Pharmaceutical manufacturing information management device and pharmaceutical manufacturing information management method

Abstract

Allows access to multiple databases. [Solution] The pharmaceutical manufacturing information management device 100 includes a search unit 112 that searches for related information items, which are information items related to the selected information item, when an information item is selected from the search results of information items related to pharmaceutical manufacturing stored in database servers 211, 212, and a display control unit 113 that displays the related information items. The search unit 112 searches for related information items in the database server 211, 212 corresponding to the selected information item among the multiple database servers 211, 212.

Description

Technical Field

[0001] The present invention relates to a pharmaceutical manufacturing information management apparatus and a pharmaceutical manufacturing information management method for managing data related to pharmaceutical manufacturing.

Background Art

[0002] Data (information) related to pharmaceutical manufacturing is enormous and the data is associated with each other. The data to be managed, the relationships between the data, and thus the access procedures to the data also vary depending on the pharmaceutical manufacturer. For this reason, a management system tailored to individual pharmaceutical manufacturers has been provided by modifying the screen display program of the package product for pharmaceutical manufacturing information management. The access procedure indicates which data (information) to access from which data, for example, accessing the test data of the inventory item from the inventory item data.

[0003] On the other hand, in the regulations (GMP (Good Manufacturing Practice) ordinance) in the pharmaceutical manufacturing field, it is obligatory to store various data related to manufacturing for 5 to 10 years in principle after the expiration date of the product. The storage period varies depending on the type of data and the manufacturing product type. In particular, pharmaceuticals and biopharmaceuticals with a high risk require even longer data storage.

[0004] Thus, in pharmaceutical manufacturing, it is necessary to store data for a long time and refer to those data as needed. Even when upgrading the version of the system for managing data or updating the hardware, the old system needs to be separated and left behind. For this reason, it becomes difficult to access old data and it causes a burden on user resources.

[0005] Furthermore, when using both the old and new databases, audits require the collection of pharmaceutical manufacturing data (information) scattered throughout both the new and old systems. To improve this workload, it is desirable to be able to access both the old and new databases from the new system, display the information in the new system, and generate reports. For this reason, a screen display function that can flexibly accommodate the different data structures of each pharmaceutical manufacturer is required.

[0006] Patent Document 1 describes an invention that allows pharmaceutical manufacturers to customize screens. This invention is a database reference screen creation system for creating a screen for referencing database information, and comprises a management unit, a screen configuration modification unit, and a screen provision unit. The management unit manages item information indicating each item managed by the database, search method information defining a search method for each item information, search condition information defining search conditions for searching the database based on the search method, and result display method information defining a method for displaying search results extracted from the database based on the search method. The screen configuration modification unit modifies the configuration of the search screen for searching the database according to the search method information and search condition information, and the configuration of the result display screen for displaying search results according to the result display method. The screen provision unit provides the search screen and result display screen modified by the screen configuration modification unit to the user terminal for display. [Prior art documents] [Patent Documents]

[0007] [Patent Document 1] Japanese Patent Publication No. 2015-162122 [Overview of the project] [Problems that the invention aims to solve]

[0008] By using the invention described in Patent Document 1, pharmaceutical manufacturers can set screen configurations and data search conditions, and access data in a procedure of their choice. However, the invention described in Patent Document 1 does not support access to old databases. This invention was made in view of the above background, and aims to provide a pharmaceutical manufacturing information management device and a pharmaceutical manufacturing information management method that can access multiple databases. [Means for solving the problem]

[0009] To solve the above-mentioned problems, the pharmaceutical manufacturing information management device according to the present invention comprises a search unit that searches for related information items which are information items related to the selected information item when an information item is selected from the search results of information items related to pharmaceutical manufacturing stored in a database server, and a display control unit that displays the related information items, wherein the search unit searches for the related information items in the database server corresponding to the selected information item among a plurality of database servers. [Effects of the Invention]

[0010] According to the present invention, it is possible to provide a pharmaceutical manufacturing information management device and a pharmaceutical manufacturing information management method that can access multiple databases. Other problems, configurations, and effects will be clarified by the following description of embodiments. [Brief explanation of the drawing]

[0011] [Figure 1] This is a screen configuration diagram of the pharmaceutical manufacturing information management screen displayed by the pharmaceutical manufacturing information management device according to this embodiment. [Figure 2] This flowchart shows the procedure for obtaining pharmaceutical manufacturing information according to this embodiment. [Figure 3] This is a functional block diagram of the pharmaceutical manufacturing information management device according to this embodiment. [Figure 4] This figure shows the data structure of the screen setting information according to this embodiment. [Figure 5] This figure shows the data structure of the item information according to this embodiment. [Figure 6] This is a flowchart of the pharmaceutical manufacturing information management screen processing according to this embodiment. [Figure 7] This is a screen configuration diagram of a manufacturing information screen according to a modified example of this embodiment. [Figure 8] This is a screen configuration diagram of an inventory screen according to a modified example of this embodiment. [Figure 9] This figure shows the data structure of screen setting information according to a modified example of this embodiment. [Figure 10] This is a hardware configuration diagram showing an example of a computer that implements the functions of the pharmaceutical manufacturing information management device according to the above embodiment. [Modes for carrying out the invention]

[0012] ≪Instructions for Using the Pharmaceutical Manufacturing Information Management System≫ Before describing the configuration of the pharmaceutical manufacturing information management device 100 (see Figure 3 below) in an embodiment for carrying out the present invention, the procedure for using the pharmaceutical manufacturing information management device 100 will be described. Figure 1 is a screen configuration diagram of the pharmaceutical manufacturing information management screen 310 displayed by the pharmaceutical manufacturing information management device 100 according to this embodiment. The upper part of the pharmaceutical manufacturing information management screen 310 is arranged in the manufacturing information search area 311. The middle part of the pharmaceutical manufacturing information management screen 310 is arranged in the manufacturing information list area 312 and the inventory list area 313. The lower part of the pharmaceutical manufacturing information management screen 310 is arranged in the test instruction list area 314, the test item list area 315 and the test details area 316.

