Abstract:
A regulatory information retrieval system is disclosed. In one embodiment, the method comprises building ingredient data for manufacturing businesses. Then, those ingredients are compared with regulatory requirements. Relevant requirements are identified regarding permitted usage are extracted and converted to a guideline document. The guideline document can be viewed in a variety of ways, such as a detailed view, or an overview of repositories searched. The guidelines may then be converted to a file format that can be imported by other business applications.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present patent document is a division of U.S. patent application Ser. No. 13029262, filed Feb. 17, 2011, entitled “AUTOMATED REGULATORY GUIDELINE MANAGEMENT SYSTEM”, the disclosure of which is incorporated herein by reference. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates generally to information retrieval. 
       BACKGROUND 
       [0003]    Businesses such as food manufacturers, cosmetic companies, and the like, have a need to manage many ingredients and formulas for manufacture of their products. There are many regulations pertaining to most of these ingredients, and the regulations vary in different countries. Keeping track of such regulations is a time-consuming and costly activity for these businesses. Therefore, it is desirable to have an improved regulatory information retrieval system to reduce the time and cost associated with these activities. 
       SUMMARY 
       [0004]    Embodiments of the present invention provide systems and method for identifying regulator and customer restrictions pertaining to various substances, and the creation of file format guidelines for managing changes to those restrictions. There are various repositories available on the Internet, such as from the US Food and Drug Administration (FDA), and similar organizations in other countries. Much of this information can be “crawled” by a search engine which retrieves this information, and indexes it for fast retrieval. However, there are other documents that are not in text form. These may be TIFF files, graphic PDF files, or other formats. In some cases, these may undergo Optical Character Recognition (OCR) to convert the graphic images to text for storage. 
         [0005]    In addition to retrieving relevant passages based on search terms, embodiments of the present invention apply a thesaurus to search terms to further expand the search. This allows identification of relevant passages that may not use the exact words of the search term. For example, acetylsalicylic acid also commonly is referred to as “aspirin.” Hence, a search regarding regulations for acetylsalicylic acid may also retrieve information citing “aspirin” as relevant. 
         [0006]    Embodiments of the present invention also apply emphasis to important words in the relevant passages. These important words may comprise “regulatory words” which help identify important rules and restrictions within the relevant passages. 
         [0007]    The collection of relevant passages with emphasized words is used to comprise a guideline. The guideline is a form and the collection of an intelligent search result that provides a user with important information regarding a particular substance, identifying the categories of use, and the applicable restrictions. The user may optionally enter other parameters regarding his/her use of the substance prior to the search. These parameters may include, but are not limited to, the type of application (e.g. food, cosmetic, etc . . . ), the geographic location (e.g. U.S., Canada, Europe, etc . . . ), and the intended age range of usage (e.g. a children&#39;s medicine, adult product, etc . . . ). These parameters help focus the search to retrieve relevant regulations (e.g. for the proper countries), applications (such as cosmetics), and age groups. For example, a user planning to use an ingredient for a children&#39;s shampoo to be sold in Europe needs to refer to pertinent regulations for that situation. 
         [0008]    Furthermore, the guideline information can be formatted into a data format, such as CSV (comma separated value) such that it may be imported into a third party program such as a formulation management system, or a spreadsheet application. In this way, the guideline information can be integrated into existing information systems. 
         [0009]    In one embodiment, the method comprises building ingredient data for manufacturing businesses. Then, those ingredients are compared with regulatory requirements. Relevant requirements are identified regarding permitted usage, which then are extracted and converted to a guideline document. The guideline document can be viewed in a variety of ways, such as a detailed view, or an overview of repositories searched. The guidelines may then be converted to a file format that can be imported by other business applications. 
         [0010]    The guidelines may include a variety of metadata that is part of the file format (e.g. CSV) that is imported into a third party software package. This metadata may include, but is not limited to:
   An automatically generated reference number for the guideline;   Packaging and labeling restrictions;   Date of the regulation;   Author (source) of the regulation;   Country of the regulation;   Formulation restriction on composition percentages; and   Shelf life.   
 
         [0018]    This metadata may be entered manually, or where possible, automatically populated. For example, when retrieving data from an FDA website, it is known that the country of the regulation is the United States, and the Author (source) of the regulation is the FDA. 
