Most companies are required to provide a qualification submission to gain authorization to sell their products in the markets of a given geography. 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 artefacts 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.

The Windchill Regulatory Master module is a licensed feature. The Regulatory Master license usage is recorded for following user actions:

For license related details, see Out-of-the-Box Profiles and Managing User License Entitlements.

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:

All regulatory submissions appear as search results using advanced search. You can also search for regulatory submission using Indexed (Solr) search and find them based on the primary content.

Administrators should create regulatory submission report and submit it to the regulatory agency to get their product certified.

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.