[0013] Figure 2 is a flowchart illustrating the procedure for acquiring pharmaceutical manufacturing information according to this embodiment. Referring to Figures 1 and 2, the procedure for a user of the pharmaceutical manufacturing information management device 100 to access test information of the manufactured product (product) from the manufacturing process date will be explained.

[0014] In step S11, the user specifies the conditions for searching for manufacturing information and conducts a search. To explain in detail, the user inputs the search conditions in the manufacturing information search area 311 and presses the "Search" button. Then, a list of manufacturing numbers and manufacturing product names, which are the identification information of the manufacturing information that matches the search conditions, is displayed in the manufacturing information list area 312. In FIG. 1, the start date and end date of the manufacturing process are specified as the search conditions. Also, the manufacturing number and manufacturing product name are displayed as the manufacturing information of the search results.

[0015] In step S12, the user selects the manufacturing information. Then, the product name code and lot number of the inventory information corresponding to (related to) the manufacturing information are displayed in the inventory list area 313. In FIG. 1, the selected manufacturing information ("M000082379", "HIJKL") is highlighted (hatched) and displayed.

[0016] In step S13, the user selects the inventory information. Then, the test instruction number of the test instruction corresponding to (related to) the inventory information is displayed in the test instruction list area 314. In FIG. 1, the selected inventory information ("IA3N000341", "L0290000132") is highlighted and displayed.

[0017] In step S14, the user selects the test instruction number. Then, the test item name of the test corresponding to (related to) the test instruction number is displayed in the test item list area 315. In FIG. 1, the selected test instruction number ("S0000003864") is highlighted and displayed.

[0018] In step S15, the user selects the test item name. Then, the test detailed information of the test item corresponding to (related to) the test item name is displayed in the test detailed information area 316. In FIG. 1, the selected test item name ("A02 (content)") is highlighted and displayed.

[0019] As explained above, users can access detailed test information by specifying manufacturing conditions to search for manufacturing information, and then navigating through inventory information, test order numbers, and test item names in that order. In the following, the manufacturing information and inventory information displayed in the search results in the manufacturing information list area 312 and inventory list area 313 will be referred to as information items or simply items. For example, there are two information items / items displayed in the test order list area 314, and their test order numbers are "S0000003843" and "S0000003864". When selecting an information item to search for related information items, the selected information item will be referred to as the selected information item, and the related information items will be referred to as the related information items.

[0020] The procedures for accessing pharmaceutical manufacturing information are not limited to those described above; for example, the following may also be used. (1) Raw material arrival ⇔ Raw material inventory ⇔ Raw material testing (2) Raw material inventory ⇔ Inbound / Outbound shipments ⇔ Manufacturing ⇔ Testing ⇔ Shipment decision ⇔ Shipment (3) Inventory ⇔ Testing ⇔ Manufacturing (4) Manufacturing equipment ⇔ Manufacturing (5) Manufacturing equipment ⇔ Equipment testing (6) Manufacturing ⇔ Deviation

[0021] For example, in (1), the user accesses information items related to pharmaceutical manufacturing as follows: First, by specifying the conditions for searching for raw material arrival information and performing a search, a list of raw material arrival information is displayed. Next, a raw material arrival information item is selected and related raw material inventory information is displayed. Subsequently, a raw material inventory information item is selected and related raw material testing information is displayed.

[0022] Furthermore, (1) also shows the reverse access. First, by specifying the conditions for searching for raw material test information and performing a search, a list of raw material test information is displayed. Next, an item in the raw material test information is selected and the related raw material inventory information is displayed. Subsequently, an item in the raw material inventory information is selected and the related raw material arrival information is displayed. Regarding (3), as shown in Figure 1, you can access inventory information from manufacturing information, or vice versa.

[0023] Data such as inventory, testing, and manufacturing are stored in database servers (see database servers 211 and 212 shown in Figure 3 below), but there may be more than one database server. Information items related to pharmaceutical manufacturing may be stored in multiple database servers depending on the creation date and time of the information item (data). Note that the testing in (2) refers to the testing of manufactured products, and includes the test instructions, test items, and detailed test information shown in Figure 1.

[0024] As explained above, the combination of selected information items and related information items is one of the following: The selected information item is manufacturing information for the drug, and the related information item is inventory information for that drug. The selected information item is inventory information for the drug, and the related information item is manufacturing information for that drug. The selected information item is drug inventory information, and the related information item is the trial information for that drug. The selected information item is drug trial information, and the related information item is inventory information for that drug.

[0025] The selected information item is information on the arrival of raw materials for pharmaceuticals, and the related information item is the inventory of those raw materials for pharmaceuticals. The selected information item is the raw material inventory for the pharmaceutical, and the related information item is the raw material arrival information for that pharmaceutical. The selected information item is the raw material inventory of the pharmaceutical, and the related information item is the raw material testing information of that pharmaceutical. The selected information item is the raw material testing information for the pharmaceutical, and the related information item is the raw material inventory for that pharmaceutical.