         [0019]    Embodiments of the present invention also provide a method for generating viewable reports that display collected content on ingredient compliance. Fields are mapped to the guideline data structure so it can be fetched and displayed in these reports. A file can be exported summarizing this viewable report. 
         [0020]    Embodiments of the present invention also provide a method for retrieving regulatory information. The method comprises indexing a plurality of regulatory corpuses, thereby forming a plurality of full-text searchable databases; receiving a search query comprising at least one search term; executing the search query on the plurality of full-text searchable databases to identify a plurality of relevant passages; emphasizing search terms within the plurality of relevant passages; and emphasizing regulatory words within the plurality of relevant passages, thereby forming emphasized relevant passages. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  shows a block diagram of a system in accordance with an embodiment of the present invention. 
           [0022]      FIG. 2  shows details of a server used in the embodiment of  FIG. 1 . 
           [0023]      FIG. 3  is a flowchart outlining a method in accordance with an embodiment of the present invention. 
           [0024]      FIG. 4  shows an example of a search entry user interface. 
           [0025]      FIG. 5  shows an example of a repository listing user interface. 
           [0026]      FIG. 6  shows an example of a detailed repository search results user interface. 
           [0027]      FIG. 7  shows an example of a repository document view user interface. 
           [0028]      FIG. 8  shows an example of a relevant phrase and associated metadata. 
           [0029]      FIG. 9  shows an example of an automated guideline view user interface. 
       
    
    
     DETAILED DESCRIPTION 
       [0030]      FIG. 1  shows a block diagram of a system  100  in accordance with an embodiment of the present invention. System  100  interacts with one or more client devices (examples shown as  102  and  103 ), which may be a personal computer or other suitable platform for running a client device. In one embodiment, the client device  102  is a computer that executes a browser to render a so-called “web-based” user interface. The client device communicates with a backend search module  104 . The backend search module  104  receives search requests from client device  102  and in turn, sends the search request to a plurality of content servers (indicated as  106 ,  108 , and  110 ). While three content servers ( 106 ,  108 ,  110 ) are shown in  FIG. 1 , embodiments of the present invention may have more or fewer content servers. 
         [0031]    The content servers ( 106 ,  108 ,  110 ) each comprise one or more databases. Each content server performs a search on the data in the databases using the search query that is communicated from the client device  102 . The results of the search are then sent back to the backend search module  104  which then sends the results to the client device  102 . The content servers ( 106 ,  108 ,  110 ), backend search module  104 , and client device  102  are devices comprising a processor, and non-transitory computer storage which contains machine instructions, that when executed by the processor, perform methods disclosed herein. These devices are interconnected via communications network  112 . In one embodiment, communications network  112  may include the Internet  124 . Other embodiments may comprise multiple client devices, such as client device  103 . Hence, embodiments of the present invention may support multiple simultaneous users. The content servers ( 106 ,  108 ,  110 ) build internal, searchable databases based on existing regulatory corpuses  120  and  122 . In practice, there may be many such regulatory corpuses. In one embodiment, the regulatory corpuses may include regulations available on the Internet from the US Food and Drug Administration, and counterpart agencies internationally. 
         [0032]      FIG. 2  shows details of a content server  200  used in the embodiment of  FIG. 1 . Architecturally, content server  200  is similar to content servers ( 106 ,  108 ,  110 ) of  FIG. 1 . Content server  200  comprises a processor  211 , and non-transitory computer storage  213  which contains machine instructions, that when executed by the processor, perform methods disclosed herein. Content server  200  comprises multiple repositories ( 224 ,  226 ,  228 ). Each repository is a full text searchable repository, which is searched by search engine  222 . In one embodiment, search engine  222  is comprised of a fully inverted indexing system, such as Livelink Discovery Server by Open Text Corporation. Application Programming Interface (API) module  220  interfaces with the backend search module  104 . It receives search queries from the backend search module  104  and, upon completion of execution of the search queries, communicates search results to the backend search module  104  for dissemination to client devices (see  102 ,  103  of  FIG. 1 ). In one embodiment, API module  220  is implemented via PHP. In another embodiment, the API module  220  is implemented via dot Net framework. 
