission information page.
The default process flow in a regulatory submission is as follows:
1. In Progress
2. Completed
3. Cancelled
 |
Additional lifecycle states and lifecycle transitions can be added through configuration of the lifecycle template.
|
Searching a Regulatory Submission
All regulatory submissions appear as search results using advanced search.
Reporting a Regulatory Submission
Administrators should create regulatory submission report and submit it to the regulatory agency to get their product certified.
Deleting a Regulatory Submission
The delete action is available on the regulatory submissions table. Select one or more regulatory submission records and click 
Delete.
Delete.Expiration of Regulatory Submission
You can set an expiration date to a regulatory submission. When, the expiration date has passed, the regulatory submission will expire automatically. You can modify the expiration date from the edit wizard of the regulatory submission.
Follow-up of a Non-Revisable Regulatory Submission
You can create a new iteration of a regulatory submission that has been completed or has expired.
Revision of a Revisable Regulatory Submission
You can revise a regulatory submission after the submission has been completed or has expired.