System and method for managing structured content

Abstract

A computer-implemented process for creating an original drawing associated with a selected product. The process includes receiving and storing in a computer memory medium an updatable database embodying machine readable instructions corresponding to one or more instances of textual content information relating to the selected product, and generating, using the computer processor, a first original drawing template file for a first structured document (e.g., embodying a packaged or tagged original drawing) and a second original drawing template file for a second structured document different from the first structured document (e.g., embodying a non-packaged, non-tagged related document). Each instance has a unique identifier but is free of any style or location information. The first protograph template and the second protograph template include all style and location information associated with the presentation of the instances in the respective first structured document and second structured document.

Description

Background Art

[0001] Manufacturers of certain products, particularly those in highly regulated areas such as drugs, are often ordered to provide specific content (i.e., warnings, cautions, ingredients, etc.) on or in product packaging, advertising, instructions for use (IFUs) and other product inserts and regulatory documents. This information content may need to be modified for different jurisdictions to reflect different requirements and to provide information in any and all languages ​​relevant to the jurisdiction. The content may also need to be updated from time to time due to changes in regulations, new information, and changes in product or packaging configurations. Manufacturers of consumer products in the pharmaceutical field report an increase (approximately 40%) in product-related updates triggered by product releases, health authority requirements, new indications, quality updates, etc. The challenge facing pharmaceutical / life science companies is not only to provide this information on the package, but also to provide this information in the IFU and submission documents to various regulatory agencies to meet SPL, QRD or other standards. As understood by those skilled in the art, structured product labels (SPLs) are document marking standards approved by Health Level Seven (HL7) and adopted by the United States (US) Food and Drug Administration (FDA) as a mechanism for exchanging product and facility information. Similarly, the European Medicines Agency (EMA) Quality Review of Documents (QRD) Working Group develops, reviews and updates templates for product information used by applicants and marketing authorization holders for human medicines. The many touchpoints and systems make it complex and time-consuming for manufacturers to stay compliant.

[0002] Manufacturers often create unstructured documents that are duplicated across multiple systems, which prolongs development time, increases the cost of bringing a drug to market, creates excessive rework costs, and leaves manufacturers vulnerable to errors and omissions. Summary of the invention

[0003] One aspect of the present invention relates to a computer-implemented process for creating an artwork associated with a selected product. The process includes receiving and storing an updateable database embodying machine-readable instructions in a computer storage medium, the machine-readable instructions corresponding to one or more instances of text content information related to the selected product, and using a computer processor to generate a first artwork template file for a first structured document and a second artwork template file for a second structured document. Each instance has a unique identifier, but without any style or position information. The first artwork template file and the second artwork template file each include at least one first placeholder, which embodies a unique identifier corresponding to at least one instance of the one or more instances of content information accessed from the database. The first artwork template file and the second artwork template file each include all style and position information associated with the presentation of at least one instance in the corresponding first structured document and the second structured document. The second structured document is different from the first structured document. The first structured document can embody a packaging or label artwork, and the second structured document can embody a non-packaging, non-label related document, such as a regulatory submission, an electronically released document, or a printed physical document, such as instructions for use and / or a product insert.

[0004] Another aspect of the present invention relates to a computer-implemented management system for creating a structured document associated with a selected product. The system includes a computer processor; a user interface connected to the computer processor; a non-transitory computer storage medium accessible by the computer processor and having a first portion programmed with machine-readable instructions for causing the computer processor to perform the steps described above.

[0005] Yet another aspect of the present invention relates to a non-transitory computer storage medium programmed with machine-readable instructions for causing a computer processor to perform the steps described above.

[0006] The selected product associated with any of the processes, systems, and computer storage media described herein may be a healthcare related product, such as a pharmaceutical, a nutraceutical, a cosmeceutical, a medical or biomedical device, or a food related product.

[0007] One or more examples of user input information associated with any of the processes, systems, and computer storage media described herein may include, for example: information relating to dosage or administration of a selected product, form or strength of a selected product, indications or uses for a selected product, warnings or precautions relating to a selected product, adverse reactions associated with a selected product, data regarding use of a selected product in a particular population, material changes of a selected product within a predefined amount of time, qualitative and quantitative information regarding a selected product, and a compositional structure of a selected product. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a schematic illustration of attributes of exemplary systems and methods of embodiments of the present invention.