         [0033]    Optionally, an embodiment may further comprise Optical Character Recognition (OCR) module  225 . In some cases, relevant documents from Internet sources may not be in a text-searchable form, and may comprise graphics files such as TIFF files or PDF files with no searchable text. In this case, OCR module  225  performs an OCR process to convert information to text, such that it may be stored in one or more of the repositories ( 224 ,  226 ,  228 ). 
         [0034]      FIG. 3  is a flowchart  300  outlining a method in accordance with an embodiment of the present invention. When a search query  333  is processed, the search query  333 , full-text database  332 , and thesaurus  330  provide input to match algorithm  334 . Match algorithm  334  compares the terms from query  333  with entries in full-text database  332 . Synonyms for the query terms are derived from the thesaurus  330 . For example, given a search query  333  with the term “aspirin,” the thesaurus  330  is checked for synonyms, and may return alternative terms, such as “acetylsalicylic acid,” and “ASA.” These terms are also used to form a “synonym search query,” which is then used to search full-text database  332  to collect addition relevant results. 
         [0035]    Documents and passages within full-text database  332  that match the search query from the original terms or synonyms are input to the emphasis algorithm  336 . The emphasis algorithm  336  highlights important terms within the relevant passages and documents supplied by match algorithm  334 , thereby creating emphasized relevant passages. The emphasis algorithm  336  highlights the terms and related synonyms from the search query  333 . Emphasis algorithm  336  may provide emphasis (e.g. via boldface font, colors, underlining, highlighting, or a combination thereof), for important words in a regulatory context. These “regulatory words” may include, but are not limited to: Shall, must, can, may, cannot, allow, permit, require, prohibit, ban, forbid. 
         [0036]    Other words may also be included or omitted, depending on the application. The emphasis algorithm  336  may apply the regulatory words with a stemming process, such that “stemmed regular words,” which are various tenses of the words, also get highlighted. For example, with the regulatory word “prohibit,” it is also possible to highlight stemmed regulatory words such as “prohibiting” and “prohibited” by applying a word stemming process. The output of the emphasis algorithm is an emphasized document database (EDD)  338  that comprises the relevant documents and/or passages from the full-text database  332  with the search terms, synonyms, and regulatory words emphasized. The EDD is then used as source material for generating guidelines for various substances. In one embodiment, the EDD is converted into a CSV (comma separated value) file, such that it may be imported into a formulation management software package, such as Optiva. The fields within the CSV file may include, but are not limited to, an automatically generated reference number for the guideline, packaging and labeling restrictions, date of the regulation, author of the regulation, country of the regulation, formulation restriction on composition percentages, and shelf life. 
         [0037]      FIG. 4  shows an example of a search entry user interface  400 . User interface  400  comprises a search text entry field  440 , where the user enters search query terms. In  FIG. 4 , the search term “Corn oil” is entered into text field  440 , as an example. Prior to performing the search, the user may select repositories to search from a plurality of content repositories and user repositories. Content repositories are typically information repositories available on the Internet, such as US FDA websites, or other regulatory bodies internationally. 
         [0038]    Content repository  448 , which is “EU Sweeteners” is selected to be searched by selecting checkbox  446 . To skip searching a repository, it is unchecked, as shown with checkbox  454 . Since checkbox  454  is not selected, the corresponding repository (FDA Cosmetic Labeling) is not searched. In one embodiment, repositories are grouped by geographical location. For example, group  450  comprises repositories covering North America. Select All button  456  enables a user to select all the repositories in a selected group. Similarly, Clear All button  458  enables a user to clear all the repositories in a selected group. Open All Group button  460  expands all groups to reveal the repositories contained within the groups. Similarly, Close All Group button  462  collapses all the groups. 
         [0039]    User repositories section  452  contains local databases acquired by the user. Select All button  464  and Clear All button  466  allow for easy selection or de-selection of the user repositories  453 ,  455 , and  457 . 
         [0040]    Once the user has selected the desired content repositories and user repositories, the search can be initiated with the invocation of the Search button  442 . The Clear button  444  clears the search text entry field  440 . 
