WO2020158581A1 - Quality control device, quality control system, quality control method, and quality control program - Google Patents
Quality control device, quality control system, quality control method, and quality control program Download PDFInfo
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- WO2020158581A1 WO2020158581A1 PCT/JP2020/002400 JP2020002400W WO2020158581A1 WO 2020158581 A1 WO2020158581 A1 WO 2020158581A1 JP 2020002400 W JP2020002400 W JP 2020002400W WO 2020158581 A1 WO2020158581 A1 WO 2020158581A1
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- 238000011156 evaluation Methods 0.000 claims abstract description 94
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Images
Classifications
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12M—APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS
- C12M1/00—Apparatus for enzymology or microbiology
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
- C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
- C12N5/10—Cells modified by introduction of foreign genetic material
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- G—PHYSICS
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- G05B—CONTROL OR REGULATING SYSTEMS IN GENERAL; FUNCTIONAL ELEMENTS OF SUCH SYSTEMS; MONITORING OR TESTING ARRANGEMENTS FOR SUCH SYSTEMS OR ELEMENTS
- G05B19/00—Programme-control systems
- G05B19/02—Programme-control systems electric
- G05B19/418—Total factory control, i.e. centrally controlling a plurality of machines, e.g. direct or distributed numerical control [DNC], flexible manufacturing systems [FMS], integrated manufacturing systems [IMS] or computer integrated manufacturing [CIM]
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
- G06Q50/04—Manufacturing
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P90/00—Enabling technologies with a potential contribution to greenhouse gas [GHG] emissions mitigation
- Y02P90/02—Total factory control, e.g. smart factories, flexible manufacturing systems [FMS] or integrated manufacturing systems [IMS]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P90/00—Enabling technologies with a potential contribution to greenhouse gas [GHG] emissions mitigation
- Y02P90/30—Computing systems specially adapted for manufacturing
Definitions
- the present disclosure relates to a quality control device, a quality control system, a quality control method, and a quality control program.
- Pluripotent stem cells such as ES (Embryonic Stem) cells and iPS (Induced Pluripotent Stem) cells have the ability to differentiate into cells of various tissues, and are involved in regenerative medicine, drug development, and disease elucidation, etc. Has been attracting attention as a possible application.
- pluripotent stem cells such as ES cells and iPS cells
- cells that have been induced to differentiate are irradiated with measurement light, and the quality is evaluated based on spectral data of transmitted light and/or reflected light.
- the present disclosure provides a quality control device, a quality control system, a quality control method, and a quality control capable of specifying a factor that affects quality during the period from the production of a product to its use.
- the purpose is to provide the program.
- the quality control device of the present disclosure shows product information including at least one piece of product manufacturing information, product transportation information, and product usage information, and a product quality evaluation result.
- An acquisition unit that acquires product information and evaluation result information from accumulated data that is associated with evaluation result information, and a factor that affects quality evaluation results based on the product information and evaluation result information acquired by the acquisition unit
- an output unit that outputs the extraction result of the extraction unit.
- the output unit preferably determines the output destination of the extraction result based on whether the factor is related to manufacturing information, transportation information, or usage information.
- manufacturing information includes product ID (IDentification), product manufacturing date, product manufacturer, type of cells contained in the product, passage number of cells contained in the product, lot of cells contained in the product, product Number of cells contained, cell density in the product, type of medium when the cells in the product were cultured, manufacturer of the medium of the cells contained in the product, lot of the medium of the cells contained in the product, cells contained in the product Amount of culture medium, pH of culture medium of cells contained in product, seeding method of cells contained in product, number of times of exchange of culture medium of cells contained in product, culture vessel for cells contained in product, culture of cells contained in product Equipment, period of culturing cells contained in the product, oxygen concentration when culturing cells contained in the product, carbon dioxide concentration when culturing cells contained in the product, temperature when culturing cells contained in the product, included in the product It is preferable that it is at least one of humidity during culturing of cells to be cultured, location of production of cells contained in the product, type of medium used to transport or store the product, and
- transportation information includes product ID, product carrier, product transportation route, product transportation period, product transportation temperature, product transportation humidity, product transportation vibration state, product transportation. It is preferably at least one of the previous storage period, the delivery date of the product, and the post-transportation evaluation result of the product.
- the usage information includes product ID, product delivery date, product storage environment, product storage period, product user, product usage date, product usage location, compound added to cells contained in the product, Manufacturer of compound added to cells contained in product, lot of compound added to cells contained in product, final concentration of compound added to cells contained in product, addition period of compound added to cells contained in product, It is preferable that at least one of the result of the presence or absence of the influence of the compound added to the cells contained in the product and the information of the patient to which the cells contained in the product have been administered.
- the output unit can change at least one of the output destination of the extraction result and the output timing of the extraction result based on the user's instruction input.
- the quality management system of the present disclosure includes the quality management device of the present disclosure and an evaluation result database that stores accumulated data.
- the quality control method of the present disclosure stores product information including at least one of product manufacturing information, product transportation information, and product usage information and evaluation result information indicating a product quality evaluation result in association with each other.
- the product information and the evaluation result information are acquired from the accumulated data, the factors affecting the quality evaluation result are extracted based on the product information and the evaluation result information, and the extraction result is output.
- the quality control program of the present disclosure associates and accumulates product information including at least one of product manufacturing information, product transportation information, and product usage information, and evaluation result information indicating a product quality evaluation result.
- product information including at least one of product manufacturing information, product transportation information, and product usage information, and evaluation result information indicating a product quality evaluation result.
- the procedure for acquiring product information and evaluation result information from the stored data, the step for extracting the factors that affect the quality evaluation result based on the product information and the evaluation result information, and the step for outputting the extraction result are stored on the computer. Let it run.
- a quality control device capable of identifying a factor affecting quality from the time a product is manufactured to the time it is used. be able to.
- the flowchart which shows the process performed in 1st Embodiment. The figure which shows an example of the information acquired from the evaluation result database in 1st Embodiment.
- FIG. 1 is a diagram showing a schematic configuration of a drug discovery research system to which the quality control system according to the first embodiment of the present disclosure is applied.
- the drug discovery research system 1 shown in FIG. 1 includes product information including product manufacturing information, product transportation information, and product usage information during the period from the manufacture of a product 30 containing cultured cells to its use.
- the drug discovery research system 1 includes an information input workstation (hereinafter, referred to as an information input WS) 2 installed in a facility of a manufacturer of a product 30 and a facility of a carrier of the product 30.
- Information input workstation (hereinafter referred to as information input WS) 3 installed, information input workstation (hereinafter referred to as information input WS) 4 installed in the facility of the user of product 30, information server 5, evaluation
- a result database 6 and a quality control workstation (hereinafter referred to as quality control WS) 7 are connected to each other via a wired or wireless network 8 in a communicable state.
- Each device is a computer in which an application program for functioning as a component of the drug discovery research system 1 is installed.
- the application program is recorded and distributed in a recording medium such as a DVD-ROM (Digital Versatile Disc Read Only Memory) or a CD-ROM (Compact Disc Read Only Memory), and is installed in the computer from the recording medium.
- a recording medium such as a DVD-ROM (Digital Versatile Disc Read Only Memory) or a CD-ROM (Compact Disc Read Only Memory)
- it is stored in a storage device of a server computer connected to the network or a network storage in a state accessible from the outside, and downloaded to the computer used by the manufacturer, the carrier, or the product user upon request. Is installed.
- the product 30 is a cell culture device.
- the cell culture device may be, for example, an organ chip.
- the information input WS2 is a computer installed in the facility of the manufacturer of the product 30 and used by the manufacturer to input the manufacturing information of the product 30, and includes a processing device, a display, and an input device such as a keyboard and a mouse. To be done.
- the process of receiving the input of the manufacturing information of the product 30, the process of transmitting the manufacturing information of the product 30 to the evaluation result database 6 included in the information server 5, and the like execute the software programs for each process. It is done by doing.
- the manufacturing information entered here includes the product ID (IDentification), the product manufacturing date, the product manufacturer, the type of cells contained in the product, the number of passages of cells contained in the product, and the cells contained in the product.
- Lot number of cells in product, cell density in product, type of medium when cells in product are cultured, manufacturer of medium for cells in product, lot of medium for cells in product, product Amount of cell culture medium contained, pH of cell culture medium contained in the product, seeding method of cells contained in the product, frequency of replacement of the cell culture medium contained in the product, cell culture container contained in the product, contained in the product Cell culture device, cell culture period of the product, oxygen concentration of the cell culture of the product, carbon dioxide concentration of the cell culture of the product, temperature of the cell culture of the product , At least one of the humidity of the cells contained in the product during culture, the place of manufacture of the cells contained in the product, the type of medium used to transport or store the product, and the post-production evaluation result of the cells contained in the product. It is preferable to have.
- the information related to the manufacturing date such as the manufacturing start date or the manufacturing end date can be used.
- the passage number of cells contained in the product when the product 30 is a cell culture device as in the present embodiment, it is the passage number of cells at the time of seeding cells in the cell culture device.
- the passage number of cells cultured in the artificial biological part when autologous cells are used, it is cell donor information, and when allogeneic cells (for example, commercially available cells) are used, it is a lot number at the time of manufacturing (for example, cell culture).
- the oxygen concentration of the cells contained in the product at the time of culturing may be an average value of the oxygen concentration, or information on the change over time of the oxygen concentration.
- the type of medium for transporting or storing the product the medium used for culturing the cells of the product may be different from the medium used for transporting or storing. In the case of frozen transportation or frozen storage, a medium for transportation or storage is unnecessary. When it is not frozen or frozen, it is transported or stored using a medium for transportation or storage at about 37°C.
- the information input WS3 is a computer installed in the facility of the carrier of the product 30 and used by the carrier to input the transport information of the product 30, and includes a processing device, a display, and an input device such as a keyboard and a mouse. To be done.
- the process of receiving the input of the transportation information of the product 30, the process of transmitting the transportation information of the product 30 to the evaluation result database 6 included in the information server 5, and the like execute the software programs for each processing. It is done by doing.
- the transportation information input here includes a product ID, a product carrier, a product transportation route, a product transportation period, a product transportation temperature, a product transportation humidity, and a product transportation vibration state. , At least one of the storage period of the product at the destination, the delivery date of the product, and the post-transport evaluation result of the product.
- the temperature at which the product is transported may be the average value of the temperature, or may be the change information of the temperature with time.
- the information input WS4 is a computer installed in the facility of the user of the product 30 and used by the user to input the use information of the product 30.
- the information input WS4 includes a processing device, a display, and an input device such as a keyboard and a mouse. To be done.
- the process of receiving the input of the use information of the product 30, the process of transmitting the use information of the product 30 to the evaluation result database 6 included in the information server 5, and the like execute the software programs for each process. It is done by doing.
- the usage information entered here includes the product ID, product delivery date, product storage environment, product storage period, product user, product usage date, product usage location, and cells contained in the product.
- Compound added manufacturer of compound added to cells contained in product, lot of compound added to cells contained in product, final concentration of compound added to cells contained in product, compound added to cells contained in product It is preferable that at least one of the addition period, the result of the presence or absence of the influence of the compound added to the cells contained in the product, and the information of the patient to whom the cells contained in the product were administered.
- the final concentration of the compound added to the cells contained in the product is the concentration of the compound in the medium when the compound is dissolved in the medium after adding the compound to the cell medium.
- the effect of the compound added to the cells contained in the product is drug efficacy or toxicity.
- the information server 5 is a general-purpose computer with relatively high processing capacity, on which a software program that provides the functions of a database management system (DBMS) is installed.
- the information server 5 also includes a large-capacity storage in which the evaluation result database 6 is configured.
- This storage may be a large-capacity hard disk device connected to the information server 5 by a data bus, or may be connected to a NAS (Network Attached Storage) and a SAN (Storage Area Network) connected to the network 8. It may be a disk device.
- the information server 5 requests registration of various information from the information input WS2, the information input WS3, and the information input WS4 installed in each of the facility of the manufacturer, the facility of the carrier, and the facility of the user.
- the information is prepared in a database format and registered in the evaluation result database 6. Further, when the information server 5 receives the browsing request from the quality control WS 7 via the network 8, the information server 5 searches the information registered in the evaluation result database 6 and sends the extracted information to the requesting quality control WS 7. ..
- the evaluation result database 6 includes the manufacturing information of the product 30, the transportation information of the product 30, and the usage information of the product 30 input from the information input WS2, the information input WS3, and the information input WS4 installed in each facility.
- the product information and the evaluation result information indicating the quality evaluation result of the product 30 are registered in association with each other, and the registered information is accumulated.
- the quality control WS 7 includes the quality control device 10 according to the first embodiment.
- the configuration of the quality control WS 7 will be described later.
- the network 8 is a wired or wireless local area network configured in each facility of a manufacturer's facility, a carrier's facility, and a user's facility, and the Internet or a dedicated network connecting the local area networks of each facility. It is composed of lines.
- the quality control WS 7 is a computer used by an administrator to identify factors that affect quality from the time the product 30 is manufactured to the time it is used.
- the quality control WS 7 includes a processing device, a display, a keyboard, a mouse, and the like. It is composed of the input device.
- the administrator is a person who manages information input/output by the manufacturer, the carrier, and the user.
- each process such as an information browsing request to the information server 5, a factor identification process based on the information received from the information server 5, and a display of a factor identification result executes a software program for each process. It is done by Since these processes are performed by a well-known software program, detailed description is omitted here.
- the quality control program according to the first embodiment is installed in the quality control WS 7.