[0009] FIG. 2 is a schematic illustration of an exemplary prior art information flow associated with creating a structured document.

[0010] Figure 3 is a schematic illustration of an exemplary information flow associated with creating a structured document according to an embodiment of the present invention.

[0011] Figure 4 is a more detailed schematic illustration of an exemplary information flow associated with creating a structured document according to an embodiment of the present invention.

[0012] Figure 5 are schematic illustrations of aspects of exemplary systems and methods of embodiments of the invention.

[0013] Figure 6 is a schematic illustration of aspects of supporting hardware associated with exemplary embodiments of the present invention. DETAILED DESCRIPTION

[0014] Embodiments of the present invention provide such as Figure 1A system 100 is illustrated in which a user is permitted to specify, create, review, and manage structure and artwork 110 (e.g., aesthetic features such as, but not limited to, styles, fonts, and template layouts) that are separate and distinct from the specification of content 120 or color 130, such that a single repository for content can be used in multiple endpoint structures for that content. By creating a "digital twin" 140 for each unit of structured content, the same content and color theme can be used for regulatory submissions 150, physical print documents (e.g., IFUs) 160, electronic publications 170, and product packaging (not shown). Although structure, content, and color are depicted as separate categories, it should be understood that fewer or more categories may be provided with content separated from non-content categories. As depicted, the digital twin includes a label 180 without any content (given the size limitations of the patent drawings), but it should be understood that the label 180 typically includes both text and graphical information, including branding, artwork, trademarks, barcodes, usage and ingredient information, and the like.

[0015] 2 , a prior art system 200 for merging an artwork / template 210, assets in the form of .PSD, .PNG, and .JPG files (212, 214, 216, respectively), and content for a document typically involves transforming the base content (e.g., provided in the form of an Extensible Markup Language (.XML) file) 220 first into an artwork-specific transformation file (e.g., an XSLT file) 230, and then into an artwork XML file 240, before merging the content, assets, and artwork / template together into an artwork product (e.g., an .INDD file for use with InDesign software) 250. The artwork-specific transformation file contains the various styles, fonts, and layout information required to map the content onto the template.

[0016] In contrast, Figure 3 As depicted in , embodiments of the present invention permit merging an artwork / template 310 file, artwork assets 312, 314, 316, and content .XML file 320 having features further described below to form an artwork file 350 without creating artwork-specific transformation files.

[0017] like Figure 4 As shown in more detail in FIG. 1 , in one embodiment, the process may include providing content in the form of a Darwin Information Typing Architecture (.DITA) format file and a .MAP file 410 in step 1a, which is used to create a first .XML file 420, and providing one or more WebCenter Content (WCC) files 430 in step 1b, which are used to create a second .XML file 440. Figure 3, these respective .XML files can be merged into a single .XML file 320 in step 3, which is merged with the InDesign template file .INDD 310 in step 4 to create an InDesign artwork file .INDD 350, which can then be used in step 5 to create a merged (e.g., PDF) file 460 suitable for further processing (including printing). Step 4 includes opening the InDesign template / artwork 310 and applying the content by importing the XML 320, which pulls in other assets (e.g., 312, 314, 316) referenced from the XML.

[0018] In contrast to the prior art, the .INDD template file 310 includes all of the location and style specifications to be applied to each unit of content supplied by the content .XML file 320. Each unit of content provided in the .XML file 320 includes a unique identifier (e.g., Header 1) that maps to the same unique identifier in the .INDD template file 310. Thus, content (without style and location information) can be merged with a template, where the template contains all of the location and style information. The .INDD template file 310 can be created by an individual with relatively less training than is required to create the prior art .XSLT file 230. The separation of the template creation step and the content creation step allows a single content database to be used with multiple templates, and changes to content can be easily leveraged across multiple documents.

