System and method for recording a process

Abstract

The computer for recording a process of manufacturing a pharmaceutical, etc., acquires one or more procedure manual data in a first format from a user terminal in the order of steps of a process of manufacturing a pharmaceutical, etc. The first format is converted to a second format, and a record is output in the second format to a user terminal, the record being associated with: for each procedure manual, (A) a procedure of each step, the procedure being indicated by the procedure manual data; (B) a free description field for inputting a record content; (C) a checkbox for indicating that an operation was conducted for each step; and (D) a timestamp for recording a date and time when the operation was conducted. A blockchain is formed by grouping an item input for each step into a block and linking the block to the blockchain.

Description

SYSTEM AND METHOD FOR RECORDING A PROCESSTECHNICAL FIELD

[0001] The present disclosure relates to a process and a method for recording a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps.BACKGROUND

[0002] In the pharmaceutical industry, products are manufactured through multiple complex processes. However, the digital recording of processes such as "receiving" raw materials, "maintaining" equipment, and "manufacturing" and "inspection" of products is still insufficient. For example, since FDA (Food and Drug Administration) began approving electronic records, the digital recording along with the automation of production facilities has progressed for large-scale manufactured low- and medium-molecular-weight pharmaceuticals and antibody drugs, which were previously recorded on paper. However, regenerative medical products such as cell-based drugs are still being recorded on paper because those products are labor-intensively produced on a smaller scale through many steps. Especially, small- and medium-sized pharmaceutical companies and pharmaceutical raw material manufacturing companies are keeping recording on paper.

[0003] For example, Patent Document 1 discloses a computer system that manages the flow from production of a pharmaceutical at a pharmaceutical company to administration of it to a patient (PatentDocument 1).

[0004] DOCUMENT IN THE EXISTING ART

[0005] Patent Document

[0006] Patent Document D WO 2006 / 071808 ASUMMARY

[0007] However, Patent Document 1 is not sufficient for managing the manufacturing a pharmaceutical and a pharmaceutical raw material in a multi-step process. For example, the manufacturing process of regenerative medical products, which is labor-intensive and involves many steps, mandates an operation in a sterile cleanroom. This requires printed paper to be sterilized using an autoclave or alcohol spray. The use of an autoclave consumes plastic for sealing the paper and requires several hours.

[0008] In addition, the manufacturing period for a regenerative medical product with around two months is required to print about 500 sheets of record. To have the quality control personnel review the printed record after manufacturing, the order of the sheets should be checked, and the record should be reviewed by multiple people, using the same paper. This is labor-intensive, and the record must be stored for a specified period of five years.

[0009] Furthermore, existing electronic systems designed for process recording management of effortless process requires the documentation of a procedure manual and a record to be generated on each companyspecific interface. This means that the procedure manual document already generated for a clinical trial application cannot be used withoutchange. This is a problem because it takes a time to start to use the generated document with a high barrier.

[0010] Therefore, the inventor focused on the fact that it becomes easy to prepare and implement process recording for pharmaceuticals or pharmaceutical raw materials as stipulated in the Pharmaceutical Affairs Law by recording a manufacturing process based on a "manufacturing procedure manual" that is generated and submitted in an electronic file by any company who applies for a clinical trial studying a new medicine and based on a "record" that is electronically supplemented with details in a manner appropriate to facilities and equipment and by grouping the record for each step as a block and linking the block to a blockchain, even if multiple steps are involved.

[0011] In view of these problems, an objective of the present disclosure is to provide a system and a method for recording a process that facilitates to record a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps and allows the use of the record as an electronic laboratory notebook, by using a process recording screen generated by acquiring the electronic file of a procedure manual, grouping a record input for each step as a block, and linking the block to a blockchain.

[0012] The present disclosure provides the solution for solving the technical problem.

[0013] A first aspect of the present disclosure is a computer for recording a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps, including:

[0014] an acquisition unit that acquires one or more procedure manual data in a first format from a user terminal in the order of steps of a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment as many as necessary for recording the process of manufacturing the pharmaceutical or the pharmaceutical raw material or of conducting the life science experiment, the procedure manual being stipulated by law;

[0015] a conversion unit that converts the first format to a second format (e.g., HTML, application screen);

[0016] a record output unit that outputs a record in the second format to a user terminal, the record being associated with:

[0017] for each procedure manual,

[0018] (A) a procedure of each step, the procedure being indicated by the procedure manual data,

[0019] (B) a free description field for inputting a record content;

[0020] (C) a checkbox for indicating that an operation was conducted for each step, and

[0021] (D) a timestamp for recording a date and time when the operation was conducted; and

[0022] a blockchain formation unit that forms a blockchain by grouping an item input for each step into a block and linking the block to the blockchain.