- the quality control program is recorded and distributed in a recording medium such as a DVD or a CD-ROM, and is installed in the computer from the recording medium.
- a recording medium such as a DVD or a CD-ROM
- it is stored in a storage device of a server computer connected to the network or a network storage so as to be accessible from the outside, and is downloaded and installed in the quality control WS 7 in response to a request.
- FIG. 2 is a diagram showing a schematic configuration of the quality control device according to the first embodiment of the present disclosure realized by installing a quality control program.
- the quality control device 10 includes a CPU (Central Processing Unit) 11, a memory 12 and a storage 13 as a standard computer configuration. Further, a display 14 such as a liquid crystal display and an input unit 15 such as a keyboard and a mouse are connected to the quality control device 10.
- the quality control device 10 is included in the quality control WS 7.
- the storage 13 comprises a storage device such as a hard disk or SSD (Solid State Drive).
- the storage 13 stores various information including information acquired from the information server 5 via the network 8 and information necessary for the processing of the quality control device 10.
- the quality management program is stored in the memory 12.
- the quality management program acquires the product information and the evaluation result information from the information server 5, and extracts the factors that affect the quality evaluation result based on the acquired product information and the evaluation result information. Specifies the processing and processing for outputting the extraction result.
- the CPU 11 executes these processes in accordance with the program, so that the computer obtains the product information and the evaluation result information from the information server 5, the quality evaluation result based on the acquired product information and the evaluation result information. It functions as an extraction unit 22 that extracts a factor that influences the output and an output unit 23 that outputs the extraction result.
- the CPU 11 executes the function of each unit by the quality control program.
- FPGA A programmable logic device PLD that is a processor whose circuit configuration can be changed after manufacturing (Field Programmable Gate Array) or the like can be used.
- the processing of each unit may be executed by a dedicated electric circuit or the like which is a processor having a circuit configuration specifically designed for executing a specific processing such as an ASIC (Application Specific Integrated Circuit).
- One processing unit may be configured by one of these various processors, or may be a combination of two or more processors of the same type or different types (for example, a plurality of FPGAs or a combination of CPU and FPGA). It may be configured. Further, the plurality of processing units may be configured by one processor. As an example of configuring a plurality of processing units with one processor, firstly, as represented by computers such as clients and servers, one processor is configured with a combination of one or more CPUs and software. There is a form in which the processor functions as a plurality of processing units.
- SoC system-on-chip
- a processor that realizes the functions of the entire system including a plurality of processing units by one IC (Integrated Circuit) chip is used.
- IC Integrated Circuit
- the various processing units are configured by using one or more of the above various processors as a hardware structure.
- the hardware-like structure of these various processors is more specifically an electric circuit (circuitry) that combines circuit elements such as semiconductor elements.
- the memory 12 stores a program that executes the function.
- FIG. 3 is a flowchart showing the processing performed in the first embodiment.
- step S10 After the manufacturer manufactures the product 30 (step S10), the manufacturer judges the quality of the product 30 and inputs the manufacturing information of the product 30 from the information input WS2 (step S11).
- the information input here is accumulated in the evaluation result database 6 provided in the information server 5.
- the manufacturing information includes, for example, the ID of the product 30, the manufacturing date of the product 30 (here, the manufacturing end date of the product 30), the lot of cells contained in the product 30, and the cells contained in the product 30. 5 types of information of the type of medium and the evaluation result of the product 30 after manufacturing.
- the quality of the cell culture device which is the product 30 is determined.
- This quality determination method detects abnormalities in the morphology of cells in the cell culture device, the number of cells, cell density, contamination, abnormalities of substrates other than cells (eg, assembly, cracking, etc.), etc. Alternatively, it may be performed visually, or may be performed by photographing the cell culture device with a camera and analyzing the photographed image with a computer. In addition, you may use well-known methods other than this.
- the quality of the product 30 is not limited to being determined once after the production, but may be performed a plurality of times including the middle of the production process (for example, the cell culture process).
- step S11 when the quality judgment of the product 30 is bad (NG: No Good) (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, in the quality control WS7, factors affecting the quality evaluation result are extracted (step S12).
- the evaluation result information is information indicating the final quality evaluation result of the product 30, and is different from the quality evaluation result in the manufacturing stage (the above-mentioned quality judgment in the present embodiment).
- the evaluation result information may have the same contents as the last quality evaluation result in the manufacturing stage, or may have contents comprehensively judged from a plurality of quality evaluation results in the manufacturing stage.
- the content of the evaluation result information may be determined by calculating a score for each item by comparing with a predetermined threshold value or table based on a plurality of manufacturing information including quality evaluation results in the manufacturing stage.
- it may be performed using artificial intelligence (AI) that performs machine learning or deep learning learned based on a plurality of manufacturing information including quality evaluation results at the manufacturing stage.
- AI artificial intelligence
- the acquisition unit 21 acquires product information and evaluation result information from the information server 5.
- FIG. 4 shows an example of the information acquired by the acquisition unit 21.
- the extraction unit 22 extracts factors that affect the quality evaluation result based on the product information and the evaluation result information acquired by the acquisition unit 21. As shown in the acquisition example shown in FIG. 4, since the manufacturing stage is NG, the extraction unit 22 determines the manufacturing date of the product 30, the lot of cells contained in the product 30, and the type of medium of the cells contained in the product 30. Is extracted as a candidate for a factor affecting the quality evaluation result. Further, it is possible to narrow down the candidates of factors affecting the extracted quality evaluation result by using artificial intelligence that performs machine learning or deep learning learned based on a plurality of manufacturing information including evaluation results in the manufacturing stage.
- the output unit 23 outputs the extraction result (that is, the candidate of the factor affecting the quality evaluation result) to the display 14 included in the quality control WS 7. Further, the output unit 23 outputs the extraction result by mail, pop-up display, highlight display, or the like to the information input WS2 installed in the manufacturer's facility having factors that affect the quality evaluation result. Then, the process ends.
- step S11 when the quality determination of the product 30 is good (OK: Okay) (determination result Yes), the product 30 is sent for transportation, and after the product 30 is transported to the user by the transporter, it is transported.
- the person inputs the transportation information of the product 30 from the information input WS3 (step S13).
- the information input here is accumulated in the evaluation result database 6 provided in the information server 5.
- the transportation information is, for example, four types of information including the ID of the product 30, the transportation route of the product 30, the temperature of the transportation of the product 30, and the post-transport evaluation result of the product 30.
- the post-transport evaluation result of the product 30 is input by the user of the product 30.
- the information such as the temperature during transportation and the humidity during transportation may be acquired by, for example, embedding the measuring chip in the product 30, or by embedding the measuring chip in the case in which the product 30 is packed. ..
- step S14 the user of the product 30 determines whether the product 30 is good or bad in order to obtain the post-transport evaluation result of the product 30 (step S14), and inputs the result as transport information of the product 30. Input from WS4.
- step S14 when the quality judgment of the product 30 is NG (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, in the quality control WS7, the factors affecting the quality evaluation result are extracted (step S15).
- the evaluation result information is information indicating the final quality evaluation result of the product 30 as described above, and is information different from the quality evaluation result in the transportation stage (the above-described quality determination in the present embodiment). ..
- the evaluation result information may have the same content as the last quality evaluation result at the transportation stage, or the content comprehensively judged from a plurality of quality evaluation results at the transportation stage.
- the content of the evaluation result information may be determined by calculating a score for each item by comparing with a predetermined threshold value or table based on a plurality of pieces of transportation information including the quality evaluation result in the transportation stage. Alternatively, it may be performed using artificial intelligence that performs machine learning or deep learning based on a plurality of pieces of transportation information including quality evaluation results in the transportation stage.
- the acquisition unit 21 acquires product information and evaluation result information from the information server 5. An example of the information acquired by the acquisition unit 21 is shown in FIG.
- the extraction unit 22 extracts factors that affect the quality evaluation result based on the product information and the evaluation result information acquired by the acquisition unit 21.
- the extraction unit 22 uses the transport route of the product 30 and the temperature during transport of the product 30 as the quality evaluation result. It is extracted as a candidate for influencing factors. Further, it is possible to narrow down the candidates of factors affecting the extracted quality evaluation result by using the artificial intelligence that performs machine learning or deep learning learned based on a plurality of pieces of transportation information including the evaluation result in the transportation stage.
- the output unit 23 outputs the extraction result to the display 14 included in the quality control WS 7. Further, the output unit 23 outputs the extraction result to the information input WS3 installed in the facility of the carrier having a factor affecting the quality evaluation result by e-mail, pop-up display, highlight display, or the like. Then, the process ends.
- step S14 when the quality determination of the product 30 is OK (determination result Yes), the product 30 is actually used, and after the user uses the product 30 (step S16), the user The test result using the product 30 is determined, and the usage information of the product 30 is input from the information input WS4 (step S17).
- the information input here is accumulated in the evaluation result database 6 provided in the information server 5.
- the use of the product 30 means that the user adds a compound to the product 30 and evaluates the influence of the compound (for example, drug effect or toxicity).
- the usage information is, for example, four types of information: the ID of the product 30, the date of use of the product 30, the compound added to the cells contained in the product 30, and the post-use evaluation result of the product 30.
- information such as the storage environment of the product 30 and the storage period of the product 30 may be used as the usage information.
- the storage environment of the product 30 is information on the storage environment of the product 30, such as the storage location and the temperature and/or humidity at the storage location.
- step S17 if the test result using the product 30 is different from the normal result (NG) (judgment result No), the final quality evaluation result is also NG, and this content becomes the evaluation result information. Then, in the quality control WS7, the factors affecting the quality evaluation result are extracted (step S18).
- the test result using the product 30 is different from the usual result when it differs from the test result expected from the compound added to the product 30, and when the cell culture device manufactured under the same manufacturing conditions is used. For example, when the test results are different.
- the evaluation result information is information indicating the final quality evaluation result of the product 30 as described above, and is information different from the quality evaluation result in the use stage (the above test result in the present embodiment). ..
- the evaluation result information may have the same content as the last quality evaluation result in the use stage, or the content comprehensively judged from a plurality of quality evaluation results in the use stage.
- the content of the evaluation result information may be determined by calculating a score for each item by comparing with a predetermined threshold value or table based on a plurality of use information including quality evaluation results at the use stage.
- artificial intelligence that performs machine learning or deep learning based on a plurality of pieces of usage information including quality evaluation results at the usage stage may be used.
- the acquisition unit 21 acquires product information and evaluation result information from the information server 5.
- FIG. 6 shows an example of the information acquired by the acquisition unit 21.
- the extraction unit 22 extracts factors that affect the quality evaluation result based on the product information and the evaluation result information acquired by the acquisition unit 21.
- the extraction unit 22 uses the compound added to cells contained in the product 30 on the date of use and the product 30. It is extracted as a candidate for factors that affect the quality evaluation result.
- the output unit 23 outputs the extraction result to the display 14 included in the quality control WS 7. Further, the output unit 23 outputs the extraction result to the information input WS4 installed in the facility of the user having a factor affecting the quality evaluation result by mail, pop-up display, highlight display, or the like. Then, the process ends.
- step S17 when the test result using the product 30 is the normal result (OK) (determination result Yes), the final quality evaluation result is also OK, and this content becomes the evaluation result information, and the processing ends. To do.
- the quality control WS 7 may output the result.
- the acquisition unit 21 acquires product information and evaluation result information from the information server 5.
- FIG. 7 shows an example of the information acquired by the acquisition unit 21. Since the final quality evaluation result is OK, the extraction unit 22 does not extract the factor.
- the output unit 23 simply outputs the information acquired by the acquisition unit 21 to the display 14 included in the quality control WS 7.
- the quality control WS 7 acquires all or a part of the product information and the evaluation result information accumulated in the evaluation result database 6, and as shown in FIG. 8, calculates the NG number and the NG rate for each condition, The counting result may be output to the display 14 included in the quality control WS 7.
- the extraction unit 22 when the extraction unit 22 extracts the factors that affect the quality evaluation result, the extraction unit 22 selects among the candidates of the factors that affect the quality evaluation result, based on the result of counting the NG number and the NG rate for each condition. Therefore, the process of removing the factor of low NG rate may be performed.
- the system configuration is the same as in the first embodiment, and only the type of product 30 and the processing to be performed are different from those in the first embodiment. Therefore, the details of the system will be described here. Detailed description is omitted.
- the product 30 is an artificial biological part such as cartilage, skin, myocardial sheet, or nerve cell.
- FIG. 9 is a flowchart showing the processing performed in the second embodiment. Note that detailed description of the same contents as in the first embodiment will be omitted.
- step S20 After the manufacturer manufactures the product 30 (step S20), the manufacturer determines whether the product 30 is good or bad, and inputs the manufacturing information of the product 30 from the information input WS2 (step S21).
- the information input here is accumulated in the evaluation result database 6 provided in the information server 5.
- the quality of the artificial biological component which is the product 30 is determined.
- This method of quality determination is to detect abnormalities in the morphology of cells in the artificial biological part, cell number, cell density, contamination, differentiation or undifferentiation determination of cells, etc., and may be performed visually.
- the artificial biological component may be photographed by a camera and the photographed image may be analyzed by a computer.
- the quality of the product 30 is not limited to being determined once after the production, but may be performed a plurality of times including the middle of the production process (for example, the cell culture process).
- step S21 when the quality judgment of the product 30 is NG (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, in the quality control WS7, the factors affecting the quality evaluation result are extracted (step S22), and then the process ends.
