Create a Commitment

As a condition of approving a pharmaceutical product to be marketed, or approving changes to the products, a Health Authority may require changes to a Submission, or require that additional information be provided in areas such as safety, efficacy or optimal dosage. These are regulatory commitments. When you receive a regulatory commitment from a Health Authority, create a commitment in Veeva RIM Basics to track progress and ensure a timely response.

Create a Commitment

To create a commitment:

1. Navigate to Submission Mgmt > Health Authority Communications > Commitments and click Create.

   

2. Enter the commitment Details, including a Due Date. Assign a Commitment Owner to connect the commitment to a Veeva RIM Basics user.

3. Enter the Commitment Text from the correspondence exactly, without any modifications.

4. Click Save.

   

5. Navigate to the Correspondence section and click Add.

   

6. Select one or more correspondence documents from your library to associate to the commitment and click Close.

   

Work on a Commitment

To work on the tasks needed for the commitment:

1. Navigate to the commitment record and select Change State to Ongoing from the Workflow menu.

   

2. Click Yes.

   

Close a Commitment

When the commitment has been fulfilled, you can close it.

To close a commitment:

1. Navigate to the commitment record and select Change State to Closed from the Workflow menu.

   

2. Click Yes.