Creating a Regulatory Submission

Additional Capabilities > Windchill Quality Management Solutions > Windchill Regulatory Submissions > Managing Regulatory Submissions > Creating a Regulatory Submission

You can create a regulatory submission in two ways:

• From the information page of a part, a regulatory decision, or a place

• From the Regulatory Submissions table page

Creating a Regulatory Submission from the Information Page

To create a regulatory submission, perform following steps:

1. Navigate to the information page of the part for which you want to create a regulatory submission.

2. Click

to add new tab and open the Customize drop-down menu.

3. Click Customize > Quality > Regulatory Submission. The Regulatory Submissions table appears. You can rename the tab as required.

4. Click Actions > New Regulatory Submission. A New Regulatory Submission wizard opens. You can use the navigation breadcrumbs or the actions at the bottom of this New Regulatory Submission wizard to navigate the wizard.

5. Add details for Set Context and Set Attributes step. The Set Context step is displayed if no context is available.

6. On the Assign Subjects step, assign subjects to the regulatory submission by adding parts, places, customer experiences, or regulatory decisions in the Subject Picker window. The subject objects are controlled by the type of regulatory submission you are creating. When done, click Next to assign drivers.

7. (Optional). On the Assign Drivers step, assign drivers by adding any additional parts, documents, UDI super sets, regulatory decisions, customer experiences, regulatory submissions, or places that may be needed for the regulatory submission. The driver objects depend on the type of regulatory submission you are creating.

8. Complete all the details in the New Regulatory Submission wizard and click Finish.

The newly created regulatory submission is added in the Regulatory Submissions table. For more information, see Regulatory Submissions Table Page.

Creating a Regulatory Submission from the Regulatory Submissions Table Page

To create a regulatory submission, perform following steps:

1. Click Actions > New Regulatory Submission on the Regulatory Submissions Table Page. This opens the New Regulatory Submission wizard. You can use the navigation breadcrumbs or the actions at the bottom of this New Regulatory Submission wizard to navigate the wizard.

2. Add details for the Set Attributes step and click Next.

3. On the Assign Subjects step, assign subjects to the regulatory submission by adding parts, places, customer experiences, or regulatory decisions in the Subject Picker window. The subject objects are controlled by the type of regulatory submission you are creating. When done, click Next to assign drivers.

4. (Optional). On the Assign Drivers step, assign drivers by adding any additional parts, documents, UDI super sets, regulatory decisions, customer experiences, regulatory submissions, or places that may be needed for the regulatory submission. The driver objects depend on the type of regulatory submission you are creating.

5. Click Finish.

The regulatory submission is created in the Regulatory Submissions table.