[0019] Compared with the prior art method, the .XML file 320 is universal and can be used for different original images. It does not rely on the specific transformation of the original image. All style configurations are contained in the original image template 310. Specific naming rules are used to determine what style should be used for the content within the marked original image element. Although this method may not be as flexible as the prior art method depicted in Figure 2, the creation and setting of the original image template can be performed only by operators without technical knowledge of XML and XSLT transformation. No separate file for style mapping is required because everything is embedded in the InDesign file.

[0020] The file structure and method described above allow for Figure 5 , where a user may request a change to content in step 510 (e.g., prompted by a new product launch, a change request, a new regulatory requirement, a quality signal, etc.), and in step 520 a change may be made to the content based on data from a legacy QRD, an enterprise resource planning (ERP) system (such as System) or XML file input to modify the corresponding topic in the topic library (e.g., dosage and administration, dosage form and strength, indications and usage, warnings and prevention, adverse reactions, use in specific populations, recent major changes, qualitative and quantitative information, or drug forms). The results of the modification can be viewed across multiple structured documents (e.g., QRD, IFU, company core data sheet (CCDS), or ACS original drawing document) 530, and these structured documents can be output in any form that may be required (e.g., Word, XML, PDF) according to any number of output templates (e.g., .doc, .pdf, .id, .ai) 540 in step 550. The workflow between the request step 510 and the output step 550 can also include localization steps (e.g., translation, consideration of local laws) and approval (e.g., approval by marketing, legal, management or other stakeholders).

[0021] Embodiments may include a user interface that allows a user to view how various contents are combined with the original image during editing. The user interface may also allow a user to select a portion of the content to be edited, in which case the editor may provide the user with information about each instance (e.g., each document) in which the specific portion of the content is used, as well as status information about each instance. The status information may show the time when the content was last edited, the version number, and the content status (i.e., whether the content is being actively edited elsewhere or whether it is used in a document under active editing). Each content item may include information identifying a content manager with authorization to change. Therefore, whenever a user makes a change, each content manager may be given an automatic notification of the change (i.e., via email, text message, or via a notification within the application software, or via a messaging component dedicated to the application software). The content manager may be required to approve the change positively before the change can be implemented across the various original image documents involved. The editor user interface may also suggest whether the change violates any rules based on the original image if implemented. For example, if a change to the text will cause the text to overflow a predetermined text box size, the user may be notified of "text overflow." Thus, the user will be prompted to make changes to the original image and / or modify the requested content change to avoid unexpected results produced by the change. The editor may allow the user to conduct a text search for keywords to locate content to be edited within the document. The editor may flag changes that suggest the need for translation or regulatory approval to alert the user.

[0022] The described content management process is more efficient than the prior art process, and it is expected to promote better quality and compliance for the content produced for different channels. The system and process permit the coordination of regulatory work across corporate headquarters, branches and partners in a single system that is closely integrated with the label and packaging department, and by promoting content reuse across multiple outputs, it is expected to significantly reduce the cost of label / IFU and submission document creation. It is also expected that the system and method will significantly reduce risks and reduce the number of recalls by realizing automated XML publishing, and it is also expected to significantly improve the quality of translation. The solution as described is also expected to reduce the turnaround time for changes and potentially eliminate the need for domestic review of changes that have been reviewed or do not involve country-based changes. Structured content management as described in this article enables management of content, tracking edits, and processing of local variants and translations, while promoting reuse. Submission documents, IFUs and labels can be automatically generated from structured content as described in this article, thereby reducing the delivery time of content creation and original image generation from months to weeks, while increasing compliance and reducing errors. Therefore, the same structured content can be used to create packaging as well as flyers and other text-based documents.

[0023] The solution enables tighter integration of text changes in complex documents with non-text outputs using a system that was historically designed to manage updates to artwork. The solution also provides traceability through which users can find every use of every element anywhere in the system, where changes to inputs are linked to physical outputs.