[0026] The selected information item is the raw material inventory information for the pharmaceutical, and the related information item is the inbound / outbound information for the raw material of that pharmaceutical. The selected information item is the inbound / outbound information of the raw materials for the pharmaceutical, and the related information item is the inventory information of the raw materials for that pharmaceutical. The selected information item is inventory information for the raw materials of the pharmaceutical product, and the related information item is manufacturing information for the pharmaceutical product. The selected information item is manufacturing information for the pharmaceutical product, and the related information item is inventory information for the raw materials of that pharmaceutical product.

[0027] The selected information item is manufacturing information for the drug, and the related information item is testing information for that drug. The selected information item is drug testing information, and the related information item is the manufacturing information of that drug. The selected information item is drug testing information, and the related information item is the release decision information for that drug. The selected information item is the drug's release decision information, and the related information item is the drug's test information.

[0028] The selected information item is the drug shipment decision information, and the related information item is the shipment information of that drug. The selected information item is the shipment information of the drug, and the related information item is the shipment decision information of that drug. The selected information item is information about the manufacturing facilities for the pharmaceutical product, and the related information item is a combination of that information and the manufacturing information for the pharmaceutical product in question. The selected information item is manufacturing information for the pharmaceutical product, and the related information item is information about the manufacturing facilities for that pharmaceutical product.

[0029] The selected information item is equipment information for the manufacturing equipment, and the related information item is equipment test information for that manufacturing equipment. The selected information item is equipment test information for the manufacturing equipment, and the related information item is equipment information for that manufacturing equipment. A combination in which the selected information item is manufacturing information of the drug, and the related information item is deviation information of the drug. A combination where the selected information item is drug deviation information, and the related information item is manufacturing information for that drug.

[0030] <<Configuration of the Pharmaceutical Manufacturing Information Management System>> Figure 3 is a functional block diagram of the pharmaceutical manufacturing information management device 100 according to this embodiment. The pharmaceutical manufacturing information management device 100 is a computer and comprises a control unit 110, a storage unit 120, and a communication unit 180. The communication unit 180 is equipped with a communication device and is capable of sending and receiving data with database servers 211, 212 and terminal 220. Terminal 220 is a terminal used by users of the pharmaceutical manufacturing information management device 100 to access pharmaceutical manufacturing information.

[0031] Database Server Configuration Database servers 211 and 212 store data (information) related to pharmaceutical manufacturing. In the following explanation, it is assumed that there are two database servers, 211 and 212, depending on the date the data was created. For example, data created before a certain point in time is stored in database server 211, and data created after that point in time is stored in database server 212. In the following explanation, "a certain point in time" is assumed to be January 1, 2024. This indicates that, with the update of the database servers, old data from before January 1, 2024 will be stored in database server 211, and new data from that date onward will be stored in database server 212.

[0032] Database servers 211 and 212 store information such as raw material receipts, raw material inventory, raw material testing, raw material inventory, inventory receipts and issues, manufacturing, testing, and shipping. Furthermore, this information is stored in association with information relevant to search and access procedures. An example is shown below.

[0033] As shown in the manufacturing information search area 311 (see Figure 1), manufacturing information can be searched using criteria such as manufacturing number, product name, process, process output, process start date, and process end date. For this reason, manufacturing information is stored in database servers 211 and 212, associated with information such as manufacturing number and process.

[0034] Furthermore, as shown in the manufacturing information list area 312 and the inventory list area 313, inventory information is accessible from manufacturing information, and inventory information and manufacturing information are associated and stored in database servers 211 and 212. For example, manufacturing information is associated with inventory information of manufactured goods produced in the manufacturing process indicated by the manufacturing information. Conversely, inventory information is associated with manufacturing information of the manufacturing process that produced the manufactured goods in the inventory indicated by the inventory information.

[0035] As shown in "(2) Raw material inventory ⇔ Inbound / Outbound shipments ⇔ Manufacturing ⇔ Testing ⇔ Shipment decision ⇔ Shipment", manufacturing information and testing information are mutually accessible, and manufacturing and testing are associated and stored in database servers 211 and 212. Since manufacturing and testing are performed at the same time, manufacturing information and testing information are stored in the same database servers 211 and 212. For example, if an information item of manufacturing information is in database server 211, then the information item of testing information related to (corresponding to) that information item is also in database server 211.

[0036] Depending on the related information (information items related to a given information item), the information item and its related information may be stored in different database servers 211 and 212. For example, suppose the first raw material used in the manufacture of a certain product was received before January 1, 2024, and the raw material inventory information is stored in database server 211. Also, suppose the second raw material was received after January 1, 2024, and the raw material inventory information is stored in database server 212. In such a case, the raw material inventory information related to the receiving and issuing information related to the manufacturing information in "(2) Raw material inventory ⇔ Inbound / Outbound ⇔ Manufacturing ⇔ Testing ⇔ Shipment decision ⇔ Shipment" will be stored in both database servers 211 and 212. More specifically, the raw material inventory information for the first raw material is stored in database server 211, and the raw material inventory information for the second raw material is stored in database server 212.