- step S21 when the quality determination of the product 30 is OK (determination result Yes), the product 30 is sent for transportation, and after the product 30 is transported to the user by the transporter, the transporter determines the product 30.
- Part of the transportation information (in this embodiment, the ID of the product 30, the transportation route of the product 30, and the temperature of the transportation of the product 30) is input from the information input WS3 (step S23).
- the information input here is accumulated in the evaluation result database 6 provided in the information server 5.
- step S24 Before using the product 30, the user of the product 30 determines whether the product 30 is good or bad in order to obtain the post-transport evaluation result of the product 30 (step S24), and inputs the result as transport information of the product 30. Input from WS4.
- step S24 when the quality judgment of the product 30 is NG (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, after the factors affecting the quality evaluation result are extracted in the quality control WS7 (step S25), the process ends.
- step S24 If the quality of the product 30 is OK in step S24 (determination result Yes), the product 30 is actually transplanted to the patient, and the doctor (ie, the user) transplants the product 30 to the patient ( After step S26), the user determines the result of the follow-up observation of the patient who transplanted the product 30, and inputs the use information of the product 30 from the information input WS4 (step S27).
- the information input here is accumulated in the evaluation result database 6 provided in the information server 5.
- step S27 if the result of follow-up observation of the patient who transplanted the product 30 is not good (NG: judgment result No), the final quality evaluation result is also NG, and this content becomes evaluation result information. Then, in the quality control WS7, the factors that affect the quality evaluation result are extracted (step S28), and then the process ends.
- step S27 if the result of the follow-up observation of the patient who transplanted the product 30 is good (OK: determination result Yes), the final quality evaluation result is also OK, and this content becomes evaluation result information, and the process ends. ..
- the quality control system of the present disclosure is not limited to the above embodiment, and the configurations of the first and second embodiments are not limited thereto. Various modifications and changes are also included in the scope of the technology of the present disclosure.
- the products handled by the quality control system according to the present disclosure are not limited to organ chips (Organ on a Chip) and artificial biological parts, and may be any type of products.
- the product information is not limited to the mode in which all the product manufacturing information, the product transportation information, and the product usage information are acquired, and one of the product manufacturing information, the product transportation information, and the product usage information is used. One or two pieces of information may be acquired.
- the input of product manufacturing information, product transportation information, and product usage information is not limited to the above, and anyone may input.
- the manufacturer may input the transport information of the product 30 by the transporter.
- the manufacturing stage is output to the manufacturer
- the transportation stage is output to the carrier
- the usage stage is output to the user.
- the present invention is not limited to such an aspect, and the factor extracted at any stage may be output to the manufacturer and the administrator.
- the administrator may be allowed to select the output destination and the output timing of the extraction result of the factors that affect the quality evaluation result.
- the administrator may be allowed to select the output destination and the output timing of the extraction result of the factors that affect the quality evaluation result.
- the administrator may perform unified management by collecting and inputting all the information at the manufacturing stage, the transportation stage, and the use stage. Further, the administrator may perform unified management by collecting and inputting some information in the manufacturing stage, the transportation stage, and the use stage.
- the user may be allowed to select that information so that it is excluded from the scope of unified management.
- the information selected by the user to be excluded from the centralized management is not processed in the cloud but is installed in the information input WS under the user's source. It should be processed by the browser that is running. In addition, you may install the special software which performs the said process with respect to a browser.
- the software used in the quality control system of the present disclosure may be an install type or a cloud type.
- the evaluation result information may be acquired not only OK/NG but also the image information and/or other information as the basis.
- Other information includes manufacturing information, transportation information, usage information, and the like.
- the user may be able to select whether to acquire the image information and/or other information together.
- the manufacturer may also be able to select the input items for manufacturing information, transportation information, and usage information.
- the evaluation result database may be included in the quality control device.
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Abstract
A quality control program comprising: an acquisition unit acquiring product information and evaluation result information from stored data wherein the product information, which contains product manufacture information and/or product transport information and/or product utilization information, is stored in association with the evaluation result information which shows the results of product quality evaluation; an extraction unit extracting a factor which affects the quality evaluation results on the basis of the product information and the evaluation result information acquired by the acquisition unit; and an output unit outputting the results of the extraction by the extraction unit.
Description
本開示は、品質管理装置、品質管理システム、品質管理方法、および品質管理プログラムに関するものである。
The present disclosure relates to a quality control device, a quality control system, a quality control method, and a quality control program.
ＥＳ（Embryonic Stem）細胞およびｉＰＳ（Induced Pluripotent Stem）細胞等の多能性幹細胞は、種々の組織の細胞に分化する能力を備えたものであり、再生医療、薬の開発、および病気の解明等において応用が可能なものとして注目されている。
Pluripotent stem cells such as ES (Embryonic Stem) cells and iPS (Induced Pluripotent Stem) cells have the ability to differentiate into cells of various tissues, and are involved in regenerative medicine, drug development, and disease elucidation, etc. Has been attracting attention as a possible application.
そして、ＥＳ細胞およびｉＰＳ細胞等の多能性幹細胞並びに分化誘導された細胞等に測定光を照射し、透過光および／または反射光のスペクトルデータに基づいて、品質を評価する方法が提案されている（例えば、国際公開第２０１６／０８０４４２号）。
Then, a method has been proposed in which pluripotent stem cells such as ES cells and iPS cells, and cells that have been induced to differentiate are irradiated with measurement light, and the quality is evaluated based on spectral data of transmitted light and/or reflected light. (For example, International Publication No. 2016/080442).
培養細胞を用いた創薬研究において、同じ種類の培養細胞製品であり、同じ程度の品質評価を受けた製品であっても、使用する施設が異なると、同じ結果が得られない場合があることが知られている。創薬研究において高い品質管理を実現するためには、製品が製造されてから使用されるまでの間で、品質に影響を与える要因を特定し、対策をたてることが重要となる。
In drug discovery research using cultured cells, the same results may not be obtained even if the same type of cultured cell product has undergone the same level of quality evaluation, depending on the facility used. It has been known. In order to realize high quality control in drug discovery research, it is important to identify the factors that affect the quality and take countermeasures from the time the product is manufactured to the time it is used.
本開示は、上記の問題に鑑み、製品が製造されてから使用されるまでの間における、品質に影響を与える要因の特定が可能な品質管理装置、品質管理システム、品質管理方法、および品質管理プログラムを提供することを目的とする。
In view of the above problems, the present disclosure provides a quality control device, a quality control system, a quality control method, and a quality control capable of specifying a factor that affects quality during the period from the production of a product to its use. The purpose is to provide the program.
上記目的を達成するために、本開示の品質管理装置は、製品の製造情報、製品の運搬情報、および製品の使用情報のうち少なくとも１つの情報からなる製品情報と、製品の品質評価結果を示す評価結果情報とを関連付けて蓄積した蓄積データから製品情報および評価結果情報を取得する取得部と、取得部が取得した製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する抽出部と、抽出部による抽出結果を出力する出力部とを備える。
In order to achieve the above object, the quality control device of the present disclosure shows product information including at least one piece of product manufacturing information, product transportation information, and product usage information, and a product quality evaluation result. An acquisition unit that acquires product information and evaluation result information from accumulated data that is associated with evaluation result information, and a factor that affects quality evaluation results based on the product information and evaluation result information acquired by the acquisition unit And an output unit that outputs the extraction result of the extraction unit.
本開示の品質管理装置において、出力部は、要因が、製造情報、運搬情報、または使用情報のいずれに関連するかに基づいて、抽出結果の出力先を決定することが好ましい。
In the quality control device of the present disclosure, the output unit preferably determines the output destination of the extraction result based on whether the factor is related to manufacturing information, transportation information, or usage information.
また、製造情報は、製品のＩＤ（IDentification）、製品の製造日、製品の製造者、製品に含まれる細胞の種類、製品に含まれる細胞の継代数、製品に含まれる細胞のロット、製品に含まれる細胞数、製品における細胞密度、製品に含まれる細胞を培養した際の培地の種類、製品に含まれる細胞の培地の製造元、製品に含まれる細胞の培地のロット、製品に含まれる細胞の培地の量、製品に含まれる細胞の培地のｐＨ、製品に含まれる細胞の播種方法、製品に含まれる細胞の培地の交換回数、製品に含まれる細胞の培養容器、製品に含まれる細胞の培養装置、製品に含まれる細胞の培養期間、製品に含まれる細胞の培養時の酸素濃度、製品に含まれる細胞の培養時の二酸化炭素濃度、製品に含まれる細胞の培養時の温度、製品に含まれる細胞の培養時の湿度、製品に含まれる細胞の製造場所、製品を輸送または保管する際の培地の種類、および製品に含まれる細胞の製造後評価結果のうち少なくとも１つであることが好ましい。
In addition, manufacturing information includes product ID (IDentification), product manufacturing date, product manufacturer, type of cells contained in the product, passage number of cells contained in the product, lot of cells contained in the product, product Number of cells contained, cell density in the product, type of medium when the cells in the product were cultured, manufacturer of the medium of the cells contained in the product, lot of the medium of the cells contained in the product, cells contained in the product Amount of culture medium, pH of culture medium of cells contained in product, seeding method of cells contained in product, number of times of exchange of culture medium of cells contained in product, culture vessel for cells contained in product, culture of cells contained in product Equipment, period of culturing cells contained in the product, oxygen concentration when culturing cells contained in the product, carbon dioxide concentration when culturing cells contained in the product, temperature when culturing cells contained in the product, included in the product It is preferable that it is at least one of humidity during culturing of cells to be cultured, location of production of cells contained in the product, type of medium used to transport or store the product, and post-production evaluation result of cells contained in the product. ..
また、運搬情報は、製品のＩＤ、製品の運搬者、製品の運搬経路、製品の運搬期間、製品の運搬時の温度、製品の運搬時の湿度、製品の運搬時の振動状態、製品の運搬先での保管期間、製品の納品日、および製品の運搬後評価結果のうち少なくとも１つであることが好ましい。
In addition, transportation information includes product ID, product carrier, product transportation route, product transportation period, product transportation temperature, product transportation humidity, product transportation vibration state, product transportation. It is preferably at least one of the previous storage period, the delivery date of the product, and the post-transportation evaluation result of the product.
また、使用情報は、製品のＩＤ、製品の納品日、製品の保管環境、製品の保管期間、製品の使用者、製品の使用日、製品の使用場所、製品に含まれる細胞に添加した化合物、製品に含まれる細胞に添加した化合物の製造元、製品に含まれる細胞に添加した化合物のロット、製品に含まれる細胞に添加した化合物の最終濃度、製品に含まれる細胞に添加した化合物の添加期間、製品に含まれる細胞に添加した化合物による影響の有無の結果、および製品に含まれる細胞を投与した患者の情報のうち少なくとも１つであることが好ましい。
In addition, the usage information includes product ID, product delivery date, product storage environment, product storage period, product user, product usage date, product usage location, compound added to cells contained in the product, Manufacturer of compound added to cells contained in product, lot of compound added to cells contained in product, final concentration of compound added to cells contained in product, addition period of compound added to cells contained in product, It is preferable that at least one of the result of the presence or absence of the influence of the compound added to the cells contained in the product and the information of the patient to which the cells contained in the product have been administered.
また、出力部は、抽出結果の出力先および抽出結果の出力タイミングのうち少なくとも１つを、ユーザーの指示入力に基づいて変更可能であることが好ましい。
Moreover, it is preferable that the output unit can change at least one of the output destination of the extraction result and the output timing of the extraction result based on the user's instruction input.
本開示の品質管理システムは、本開示の品質管理装置と、蓄積データを蓄積する評価結果データベースとを備える。
The quality management system of the present disclosure includes the quality management device of the present disclosure and an evaluation result database that stores accumulated data.
本開示の品質管理方法は、製品の製造情報、製品の運搬情報、および製品の使用情報のうち少なくとも１つの情報からなる製品情報と、製品の品質評価結果を示す評価結果情報とを関連付けて蓄積した蓄積データから製品情報および評価結果情報を取得し、製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出し、抽出結果を出力する。
The quality control method of the present disclosure stores product information including at least one of product manufacturing information, product transportation information, and product usage information and evaluation result information indicating a product quality evaluation result in association with each other. The product information and the evaluation result information are acquired from the accumulated data, the factors affecting the quality evaluation result are extracted based on the product information and the evaluation result information, and the extraction result is output.
本開示の品質管理プログラムは、製品の製造情報、製品の運搬情報、および製品の使用情報のうち少なくとも１つの情報からなる製品情報と、製品の品質評価結果を示す評価結果情報とを関連付けて蓄積した蓄積データから製品情報および評価結果情報を取得する手順と、製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する手順と、抽出結果を出力する手順とをコンピュータに実行させる。
The quality control program of the present disclosure associates and accumulates product information including at least one of product manufacturing information, product transportation information, and product usage information, and evaluation result information indicating a product quality evaluation result. The procedure for acquiring product information and evaluation result information from the stored data, the step for extracting the factors that affect the quality evaluation result based on the product information and the evaluation result information, and the step for outputting the extraction result are stored on the computer. Let it run.
本開示によれば、製品が製造されてから使用されるまでの間における、品質に影響を与える要因の特定が可能な品質管理装置、品質管理システム、品質管理方法、および品質管理プログラムを提供することができる。
According to the present disclosure, there are provided a quality control device, a quality control system, a quality control method, and a quality control program capable of identifying a factor affecting quality from the time a product is manufactured to the time it is used. be able to.
