Computer-implemented infrastructure, methods, systems, and computer-readable media for generating and managing product labels for a product across a plurality of jurisdictions
A system for generating product label changes is described. The system includes a product labeling platform executable on a network enabled computing device and a database of at least one selectable master label and at least one selectable jurisdiction label associated with a labeled product. The platform associates at least one selected descriptor from a first pre-defined descriptor set to each change made to a selected master label, and further associates at least one selected descriptor from a second pre-defined descriptor set to each change made to a selected jurisdiction label. The platform further associates a report including the selected descriptors from the first and second pre-defined descriptor sets with the changed label. A system for generating and managing product labels for a product across multiple jurisdictions is also disclosed. Methods including a computer-implemented method of updating a product label and a computer-implemented method of generating and managing product labels for a product across a plurality of jurisdictions are also disclosed.
1. A system for generating and managing product labels for a product across a plurality of jurisdictions, the system comprising:
a computer comprising a storage device comprising:
a database management system; and
computer-readable program code including steps for:
generating a master label for the product by:
presenting a first graphical user interface comprising:
a plurality of master template headers stored, at least in part, in the database management system; and
corresponding master label fields for input of master label content associated with the master template headers;
receiving master label input to the corresponding master label fields via the first graphical user interface; and
storing the master label content input in a master label data structure at least in part in the database management system;
presenting a second graphical user interface comprising:
the plurality of master template headers;
corresponding master label content stored in the master label data structure stored, at least in part, in the database management system;
a plurality of jurisdiction template headers stored, at least in part, in the database management system; and
corresponding jurisdiction-specific product label fields for input of jurisdiction-specific product label content associated with the jurisdiction-specific product label headers;
allowing a user to select and modify portions of the master label content to populate the jurisdiction-specific product label fields;
receiving jurisdiction-specific product label input to the corresponding jurisdiction-specific product label fields via the second graphical user interface; and
storing the jurisdiction-specific product label input in a jurisdiction-specific product label data structure at least in part in the database management system;
wherein the second graphical user interface displays the master label and the jurisdiction-specific label side-by-side; and
wherein the second graphical user interface is further configured to synchronize positioning of the master label and the jurisdiction-specific label along a vertical axis of the second graphical user interface such that corresponding content of the master label and the jurisdiction-specific label text are shown at the same position along the vertical axis.
2. The system of claim 1 , wherein the master label data structure comprises:
references to master template headers from the master label data structure; and
modified master label headers.
3. The system of claim 1 , wherein the master label data structure and the jurisdiction-specific product label data structure are implemented in a database.
4. The system of claim 1 , wherein the plurality of master template headers are defined by a master template.
5. The system of claim 1 , wherein the master label data structure and the jurisdiction-specific product label data structure contain references to a database.
6. The system of claim 1 , wherein the computer-readable program code further includes steps for:
presenting the master label or the jurisdiction-specific product label to one or more users for review, QC, or approval based on a workflow specified in computer-readable media.
7. The system of claim 6 , wherein the computer-readable program code further includes steps for:
tracking the review, QC, or approval of the master label or the jurisdiction-specific product label in computer-readable media.
8. The system of claim 7 , wherein the computer-readable program code further includes steps for:
generating a report detailing the tracked review, QC, and approval of the master label or the jurisdiction-specific product label.
9. The system of claim 1 , wherein the corresponding content is identified independent of text contained therein.
10. The system of claim 1 , wherein the computer-readable program code further includes steps for:
receiving a request to change a portion of at least one of the master label and the jurisdiction-specific product label; and
prompting the user to qualify the requested change by selecting at least one descriptor from a pre-defined descriptor set including one or more selected from the group consisting of: a change rationale, a safety change, a change type, alignment to a source label, and label deadlines.
11. The system of claim 10 , wherein the computer-readable program code further includes steps for:
tracking the requested changes; and
generating a report of changes, the report comprising:
the at least one descriptor selected from the pre-defined descriptor set;
a status of an anticipated change to a label;
a status of a changed label; and
a summary of the changes.
12. The system of claim 10 , wherein the change rationale metadata requires identification of a reason for the change.
13. The system of claim 10 , wherein the reason for the change can include one or more selected from the group consisting of: “new data”, “health authority request”, and “update to source label”.
14. The system of claim 10 , wherein the “change type” metadata requires identification of the change selected from the group consisting of: “urgent”, “non-urgent”, “mandatory”, “optional”, and “administrative”.
15. The system of claim 10 , wherein the “alignment to source label” metadata requires identification of a degree of the change in relationship to a source label and selected from the group consisting of: “major deviation”, “minor deviation”, and “aligned”.
16. The system of claim 10 , wherein the “label deadlines” metadata requires identification of a deadline for implementation of the change.
17. The system of claim 16 , wherein the “label deadlines” metadata further comprises identification of compliance to the identified deadline for implementation of the change.
18. The system of claim 17 , wherein the identification of compliance is selected from the group consisting of: “compliant”, “not applicable”, and “delegated”.
19. A system for generating and managing product labels for a product across a plurality of jurisdictions, the system comprising:
a computer comprising a storage device comprising:
a database management system; and
computer-readable program code including steps for:
generating a master label for the product by:
presenting a first graphical user interface comprising:
a plurality of master template headers stored, at least in part, in the database management system; and
corresponding master label fields for input of master label content associated with the master template headers;
receiving master label input to the corresponding master label fields via the first graphical user interface; and
storing the master label content input in a master label data structure at least in part in the database management system;
presenting a second graphical user interface comprising:
the plurality of master template headers;
corresponding master label content stored in the master label data structure stored, at least in part, in the database management system;
a plurality of jurisdiction template headers stored, at least in part, in the database management system; and
corresponding jurisdiction-specific product label fields for input of jurisdiction-specific product label content associated with the jurisdiction-specific product label headers;
allowing a user to select and modify portions of the master label content to populate the jurisdiction-specific product label fields;
receiving jurisdiction-specific product label input to the corresponding jurisdiction-specific product label fields via the second graphical user interface; and
storing the jurisdiction-specific product label input in a jurisdiction-specific product label data structure at least in part in the database management system;
wherein the jurisdiction-specific product label data structure comprises:
references to jurisdiction template headers from the jurisdiction template;
modified jurisdiction label headers;
references to unmodified label elements from the master label data structure; and
modified label elements relative to the master label data structure.
20. A system for generating and managing product labels for a product across a plurality of jurisdictions, the system comprising:
a computer comprising a storage device comprising:
a database management system; and
computer-readable program code including steps for:
generating a master label for the product by:
presenting a first graphical user interface comprising:
a plurality of master template headers stored, at least in part, in the database management system; and
corresponding master label fields for input of master label content associated with the master template headers;
receiving master label input to the corresponding master label fields via the first graphical user interface; and
storing the master label content input in a master label data structure at least in part in the database management system;
presenting a second graphical user interface comprising:
the plurality of master template headers;
corresponding master label content stored in the master label data structure stored, at least in part, in the database management system;
a plurality of jurisdiction template headers stored, at least in part, in the database management system; and
corresponding jurisdiction-specific product label fields for input of jurisdiction-specific product label content associated with the jurisdiction-specific product label headers;
allowing a user to select and modify portions of the master label content to populate the jurisdiction-specific product label fields;
receiving jurisdiction-specific product label input to the corresponding jurisdiction-specific product label fields via the second graphical user interface; and
storing the jurisdiction-specific product label input in a jurisdiction-specific product label data structure at least in part in the database management system;
wherein at least one of the master label data structure and the jurisdiction-specific product label data structure includes change tracking data.