[0037] Thus, depending on the related information, an information item (selected information item) and related information items (related information items) may be stored in the same database server, or they may be stored in multiple database servers, including different database servers. Therefore, when searching for related information items of an information item, it is necessary to switch the database server search depending on the relationship between the selected information item and the related information items, whether to search the same database server where the information item is stored or to include other database servers as well. In the following, the case where the selected information item and its related information items are stored in the same database server may be referred to as Type I (co-existing). Also, the case where they are stored in multiple database servers (database servers 211, 212) may be referred to as Type II (non-co-existing).

[0038] ≪Pharmaceutical Manufacturing Information Management System: Memory Unit≫ The memory unit 120 is comprised of memory devices such as ROM (Read Only Memory), RAM (Random Access Memory), and SSD (Solid State Drive). The memory unit 120 stores screen setting information 130, item information 140, database information 150, and program 128. The various contents of the memory unit 120 may be stored in an external storage device such as a cloud server and read as needed. The program 128 includes a description of the processing of the functional unit provided in the control unit 110, which will be described later.

[0039] ≪Memory Section: Screen Settings Information≫ Figure 4 shows the data structure of the screen setting information 130 according to this embodiment. The screen setting information 130 includes information relating to the configuration of the screen displayed by the pharmaceutical manufacturing information management device 100. For example, for the pharmaceutical manufacturing information management screen 310 (see Figure 1), the screen setting information 130 includes information relating to the position and size of areas included in the screen, such as the manufacturing information search area 311, and the information items (display items) to be displayed.

[0040] Furthermore, the screen setting information 130 includes the processing content for when an information item displayed in the area is selected, as part of the item selection processing. For example, in the pharmaceutical manufacturing information management screen 310, manufacturing information and inventory information are created at the same time and therefore stored in the same database server (Type I). For this reason, the item selection processing in the manufacturing information list area 312 includes the processing content to search for and retrieve inventory information related to the information item in the same database server where the information item is stored, and to display it in the inventory list area 313, when an information item of the displayed manufacturing information is selected.

[0041] As described above, the "raw material inventory" related to "inbound and outbound" in "(2) Raw material inventory ⇔ Inbound and outbound ⇔ Manufacturing ⇔ Testing ⇔ Shipment determination ⇔ Shipment" is stored in both database servers 211 and 212 (Type II). Therefore, when accessing related raw material inventory from inbound and outbound information, it is necessary to search both database servers 211 and 212. The processing when an item is selected in the inbound and outbound information area (not shown) includes the following: when an information item of the inbound and outbound information is selected, the raw material inventory information related to that information item is searched and retrieved in both database servers 211 and 212 and displayed in the raw material inventory list area (not shown).

[0042] Furthermore, the processing related to searching and retrieving inventory information associated with the selected item in either one (Type I) or both (Type II) of database servers 211 and 212 is also referred to as the search processing content. The search processing content may include search location information indicating whether the database to be searched is the same database as the selected item (Type I, co-located) or both database servers 211 and 212 (Type II, non-co-located), as well as a search command (query).

[0043] ≪Storage section: Item information≫ Figure 5 shows the data structure of item information 140 according to this embodiment. Item information 140 includes information related to the information items of the search results displayed on the screen displayed by the pharmaceutical manufacturing information management device 100. For example, item information 140 for the pharmaceutical manufacturing information management screen 310 (see Figure 1) includes information related to each information item displayed in the manufacturing information list area 312, inventory list area 313, test instruction list area 314, and test item list area 315.

[0044] The information related to the manufacturing information items displayed in the manufacturing information list area 312 includes not only the manufacturing number and product name for each displayed information item, but also the identification information of the database servers 211 and 212 that contain that information item. For example, suppose you search for manufacturing information by specifying the product name on the pharmaceutical manufacturing information management screen 310 (see Figure 1). Then, the manufacturing information search area 311 will display information items for manufacturing information before January 1, 2024, and information items for manufacturing information after that date. In this case, the item information 140 will include the identification information of database server 211 for information items before that date, and the identification information of database server 212 for information items after that date. In Figure 5, "M000082342" is the manufacturing number, "ABCDEFG" is the product name, and "DB1" is the identification information of database server 211. The identification information of database servers 211 and 212 is not displayed on the screen (see Figure 1).

[0045] ≪Memory Section: Database Information≫ Returning to Figure 3, let's continue the explanation of the storage unit 120. The database information 150 stores the identification information, addresses, and authentication information for accessing the database servers 211 and 212, all associated with each other. Other information, such as the database type of the database server, may also be stored in the database information 150.

[0046] ≪Pharmaceutical Manufacturing Information Management System: Control Unit≫ The control unit 110 includes a CPU (Central Processing Unit) and comprises a screen setting unit 111, a search unit 112, and a display control unit 113.

[0047] ≪Control Unit: Screen Settings Unit≫ The screen setting unit 111 receives information relating to the screen configuration to be displayed by the pharmaceutical manufacturing information management device 100, as instructed by the administrator of the pharmaceutical manufacturing information management device 100. The screen setting unit 111 stores the received screen configuration information in the screen setting information 130.

[0048] As described above, the pharmaceutical manufacturing information management device 100 includes a screen setting unit 111 that stores in the storage unit 120 the position and size of the selected information item list display area that displays a list of selected information items, the position and size of the related information item list display area that displays a list of related information items, and search location information (see item selection processing shown in Figure 4) that indicates the relationship between the selected information item and the related information item.