以下、図面を参照して本開示の実施形態について説明する。図１は本開示の第１の実施形態による品質管理システムを適用した創薬研究システムの概略構成を示す図である。
Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. FIG. 1 is a diagram showing a schematic configuration of a drug discovery research system to which the quality control system according to the first embodiment of the present disclosure is applied.
図１に示す創薬研究システム１は、培養細胞を含む製品３０が製造されてから使用されるまでの間において、製品の製造情報、製品の運搬情報、および製品の使用情報からなる製品情報と、製品の品質評価結果を示す評価結果情報とを関連付けて蓄積し、蓄積した情報に基づいて品質に影響を与える要因を抽出するためのシステムである。
The drug discovery research system 1 shown in FIG. 1 includes product information including product manufacturing information, product transportation information, and product usage information during the period from the manufacture of a product 30 containing cultured cells to its use. A system for associating and accumulating evaluation result information indicating a product quality evaluation result, and extracting a factor affecting quality based on the accumulated information.
図１に示すように、創薬研究システム１は、製品３０の製造者の施設内に設置された情報入力ワークステーション（以下、情報入力ＷＳとする）２、製品３０の運搬者の施設内に設置された情報入力ワークステーション（以下、情報入力ＷＳとする）３、製品３０の使用者の施設内に設置された情報入力ワークステーション（以下、情報入力ＷＳとする）４、情報サーバ５、評価結果データベース６、品質管理ワークステーション（以下、品質管理ＷＳとする）７が、有線または無線のネットワーク８を介して互いに通信可能な状態で接続されて構成されている。
As shown in FIG. 1, the drug discovery research system 1 includes an information input workstation (hereinafter, referred to as an information input WS) 2 installed in a facility of a manufacturer of a product 30 and a facility of a carrier of the product 30. Information input workstation (hereinafter referred to as information input WS) 3 installed, information input workstation (hereinafter referred to as information input WS) 4 installed in the facility of the user of product 30, information server 5, evaluation A result database 6 and a quality control workstation (hereinafter referred to as quality control WS) 7 are connected to each other via a wired or wireless network 8 in a communicable state.
各機器は、創薬研究システム１の構成要素として機能させるためのアプリケーションプログラムがインストールされたコンピュータである。アプリケーションプログラムは、ＤＶＤ－ＲＯＭ（Digital Versatile Disc Read Only Memory）あるいはＣＤ－ＲＯＭ（Compact Disc Read Only Memory）等の記録媒体に記録されて配布され、その記録媒体からコンピュータにインストールされる。または、ネットワークに接続されたサーバコンピュータの記憶装置、もしくはネットワークストレージに、外部からアクセス可能な状態で記憶され、要求に応じて製造者、運搬者、または、製品の使用者が使用するコンピュータにダウンロードされ、インストールされる。
Each device is a computer in which an application program for functioning as a component of the drug discovery research system 1 is installed. The application program is recorded and distributed in a recording medium such as a DVD-ROM (Digital Versatile Disc Read Only Memory) or a CD-ROM (Compact Disc Read Only Memory), and is installed in the computer from the recording medium. Or, it is stored in a storage device of a server computer connected to the network or a network storage in a state accessible from the outside, and downloaded to the computer used by the manufacturer, the carrier, or the product user upon request. Is installed.
第１の実施形態において、製品３０は、細胞培養デバイスである。細胞培養デバイスとしては、例えば、臓器チップ（Organ on a Chip）とすることができる。
In the first embodiment, the product 30 is a cell culture device. The cell culture device may be, for example, an organ chip.
情報入力ＷＳ２は、製品３０の製造者の施設内に設置され、製造者が、製品３０の製造情報を入力するためのコンピュータであり、処理装置、ディスプレイ、並びにキーボードおよびマウス等の入力装置により構成される。情報入力ＷＳ２では、製品３０の製造情報の入力を受け付ける処理、情報サーバ５が備える評価結果データベース６に対して、製品３０の製造情報を送信する処理等が、各処理のためのソフトウェアプログラムを実行することにより行われる。
The information input WS2 is a computer installed in the facility of the manufacturer of the product 30 and used by the manufacturer to input the manufacturing information of the product 30, and includes a processing device, a display, and an input device such as a keyboard and a mouse. To be done. In the information input WS2, the process of receiving the input of the manufacturing information of the product 30, the process of transmitting the manufacturing information of the product 30 to the evaluation result database 6 included in the information server 5, and the like execute the software programs for each process. It is done by doing.
ここで入力される製造情報としては、製品のＩＤ（IDentification）、製品の製造日、製品の製造者、製品に含まれる細胞の種類、製品に含まれる細胞の継代数、製品に含まれる細胞のロット、製品に含まれる細胞数、製品における細胞密度、製品に含まれる細胞を培養した際の培地の種類、製品に含まれる細胞の培地の製造元、製品に含まれる細胞の培地のロット、製品に含まれる細胞の培地の量、製品に含まれる細胞の培地のｐＨ、製品に含まれる細胞の播種方法、製品に含まれる細胞の培地の交換回数、製品に含まれる細胞の培養容器、製品に含まれる細胞の培養装置、製品に含まれる細胞の培養期間、製品に含まれる細胞の培養時の酸素濃度、製品に含まれる細胞の培養時の二酸化炭素濃度、製品に含まれる細胞の培養時の温度、製品に含まれる細胞の培養時の湿度、製品に含まれる細胞の製造場所、製品を輸送または保管する際の培地の種類、および製品に含まれる細胞の製造後評価結果のうち少なくとも１つであることが好ましい。
The manufacturing information entered here includes the product ID (IDentification), the product manufacturing date, the product manufacturer, the type of cells contained in the product, the number of passages of cells contained in the product, and the cells contained in the product. Lot, number of cells in product, cell density in product, type of medium when cells in product are cultured, manufacturer of medium for cells in product, lot of medium for cells in product, product Amount of cell culture medium contained, pH of cell culture medium contained in the product, seeding method of cells contained in the product, frequency of replacement of the cell culture medium contained in the product, cell culture container contained in the product, contained in the product Cell culture device, cell culture period of the product, oxygen concentration of the cell culture of the product, carbon dioxide concentration of the cell culture of the product, temperature of the cell culture of the product , At least one of the humidity of the cells contained in the product during culture, the place of manufacture of the cells contained in the product, the type of medium used to transport or store the product, and the post-production evaluation result of the cells contained in the product. It is preferable to have.
なお、製品の製造日について、製造が１日で終わらない場合には、製造開始日、または製造終了日等、製造日に関連する情報とすることができる。また、製品に含まれる細胞の継代数について、製品３０が本実施形態のように細胞培養デバイスである場合には、細胞培養デバイスに細胞を播種した時点での細胞の継代数であり、製品３０が人工生体部品である場合には、人口生体部品において培養している細胞の継代数である。また、細胞のロットについて、自家細胞を使う場合は細胞のドナー情報であり、他家細胞（例えば、市販の細胞）を使用する場合は製造時（例えば、細胞培養）のロット番号である。また、製品に含まれる細胞の培養時の酸素濃度については、酸素濃度の平均値でもよいし、酸素濃度の経時変化情報でもよい。また、製品を輸送または保管する際の培地の種類について、培地は、製品の細胞を培養する際に使用する培地と、輸送または保管時に使用する培地が異なる場合がある。凍結輸送または凍結保管の場合には、輸送用または保管用の培地は不要となる。凍結輸送または凍結保管でない場合には、３７℃程度の輸送用または保管用の培地を用いて、輸送または保管する。
Regarding the manufacturing date of the product, if the manufacturing is not completed in one day, the information related to the manufacturing date such as the manufacturing start date or the manufacturing end date can be used. Regarding the passage number of cells contained in the product, when the product 30 is a cell culture device as in the present embodiment, it is the passage number of cells at the time of seeding cells in the cell culture device. When is an artificial biological part, it is the passage number of cells cultured in the artificial biological part. Regarding the lot of cells, when autologous cells are used, it is cell donor information, and when allogeneic cells (for example, commercially available cells) are used, it is a lot number at the time of manufacturing (for example, cell culture). Further, the oxygen concentration of the cells contained in the product at the time of culturing may be an average value of the oxygen concentration, or information on the change over time of the oxygen concentration. Regarding the type of medium for transporting or storing the product, the medium used for culturing the cells of the product may be different from the medium used for transporting or storing. In the case of frozen transportation or frozen storage, a medium for transportation or storage is unnecessary. When it is not frozen or frozen, it is transported or stored using a medium for transportation or storage at about 37°C.
情報入力ＷＳ３は、製品３０の運搬者の施設内に設置され、運搬者が、製品３０の運搬情報を入力するためのコンピュータであり、処理装置、ディスプレイ、並びにキーボードおよびマウス等の入力装置により構成される。情報入力ＷＳ３では、製品３０の運搬情報の入力を受け付ける処理、情報サーバ５が備える評価結果データベース６に対して、製品３０の運搬情報を送信する処理等が、各処理のためのソフトウェアプログラムを実行することにより行われる。
The information input WS3 is a computer installed in the facility of the carrier of the product 30 and used by the carrier to input the transport information of the product 30, and includes a processing device, a display, and an input device such as a keyboard and a mouse. To be done. In the information input WS3, the process of receiving the input of the transportation information of the product 30, the process of transmitting the transportation information of the product 30 to the evaluation result database 6 included in the information server 5, and the like execute the software programs for each processing. It is done by doing.
ここで入力される運搬情報としては、製品のＩＤ、製品の運搬者、製品の運搬経路、製品の運搬期間、製品の運搬時の温度、製品の運搬時の湿度、製品の運搬時の振動状態、製品の運搬先での保管期間、製品の納品日、および製品の運搬後評価結果のうち少なくとも１つであることが好ましい。なお、製品の運搬時の温度については、温度の平均値でもよいし、温度の経時変化情報でもよい。
The transportation information input here includes a product ID, a product carrier, a product transportation route, a product transportation period, a product transportation temperature, a product transportation humidity, and a product transportation vibration state. , At least one of the storage period of the product at the destination, the delivery date of the product, and the post-transport evaluation result of the product. The temperature at which the product is transported may be the average value of the temperature, or may be the change information of the temperature with time.
情報入力ＷＳ４は、製品３０の使用者の施設内に設置され、使用者が、製品３０の使用情報を入力するためのコンピュータであり、処理装置、ディスプレイ、並びにキーボードおよびマウス等の入力装置により構成される。情報入力ＷＳ３では、製品３０の使用情報の入力を受け付ける処理、情報サーバ５が備える評価結果データベース６に対して、製品３０の使用情報を送信する処理等が、各処理のためのソフトウェアプログラムを実行することにより行われる。
The information input WS4 is a computer installed in the facility of the user of the product 30 and used by the user to input the use information of the product 30. The information input WS4 includes a processing device, a display, and an input device such as a keyboard and a mouse. To be done. In the information input WS3, the process of receiving the input of the use information of the product 30, the process of transmitting the use information of the product 30 to the evaluation result database 6 included in the information server 5, and the like execute the software programs for each process. It is done by doing.
ここで入力される使用情報としては、製品のＩＤ、製品の納品日、製品の保管環境、製品の保管期間、製品の使用者、製品の使用日、製品の使用場所、製品に含まれる細胞に添加した化合物、製品に含まれる細胞に添加した化合物の製造元、製品に含まれる細胞に添加した化合物のロット、製品に含まれる細胞に添加した化合物の最終濃度、製品に含まれる細胞に添加した化合物の添加期間、製品に含まれる細胞に添加した化合物による影響の有無の結果、および製品に含まれる細胞を投与した患者の情報のうち少なくとも１つであることが好ましい。なお、製品に含まれる細胞に添加した化合物の最終濃度については、細胞の培地に化合物を添加した後、培地に化合物が溶解したときの培地における化合物の濃度である。また、製品に含まれる細胞に添加した化合物による影響については、薬効または毒性のことである。
The usage information entered here includes the product ID, product delivery date, product storage environment, product storage period, product user, product usage date, product usage location, and cells contained in the product. Compound added, manufacturer of compound added to cells contained in product, lot of compound added to cells contained in product, final concentration of compound added to cells contained in product, compound added to cells contained in product It is preferable that at least one of the addition period, the result of the presence or absence of the influence of the compound added to the cells contained in the product, and the information of the patient to whom the cells contained in the product were administered. The final concentration of the compound added to the cells contained in the product is the concentration of the compound in the medium when the compound is dissolved in the medium after adding the compound to the cell medium. In addition, the effect of the compound added to the cells contained in the product is drug efficacy or toxicity.
情報サーバ５は、汎用の比較的処理能力の高いコンピュータにデータベース管理システム（ＤＢＭＳ：DataBase Management System）の機能を提供するソフトウェアプログラムがインストールされたものである。また、情報サーバ５は評価結果データベース６が構成される大容量ストレージを備えている。このストレージは、情報サーバ５とデータバスによって接続された大容量のハードディスク装置であってもよいし、ネットワーク８に接続されているＮＡＳ（Network Attached Storage）およびＳＡＮ（Storage Area Network）に接続されたディスク装置であってもよい。また、情報サーバ５は、製造者の施設、運搬者の施設、および使用者の施設の各々の施設内に設置された情報入力ＷＳ２、情報入力ＷＳ３、および情報入力ＷＳ４からの各種情報の登録要求を受け付けると、その情報をデータベース用のフォーマットに整えて評価結果データベース６に登録する。また、情報サーバ５は、品質管理ＷＳ７からの閲覧要求をネットワーク８経由で受信すると、評価結果データベース６に登録されている情報を検索し、抽出された情報を要求元の品質管理ＷＳ７に送信する。
The information server 5 is a general-purpose computer with relatively high processing capacity, on which a software program that provides the functions of a database management system (DBMS) is installed. The information server 5 also includes a large-capacity storage in which the evaluation result database 6 is configured. This storage may be a large-capacity hard disk device connected to the information server 5 by a data bus, or may be connected to a NAS (Network Attached Storage) and a SAN (Storage Area Network) connected to the network 8. It may be a disk device. Further, the information server 5 requests registration of various information from the information input WS2, the information input WS3, and the information input WS4 installed in each of the facility of the manufacturer, the facility of the carrier, and the facility of the user. Is accepted, the information is prepared in a database format and registered in the evaluation result database 6. Further, when the information server 5 receives the browsing request from the quality control WS 7 via the network 8, the information server 5 searches the information registered in the evaluation result database 6 and sends the extracted information to the requesting quality control WS 7. ..