[0023] According to the present disclosure according to a first aspect of the present disclosure, a process recording screen is automatically generated based on the acquired procedure manual data. This facilitates to record a process of manufacturing a pharmaceutical or apharmaceutical raw material and of conducting a life science experiment through multiple steps. For each step, text data as a note, a related file, whether an operation was conducted, and a date and time when the operation was conducted are grouped in a block to link to a blockchain. As the result, like a paper-based record, such as a laboratory notebook, the entire process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment can be recorded in more detail as electronic data. Furthermore, a user can check the edit history of a record of an operation that the user has input, allowing the user to transparently and accurately understand and to manage the progress of a process and the history of an operation.

[0024] According to a second aspect of the present disclosure, the computer for recording a process according to the first aspect of the present disclosure, further including:

[0025] a hash generation unit that generates a hash value by converting the input item into a character string and hashing the character string when the block is formed, in which

[0026] the blockchain formation unit adds the hash value to the formed block.

[0027] According to the second aspect of the present disclosure, a hash value generated by converting a record of an operation that a user has input for each step to a character string, the character string is hashed to generated a hash value, and the hash value is added to a block linking to a blockchain. This enables to detect tampering and verify the integrity in the record of an operation in a block, that is, a record of the operation for each step.

[0028] According to a third aspect of the present disclosure, the computer for recording a process according to the first aspect of the present disclosure, in which

[0029] the hash generation unit concatenates the character string into which the item has been converted with the hash value of the last block of the blockchain and hashes the concatenation, when generating the hash value.

[0030] According to the third aspect of the present disclosure, a new hash value is generated in combination with the hash value of a record of the previous operation, and the generated new hash value is stored as the hash value of the current operation record in a block linking to a blockchain. This also enables to ensure the correct order of the blocks, that is, the order of operations and thereby ensures the integrity and the reliability of a record of an operation of all the multiple steps and prevents data tampering.

[0031] According to a fourth aspect of the present disclosure, the computer for recording a process according to the second aspect of the present disclosure, in which

[0032] the record output unit outputs a date and time when the hash value was added to the block by the blockchain formation unit to the user terminal.

[0033] According to the fourth aspect of the present disclosure, a date and time when a hash value for each step is added to a block linking to the blockchain is output. This enables to check that the past hash values have been changed if a record of an operation is tampered. Furthermore, a date and time when the hash value is added to a block is later than atimestamp recording a date and time when the operation was conducted. This enables to prevent data tampering and unauthorized access.

[0034] According to a fifth aspect of the present disclosure, the computer for recording a process according to the first aspect of the present disclosure, in which

[0035] the acquisition unit acquires a preferred language of a user from the user terminal, and

[0036] the conversion unit translates the procedure manual data into the preferred language of the user and converts the translated procedure manual data into the second format if the acquired preferred language of the user is different from the language of the procedure manual data.

[0037] According to the fifth aspect of the present disclosure, if the procedure manual data in the first format (such as MS-Word® or PDF) is different from the preferred language of a user, the procedure manual data is automatically translated into that language, allowing the user to understand the content of the procedure manual more easily and quickly.

[0038] According to a sixth aspect of the present disclosure, the computer for recording a process, according to the fifth aspect of the present disclosure, further including:

[0039] a learning unit that generates a trained model by learning the procedure manual data and the translated procedure manual data.

[0040] According to the sixth aspect of the present disclosure, the procedure manual data before and after translation are learned to generate a trained model. This enables to improve the accuracy of automatic translation.

[0041] According to a seventh aspect of the present disclosure, thecomputer for recording a process according to the fifth aspect of the present disclosure, in which

[0042] the conversion unit predicts the procedure manual data in the preferred language of the user based on the trained model and converts the predicted procedure manual data into the second format.

[0043] According to the seventh aspect of the present disclosure, automatic translation only needs to be performed once for a specific version of the procedure manual data. This enables to save a time for translation processing when the same document is loaded multiple times.

[0044] Although the present disclosure falls under the category of a computer system, it also exhibits similar functions and effects in another category such as a method, according to the respective category.

[0045] The present disclosure enables to provide a system and a method for recording a process that facilitates to record a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps and allows the use of the record as an electronic laboratory notebook, by using a process recording screen generated by acquiring the electronic file of a procedure manual, grouping a record input for each step as a block, and linking the block to a blockchain.BRIEF DESCRIPTION OF THE DRAWINGS

[0046] FIG. 1 is a diagram illustrating the overview of the system for recording a process 1 according to one embodiment of the present disclosure.

[0047] FIG. 2 is a diagram illustrating the functional configuration of thesystem for recording a process 1 according to this embodiment.