[0049] ≪Control Unit: Search Unit≫ When a user specifies search criteria and instructs a search, the search unit 112 retrieves information items that match the search criteria by searching the database servers 211 and 212. The search unit 112 also retrieves related information items associated with the selected information items by accessing the database servers 211 and 212. The search unit 112 stores the search results in the item information 140 along with the identification information of the database servers 211 and 212 that were searched.

[0050] The search process details are included in the item selection process (see Figure 4) contained in the screen setting information 130. The search process details also include search location information. For example, the search location information in the manufacturing information list area 312 is type I. When an information item of the manufacturing information displayed in the manufacturing information list area 312 is selected, inventory information related to that information item is searched on the same database server where that information item (selected information item) is stored (type I). If the search location information included in the search process details is type II, the search unit 112 searches both database servers 211 and 212.

[0051] ≪Control Unit: Display Control Unit≫ The display control unit 113 creates a screen based on the screen setting information 130 and item information 140 and sends it to the terminal 220 (displaying the screen on the terminal 220's display). The following describes the processing contents of the search unit 112 and the display control unit 113 using the pharmaceutical manufacturing information management screen 310 as an example.

[0052] ≪Control Unit: Example of processing by the search unit and display control unit≫ Initially, the display control unit 113 displays the initial screen, the pharmaceutical manufacturing information management screen 310. The initial screen is a screen in which no information items are displayed in any of the areas, such as the manufacturing information search area 311 or the manufacturing information list area 312.

[0053] For example, suppose a search for manufacturing information is instructed with a specified process start date and process end date, as shown in the manufacturing information search area 311 in Figure 1. The search unit 112 then searches the database servers 211 and 212 for manufacturing information that matches the specified process start date and process end date. The search unit 112 stores the information items of the search results in the item information 140 along with the identification information of the database servers 211 and 211 where the information items were stored. The display control unit 113 displays the manufacturing number and the manufactured product name from the information items in the item information 140 in the manufacturing information list area 312 (see the manufacturing information list area 312 shown in Figure 1).

[0054] Next, suppose the user selects an information item (selected information item) in the manufacturing information list area 312 where the manufacturing number is "M000082379" and the manufactured product name is "HIJKL". Then the search unit 112 refers to the search location information (Type I) included in the item selection processing of the manufacturing information list area 312 in the screen setting information 130 and obtains the identification information of the database server where the selected information item was stored. Next, the search unit 112 searches the database server corresponding to the identification information for the inventory information (related information item) as related information. The search unit 112 stores the search result information item in the item information 140 along with the identification information of the database servers 211,211 where the information item was stored. The display control unit 113 displays the product name code and lot number of the inventory information in the item information 140 in the inventory list area 313 (see inventory list area 313 shown in Figure 1).

[0055] In this way, users can successively access related information, such as manufacturing information obtained by specifying conditions and searching, then inventory information, followed by test instructions, test items, and detailed test information.

[0056] As described above, the pharmaceutical manufacturing information management device 100 includes a search unit 112 that searches for related information items, which are information items related to the selected information item, when an information item is selected from the search results of information items related to pharmaceutical manufacturing stored in the database servers 211, 212. The search unit 112 searches for related information items in the database server corresponding to the selected information item among the multiple database servers 211, 212. The pharmaceutical manufacturing information management device 100 also includes a display control unit 113 that displays relevant information items.

[0057] The search unit 112 refers to search location information indicating whether the selected information item and its related information item are cohabiting (Type I), meaning they are stored in the same database servers 211, 212, or not cohabiting (Type II), meaning they are not necessarily stored in the same database servers 211, 212. If the selected information item and the related information item are identical, the search unit 112 searches for the related information item in the same database server where the selected information item was stored. If they are not identical, the search unit 112 searches for the related information item in multiple database servers.

[0058] The search unit 112 searches for related information items in the database server corresponding to the search location information (see item selection processing shown in Figure 4) for the selected information item displayed in the selected information item list display area. The display control unit 113 displays the related information items of the search results in the related information item list display area.

[0059] <<Processing of the pharmaceutical manufacturing information management screen>> Figure 6 is a flowchart of the pharmaceutical manufacturing information management screen processing according to this embodiment. The screen processing related to the pharmaceutical manufacturing information management screen 310 will be explained with reference to Figure 6.

[0060] In step S21, the display control unit 113 transmits the initial screen of the pharmaceutical manufacturing information management screen 310 to the terminal 220. In step S22, the display control unit 113 accepts user input on the pharmaceutical manufacturing information management screen 310.

[0061] In step S23, if the operation received in step S22 is an operation to search for manufacturing information by specifying manufacturing information search conditions in the manufacturing information search area 311 (see step S11 in Figure 1) the display control unit 113 proceeds to step S24 (step S22 → manufacturing information search). If the operation is to select an information item of manufacturing information in the manufacturing information list area 312 (see step S12) (step S22 → select manufacturing information), the display control unit 113 proceeds to step S25.

[0062] If the operation is to select an information item of inventory information in the inventory list area 313 (see step S13) (step S22 → select inventory information), the display control unit 113 proceeds to step S26. If the operation is to select an information item for the test instruction number in the test instruction list area 314 (see step S14) (step S22 → select test instruction number), the display control unit 113 proceeds to step S27.

[0063] If the operation is to select an information item for a test item in the test item list area 315 (see step S15) (step S22 → select test item), the display control unit 113 proceeds to step S28. If the operation is an operation that instructs termination (pressing the "×" in the upper right corner of the pharmaceutical manufacturing information management screen 310) (step S22 → instruction to terminate), the display control unit 113 terminates the processing of the pharmaceutical manufacturing information management screen.

