Systems and methods for managing regulatory information

• US 20070198477A1
• Filed: 02/15/2006
• Published: 08/23/2007
• Est. Priority Date: 02/15/2006
• Status: Active Grant

• Current Assignee: Genzyme Corporation (Sanofi )
• Original Assignee: Genzyme Corporation (Sanofi )
• Inventors: Granfield, Richard, Mehta, Monica, Lawton, Alison, Kiely, James, Puig, David, Carle, Rachel, Durham, Mary
• Granted Patent: US 8,131,560 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: G06Q 10/109 Time management, e.g. calendars, reminders, meetings or time accounting
• CPC Class Codes: G06Q 30/018 Certifying business or products
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

Systems, methods, and articles of manufacture are provided for managing regulatory data pertaining to a healthcare product. For example, the system may include a network interface for receiving, from a client terminal, a request for regulatory data related to regulatory activity about a product as it pertains to a regulatory authority. The system also includes interconnected information stores for storing regulatory data associated with the product, where the information stores may include: contact records associated with respective contacts with the regulatory authority; commitment records associated with respective commitments made to the regulatory authority; and product information records associated with respective documents associated with the product. The system also includes a processing module for identifying, in response to the received request, each contact record, commitment record, product information record, and central files record associated with the product related to the received request.

Claims

1. A system for managing regulatory data pertaining to a healthcare product, comprising:

a plurality of interconnected information stores for storing respective types of regulatory data associated with the healthcare product; and

a processing module for identifying, in response to a received request, regulatory data about the healthcare product stored in the interconnected information stores.

2. The system of claim 1, wherein the interconnected information stores comprise two or more of the following record types:

calendar records, contact records, commitment records, product information records, and central files records.

3. The system of claim 2, wherein the contact records are digitally signed.

4. The system of claim 2, wherein the commitment records reflect commitments made to a regulatory authority associated with the healthcare product.

5. The system of claim 2, wherein the product information records include information pertaining to a third party involved in developing the healthcare product.

6. The system of claim 2, wherein the central files records are integrated with an external document management system.

7. The system of claim 1, wherein the processing module further includes:

a database module that interconnects the plurality of information stores by using data patterns shared among the information stores.

8. The system of claim 1, wherein the processing module generates data relationships between records stored in the plurality of interconnected information stores.

9. The system of claim 1, wherein said processing module further includes:

an interface module for retrieving, in response to the received request, configuration data used to present user interface templates from a memory module.

10. The system of claim 1, wherein the processing module further includes a security module for configuring access by a user by assigning a user access rights to categories of information based on a security profile assigned to the user.

11. The system of claim 10, wherein the access rights reflect at least one of:

which functions the user may perform, what regulatory data the user may access, what requesting data the user may modify, or what user interface templates are presented to the user.

12. A method for managing regulatory data pertaining to a healthcare product, comprising:

storing, in a plurality of interconnected information stores, respective types of regulatory data associated with the healthcare product; and

identifying, in response to a received request, regulatory data about the healthcare product stored in the interconnected information stores.

13. The method of claim 12, wherein storing regulatory data in the interconnected information stores comprises storing two or more databases storing the following record types:

calendar records, contact records, commitment records, product information records, and central files records.

14. The method of claim 13, further including:

digitally signing the contact records.

15. The method of claim 13, further including:

integrating the central files records with an external document management system.

16. The method of claim 12, further comprising:

interconnecting the plurality of information stores by using data patterns shared among the information stores.

17. The method of claim 12, further comprising:

generating data relationships between records stored in the plurality of interconnected information stores.

18. The method of claim 12, further including:

retrieving, in response to the retrieved request, configuration data used to present user interface templates from a memory module.

19. The method of claim 12, further including:

configuring access by a user via a security module by assigning a user access rights to categories of information based on a security profile assigned to the user.

20. A computer-readable medium including instructions for performing, when executed by a processor, a method for managing regulatory data, the method comprising:

storing, in a plurality of interconnected information stores, respective types of regulatory data associated with the healthcare product; and

identifying, in response to a received request, regulatory data about the healthcare product stored in the interconnected information stores.