評価結果データベース６には、各施設内に設置された情報入力ＷＳ２、情報入力ＷＳ３、および情報入力ＷＳ４から入力された製品３０の製造情報、製品３０の運搬情報、および製品３０の使用情報からなる製品情報と、製品３０の品質評価結果を示す評価結果情報とが関連付けて登録され、登録された情報が蓄積される。
The evaluation result database 6 includes the manufacturing information of the product 30, the transportation information of the product 30, and the usage information of the product 30 input from the information input WS2, the information input WS3, and the information input WS4 installed in each facility. The product information and the evaluation result information indicating the quality evaluation result of the product 30 are registered in association with each other, and the registered information is accumulated.
品質管理ＷＳ７は、第１の実施形態による品質管理装置１０を内包するものである。品質管理ＷＳ７の構成については後述する。
The quality control WS 7 includes the quality control device 10 according to the first embodiment. The configuration of the quality control WS 7 will be described later.
ネットワーク８は、製造者の施設、運搬者の施設、および使用者の施設の各々の施設内に構成された有線または無線のローカルエリアネットワークと、各施設のローカルエリアネットワーク同士を接続するインターネットまたは専用回線により構成されている。
The network 8 is a wired or wireless local area network configured in each facility of a manufacturer's facility, a carrier's facility, and a user's facility, and the Internet or a dedicated network connecting the local area networks of each facility. It is composed of lines.
以下、本実施形態による品質管理ＷＳ７について詳細に説明する。品質管理ＷＳ７は、製品３０が製造されてから使用されるまでの間で、品質に影響を与える要因を特定するために管理者が利用するコンピュータであり、処理装置、ディスプレイ、並びにキーボードおよびマウス等の入力装置により構成される。ここで、管理者とは、製造者、運搬者、および使用者から入出力される情報を管理する者である。
The quality control WS 7 according to this embodiment will be described in detail below. The quality control WS 7 is a computer used by an administrator to identify factors that affect quality from the time the product 30 is manufactured to the time it is used. The quality control WS 7 includes a processing device, a display, a keyboard, a mouse, and the like. It is composed of the input device. Here, the administrator is a person who manages information input/output by the manufacturer, the carrier, and the user.
品質管理ＷＳ７では、情報サーバ５に対する情報の閲覧要求、情報サーバ５から受信した情報に基づく要因特定処理、および要因の特定結果の表示等の各処理が、各処理のためのソフトウェアプログラムを実行することにより行われる。なお、これらの処理は、周知のソフトウェアプログラムにより行われるため、ここでは詳細な説明は省略する。
In the quality control WS 7, each process such as an information browsing request to the information server 5, a factor identification process based on the information received from the information server 5, and a display of a factor identification result executes a software program for each process. It is done by Since these processes are performed by a well-known software program, detailed description is omitted here.
品質管理ＷＳ７には、第１の実施形態による品質管理プログラムがインストールされてなる。品質管理プログラムは、ＤＶＤあるいはＣＤ－ＲＯＭ等の記録媒体に記録されて配布され、その記録媒体からコンピュータにインストールされる。または、ネットワークに接続されたサーバコンピュータの記憶装置、もしくはネットワークストレージに、外部からアクセス可能な状態で記憶され、要求に応じて品質管理ＷＳ７にダウンロードされ、インストールされる。
The quality control program according to the first embodiment is installed in the quality control WS 7. The quality control program is recorded and distributed in a recording medium such as a DVD or a CD-ROM, and is installed in the computer from the recording medium. Alternatively, it is stored in a storage device of a server computer connected to the network or a network storage so as to be accessible from the outside, and is downloaded and installed in the quality control WS 7 in response to a request.
図２は、品質管理プログラムをインストールすることにより実現される、本開示の第１の実施形態による品質管理装置の概略構成を示す図である。図２に示すように、品質管理装置１０は、標準的なコンピュータの構成として、ＣＰＵ（Central Processing Unit）１１、メモリ１２およびストレージ１３を備えている。また、品質管理装置１０には、液晶ディスプレイ等のディスプレイ１４、並びにキーボードおよびマウス等の入力部１５が接続されている。なお、品質管理装置１０は、品質管理ＷＳ７に内包されるものとなる。
FIG. 2 is a diagram showing a schematic configuration of the quality control device according to the first embodiment of the present disclosure realized by installing a quality control program. As shown in FIG. 2, the quality control device 10 includes a CPU (Central Processing Unit) 11, a memory 12 and a storage 13 as a standard computer configuration. Further, a display 14 such as a liquid crystal display and an input unit 15 such as a keyboard and a mouse are connected to the quality control device 10. The quality control device 10 is included in the quality control WS 7.
ストレージ１３は、ハードディスクまたはＳＳＤ（Solid State Drive）等のストレージデバイスからなる。ストレージ１３には、ネットワーク８を経由して情報サーバ５から取得した情報および品質管理装置１０の処理に必要な情報を含む各種情報が記憶されている。
The storage 13 comprises a storage device such as a hard disk or SSD (Solid State Drive). The storage 13 stores various information including information acquired from the information server 5 via the network 8 and information necessary for the processing of the quality control device 10.
また、メモリ１２には、品質管理プログラムが記憶されている。品質管理プログラムは、ＣＰＵ１１に実行させる処理として、情報サーバ５から製品情報および評価結果情報を取得する処理、取得した製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する処理、抽出結果を出力する処理を規定する。
Further, the quality control program is stored in the memory 12. The quality management program, as the processing to be executed by the CPU 11, acquires the product information and the evaluation result information from the information server 5, and extracts the factors that affect the quality evaluation result based on the acquired product information and the evaluation result information. Specifies the processing and processing for outputting the extraction result.
そして、ＣＰＵ１１がプログラムに従いこれらの処理を実行することで、コンピュータは、情報サーバ５から製品情報および評価結果情報を取得する取得部２１、取得した製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する抽出部２２、および抽出結果を出力する出力部２３として機能する。
Then, the CPU 11 executes these processes in accordance with the program, so that the computer obtains the product information and the evaluation result information from the information server 5, the quality evaluation result based on the acquired product information and the evaluation result information. It functions as an extraction unit 22 that extracts a factor that influences the output and an output unit 23 that outputs the extraction result.
なお、本実施形態においては、ＣＰＵ１１が品質管理プログラムによって、各部の機能を実行するようにしたが、ソフトウェアを実行して各種の処理部として機能する汎用的なプロセッサとしては、ＣＰＵ１１の他、ＦＰＧＡ (Field Programmable Gate Array)等の製造後に回路構成を変更可能なプロセッサであるプログラマブルロジックデバイス（Programmable Logic Device:ＰＬＤ）を用いることができる。また、ＡＳＩＣ（Application Specific Integrated Circuit）等の特定の処理を実行させるために専用に設計された回路構成を有するプロセッサである専用電気回路等により、各部の処理を実行するようにしてもよい。
In the present embodiment, the CPU 11 executes the function of each unit by the quality control program. However, as a general-purpose processor that executes software and functions as various processing units, in addition to the CPU 11, FPGA A programmable logic device (PLD) that is a processor whose circuit configuration can be changed after manufacturing (Field Programmable Gate Array) or the like can be used. Further, the processing of each unit may be executed by a dedicated electric circuit or the like which is a processor having a circuit configuration specifically designed for executing a specific processing such as an ASIC (Application Specific Integrated Circuit).
１つの処理部は、これら各種のプロセッサのうちの１つで構成されてもよいし、同種または異種の２つ以上のプロセッサの組み合わせ（例えば、複数のＦＰＧＡ、またはＣＰＵとＦＰＧＡの組み合わせ等）で構成されてもよい。また、複数の処理部を１つのプロセッサで構成してもよい。複数の処理部を１つのプロセッサで構成する例としては、第１に、クライアントおよびサーバ等のコンピュータに代表されるように、１つ以上のＣＰＵとソフトウェアの組み合わせで１つのプロセッサを構成し、このプロセッサが複数の処理部として機能する形態がある。第２に、システムオンチップ（System On Chip:ＳｏＣ）等に代表されるように、複数の処理部を含むシステム全体の機能を１つのＩＣ（Integrated Circuit）チップで実現するプロセッサを使用する形態がある。このように、各種の処理部は、ハードウェア的な構造として、上記各種のプロセッサを１つ以上用いて構成される。
One processing unit may be configured by one of these various processors, or may be a combination of two or more processors of the same type or different types (for example, a plurality of FPGAs or a combination of CPU and FPGA). It may be configured. Further, the plurality of processing units may be configured by one processor. As an example of configuring a plurality of processing units with one processor, firstly, as represented by computers such as clients and servers, one processor is configured with a combination of one or more CPUs and software. There is a form in which the processor functions as a plurality of processing units. Secondly, as represented by a system-on-chip (SoC), etc., there is a form in which a processor that realizes the functions of the entire system including a plurality of processing units by one IC (Integrated Circuit) chip is used. is there. As described above, the various processing units are configured by using one or more of the above various processors as a hardware structure.
さらに、これらの各種のプロセッサのハードウェア的な構造は、より具体的には、半導体素子等の回路素子を組み合わせた電気回路（circuitry）である。
Furthermore, the hardware-like structure of these various processors is more specifically an electric circuit (circuitry) that combines circuit elements such as semiconductor elements.
なお、メモリ１２には、品質管理ＷＳ７が品質管理装置１０以外の処理を行うための装置として機能する場合には、その機能を実行するプログラムが記憶される。
If the quality management WS 7 functions as a device for performing processing other than the quality management device 10, the memory 12 stores a program that executes the function.
次いで、第１の実施形態において行われる処理について説明する。図３は第１の実施形態において行われる処理を示すフローチャートである。
Next, the processing performed in the first embodiment will be described. FIG. 3 is a flowchart showing the processing performed in the first embodiment.
製造者による製品３０の製造（ステップＳ１０）の後、製造者が、製品３０の良否判定を行い、かつ製品３０の製造情報を情報入力ＷＳ２から入力する（ステップＳ１１）。ここで入力された情報は、情報サーバ５が備える評価結果データベース６に蓄積される。
After the manufacturer manufactures the product 30 (step S10), the manufacturer judges the quality of the product 30 and inputs the manufacturing information of the product 30 from the information input WS2 (step S11). The information input here is accumulated in the evaluation result database 6 provided in the information server 5.
本実施形態において製造情報は、１例として、製品３０のＩＤ、製品３０の製造日（ここでは製品３０の製造終了日とする）、製品３０に含まれる細胞のロット、製品３０に含まれる細胞の培地の種類、および製品３０の製造後評価結果の５種類の情報とする。
In the present embodiment, the manufacturing information includes, for example, the ID of the product 30, the manufacturing date of the product 30 (here, the manufacturing end date of the product 30), the lot of cells contained in the product 30, and the cells contained in the product 30. 5 types of information of the type of medium and the evaluation result of the product 30 after manufacturing.
製品３０の製造後評価結果の取得について、本実施形態では一例として製品３０である細胞培養デバイスの良否判定を行う。この良否判定の方法は、細胞培養デバイス内の細胞の形態の異常、細胞数、細胞密度、コンタミネーション、細胞以外の基板の異常（例えば、組付け、ひび割れ等）等を検出するものであって、目視で行ってもよいし、細胞培養デバイスをカメラで撮影し、撮影画像をコンピュータで解析することにより行ってもよい。なお、これ以外の周知の方法を用いてもよい。なお、製品３０の良否判定については、製造後に１回だけ行う態様に限らず、製造工程（例えば、細胞の培養工程）の途中を含めて複数回行ってもよい。
Regarding acquisition of the post-manufacturing evaluation result of the product 30, in the present embodiment, as an example, the quality of the cell culture device which is the product 30 is determined. This quality determination method detects abnormalities in the morphology of cells in the cell culture device, the number of cells, cell density, contamination, abnormalities of substrates other than cells (eg, assembly, cracking, etc.), etc. Alternatively, it may be performed visually, or may be performed by photographing the cell culture device with a camera and analyzing the photographed image with a computer. In addition, you may use well-known methods other than this. The quality of the product 30 is not limited to being determined once after the production, but may be performed a plurality of times including the middle of the production process (for example, the cell culture process).
ステップＳ１１において、製品３０の良否判定が不良（ＮＧ：No Good）だった場合（判定結果Ｎｏ）、最終的な品質評価結果もＮＧとなり、この内容が評価結果情報となる。そして、品質管理ＷＳ７において、品質評価結果に影響を与える要因の抽出が行われる（ステップＳ１２）。
In step S11, when the quality judgment of the product 30 is bad (NG: No Good) (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, in the quality control WS7, factors affecting the quality evaluation result are extracted (step S12).
