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 computer-implemented method of generating and managing pharmaceutical labels across a plurality of jurisdictions, the computer-implemented method comprising:
generating a master label for the pharmaceutical by:
presenting a first graphical user interface comprising:
a plurality of master template headers defined by a master template; and
corresponding master label fields for input of master label text content associated with the master template headers;
receiving master label text input to the corresponding master label fields via the first graphical user interface; and
storing the master label text content input in a master label data structure; and
upon receiving a request to generate a jurisdiction-specific pharmaceutical label for the pharmaceutical for the particular jurisdiction:
presenting a second graphical user interface comprising:
the plurality of master template headers defined by the master template;
corresponding master label text content stored in the master label data structure;
a plurality of jurisdiction template headers defined by a jurisdiction template; and
corresponding jurisdiction-specific pharmaceutical label fields for input of jurisdiction-specific pharmaceutical label text content associated with the jurisdiction-specific pharmaceutical label headers;
allowing a user to select and modify portions of the master label text content to populate the jurisdiction-specific pharmaceutical label fields;
receiving jurisdiction-specific pharmaceutical label text input to the corresponding jurisdiction-specific pharmaceutical label fields via the second graphical user interface; and
storing the jurisdiction-specific pharmaceutical label text input in a jurisdiction-specific pharmaceutical label data structure;
wherein the jurisdiction-specific pharmaceutical 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 corresponding to the unmodified label elements, relative to the master label data structure.
2. The computer-implemented method 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 computer-implemented method of claim 1 , further comprising:
presenting the master label or the jurisdiction-specific pharmaceutical label to a plurality of users via a workflow for review, QC, or approval and tracking and reporting that workflow in computer-readable media; and
accepting modifications to the master label or the jurisdiction-specific pharmaceutical label from the plurality of users.
4. The computer-implemented method of claim 1 , further comprising:
receiving a request to change a portion of at least one of the master label and the jurisdiction-specific pharmaceutical label.
5. The computer-implemented method of claim 4 , further comprising:
tracking requested changes; and
generating a report of the changes, the report comprising:
at least one descriptor selected from a 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.
6. The method of claim 4 , further comprising the step of:
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.
7. The method of claim 6 , further comprising the step of refining the descriptor by selecting additional metadata from the group consisting of: “new data”, “health authority request”, “update to source label,” “urgent”, “non-urgent”, “mandatory”, “optional”, “administrative”, “major deviation”, “minor deviation”, “aligned”, “compliant”, “not applicable”, and “delegated”.
8. A computer-implemented method of generating and managing pharmaceutical labels across a plurality of jurisdictions, the computer-implemented method comprising:
generating a master label for the pharmaceutical by:
presenting a first graphical user interface comprising:
a plurality of master template headers defined by a master template; and
corresponding master label fields for input of master label text content associated with the master template headers;
receiving master label text input to the corresponding master label fields via the first graphical user interface; and
storing the master label text content input in a master label data structure; and
upon receiving a request to generate a jurisdiction-specific pharmaceutical label for the pharmaceutical for the particular jurisdiction:
presenting a second graphical user interface comprising:
the plurality of master template headers defined by the master template;
corresponding master label text content stored in the master label data structure;
a plurality of jurisdiction template headers defined by a jurisdiction template; and
corresponding jurisdiction-specific pharmaceutical label fields for input of jurisdiction-specific pharmaceutical label text content associated with the jurisdiction-specific pharmaceutical label headers;
allowing a user to select and modify portions of the master label text content to populate the jurisdiction-specific pharmaceutical label fields;
receiving jurisdiction-specific pharmaceutical label text input to the corresponding jurisdiction-specific pharmaceutical label fields via the second graphical user interface; and
storing the jurisdiction-specific pharmaceutical label text input in a jurisdiction-specific pharmaceutical label data structure;
wherein at least one of the master label data structure and the jurisdiction-specific pharmaceutical label data structure includes change tracking data.
9. A computer-implemented method of generating and managing pharmaceutical labels across a plurality of jurisdictions, the computer-implemented method comprising:
generating a master label for the pharmaceutical by:
presenting a first graphical user interface comprising:
a plurality of master template headers defined by a master template; and
corresponding master label fields for input of master label text content associated with the master template headers;
receiving master label text input to the corresponding master label fields via the first graphical user interface; and
storing the master label text content input in a master label data structure; and
upon receiving a request to generate a jurisdiction-specific pharmaceutical label for the pharmaceutical for the particular jurisdiction:
presenting a second graphical user interface comprising:
the plurality of master template headers defined by the master template;
corresponding master label text content stored in the master label data structure;
a plurality of jurisdiction template headers defined by a jurisdiction template; and
corresponding jurisdiction-specific pharmaceutical label fields for input of jurisdiction-specific pharmaceutical label text content associated with the jurisdiction-specific pharmaceutical label headers;
allowing a user to select and modify portions of the master label text content to populate the jurisdiction-specific pharmaceutical label fields;
receiving jurisdiction-specific pharmaceutical label text input to the corresponding jurisdiction-specific pharmaceutical label fields via the second graphical user interface; and
storing the jurisdiction-specific pharmaceutical label text input in a jurisdiction-specific pharmaceutical label data structure
wherein the second graphical user interface displays the master label and the jurisdiction-specific pharmaceutical 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 pharmaceutical label along a vertical axis of the second graphical user interface such that corresponding sections of the master label text and the jurisdiction-specific pharmaceutical label text are shown at the same position along the vertical axis.
10. The computer-implemented method of claim 9 , wherein the corresponding sections are identified independent of text contained therein.