[0064] In step S24, the search unit 112 searches for manufacturing information that matches the specified manufacturing information search conditions in the database servers 211 and 212, and stores the results in the item information 140. The display control unit 113 displays the manufacturing information in the item information 140 in the manufacturing information list area 312. Here, the manufacturing information includes information items that were stored in the database server 211 and information items that were stored in the database server 212.

[0065] In step S25, the search unit 112 searches for inventory information as related information according to the search processing content (search location information is type I) included in the item selection process in the screen setting information 130 related to the selected manufacturing information information item, and stores the search result information item in item information 140. Subsequently, the display control unit 113 displays the inventory information information item in item information 140 in the inventory list area 313.

[0066] The selected manufacturing information items are located in the manufacturing information search area 311. Therefore, the search unit 112 searches for the inventory information items in the same database server where the selected manufacturing information items were stored, in accordance with the search processing content (Type I) included in the item selection processing of the manufacturing information search area 311.

[0067] In step S26, the search unit 112 searches for test instruction information as related information according to the search processing content (Type I) included in the item selection processing in the screen setting information 130 relating to the information items of the selected inventory information, and stores the information items of the search results in the item information 140. Subsequently, the display control unit 113 displays the information items of the test instruction information in the item information 140 in the test instruction list area 314.

[0068] In step S27, the search unit 112 searches for the test items as related information according to the search processing content (Type I) included in the item selection processing in the screen setting information 130 related to the information items of the selected test instruction number, and stores the information items of the search results in the item information 140. Subsequently, the display control unit 113 displays the information items of the test items in the item information 140 in the test item list area 315.

[0069] In step S28, the search unit 112 searches for detailed test information as related information according to the search processing content (Type I) included in the item selection processing in the screen setting information 130 related to the selected test item, and stores the information items of the search results in the item information 140. Subsequently, the display control unit 113 displays the information items of the detailed test information in the item information 140 in the detailed test information area 316.

[0070] Features of the Pharmaceutical Manufacturing Information Management System By using the pharmaceutical manufacturing information management device 100, administrators can create screens for managing pharmaceutical manufacturing information. For example, administrators can create screens by setting the areas included in the screen, the position and size of the areas, the items displayed in the areas, and the actions to be taken when an item displayed in an area is selected.

[0071] After the screen is built, users can search for the desired information, select items from the search results, and then sequentially access related information (related information items) to the selected items (selected information items). For example, on the pharmaceutical manufacturing information management screen 310, users can set conditions for the manufacturing information they want to access and perform a search. From the manufacturing information in the search results, they can sequentially access inventory information, test order numbers, test items, and test details.

[0072] Although information items are stored in multiple database servers 211 and 212, the pharmaceutical manufacturing information management device 100 selects a database server according to the selected information item and searches for related information items. Therefore, users do not need to be aware of which database server 211 or 212 to search.

[0073] By using the pharmaceutical manufacturing information management device 100, it becomes possible to manage pharmaceutical manufacturing information over a long period of time. Even if the hardware or software of the database servers 211 and 212 are updated, by moving the data to the updated database server (for example, database server 211 that stores the old data), related information stored before the update can be accessed in the same way as related information stored after the update.

[0074] <<Variation: Access Order>> In the embodiment described above, the access order of information items is set in the screen setting information 130 (see Figure 4). For example, in the pharmaceutical manufacturing information management screen 310 (see Figure 1), the next information item to be accessed is determined by the settings, in the order of manufacturing information, inventory, test instructions, test items, and test details.

[0075] Alternatively, after selecting an information item, the user may be able to select the type of related information item to access next. For example, information items related to manufacturing information include inventory, receiving / shipping, testing, and manufacturing equipment. After selecting an information item of manufacturing information, the user may be able to select the related information item to access next from among inventory, receiving / shipping, testing, and manufacturing equipment.

[0076] Figure 7 is a screen configuration diagram of the manufacturing information screen 320 according to a modified example of this embodiment. The manufacturing information search area 321 and the manufacturing information list area 322 of the manufacturing information screen 320 are the same as the manufacturing information search area 311 and the manufacturing information list area 312 of the pharmaceutical manufacturing information management screen 310 (see Figure 1), respectively. In Figure 7, the user uses the pointer 325 to select the manufacturing number "M000082379" and opens the context menu 326. When the user selects the type of related information item they want to access next from the context menu 326, related information items of that type (see Figure 8 below) are displayed. Here, let's assume the user has selected "Inventory" as the type of related information item.

[0077] Figure 8 is a screen configuration diagram of the inventory screen 330 according to a modified example of this embodiment. The inventory screen 330 displays related information items of the "inventory" type selected by the user for the information item selected in the manufacturing information screen 320. In addition, the inventory screen 330 also allows the user to select the type of related information item they wish to access next, similar to the manufacturing information screen 320.

[0078] Figure 9 shows the data structure of screen setting information 130A according to a modified example of this embodiment. Compared to screen setting information 130 (see Figure 4), the number of items for "Related type selection processing" has increased. This item includes the type of related information item displayed in the context menu that opens after an information item is selected, and the processing content. This processing content is the same as the processing content described in item selection processing, and includes search processing content including search location information, and a screen that displays the search results (a screen that displays a list of related information items of the selected type).