ここで、評価結果情報とは、製品３０の最終的な品質評価結果を示す情報であって、製造段階における品質評価結果（本実施形態においては上記良否判定）とは異なる情報である。評価結果情報は、製造段階における最後の品質評価結果と同じ内容としてもよいし、製造段階における複数の品質評価結果から総合的に判断された内容としてもよい。さらに、評価結果情報の内容の決定は、製造段階における品質評価結果を含む複数の製造情報に基づいて、予め決められた閾値またはテーブルと比較して各項目でスコアを算出することにより行ってもよいし、製造段階における品質評価結果を含む複数の製造情報に基づいて学習された機械学習または深層学習を行う人工知能（artificial intelligence：ＡＩ）を用いて行ってもよい。
Here, the evaluation result information is information indicating the final quality evaluation result of the product 30, and is different from the quality evaluation result in the manufacturing stage (the above-mentioned quality judgment in the present embodiment). The evaluation result information may have the same contents as the last quality evaluation result in the manufacturing stage, or may have contents comprehensively judged from a plurality of quality evaluation results in the manufacturing stage. Further, the content of the evaluation result information may be determined by calculating a score for each item by comparing with a predetermined threshold value or table based on a plurality of manufacturing information including quality evaluation results in the manufacturing stage. Alternatively, it may be performed using artificial intelligence (AI) that performs machine learning or deep learning learned based on a plurality of manufacturing information including quality evaluation results at the manufacturing stage.
ここでの品質管理ＷＳ７の処理について説明する。まず、取得部２１は、情報サーバ５から製品情報および評価結果情報を取得する。取得部２１により取得された情報の一例を図４に示す。
Describe the processing of the quality control WS7 here. First, the acquisition unit 21 acquires product information and evaluation result information from the information server 5. FIG. 4 shows an example of the information acquired by the acquisition unit 21.
次に、抽出部２２は、取得部２１が取得した製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する。図４に示す取得例の通り、製造段階でＮＧとなっているため、抽出部２２は、製品３０の製造日、製品３０に含まれる細胞のロット、および製品３０に含まれる細胞の培地の種類を、品質評価結果に影響を与える要因の候補として抽出する。また、製造段階における評価結果を含む複数の製造情報に基づいて学習した機械学習または深層学習を行う人工知能を用いて、抽出された品質評価結果に影響を与える要因の候補を絞り込むことができる。
Next, the extraction unit 22 extracts factors that affect the quality evaluation result based on the product information and the evaluation result information acquired by the acquisition unit 21. As shown in the acquisition example shown in FIG. 4, since the manufacturing stage is NG, the extraction unit 22 determines the manufacturing date of the product 30, the lot of cells contained in the product 30, and the type of medium of the cells contained in the product 30. Is extracted as a candidate for a factor affecting the quality evaluation result. Further, it is possible to narrow down the candidates of factors affecting the extracted quality evaluation result by using artificial intelligence that performs machine learning or deep learning learned based on a plurality of manufacturing information including evaluation results in the manufacturing stage.
そして、出力部２３は、抽出結果（すなわち、品質評価結果に影響を与える要因の候補）を品質管理ＷＳ７が備えるディスプレイ１４に出力する。さらに、出力部２３は、品質評価結果に影響を与える要因を有する製造者の施設内に設置された情報入力ＷＳ２宛てに抽出結果をメール、ポップアップ表示、または、ハイライト表示等で出力する。その後、処理を終了する。
Then, the output unit 23 outputs the extraction result (that is, the candidate of the factor affecting the quality evaluation result) to the display 14 included in the quality control WS 7. Further, the output unit 23 outputs the extraction result by mail, pop-up display, highlight display, or the like to the information input WS2 installed in the manufacturer's facility having factors that affect the quality evaluation result. Then, the process ends.
ステップＳ１１において、製品３０の良否判定が良（ＯＫ：Okay）だった場合（判定結果Ｙｅｓ）、製品３０は運搬に回され、運搬者によって使用者の元へ製品３０が運搬された後、運搬者が、製品３０の運搬情報を情報入力ＷＳ３から入力する（ステップＳ１３）。ここで入力された情報は、情報サーバ５が備える評価結果データベース６に蓄積される。
In step S11, when the quality determination of the product 30 is good (OK: Okay) (determination result Yes), the product 30 is sent for transportation, and after the product 30 is transported to the user by the transporter, it is transported. The person inputs the transportation information of the product 30 from the information input WS3 (step S13). The information input here is accumulated in the evaluation result database 6 provided in the information server 5.
本実施形態において運搬情報は、１例として、製品３０のＩＤ、製品３０の運搬経路、製品３０の運搬時の温度、および製品３０の運搬後評価結果の４種類の情報とする。ただし、本実施形態では、製品３０の運搬後評価結果については、製品３０の使用者の方から入力される。また、運搬時の温度、さらに運搬時の湿度等の情報は、例えば製品３０に計測チップを埋め込んで取得してもよいし、製品３０を梱包したケースに計測チップを埋め込んで取得してもよい。
In the present embodiment, the transportation information is, for example, four types of information including the ID of the product 30, the transportation route of the product 30, the temperature of the transportation of the product 30, and the post-transport evaluation result of the product 30. However, in the present embodiment, the post-transport evaluation result of the product 30 is input by the user of the product 30. The information such as the temperature during transportation and the humidity during transportation may be acquired by, for example, embedding the measuring chip in the product 30, or by embedding the measuring chip in the case in which the product 30 is packed. ..
製品３０の使用者は、製品３０の使用前に、製品３０の運搬後評価結果を取得するために、製品３０の良否判定を行い（ステップＳ１４）、その結果を製品３０の運搬情報として情報入力ＷＳ４から入力する。ステップＳ１４において、製品３０の良否判定がＮＧだった場合（判定結果Ｎｏ）、最終的な品質評価結果もＮＧとなり、この内容が評価結果情報となる。そして、品質管理ＷＳ７において、品質評価結果に影響を与える要因の抽出が行われる（ステップＳ１５）。
Before using the product 30, the user of the product 30 determines whether the product 30 is good or bad in order to obtain the post-transport evaluation result of the product 30 (step S14), and inputs the result as transport information of the product 30. Input from WS4. In step S14, when the quality judgment of the product 30 is NG (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, in the quality control WS7, the factors affecting the quality evaluation result are extracted (step S15).
ここで、評価結果情報とは、上記の通り製品３０の最終的な品質評価結果を示す情報であって、運搬段階における品質評価結果（本実施形態においては上記良否判定）とは異なる情報である。評価結果情報は、運搬段階における最後の品質評価結果と同じ内容としてもよいし、運搬段階における複数の品質評価結果から総合的に判断された内容としてもよい。さらに、評価結果情報の内容の決定は、運搬段階における品質評価結果を含む複数の運搬情報に基づいて、予め決められた閾値またはテーブルと比較して各項目でスコアを算出することにより行ってもよいし、運搬段階における品質評価結果を含む複数の運搬情報に基づいて機械学習または深層学習を行う人工知能を用いて行ってもよい。
Here, the evaluation result information is information indicating the final quality evaluation result of the product 30 as described above, and is information different from the quality evaluation result in the transportation stage (the above-described quality determination in the present embodiment). .. The evaluation result information may have the same content as the last quality evaluation result at the transportation stage, or the content comprehensively judged from a plurality of quality evaluation results at the transportation stage. Further, the content of the evaluation result information may be determined by calculating a score for each item by comparing with a predetermined threshold value or table based on a plurality of pieces of transportation information including the quality evaluation result in the transportation stage. Alternatively, it may be performed using artificial intelligence that performs machine learning or deep learning based on a plurality of pieces of transportation information including quality evaluation results in the transportation stage.
ここでの品質管理ＷＳ７の処理について説明する。まず、取得部２１は、情報サーバ５から製品情報および評価結果情報を取得する。取得部２１により取得された情報の一例を図５に示す。
Describe the processing of the quality control WS7 here. First, the acquisition unit 21 acquires product information and evaluation result information from the information server 5. An example of the information acquired by the acquisition unit 21 is shown in FIG.
次に、抽出部２２は、取得部２１が取得した製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する。図５に示す取得例の通り、製造段階はＯＫであり、運搬段階でＮＧとなっているため、抽出部２２は、製品３０の運搬経路および製品３０の運搬時の温度を、品質評価結果に影響を与える要因の候補として抽出する。また、運搬段階における評価結果を含む複数の運搬情報に基づいて学習した機械学習または深層学習を行う人工知能を用いて、抽出された品質評価結果に影響を与える要因の候補を絞り込むことができる。
Next, the extraction unit 22 extracts factors that affect the quality evaluation result based on the product information and the evaluation result information acquired by the acquisition unit 21. As in the acquisition example shown in FIG. 5, since the manufacturing stage is OK and the transport stage is NG, the extraction unit 22 uses the transport route of the product 30 and the temperature during transport of the product 30 as the quality evaluation result. It is extracted as a candidate for influencing factors. Further, it is possible to narrow down the candidates of factors affecting the extracted quality evaluation result by using the artificial intelligence that performs machine learning or deep learning learned based on a plurality of pieces of transportation information including the evaluation result in the transportation stage.
そして、出力部２３は、抽出結果を品質管理ＷＳ７が備えるディスプレイ１４に出力する。さらに、出力部２３は、品質評価結果に影響を与える要因を有する運搬者の施設内に設置された情報入力ＷＳ３宛てに抽出結果をメール、ポップアップ表示、または、ハイライト表示等で出力する。その後、処理を終了する。
Then, the output unit 23 outputs the extraction result to the display 14 included in the quality control WS 7. Further, the output unit 23 outputs the extraction result to the information input WS3 installed in the facility of the carrier having a factor affecting the quality evaluation result by e-mail, pop-up display, highlight display, or the like. Then, the process ends.
ステップＳ１４において、製品３０の良否判定がＯＫだった場合（判定結果Ｙｅｓ）、製品３０は実際に使用されることになり、使用者による製品３０の使用（ステップＳ１６）の後、使用者が、製品３０を使用した試験結果の判定を行い、かつ製品３０の使用情報を情報入力ＷＳ４から入力する（ステップＳ１７）。ここで入力された情報は、情報サーバ５が備える評価結果データベース６に蓄積される。なお、本実施形態において製品３０の使用とは、使用者が製品３０に化合物を添加し、化合物の影響（例えば、薬効または毒性等）を評価することを意味する。
In step S14, when the quality determination of the product 30 is OK (determination result Yes), the product 30 is actually used, and after the user uses the product 30 (step S16), the user The test result using the product 30 is determined, and the usage information of the product 30 is input from the information input WS4 (step S17). The information input here is accumulated in the evaluation result database 6 provided in the information server 5. In the present embodiment, the use of the product 30 means that the user adds a compound to the product 30 and evaluates the influence of the compound (for example, drug effect or toxicity).
本実施形態において使用情報は、１例として、製品３０のＩＤ、製品３０の使用日、製品３０に含まれる細胞に添加した化合物、および製品３０の使用後評価結果の４種類の情報とする。なお、これらの情報以外にも、例えば、製品３０の保管環境および製品３０の保管期間といった情報を使用情報としてもよい。ここで、製品３０の保管環境とは、製品３０の保管場所、保管場所での温度および／または湿度等の保管環境に関する情報である。
In the present embodiment, the usage information is, for example, four types of information: the ID of the product 30, the date of use of the product 30, the compound added to the cells contained in the product 30, and the post-use evaluation result of the product 30. In addition to these pieces of information, information such as the storage environment of the product 30 and the storage period of the product 30 may be used as the usage information. Here, the storage environment of the product 30 is information on the storage environment of the product 30, such as the storage location and the temperature and/or humidity at the storage location.
ステップＳ１７において、製品３０を使用した試験結果が通常と異なる結果（ＮＧ）となった場合（判定結果Ｎｏ）、最終的な品質評価結果もＮＧとなり、この内容が評価結果情報となる。そして、品質管理ＷＳ７において、品質評価結果に影響を与える要因の抽出が行われる（ステップＳ１８）。なお、製品３０を使用した試験結果が通常と異なる結果とは、製品３０に添加した化合物から予想される試験結果と異なる場合、および同じ製造条件で製造された細胞培養デバイスを使用した場合等に試験結果が異なる場合等である。
In step S17, if the test result using the product 30 is different from the normal result (NG) (judgment result No), the final quality evaluation result is also NG, and this content becomes the evaluation result information. Then, in the quality control WS7, the factors affecting the quality evaluation result are extracted (step S18). In addition, the test result using the product 30 is different from the usual result when it differs from the test result expected from the compound added to the product 30, and when the cell culture device manufactured under the same manufacturing conditions is used. For example, when the test results are different.
ここで、評価結果情報とは、上記の通り製品３０の最終的な品質評価結果を示す情報であって、使用段階における品質評価結果（本実施形態においては上記試験結果）とは異なる情報である。評価結果情報は、使用段階における最後の品質評価結果と同じ内容としてもよいし、使用段階における複数の品質評価結果から総合的に判断された内容としてもよい。さらに、評価結果情報の内容の決定は、使用段階における品質評価結果を含む複数の使用情報に基づいて、予め決められた閾値またはテーブルと比較して各項目でスコアを算出することにより行ってもよいし、使用段階における品質評価結果を含む複数の使用情報に基づいて機械学習または深層学習を行う人工知能を用いて行ってもよい。
Here, the evaluation result information is information indicating the final quality evaluation result of the product 30 as described above, and is information different from the quality evaluation result in the use stage (the above test result in the present embodiment). .. The evaluation result information may have the same content as the last quality evaluation result in the use stage, or the content comprehensively judged from a plurality of quality evaluation results in the use stage. Furthermore, the content of the evaluation result information may be determined by calculating a score for each item by comparing with a predetermined threshold value or table based on a plurality of use information including quality evaluation results at the use stage. Alternatively, artificial intelligence that performs machine learning or deep learning based on a plurality of pieces of usage information including quality evaluation results at the usage stage may be used.
