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 - 47 . (canceled)
48 . A computer-implemented method of updating a product label, comprising the steps of:
selecting a master label or jurisdiction product label associated with a labeled product;
entering at least one change to information contained in a section of the master label or jurisdiction product label;
qualifying the at least one information change via selection of at least one descriptor from a first pre-defined descriptor set;
selecting a label for the labeled product;
entering at least one change to information contained in the label that is commensurate with the information change in the master label or jurisdiction product label;
qualifying the at least one information change in the label via selection of at least one descriptor from a second pre-defined descriptor set; and
generating a report of the at least one label change comprising the changed label and a summary including the selected descriptors from the first and second pre-defined descriptor sets.
49 . The computer-implemented method of claim 48 , wherein the first descriptor set comprises pre-defined selectable options from at least one category from the group consisting of Change Rationale, Safety Change, and Change Type.
50 . The computer-implemented method of claim 49 , wherein the pre-defined selectable options under the Change Type category include an urgency level.
51 . The computer-implemented method of claim 49 , wherein the pre-defined selectable options under the Change Type category include an identification of mandatory, optional or administrative.
52 . The computer-implemented method of claim 48 , wherein the second descriptor set comprises pre-defined selectable options pertaining to the alignment of the information change in the label to the information change in the master label.
53 . The computer-implemented method of claim 52 , wherein the pre-defined selectable options are from the group consisting of Major Deviation, Minor Deviation, and Aligned.
54 . A system for generating product label changes, comprising:
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;
wherein 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; and
wherein the platform further associates a report including the selected descriptors from the first and second pre-defined descriptor sets with the changed label.
55 . The system of claim 54 , wherein the first descriptor set comprises pre-defined selectable options from at least one category from the group consisting of Change Rationale, Safety Change, and Change Type.
56 . The system of claim 55 , wherein the pre-defined selectable options under the Change Type category include an urgency level.
57 . The system of claim 55 , wherein the pre-defined selectable options under the Change Type category include an identification of mandatory, optional or administrative.
58 . The system of claim 54 , wherein the second descriptor set comprises pre-defined selectable options pertaining to the alignment of the information change in the label to the information change in the master label.
59 . The system of claim 58 , wherein the pre-defined selectable options are from the group consisting of Major Deviation, Minor Deviation, and Aligned.
60 . The computer-implemented method of claim 49 , wherein the pre-defined selectable options under the Change Rationale category include New Data, Health Authority Request, and Update to Source Label.
61 . The system of claim 54 , wherein the platform further associates at least one of a Change Rationale or a Safety Change to each change made to a selected jurisdiction label.