[0079] When a type is selected, the search unit 112 searches for related information items of the selected type according to the search processing content of the selected type included in the search item selection processing in the screen setting information 130A, and stores the information items of the search results in the item information 140. Subsequently, the display control unit 113 displays the information items in the item information 140 on the list display screen of related information items of the selected type.

[0080] According to this modified version of the pharmaceutical manufacturing information management system, users can select related information items to access after selecting an information item. This increases the degree of freedom in accessing related information items, allowing for more efficient access to pharmaceutical manufacturing information.

[0081] As explained above, there are several types of related information items that are associated with selected information items. The search unit 112 searches for related information items of the selected type. The search unit 112 refers to search location information indicating whether the selected information item and the related information item of the selected type are cohabiting (stored in the same database server) or not cohabiting (not necessarily stored in the same database server). If the selected information item and the related information item of the selected type are identical, the search unit 112 searches for the related information item of the selected type in the same database server where the selected information item was stored. If they are not identical, the search unit 112 searches for the related information item of the selected type in multiple database servers.

[0082] The pharmaceutical manufacturing information management device 100 includes a screen setting unit 111 that stores in the storage unit 120 the position and size of the selected information item list display screen which displays a list of selected information items, the position and size of the selected type related information item list display screen which displays a list of related information items of the selected type, and search location information indicating the relationship between the selected information item and the related information items of the selected type.

[0083] The search unit 112 searches the database server according to the search location information for related information items of the selected type that are associated with the selected information item displayed on the selected information item list display screen. The display control unit 113 displays the related information items for the selected type of search result on the selected type related information item list display screen.

[0084] Hardware Configuration The pharmaceutical manufacturing information management device 100 according to the above embodiment is implemented by a computer 900 having a configuration such as that shown in Figure 10. Figure 10 is a hardware configuration diagram showing an example of a computer 900 that implements the functions of the pharmaceutical manufacturing information management device 100 according to the above embodiment. The computer 900 includes a CPU 901, ROM 902, RAM 903, SSD 904, and an input / output interface 905 (labeled as input / output I / F (Interface) in Figure 10). Furthermore, the computer 900 includes a communication interface 906 (labeled as communication I / F in Figure 10) and a media interface 907 (labeled as media I / F in Figure 10). The computer 900 may be equipped with an HDD (Hard Disk Drive) instead of the SSD 904, or it may be equipped with an HDD in addition to the SSD 904.

[0085] The CPU 901 operates based on programs stored in the ROM 902 or SSD 904 and is controlled by the control unit 110 in Figure 3. The ROM 902 stores boot programs executed by the CPU 901 when the computer 900 starts up, as well as programs related to the computer 900's hardware.

[0086] The CPU 901 controls input devices 910, such as a mouse and keyboard, and output devices 911, such as a display and printer, via the input / output interface 905. The CPU 901 acquires data from the input devices 910 and outputs the generated data to the output devices 911 via the input / output interface 905.

[0087] SSD904 stores programs executed by CPU901 and data used by those programs. Communication interface906 receives data from other devices (e.g., database servers 211, 212) not shown via the communication network and outputs it to CPU901, and also transmits data generated by CPU901 to other devices via the communication network.

[0088] The media interface 907 reads a program or data stored in the recording medium 912 and outputs it to the CPU 901 via the RAM 903. The CPU 901 loads the program from the recording medium 912 onto the RAM 903 via the media interface 907 and executes the loaded program. The recording medium 912 can be an optical recording medium such as a DVD (Digital Versatile Disk), a magneto-optical recording medium such as an MO (Magneto Optical Disk), a magnetic recording medium, a conductive memory tape medium, or a semiconductor memory.

[0089] For example, when the computer 900 functions as the pharmaceutical manufacturing information management device 100 according to the above embodiment, the CPU 901 of the computer 900 realizes the functions of the pharmaceutical manufacturing information management device 100 by executing the program 128 (see Figure 3) loaded on the RAM 903. The CPU 901 reads the program from the recording medium 912 and executes it. In addition, the CPU 901 may read the program from another device via a communication network, or it may install the program 128 from the recording medium 912 to the SSD 904 and execute it. [Explanation of symbols]

[0090] 100 Pharmaceutical Manufacturing Information Management System 111 Screen Settings Section 112 Search Section 113 Display Control Unit 130 Screen settings information 140 item information 150 Database Information 211,212 Database Servers 310 Pharmaceutical Manufacturing Information Management Screen 311,321 Manufacturing Information Search Area 312,322 Manufacturing Information List Area 313 Inventory List Area 314 Examination Instruction List Area 315 List of Test Items Area 316 Exam Details Area

Claims

1. When an information item is selected from the search results of information items related to pharmaceutical manufacturing stored in the database server, a search unit searches for related information items that are related to the selected information item, and The system includes a display control unit that displays the aforementioned related information items, The aforementioned search unit, Search for the relevant information items in the database server corresponding to the selected information item among the multiple database servers. Pharmaceutical manufacturing information management system.

2. The aforementioned search unit, Referencing search location information indicating whether the selected information item and the related information item of the selected information item are cohabiting (stored in the same database server) or not cohabiting (not necessarily stored in the same database server), If the selected information item and the related information item have the same relationship, the related information item is searched in the same database server where the selected information item was stored. If the relationships are not identical, the related information items are searched across multiple database servers. The pharmaceutical manufacturing information management device according to claim 1.