ここでの品質管理ＷＳ７の処理について説明する。まず、取得部２１は、情報サーバ５から製品情報および評価結果情報を取得する。取得部２１により取得された情報の一例を図６に示す。
Describe the processing of the quality control WS7 here. First, the acquisition unit 21 acquires product information and evaluation result information from the information server 5. FIG. 6 shows an example of the information acquired by the acquisition unit 21.
次に、抽出部２２は、取得部２１が取得した製品情報および評価結果情報に基づいて、品質評価結果に影響を与える要因を抽出する。図６に示す取得例の通り、運搬段階まではＯＫであり、使用段階でＮＧとなっているため、抽出部２２は、製品３０の使用日および製品３０に含まれる細胞に添加した化合物を、品質評価結果に影響を与える要因の候補として抽出する。また、使用段階における品質評価結果を含む複数の使用情報に基づいて学習した機械学習または深層学習を行う人工知能を用いて、抽出された品質評価結果に影響を与える要因の候補を絞り込むことができる。
Next, the extraction unit 22 extracts factors that affect the quality evaluation result based on the product information and the evaluation result information acquired by the acquisition unit 21. As in the acquisition example shown in FIG. 6, since the transportation stage is OK and the use stage is NG, the extraction unit 22 uses the compound added to cells contained in the product 30 on the date of use and the product 30. It is extracted as a candidate for factors that affect the quality evaluation result. In addition, it is possible to narrow down the candidates of factors affecting the extracted quality evaluation result by using artificial intelligence that performs machine learning or deep learning learned based on a plurality of usage information including quality evaluation results at the use stage. ..
そして、出力部２３は、抽出結果を品質管理ＷＳ７が備えるディスプレイ１４に出力する。さらに、出力部２３は、品質評価結果に影響を与える要因を有する使用者の施設内に設置された情報入力ＷＳ４宛てに抽出結果をメール、ポップアップ表示、または、ハイライト表示等で出力する。その後、処理を終了する。
Then, the output unit 23 outputs the extraction result to the display 14 included in the quality control WS 7. Further, the output unit 23 outputs the extraction result to the information input WS4 installed in the facility of the user having a factor affecting the quality evaluation result by mail, pop-up display, highlight display, or the like. Then, the process ends.
ステップＳ１７において、製品３０を使用した試験結果が通常通りの結果（ＯＫ）となった場合（判定結果Ｙｅｓ）、最終的な品質評価結果もＯＫとなり、この内容が評価結果情報となり、処理を終了する。
In step S17, when the test result using the product 30 is the normal result (OK) (determination result Yes), the final quality evaluation result is also OK, and this content becomes the evaluation result information, and the processing ends. To do.
なお、製品３０の最終的な品質評価結果がＯＫであった場合も、品質管理ＷＳ７において、結果の出力を行ってもよい。
Even if the final quality evaluation result of the product 30 is OK, the quality control WS 7 may output the result.
ここでの品質管理ＷＳ７の処理について説明する。まず、取得部２１は、情報サーバ５から製品情報および評価結果情報を取得する。取得部２１により取得された情報の一例を図７に示す。最終的な品質評価結果がＯＫであるため、抽出部２２による要因の抽出は行わない。出力部２３は、単に取得部２１が取得した情報を品質管理ＷＳ７が備えるディスプレイ１４に出力する。
Describe the processing of the quality control WS7 here. First, the acquisition unit 21 acquires product information and evaluation result information from the information server 5. FIG. 7 shows an example of the information acquired by the acquisition unit 21. Since the final quality evaluation result is OK, the extraction unit 22 does not extract the factor. The output unit 23 simply outputs the information acquired by the acquisition unit 21 to the display 14 included in the quality control WS 7.
また、上記のシーケンスが繰り返されることにより、評価結果データベース６に蓄積される製品情報および評価結果情報のサンプル数が増加する。そのため、品質管理ＷＳ７は、評価結果データベース６に蓄積された全てまたは一部の製品情報および評価結果情報を取得し、図８に示すように、条件毎にＮＧ数およびＮＧ率を集計して、集計結果を品質管理ＷＳ７が備えるディスプレイ１４に出力するようにしてもよい。
Further, by repeating the above sequence, the number of samples of product information and evaluation result information accumulated in the evaluation result database 6 increases. Therefore, the quality control WS 7 acquires all or a part of the product information and the evaluation result information accumulated in the evaluation result database 6, and as shown in FIG. 8, calculates the NG number and the NG rate for each condition, The counting result may be output to the display 14 included in the quality control WS 7.
さらに、抽出部２２は、品質評価結果に影響を与える要因の抽出を行った際に、条件毎のＮＧ数およびＮＧ率の集計結果に基づいて、品質評価結果に影響を与える要因の候補の中から、ＮＧ率の低い要因を外す処理を行ってもよい。
Further, when the extraction unit 22 extracts the factors that affect the quality evaluation result, the extraction unit 22 selects among the candidates of the factors that affect the quality evaluation result, based on the result of counting the NG number and the NG rate for each condition. Therefore, the process of removing the factor of low NG rate may be performed.
次いで、本開示の第２の実施形態について説明する。なお、第２の実施形態においては、システムの構成は上記第１の実施形態と同一であり、製品３０の種類および行われる処理のみが第１の実施形態と異なるため、ここではシステムについての詳細な説明は省略する。
Next, a second embodiment of the present disclosure will be described. In the second embodiment, the system configuration is the same as in the first embodiment, and only the type of product 30 and the processing to be performed are different from those in the first embodiment. Therefore, the details of the system will be described here. Detailed description is omitted.
第２の実施形態において、製品３０は、軟骨、皮膚、心筋シート、または神経細胞等の人工生体部品である。
In the second embodiment, the product 30 is an artificial biological part such as cartilage, skin, myocardial sheet, or nerve cell.
第２の実施形態において行われる処理について説明する。図９は第２の実施形態において行われる処理を示すフローチャートである。なお、第１の実施形態と同じ内容についての詳細な説明は省略する。
The processing performed in the second embodiment will be described. FIG. 9 is a flowchart showing the processing performed in the second embodiment. Note that detailed description of the same contents as in the first embodiment will be omitted.
製造者による製品３０の製造（ステップＳ２０）の後、製造者が、製品３０の良否判定を行い、かつ製品３０の製造情報を情報入力ＷＳ２から入力する（ステップＳ２１）。ここで入力された情報は、情報サーバ５が備える評価結果データベース６に蓄積される。
After the manufacturer manufactures the product 30 (step S20), the manufacturer determines whether the product 30 is good or bad, and inputs the manufacturing information of the product 30 from the information input WS2 (step S21). The information input here is accumulated in the evaluation result database 6 provided in the information server 5.
製品３０の製造後評価結果の取得について、本実施形態では一例として製品３０である人工生体部品の良否判定を行う。この良否判定の方法は、人工生体部品内の細胞の形態の異常、細胞数、細胞密度、コンタミネーション、細胞の分化または未分化判定等を検出するものであって、目視で行ってもよいし、人工生体部品をカメラで撮影し、撮影画像をコンピュータで解析することにより行ってもよい。なお、これ以外の周知の方法を用いてもよい。なお、製品３０の良否判定については、製造後に１回だけ行う態様に限らず、製造工程（例えば、細胞の培養工程）の途中を含めて複数回行ってもよい。
Regarding the acquisition of the post-manufacturing evaluation result of the product 30, in the present embodiment, as an example, the quality of the artificial biological component which is the product 30 is determined. This method of quality determination is to detect abnormalities in the morphology of cells in the artificial biological part, cell number, cell density, contamination, differentiation or undifferentiation determination of cells, etc., and may be performed visually. Alternatively, the artificial biological component may be photographed by a camera and the photographed image may be analyzed by a computer. In addition, you may use well-known methods other than this. The quality of the product 30 is not limited to being determined once after the production, but may be performed a plurality of times including the middle of the production process (for example, the cell culture process).
ステップＳ２１において、製品３０の良否判定がＮＧだった場合（判定結果Ｎｏ）、最終的な品質評価結果もＮＧとなり、この内容が評価結果情報となる。そして、品質管理ＷＳ７において、品質評価結果に影響を与える要因の抽出が行われた後（ステップＳ２２）、処理を終了する。
In step S21, when the quality judgment of the product 30 is NG (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, in the quality control WS7, the factors affecting the quality evaluation result are extracted (step S22), and then the process ends.
ステップＳ２１において、製品３０の良否判定がＯＫだった場合（判定結果Ｙｅｓ）、製品３０は運搬に回され、運搬者によって使用者の元へ製品３０が運搬された後、運搬者が、製品３０の運搬情報の一部（本実施形態においては製品３０のＩＤ、製品３０の運搬経路、および製品３０の運搬時の温度）を情報入力ＷＳ３から入力する（ステップＳ２３）。ここで入力された情報は、情報サーバ５が備える評価結果データベース６に蓄積される。
In step S21, when the quality determination of the product 30 is OK (determination result Yes), the product 30 is sent for transportation, and after the product 30 is transported to the user by the transporter, the transporter determines the product 30. Part of the transportation information (in this embodiment, the ID of the product 30, the transportation route of the product 30, and the temperature of the transportation of the product 30) is input from the information input WS3 (step S23). The information input here is accumulated in the evaluation result database 6 provided in the information server 5.
製品３０の使用者は、製品３０の使用前に、製品３０の運搬後評価結果を取得するために、製品３０の良否判定を行い（ステップＳ２４）、その結果を製品３０の運搬情報として情報入力ＷＳ４から入力する。ステップＳ２４において、製品３０の良否判定がＮＧだった場合（判定結果Ｎｏ）、最終的な品質評価結果もＮＧとなり、この内容が評価結果情報となる。そして、品質管理ＷＳ７において、品質評価結果に影響を与える要因の抽出が行われた後（ステップＳ２５）、処理を終了する。
Before using the product 30, the user of the product 30 determines whether the product 30 is good or bad in order to obtain the post-transport evaluation result of the product 30 (step S24), and inputs the result as transport information of the product 30. Input from WS4. In step S24, when the quality judgment of the product 30 is NG (judgment result No), the final quality evaluation result also becomes NG, and this content becomes the evaluation result information. Then, after the factors affecting the quality evaluation result are extracted in the quality control WS7 (step S25), the process ends.
ステップＳ２４において、製品３０の良否判定がＯＫだった場合（判定結果Ｙｅｓ）、製品３０は実際に患者に移植されることになり、医者（すなわち、使用者）による製品３０の患者への移植（ステップＳ２６）の後、使用者が、製品３０を移植した患者の経過観察の結果の判定を行い、かつ製品３０の使用情報を情報入力ＷＳ４から入力する（ステップＳ２７）。ここで入力された情報は、情報サーバ５が備える評価結果データベース６に蓄積される。
If the quality of the product 30 is OK in step S24 (determination result Yes), the product 30 is actually transplanted to the patient, and the doctor (ie, the user) transplants the product 30 to the patient ( After step S26), the user determines the result of the follow-up observation of the patient who transplanted the product 30, and inputs the use information of the product 30 from the information input WS4 (step S27). The information input here is accumulated in the evaluation result database 6 provided in the information server 5.
ステップＳ２７において、製品３０を移植した患者の経過観察の結果が良好でない場合（ＮＧ：判定結果Ｎｏ）、最終的な品質評価結果もＮＧとなり、この内容が評価結果情報となる。そして、品質管理ＷＳ７において、品質評価結果に影響を与える要因の抽出が行われた後（ステップＳ２８）、処理を終了する。
In step S27, if the result of follow-up observation of the patient who transplanted the product 30 is not good (NG: judgment result No), the final quality evaluation result is also NG, and this content becomes evaluation result information. Then, in the quality control WS7, the factors that affect the quality evaluation result are extracted (step S28), and then the process ends.
ステップＳ２７において、製品３０を移植した患者の経過観察の結果が良好である場合（ＯＫ：判定結果Ｙｅｓ）、最終的な品質評価結果もＯＫとなり、この内容が評価結果情報となり、処理を終了する。
In step S27, if the result of the follow-up observation of the patient who transplanted the product 30 is good (OK: determination result Yes), the final quality evaluation result is also OK, and this content becomes evaluation result information, and the process ends. ..
以上、本開示の技術をその好適な実施形態に基づいて説明したが、本開示の品質管理システムは、上記実施形態にのみ限定されるものではなく、上記第１および第２の実施形態の構成から種々の修正および変更を施したものも、本開示の技術の範囲に含まれる。
Although the technology of the present disclosure has been described above based on its preferred embodiment, the quality control system of the present disclosure is not limited to the above embodiment, and the configurations of the first and second embodiments are not limited thereto. Various modifications and changes are also included in the scope of the technology of the present disclosure.
例えば、本開示の品質管理システムで扱う製品は、臓器チップ（Organ on a Chip）および人工生体部品に限らず、どのような種類の製品であってもよい。
For example, the products handled by the quality control system according to the present disclosure are not limited to organ chips (Organ on a Chip) and artificial biological parts, and may be any type of products.