[0024] The text content information referred to herein may include, for example, but not limited to, information related to the dosage or administration of the selected product, the form or strength of the selected product, the indication or usage for the selected product, warnings or preventions related to the selected product, adverse reactions associated with the selected product, data on the use of the selected product in a specific population, material changes of the selected product within a predefined amount of time, qualitative and quantitative information about the selected product, and the composition structure of the selected product. The text content can be input via a user interface (e.g., by a user typing in the content using a keyboard), or can be captured by a machine from a pre-existing document, including from a native document (e.g., a Word document), a merged document (e.g., a PDF), or from an image (e.g., using OCR). For example, when initially populating a database for use in conjunction with an embodiment as described herein, a user can scan an existing package or document to extract the text content, and then can mark and identify a selected subset of the text content for merging in the database.

[0025] In addition to placeholders for text content (e.g., fillable fields), an artwork document as described herein may include paragraphs of general text content into which structured content may be inserted. Embodiments may include a nested structure in which one region of modifiable content may be nested within another region of modifiable content. Thus, for example, content corresponding to a dosage form may be nested within a general paragraph about medicinal chemistry that is not affected by the dosage form, wherein both the dosage form and the general paragraph may be uniquely identified and support modification.

[0026] Although discussed herein with respect to preferred embodiments with reference to certain file types, it should be understood that the present invention is not limited to any particular implementation, file type, or software compatibility.

[0027] Supported Hardware

[0028] Figure 6 is a block diagram of hardware components of various devices that may form components of an exemplary system for performing the processes described herein. A computer as described throughout this specification includes Figure 6 , and may include a specially programmed personal computer (including but not limited to a mobile device), a server accessible via a global communication network, or some combination of the above. These hardware components include but are not limited to a processor 600 (e.g., a CPU), a memory 602 for storing data and programming instructions that support the operation of the processor 600, a user interface 610 (e.g., a keyboard, a mouse, a touch screen display, etc.) for receiving instructions from a user, a display 608, a communication interface 604 (e.g., wired, wireless, Bluetooth, WiFi, etc.) for communication between devices (including but not limited to across a global computer network) and for transmitting messages as described herein (e.g., via text or email), and an original image rendering device 606. The original image rendering device 606 may include a printer for printing physical documents, an electronic publishing interface for composing electronic documents, a raster image processor (RIP) for converting a PDF into an imaging file for imaging a printing plate used, and a printer configured to use such a printing plate to print labels or product packaging, etc. The original image rendering device can be configured to receive files in any of the output formats described herein without limitation, and can include a single component, or multiple components interconnected or configured in a serial workflow. Other devices such as printers, scanners, sensors, etc. (not shown) can also be connected to the system.

[0029] Instructions, programming, or application(s) may be software or firmware used to implement device functionality associated with a device, such as a computer described throughout this specification. The program aspects of the technology may be considered a "product" or "article of manufacture," typically in the form of executable code or process instructions and / or associated data, stored or embodied on a type of machine or processor readable medium (e.g., transient or non-transitory), such as a computer memory used to download or otherwise install such programming.

[0030] Of course, other storage devices or configurations can be added to or substituted for the storage devices or configurations in the examples. Such other storage devices can be implemented using any type of storage medium having computer or processor readable instructions or programming stored therein, and can include, for example, any or all tangible memories or associated modules of a computer, processor, etc.

[0031] It should be understood that all figures shown in this article have only depicted some elements of exemplary systems, and other systems and methods may also be used. In addition, as will be appreciated by those skilled in the art, even exemplary systems may include additional components that are not clearly depicted or explained. Therefore, some embodiments may include additional elements that are not depicted in each figure or discussed in this article, and / or may omit the elements that are depicted and / or discussed that are not important for the embodiment. In still other embodiments, elements with similar functions may replace the elements described and discussed herein.

[0032] Any of the steps or functions of the systems and methods for converting graphics files for printing may be embodied in programming or one or more applications as previously described. According to some embodiments, a "function," "functions," "applications," "applications," "instructions," "instructions," or "programming" is a program(s) that executes the functions defined in a program. Various programming languages ​​may be employed to create one or more applications structured in various ways, such as an object-oriented programming language (e.g., Objective-C, Java, or C++), a procedural programming language (e.g., C or assembly language), or firmware. In a specific example, a third-party application (e.g., an application created using ANDROID ® by an entity other than the vendor of a particular platform) may be used to create an application. TM or IOS TM Software Development Kit (SDK) can be used to develop applications that run on platforms such as IOS TM ANDROID TM , Mobile software on the mobile operating system of the phone or other mobile operating system. In this example, the third-party application can call API calls provided by the operating system to facilitate the functions described in this article.