3. On the screen that displays the aforementioned information items, The position and size of the selection information item list display area that displays the list of selected information items, The position and size of the related information item list display area that displays the list of related information items, and The system further includes a screen setting unit that stores the search location information, which indicates the relationship between the selected information item and the related information item, in the storage unit. The aforementioned search unit, The related information items associated with the selected information item displayed in the aforementioned selected information item list display area are searched in the database server corresponding to the search location information. The display control unit, The relevant information items from the search results are displayed in the relevant information item list display area. The pharmaceutical manufacturing information management device according to claim 2.

4. The related information items associated with the selected information items include multiple types, The aforementioned search unit, Search for related information items of the selected type. The pharmaceutical manufacturing information management device according to claim 1.

5. The aforementioned search unit, Referencing search location information indicating whether the selected information item and the related information item of the selected type for that selected information item are cohabiting (stored in the same database server) or not cohabiting (not necessarily stored in the same database server), If the selected information item and the selected related information item of the aforementioned type have the same relationship, the related information item of the aforementioned type selected is searched in the same database server where the selected information item was stored. If the relationships are not identical, the database servers search for related information items of the selected type. The pharmaceutical manufacturing information management device according to claim 4.

6. On the screen that displays the aforementioned information items, The position and size of the selection information item list display screen that displays the list of selected information items, The position and size of the screen displaying the list of related information items for the selected type, and, The system further includes a screen setting unit that stores the search location information, which indicates the relationship between the selected information item and the related information item of that type, in the storage unit. The aforementioned search unit, The database server corresponding to the search location information searches for related information items of the selected type that are associated with the selected information item displayed on the selected information item list screen. The display control unit, The related information items of the selected type in the search results are displayed on the screen showing the list of related information items of the selected type. The pharmaceutical manufacturing information management device according to claim 5.

7. The combination of the selected information item and the related information item is, The aforementioned selection information item is manufacturing information for the pharmaceutical product, and the aforementioned related information item is inventory information for the pharmaceutical product. The aforementioned selection information item is inventory information for the drug, and the aforementioned related information item is manufacturing information for the drug, in combination. The aforementioned selection information item is inventory information for the drug, and the aforementioned related information item is a combination of the drug's test information. The aforementioned selection information item is drug testing information, and the aforementioned related information item is inventory information for the drug, in combination. The aforementioned selection information item is information on the arrival of raw materials for the pharmaceutical, and the aforementioned related information item is a combination of the raw material inventory for the pharmaceutical. The aforementioned selection information item is the raw material inventory of the pharmaceutical, and the aforementioned related information item is the raw material arrival information of the pharmaceutical, in combination. The aforementioned selected information item is the raw material inventory of the pharmaceutical, and the aforementioned related information item is the raw material testing information of the pharmaceutical, in combination. The aforementioned selected information item is the raw material testing information of the pharmaceutical, and the aforementioned related information item is the raw material inventory of the pharmaceutical, The aforementioned selected information item is the raw material inventory information for the pharmaceutical, and the aforementioned related information item is the inbound / outbound information for the raw material of the pharmaceutical, in combination. The aforementioned selection information item is the inbound / outbound information of the raw materials of the pharmaceutical, and the aforementioned related information item is the inventory information of the raw materials of the pharmaceutical, in combination. The aforementioned selected information item is the inventory information of the raw materials for the pharmaceutical, and the aforementioned related information item is the manufacturing information of the pharmaceutical, in combination. The aforementioned selected information item is manufacturing information for the pharmaceutical product, and the aforementioned related information item is a combination of the receiving and issuing information for the raw materials of the pharmaceutical product. The aforementioned selected information item is manufacturing information of the pharmaceutical product, and the aforementioned related information item is a combination of the pharmaceutical product's test information. The aforementioned selected information item is drug testing information, and the aforementioned related information item is manufacturing information of the drug, in combination. The aforementioned selected information item is drug testing information, and the aforementioned related information item is a combination of drug release decision information. The aforementioned selection information item is drug shipment decision information, and the aforementioned related information item is a combination of the drug's test information. The aforementioned selection information item is the shipment determination information for the pharmaceutical product, and the aforementioned related information item is the shipment information for the pharmaceutical product, in combination. The aforementioned selection information item is the shipment information of the pharmaceutical product, and the aforementioned related information item is the shipment determination information of the pharmaceutical product, in combination. The selected information item is information about the manufacturing equipment for the pharmaceutical product, and the related information item is a combination of the manufacturing information for the pharmaceutical product. The aforementioned selected information item is manufacturing information for the pharmaceutical product, and the aforementioned related information item is manufacturing equipment information for the pharmaceutical product, in combination. The aforementioned selection information item is equipment information of the manufacturing equipment, and the aforementioned related information item is equipment test information of the said manufacturing equipment, in combination. The aforementioned selected information item is equipment test information of the manufacturing equipment, and the aforementioned related information item is equipment information of the said manufacturing equipment, in combination. The selected information item is manufacturing information for the drug, and the related information item is deviation information for the drug; and, The combination is either: the selected information item is drug deviation information, and the related information item is manufacturing information of the drug. The pharmaceutical manufacturing information management device according to claim 1.

8. A pharmaceutical manufacturing information management system, When an information item is selected from the search results of information items related to pharmaceutical manufacturing stored in the database server, the steps include searching for related information items that are related to the selected information item, The steps of displaying the aforementioned related information items and, In the step of searching for the aforementioned related information items, Search for the relevant information items in the database server corresponding to the selected information item among the multiple database servers. Methods for managing pharmaceutical manufacturing information.

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