また、製品情報としては、製品の製造情報、製品の運搬情報、および製品の使用情報の全てを取得する態様に限らず、製品の製造情報、製品の運搬情報、および製品の使用情報のうち１つまたは２つの情報を取得する態様としてもよい。
In addition, the product information is not limited to the mode in which all the product manufacturing information, the product transportation information, and the product usage information are acquired, and one of the product manufacturing information, the product transportation information, and the product usage information is used. One or two pieces of information may be acquired.
また、製品の製造情報、製品の運搬情報、および製品の使用情報の入力については、上記に限らず、誰が入力してもよい。例えば、運搬者による製品３０の運搬情報を、製造者が入力してもよい。
The input of product manufacturing information, product transportation information, and product usage information is not limited to the above, and anyone may input. For example, the manufacturer may input the transport information of the product 30 by the transporter.
また、品質評価結果に影響を与える要因の抽出結果について、上記第１および第２の実施形態では、製造段階は製造者に、運搬段階は運搬者に、使用段階は使用者に出力するようにしているが、このような態様に限定されず、製造者および管理者に対しては、どの段階で抽出された要因であっても出力されるようにしてもよい。
In addition, regarding the extraction result of the factors affecting the quality evaluation result, in the first and second embodiments, the manufacturing stage is output to the manufacturer, the transportation stage is output to the carrier, and the usage stage is output to the user. However, the present invention is not limited to such an aspect, and the factor extracted at any stage may be output to the manufacturer and the administrator.
また、管理者が、品質評価結果に影響を与える要因の抽出結果の出力先および出力タイミングを選択できるようにしてもよい。このような態様とすることによって、品質評価結果に影響を与える要因を知られたくない相手に情報を与えないようにすることができる。また、特定の相手にのみ品質評価結果に影響を与える要因の抽出結果を出力することによって、特定に相手にのみ警告（例えば、改善が必要であるという警告）を出すことができる。
Also, the administrator may be allowed to select the output destination and the output timing of the extraction result of the factors that affect the quality evaluation result. By adopting such a mode, it is possible to prevent information from being given to a partner who does not want to be informed of factors that affect the quality evaluation result. In addition, by outputting the extraction result of the factors that affect the quality evaluation result only to a specific partner, it is possible to issue a warning (for example, a warning that improvement is necessary) to only a specific partner.
また、管理者が、製造段階、運搬段階、および使用段階における全ての情報を一元的に収集して入力する一元管理を行ってもよい。また、管理者が、製造段階、運搬段階、および使用段階における一部の情報を一元的に収集して入力する一元管理を行ってもよい。
Also, the administrator may perform unified management by collecting and inputting all the information at the manufacturing stage, the transportation stage, and the use stage. Further, the administrator may perform unified management by collecting and inputting some information in the manufacturing stage, the transportation stage, and the use stage.
一部の情報について一元管理を行う場合について、例えば、使用者が秘匿したい情報がある場合には、その情報は一元管理の範囲から外すように使用者側が選択できるようにしてもよい。ここで、例えば、クラウドによる一元管理をしている場合では、使用者が一元管理から外すように選択した情報は、クラウドでは処理せずに、使用者の元にある情報入力ＷＳにインストールされているブラウザで処理するようにすればよい。なお、ブラウザに対して、上記処理を行う専用ソフトウェアをインストールしてもよい。
In the case of unified management of some information, for example, if there is information that the user wants to conceal, the user may be allowed to select that information so that it is excluded from the scope of unified management. Here, for example, in the case of centralized management by the cloud, the information selected by the user to be excluded from the centralized management is not processed in the cloud but is installed in the information input WS under the user's source. It should be processed by the browser that is running. In addition, you may install the special software which performs the said process with respect to a browser.
また、本開示の品質管理システムにおいて用いられるソフトウェアは、インストールタイプであってもよいし、クラウドタイプであってもよい。
Also, the software used in the quality control system of the present disclosure may be an install type or a cloud type.
また、評価結果情報は、ＯＫ／ＮＧだけでなく、根拠となる画像情報および／またはその他の情報も合わせて取得してもよい。その他の情報とは、製造情報、運搬情報、および使用情報等である。また、画像情報および／またはその他の情報を合わせて取得するかどうかを、ユーザーが選択できてもよい。
Also, the evaluation result information may be acquired not only OK/NG but also the image information and/or other information as the basis. Other information includes manufacturing information, transportation information, usage information, and the like. Also, the user may be able to select whether to acquire the image information and/or other information together.
また、製造情報、運搬情報、および使用情報の入力項目は、製造者が選択できるようにしてもよい。
The manufacturer may also be able to select the input items for manufacturing information, transportation information, and usage information.
また、品質管理装置内に評価結果データベースを内包してもよい。
Also, the evaluation result database may be included in the quality control device.
また、上記以外にも、本開示の趣旨を逸脱しない範囲で適宜変更を行ってもよい。また、本開示の技術は、プログラムに加えて、プログラムを非一時的に記憶する記憶媒体にもおよぶ。
In addition to the above, appropriate changes may be made without departing from the spirit of the present disclosure. In addition to the program, the technology of the present disclosure extends to a storage medium that stores the program non-temporarily.
２０１９年１月２８日に出願された日本出願特願２０１９－０１２３８７の開示はその全体が参照により本明細書に取り込まれる。本明細書に記載された全ての文献、特許出願、及び技術規格は、個々の文献、特許出願、及び技術規格が参照により取り込まれることが具体的かつ個々に記された場合と同程度に、本明細書中に参照により取り込まれる。
The disclosure of Japanese Patent Application No. 2019-012387 filed on January 28, 2019 is incorporated herein by reference in its entirety. All documents, patent applications, and technical standards mentioned herein are to the same extent as if each individual document, patent application, and technical standard was specifically and individually noted to be incorporated by reference. Incorporated herein by reference.
Claims (9)
- 製品の製造情報、前記製品の運搬情報、および前記製品の使用情報のうち少なくとも１つの情報からなる製品情報と、前記製品の品質評価結果を示す評価結果情報とを関連付けて蓄積した蓄積データから前記製品情報および前記評価結果情報を取得する取得部と、
前記取得部が取得した前記製品情報および前記評価結果情報に基づいて、前記品質評価結果に影響を与える要因を抽出する抽出部と、
前記抽出部による抽出結果を出力する出力部とを備える品質管理装置。 From the accumulated data in which the product information including at least one information of the product manufacturing information, the product transportation information, and the product usage information and the evaluation result information indicating the quality evaluation result of the product are associated and accumulated. An acquisition unit for acquiring product information and the evaluation result information,
An extraction unit that extracts a factor that affects the quality evaluation result, based on the product information and the evaluation result information acquired by the acquisition unit;
A quality control device comprising: an output unit that outputs the extraction result obtained by the extraction unit. - 前記出力部は、前記要因が、前記製造情報、前記運搬情報、または前記使用情報のいずれに関連するかに基づいて、前記抽出結果の出力先を決定する
請求項１に記載の品質管理装置。 The quality control device according to claim 1, wherein the output unit determines an output destination of the extraction result based on whether the factor is related to the manufacturing information, the transportation information, or the usage information. - 前記製造情報は、前記製品のＩＤ、前記製品の製造日、前記製品の製造者、前記製品に含まれる細胞の種類、前記製品に含まれる細胞の継代数、前記製品に含まれる細胞のロット、前記製品に含まれる細胞数、前記製品における細胞密度、前記製品に含まれる細胞を培養した際の培地の種類、前記製品に含まれる細胞の培地の製造元、前記製品に含まれる細胞の培地のロット、前記製品に含まれる細胞の培地の量、前記製品に含まれる細胞の培地のｐＨ、前記製品に含まれる細胞の播種方法、前記製品に含まれる細胞の培地の交換回数、前記製品に含まれる細胞の培養容器、前記製品に含まれる細胞の培養装置、前記製品に含まれる細胞の培養期間、前記製品に含まれる細胞の培養時の酸素濃度、前記製品に含まれる細胞の培養時の二酸化炭素濃度、前記製品に含まれる細胞の培養時の温度、前記製品に含まれる細胞の培養時の湿度、前記製品に含まれる細胞の製造場所、前記製品を輸送または保管する際の培地の種類、および前記製品に含まれる細胞の製造後評価結果のうち少なくとも１つである
請求項１または２に記載の品質管理装置。 The manufacturing information includes the product ID, the manufacturing date of the product, the manufacturer of the product, the type of cells contained in the product, the number of passages of cells contained in the product, the lot of cells contained in the product, Number of cells contained in the product, cell density in the product, type of medium when cells contained in the product are cultured, manufacturer of medium of cells contained in the product, lot of medium of cells contained in the product , The amount of the cell culture medium contained in the product, the pH of the cell culture medium contained in the product, the seeding method of the cells contained in the product, the number of times the cell culture medium contained in the product is exchanged, the product contained in the product Cell culture container, device for culturing cells contained in the product, culture period of cells contained in the product, oxygen concentration during culture of cells contained in the product, carbon dioxide during culture of cells contained in the product Concentration, temperature when culturing cells contained in the product, humidity when culturing cells contained in the product, production site of cells contained in the product, type of medium for transporting or storing the product, and The quality control device according to claim 1, wherein the quality control device is at least one of post-production evaluation results of cells contained in the product. - 前記運搬情報は、前記製品のＩＤ、前記製品の運搬者、前記製品の運搬経路、前記製品の運搬期間、前記製品の運搬時の温度、前記製品の運搬時の湿度、前記製品の運搬時の振動状態、前記製品の運搬先での保管期間、前記製品の納品日、および前記製品の運搬後評価結果のうち少なくとも１つである
請求項１から３のいずれか１項に記載の品質管理装置。 The transportation information includes the product ID, the product carrier, the product transportation route, the product transportation period, the product transportation temperature, the product transportation humidity, and the product transportation time. The quality control device according to any one of claims 1 to 3, which is at least one of a vibration state, a storage period of the product at a destination, a delivery date of the product, and a post-transport evaluation result of the product. .. - 前記使用情報は、前記製品のＩＤ、前記製品の納品日、前記製品の保管環境、前記製品の保管期間、前記製品の使用者、前記製品の使用日、前記製品の使用場所、前記製品に含まれる細胞に添加した化合物、前記製品に含まれる細胞に添加した化合物の製造元、前記製品に含まれる細胞に添加した化合物のロット、前記製品に含まれる細胞に添加した化合物の最終濃度、前記製品に含まれる細胞に添加した化合物の添加期間、前記製品に含まれる細胞に添加した化合物による影響の有無の結果、および前記製品に含まれる細胞を投与した患者の情報のうち少なくとも１つである
請求項１から４のいずれか１項に記載の品質管理装置。 The usage information includes the ID of the product, the delivery date of the product, the storage environment of the product, the storage period of the product, the user of the product, the date of use of the product, the place of use of the product, and the product. The compound added to the cells, the manufacturer of the compound added to the cells contained in the product, the lot of the compound added to the cells contained in the product, the final concentration of the compound added to the cells contained in the product, the product It is at least one of the addition period of the compound added to the cells contained therein, the result of the presence or absence of the effect of the compound added to the cells contained in the product, and the information of the patient to whom the cells contained in the product were administered. The quality control device according to any one of 1 to 4. - 前記出力部は、前記抽出結果の出力先および前記抽出結果の出力タイミングのうち少なくとも１つを、ユーザーの指示入力に基づいて変更可能である
請求項１から５のいずれか１項に記載の品質管理装置。 The quality according to any one of claims 1 to 5, wherein the output unit can change at least one of an output destination of the extraction result and an output timing of the extraction result based on a user's instruction input. Management device. - 請求項１から６のいずれか１項に記載の品質管理装置と、
前記蓄積データを蓄積する評価結果データベースとを備える品質管理システム。 A quality control device according to any one of claims 1 to 6,
A quality control system comprising: an evaluation result database for accumulating the accumulated data. - 製品の製造情報、前記製品の運搬情報、および前記製品の使用情報のうち少なくとも１つの情報からなる製品情報と、前記製品の品質評価結果を示す評価結果情報とを関連付けて蓄積した蓄積データから前記製品情報および前記評価結果情報を取得し、
前記製品情報および前記評価結果情報に基づいて、前記品質評価結果に影響を与える要因を抽出し、
抽出結果を出力する品質管理方法。 From the accumulated data in which the product information including at least one information of the product manufacturing information, the product transportation information, and the product usage information and the evaluation result information indicating the quality evaluation result of the product are associated and accumulated. Obtain product information and the evaluation result information,
Based on the product information and the evaluation result information, extract factors that affect the quality evaluation result,
A quality control method that outputs extraction results. - 製品の製造情報、前記製品の運搬情報、および前記製品の使用情報のうち少なくとも１つの情報からなる製品情報と、前記製品の品質評価結果を示す評価結果情報とを関連付けて蓄積した蓄積データから前記製品情報および前記評価結果情報を取得する手順と、
前記製品情報および前記評価結果情報に基づいて、前記品質評価結果に影響を与える要因を抽出する手順と、
抽出結果を出力する手順とをコンピュータに実行させる品質管理プログラム。 From the accumulated data in which the product information including at least one information of the product manufacturing information, the product transportation information, and the product usage information and the evaluation result information indicating the quality evaluation result of the product are associated and accumulated. A procedure for obtaining product information and the evaluation result information,
Based on the product information and the evaluation result information, a procedure for extracting factors affecting the quality evaluation result,
A quality control program that causes a computer to execute the procedure for outputting the extraction result.
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