Working with Health Authority Interactions

Veeva RIM provides functionality that allows you to capture, review, and track health authority questions and commitments from your regulatory correspondence. The Health Authority Interaction panel, available in the Doc Info pane for the configured document types, allows you to select question text within a document and Vault automatically extracts a Health Authority Question (HAQ) or Commitment record. You can view all interactions extracted from a single document and add additional details to the records as needed to track your interactions throughout their lifecycle.

Viewing Health Authority Interactions

To view questions on a document:

Open the document that contains the questions you want to view and expand the document information panel
On the Document Information page, click the Health Authority Interaction panel icon to open the Health Authority Interaction panel. The panel displays a card for each HAQ or Commitment record extracted from highlighting a question in the document.
Change the picklist to view all interactions, only HAQs, or only commitments.
Click a card in the panel to navigate directly to the highlighted question or commitment text within the document.
Click a record link in a question or commitment card to open the HAQ or Commitment record in a pop-out browser window.

If an interaction card displays an orange caution icon (), the question or commitment was extracted from a previous version of the document. This means that its text is not highlighted in the current version of the document, and you will not be navigated to the question or commitment source in the document automatically.

Managing Health Authority Interactions

This section describes how to manage interactions in Veeva RIM.

How Vault Extracts Health Authority Questions and Commitments

The following behavior applies when you highlight a question or commitment in a document:

An HAQ or Commitment record is created for the question or commitment.
A document annotation is created for the highlighted selection.
A question or commitment card is displayed in the Health Authority Interaction panel with an HAQ or Commitment record link and question or commitment text.
The extracted question or commitment is linked in the Health Authority Question (health_authority_question__v) or Commitment (commitment__v) document field
HAQ and Commitment relationship records are created for Application, Submission, Regulatory Objective, and Product Family based on the respective fields on the document at the time of question extraction.

When an HAQ or Commitment record is created, the following fields are automatically populated on the record:

Any HAQ or Commitment record fields that match the source document fields (name and data type) are populated with the document field information.
The Question Source field or Commitment Source field is populated with a link to the highlighted interaction annotation. Click See Source to navigate to the annotation on the source document.
The Question Source Document field or Commitment Source Document field is populated with a link to the source document. Click the Source Document link to navigate to the source document.

How to Extract Health Authority Interactions

You can highlight text within a document to extract an HAQ or Commitment record. When Vault extracts an HAQ or Commitment record, it populates the values on the HAQ or Commitment record using values from matching fields on the source document.

Only one (1) user can extract questions or commitments from a document at a time. While a user is extracting questions or commitments, Vault locks the document until the user clicks Done, or 15 minutes have elapsed since the last question or commitment was extracted.

The following image displays an example of question cards and question text in the Health Authority Interactions panel for questions ans commitments highlighted in a document:

To extract questions or commitments from a document:

Open the document that contains the questions you want to extract.
Expand the Document Information panel and select Health Authority Interactions.
If there are no interactions extracted from the document yet, click Select Questions or Select Commitments.
Highlight the question or commitment text in the document. Vault extracts an HAQ or Commitment record, creates a document annotation for the highlighted selection, displays a question or commitment card with the extracted record link and text in the Health Authority Interactions panel. It also displays the HAQ or Commitment record link in the Correspondence Details section of the Document Information panel.
When you are done highlighting interactions, click Done in the Health Authority Interactions panel. Vault unlocks the document to allow other users to extract interactions from the document.
To review the HAQ or Commitment records that were extracted, click Review in the Health Authority Interactions panel. You must have a specific object selected in the picklist and not All Interactions in order to do this. Vault opens a standalone tab that displays all of the HAQ or Commitment records extracted from the document and any manually created records outside of extraction where the document is set in the Health Authority Questions or Commitments source document field. Users can view and edit the records individually or in bulk.

How to Delete Health Authority Interactions

To delete a question or commitment:

Open the document that contains the interactions you want to delete.
On the Doc Info page, click the Health Authority Interactions panel icon to open the Health Authority Interactions panel.
Hover over the card of the question or commitments you want to delete and click the Delete icon (). If the HAQ or Commitment is referenced on previous versions of the document, the HAQ or Commitment reference must be removed from the previous versions of the document before deleting.
In the confirmation message, click Delete to confirm that you want to delete the question or commitment, or click Cancel to cancel the deletion.

Limitations

The following limitations apply to HAQ and Commitment functionality:

Vault supports HAQ and Commitment extraction on document text only. If the document is a scan or an image that did not undergo OCR text extraction, question and commitment text cannot be highlighted and extracted. In addition, if the document contains images, figures, or tables, they cannot be highlighted and extracted unless they contain text that has undergone OCR text extraction.
You cannot highlight questions and commitments across two pages, and the amount of text that can be highlighted for a single question or commitment is limited according to Vault’s annotation limits.
You can extract up to 1,000 HAQs and 1,000 Commitments per document; however, the HAQ and Commitment fields in the document’s Information panel are limited to tracking and displaying 250 HAQ and 250 Commitment records.
Vault supports HAQ and Commitment extraction on CrossLink documents with a Source Binding Rule of Specific Document Version only. Vault does not support HAQ and Commitment extraction on CrossLink documents with a Source Binding Rule of Latest Version or Latest Steady State Version.
Archived documents do not support HAQ and Commitment extraction.