Editing a Regulatory Submission
You can edit a non-revisable and revisable regulatory submission from the following locations:
• Regulatory Submissions table. Navigate to Quality container > > table. Right-click a regulatory submission and select Edit. The regulatory submission Edit wizard opens.
• Regulatory Submission information page. Navigate to the regulatory submission information page, click > . The regulatory submission Edit wizard opens.
• Task information page of a regulatory submission. Click > . The regulatory submission Edit wizard opens.
Perform following steps in the regulatory submission Edit wizard:
1. In the Set Attributes tab, edit the attribute values as required, and click Next.
2. On the Assign Subjects step, assign subjects to the regulatory submission by adding parts, places, 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.
3. 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.
4. In the Set Primary Content tab, you can add or replace regulatory submission documents as attachments. Select an option from the Primary Content Source list.
5. Enter details for the selected option of attachment content and click Finish. The attached content appears in the Primary Content tab of the regulatory submission information page.