         [0041]      FIG. 5  shows an example of a repository listing user interface  500 . Repository listing user interface  500  is one of multiple ways to view search results. Repository listing user interface  500  shows the most relevant repositories for a given search query. For each repository presented, a title  580  is displayed, along with a relevancy score  578 , and a text description field  582 , which contains a description of the repository. 
         [0042]    The number of repositories searched is displayed in field  570 . The time the search took is shown in field  572 . The number of search results is displayed in field  574 . The number of duplicates in the repository list is shown in field  576 . 
         [0043]      FIG. 6  shows an example of a detailed repository search results user interface  600 . User interface  600  shows various types of documents that were searched. Each document has a type field  604 , and an expansion control  602 . The expansion control  602 A is selected to show relevant phrases  610  and  614  from documents within type “Pure, 100% Pure” as indicated for type field  608 . Within the relevant phrases  610  and  614 , relevant keywords, such as “oil,” are highlighted, as shown by reference numbers  612  and  616 . 
         [0044]      FIG. 7  shows an example of a repository document view user interface  700 . Title field  720  shows the document type where the text passages  722 ,  724 , and  726  originated from. Highlighted terms  732 ,  734 ,  736 , and  738  emphasize important information for the user. These words are emphasized by the emphasis algorithm (see  336  of  FIG. 3 ). 
         [0045]      FIG. 8  shows an example of a relevant phrase and associated metadata as organized in data format  800 . Field  804  contains a relevant phrase that is based on a user&#39;s search query. Field  808  is the country of origin for the relevant phrase. Field  812  is the date of the document containing the relevant phrase. Field  816  is the source of the relevant phrase, which may be the name of the repository and/or issuing organization. Note that while shown in tabular format in  FIG. 8 , those skilled in the art will realize that a variety of file formats are possible, such as CSV, binary data format, or relational database format. 
         [0046]      FIG. 9  shows an example of an automated guideline view user interface  900 . On the left side of user interface  900  is the region list  902  which comprises one or more geographical regions. In user interface  900 , four such regions are shown:  904  (Europe),  906  (US),  908  (Canada), and  910  (Mexico). In  FIG. 9 , region  906  (US) is highlighted. On the right side of user interface is the properties section  903 . Properties section  903  contains information for a particular substance for a highlighted region (in this case, the United States). Field  912  contains the name of the substance. Field  914  contains blacklist information for the substance. Field  916  contains the maximum level for the substance. YES/NO field  918  indicates either “YES” or “NO” as to if the maximum level is based on dry percentage. Field  920  indicates the country or region to which the information within properties section  903  applies. Field  922  indicates the form of the product. Field  923  indicates the FDA category and subcategory. Field  924  indicates the product type. Field  926  indicates the functionality of the product. Field  928  indicates the rule description pertaining to the product. This may include limitations or special considerations for a substance, such as age restrictions, storage restrictions, labeling restrictions and packaging restrictions. All the constraints of a given substance, the categories of use and the restrictions within those categories are captured in user interface  900 . This information may then be exported in the format of a data file such as a CSV file to a third party business application. 
         [0047]    As can now be appreciated, embodiments of the present invention provide query broadcasting functionality to a wide variety of data sources, such as searchable web sites and local network data repositories like Sharepoint. This provides an even greater level of flexibility and customizability of the overall system, allowing a solution offering to best meet the needs of the customer and provide the most relevant data sources. 
         [0048]    It will be recognized that the invention can take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment containing both hardware and software elements. Furthermore, in some embodiments, the invention can take the form of a computer program product accessible from a computer-usable or computer-readable medium providing program code for use by or in connection with a computing system or any instruction execution system to provide and facilitate the capabilities of the present invention. For the purposes of this description, a computer-usable or computer-readable medium can be any apparatus that can contain, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. 
         [0049]    Although the description above contains many specific details, these should not be construed as limiting the scope of the invention, but merely as providing illustrations of some of the presently preferred embodiments of the present invention. The present invention may have various other embodiments. Furthermore, while the form of the invention herein shown and described constitutes a preferred embodiment of the invention, it is not intended to illustrate all possible forms thereof. It will also be understood that the words used are words of description rather than limitation, and that various changes may be made without departing from the spirit and scope of the invention disclosed. Thus, the scope of the invention should be determined by the appended claims and their legal equivalents, rather than solely by the examples given.