[0033] Thus, machine-readable media can take many forms of tangible storage media. Non-volatile storage media include, for example, optical or magnetic disks, such as any of the storage devices in any (one or more) computers or the like, such as can be used to implement the steps described herein and / or shown in the accompanying drawings. Volatile storage media include dynamic memory, such as the main memory of such a computer platform. Tangible transmission media include coaxial cables; copper wires and optical fibers, including wiring, which includes buses within a computer system. Carrier transmission media can take the form of electrical or electromagnetic signals, or sound or light waves (such as those generated during radio frequency (RF) and infrared (IR) data communications). Thus, common forms of computer-readable media include, for example: floppy disks, flexible disks, hard disks, magnetic tapes, any other magnetic media, CD-ROMs, DVDs or DVD-ROMs, any other optical media, punched card tapes, any other physical storage media with hole patterns, RAMs, PROMs and EPROMs, FLASH-EPROMs, any other memory chips or boxes, carriers that transmit data or instructions, cables or links that transmit such carriers, or any other media from which a computer can read programming code and / or data. Many of these forms of computer readable media may be involved in carrying one or more sequences of one or more instructions to a processor for execution.

[0034] Although the invention is illustrated and described herein with reference to particular embodiments, the invention is not intended to be limited to the details shown. Rather, various modifications may be made to the details within the scope and range of equivalents of the claims without departing from the invention.

Claims

1. A computer-implemented process for creating a structured document associated with a selected product, the process comprising the steps of: a) receiving and storing in a computer storage medium an updateable database embodying machine-readable instructions corresponding to one or more instances of text content information relating to a selected product, each instance having a unique identifier but without any style or location information; b) generating, using a computer processor, a first artwork template file for a first structured document, the first artwork template file comprising at least one first placeholder, the at least one first placeholder embodying a unique identifier corresponding to at least one of the one or more instances of text content information accessed from the database, the first artwork template file comprising all style and position information associated with presentation of at least one instance in the first structured document; as well as c) using a computer processor to generate a second artwork template file for a second structured document different from the first structured document, the second artwork template file comprising at least one second placeholder, the at least one second placeholder embodying a unique identifier corresponding to at least one of the one or more instances of text content information accessed from the database, the second artwork template file comprising all style and position information associated with the presentation of the at least one instance in the second structured document.

2. The computer-implemented process of claim 1, wherein the first structured document embodies packaging or label artwork and the second structured document embodies non-packaging, non-label related documents.

3. The computer-implemented process of claim 2, wherein the non-packaging, non-label related document comprises a regulatory submission, a printed physical document, or an electronically published document.

4. The computer-implemented process of claim 3, wherein the printed physical document comprises instructions for use, a product insert, or a combination thereof.

5. A computer-implemented management system for creating a structured document associated with a selected product, the system comprising: Computer processors; a user interface connected to the computer processor; A non-transitory computer storage medium accessible by the computer processor and having a first portion programmed with machine-readable instructions for causing the computer processor to perform the steps of any one of claims 1-4.

6. A non-transitory computer storage medium programmed with machine-readable instructions for causing a computer processor to perform the steps of claim 1.

7. The process, system or medium of any one of claims 1-6, wherein the selected product is a healthcare related product.

8. The process, system or medium of any preceding claim, wherein the one or more instances of textual content are selected from the group consisting of: i) the dosage or administration of the selected product, ii) the form or strength of the product selected, iii) indications or usage for the selected product, iv) warnings or precautions concerning said selected product, v) adverse reactions associated with the selected product, vi) data on the use of the selected product in a specific population, vii) material changes in said selected product within a predefined amount of time, viii) qualitative and quantitative information about the selected product, and ix) The composition and structure of the selected product.

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