# US 11,030,232 B1 · System and method for managing regulatory information

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- Number: US 11,030,232 B1
- Document ID: US11030232B1
- Status: Granted
- Kind: B1
- Application number: 16/708,425
- Filed: 2019-12-09
- Granted: 2021-06-08
- Earliest claimed: 2017-04-21
- Assignees: Veeva Systems Inc.
- Applicants: Veeva Systems Inc.
- Inventors: Uri Reich; Sandra Komadinic; Richard Merrick; Rolando Sa; Katharyn Wilber
- Web page: https://patentgrep.com/patent/US11030232B1

## CPC

- G06F 16/38: Retrieval characterised by using metadata, e.g. metadata not derived from the content or metadata generated manually
- G06F 16/93: Document management systems
- G06F 16/168: {Details of user interfaces specifically adapted to file systems, e.g. browsing and visualisation, 2d or 3d GUIs (query results presentation G06F16/156)}
- G06F 16/332: Query formulation
- G06F 16/3331: Query processing
- G06F 16/951: Indexing; Web crawling techniques
- G06F 21/105: {Arrangements for software license management or administration, e.g. for managing licenses at corporate level}
- G06F 21/6245: {Protecting personal data, e.g. for financial or medical purposes}
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)

## Abstract

Systems and methods for managing regulatory information. The system comprises a submission controller, a registration controller and a submission archive controller. The submission controller may manage a submission structure, and allow users to search for documents in a content management system and add the documents to the submission structure. The registration controller may manage product registration information and health authority interactions globally, and capture, view and take actions upon product registrations. The submission archive controller may allow users to access a complete history of regulatory submissions and correspondence globally, with an easy to use interface. The three controllers reside in a single system that allows them to interact seamlessly with each other.

## Claims

### Claim 1

A system for managing regulatory information, comprising:
a submission controller for:
generating a submission user interface which comprising a first area for receiving a first query for a first document; a second area for receiving a request for a submission structure for a first submission, a third area for receiving a request for a first task, and a fourth area for displaying a search result in response to the first query;
in response to the request for the submission structure for the first submission, displaying the submission structure for the first submission, wherein the submission structure for the first submission comprises a hierarchy of documentation of the first submission;
in response to the first query, searching a content and data management system for the first document, and displaying a search result in the fourth area;
in response to a request for adding the first document to the submission structure for the first submission, adding the first document to the submission structure; and
storing metadata of the first document to the content and data management system, and
a registration controller for displaying a user interface for receiving product registration information.

### Claim 2 (depends on 1)

The system of claim 1, wherein the submission controller further:
in response to a second query, searches the content and data management system for a second document,
obtains a link pointing to the second document in the content and data management system, and
adds the link to a place for the second document in the submission structure for the first submission.

### Claim 3 (depends on 1)

The system of claim 1, wherein the submission structure for the first submission further comprises: a placeholder for a third document.

### Claim 4 (depends on 3)

The system of claim 3, wherein the submission controller further:
in response to a third query, searches the content and data management system for a third document;
displays the third document in the fourth area, and
adds the third document to the placeholder in the submission structure for the first submission.

### Claim 5 (depends on 1)

The system of claim 1, wherein the submission controller further: searches the content management system for a fifth document based on a selected filter.

### Claim 6 (depends on 1)

The system of claim 1, wherein the registration controller further:
displays a registration user interface which comprises an area for receiving a request for a report; and
displays a report user interface in response to the request for the report, wherein the report use interface comprises a first product registration and its status.

### Claim 7 (depends on 1)

The system of claim 1, wherein the registration controller further: displays a registration record which provides product information, and key registration dates.

### Claim 8 (depends on 1)

The system of claim 1, wherein the registration controller further: tracks bidirectional interactions with a health authority.

### Claim 9 (depends on 1)

The system of claim 1, wherein the registration controller further: relates actions to be taken to a product registration based on data in the content and management system.

### Claim 10 (depends on 1)

The system of claim 1, further comprising: a submission archive controller for displaying a submission archive user interface to enable access to previously submitted information.

### Claim 11 (depends on 10)

The system of claim 10, wherein the submission archive user interface further enables access to correspondence related to the submission.

### Claim 12 (depends on 1)

The system of claim 1, further comprising: a submission archive controller for displaying a submission archive user interface to enable access to previously submitted information and correspondence related to the submission.

### Claim 13

A regulatory information management system, comprising:
a submission controller for:
generating a submission user interface which comprising a first area for receiving a first query for a first document; a second area for receiving a request for a submission structure for a first submission, a third area for receiving a request for a first task, and a fourth area for displaying a search result in response to the first query;
in response to the request for the submission structure for the first submission, displaying the submission structure for the first submission, wherein the submission structure for the first submission comprises a hierarchy of documentation of the first submission;
in response to the first query, searching a content and data management system for the first document, and displaying a search result in the fourth area;
in response to a request for adding the first document to the submission structure for the first submission, adding the first document to the submission structure;
storing metadata of the first document to the content and data management system; and
generating a task interface in response to a request, wherein the task interface comprises a task in progress, and
a registration controller for
displaying a user interface for receiving product registration information;
displaying a registration user interface which comprises an area for receiving a request for a report; and
displaying a report user interface in response to the request for the report, wherein the report user interface comprises a first product registration and its status.

### Claim 14 (depends on 13)

The system of claim 13, wherein the registration controller further: displays a registration record which provides product information, and key registration dates.

### Claim 15 (depends on 13)

The system of claim 13, wherein the registration controller further: tracks bidirectional interactions with a health authority.

### Claim 16 (depends on 13)

The system of claim 13, wherein the registration controller further: relates actions to be taken to a product registration based on data in the content and management system.

### Claim 17 (depends on 13)

The system of claim 13, further comprising: a submission archive controller for displaying a user interface to enable access to previously submitted information and correspondence related to the submission.

### Claim 18

A system for managing regulatory information, comprising:
a submission controller for:
generating a submission user interface which comprising a first area for receiving a first query for a first document; a second area for receiving a request for a submission structure for a first submission, a third area for receiving a request for a first task, and a fourth area for displaying a search result in response to the first query;
in response to the request for the submission structure for the first submission, displaying the submission structure for the first submission, wherein the submission structure for the first submission comprises a hierarchy of documentation of the first submission;
in response to the first query, searching a content and data management system for the first document, and displaying a search result in the fourth area;
in response to a request for adding the first document to the submission structure for the first submission, adding the first document to the submission structure;
storing metadata of the first document to the content and data management system, and
generating a dashboard user interface in response to a request, wherein the dashboard user interface comprises a status of a task.