[0048] FIG. 3 is a flowchart of the process recording screen generation process executed by the system for recording a process 1 according to this embodiment.

[0049] FIG. 4 is a flowchart of the blockchain formation process executed by the system for recording a process 1 according to this embodiment.

[0050] FIG. 5 is a flowchart of the timestamp output process executed by the system for recording a process 1 according to this embodiment.

[0051] FIG. 6 is a flowchart of the hash generation process executed by the system for recording a process 1 according to this embodiment.

[0052] FIG. 7 is a flowchart of the learning process executed by the system for recording a process 1 according to this embodiment.

[0053] FIG. 8 shows an example procedure manual data 100 in a first format in the system for recording a process 1 according to this embodiment.

[0054] FIG. 9 shows an example process recording screen 200 in a second format in the system for recording a process 1 according to this embodiment.

[0055] FIG. 10 shows an example data stored in a blockchain 300 in the system for recording a process 1 according to this embodiment.

[0056] FIG. 11 shows an example record input on the process recording screen 200.

[0057] FIG. 12 shows an example where a timestamp is not shown on the process recording screen 200.DETAILED DESCRIPTION OF THE EMBODIMENTS

[0058] Hereinafter, embodiments to carry out the present disclosure (hereinafter referred to as "Embodiments") are described below in detail with reference to the attached drawings. In the drawings, the same components throughout the description of Embodiments are designated by the same reference numerals.

[0059] Overview of system for recording a process

[0060] The system for recording a process 1 according one embodiment of the present disclosure is described below with reference to FIG. 1. FIG. 1 is a diagram illustrating the overview of the system for recording a process 1 according to one embodiment of the present disclosure. The system for recording a process 1 includes a computer 2, which is a computer system for recording a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps.

[0061] Examples of the computer 2 of the system for recording a process 1 include a desktop computer, a laptop computer, a server, a mobile device such as a smartphone or a tablet, or a wearable device such as a headmounted display like smart glasses or a smartwatch.

[0062] The computer 2 of the system for recording a process 1 may be implemented with a single terminal device, multiple terminal devices, or a virtual device such as a cloud computer.

[0063] The system for recording a process 1 may be composed of the above-mentioned terminal devices instead of the computer 2.

[0064] The computer 2 of the system for recording a process 1 is data- communicatively connected with a user terminal 3, the examples of which include the above-mentioned terminal devices and other terminalsthrough a public network, etc., and executes the transmission and reception of necessary data and information.

[0065] The overview of the processes executed by the system for recording a process 1 is described below. The computer 2 of the system for recording a process 1 acquires one or more procedure manual data 100 in a first format (e.g., MS-Word®, PDF) from a user terminal 3 in the order of steps of a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment as many as necessary for recording the process of manufacturing the pharmaceutical or the pharmaceutical raw material or of conducting the life science experiment (Step Si). The procedure manual data 100 is data of production or experiment that is stipulated by law. The pharmaceutical or pharmaceutical raw material includes pharmaceutical ingredients, chemical drugs, biopharmaceuticals, cells produced through bioprocesses, antibodies, vaccines, and mRNA.

[0066] The computer 2 converts the first format to a second format (Step S2). Specifically, the computer 2 reads out the procedure manual data 100 in the first format (e.g., MS-Word®, PDF) acquired in Step S i line by line, classifies the read-out line into a title 102, a heading 104, a text 106, 108, and a table 110, and processes the information of each line according to the classification to convert the procedure manual data 100 into a second format (e.g., HTML).

[0067] The computer 2 outputs the process record to the user terminal 3 in the second format. The process record associates with the step-by-step procedures indicated by the procedure manual data 100, free description fields 112 for inputting record contents, checkboxes 114 indicating that anoperation has been conducted for each step, and timestamps 116 for recording a date and time when the operation was conducted (Step S3). Specifically, the computer 2 adds a free description field 112 for inputting a record content and a checkbox 114 for recording a timestamp according to the classification of each line of the procedure manual document data 100 converted to a HTML format in Step S2, and associates a date and time when the checkbox 114 is checked as a timestamp 116 to generate a process recording screen 200, and outputs the generated process recording screen 200 to the user terminal 3.

[0068] The computer 2 forms a blockchain by grouping an item input for each step into a block and linking the block to the blockchain 300 (Step S4). Specifically, the computer 2 groups the record contents that have been input by a user (e.g., the contents input by the use, the dates and times when operations were conducted) for each step on the process recording screen 200 that has been output to the user terminal in Step S3 to form a data block and links the formed data block to a blockchain 300.

[0069] System configuration of system for recording a process 1

[0070] The system configuration of the system for recording a process 1 according to this embodiment is described below with reference to FIG. 2. The system for recording a process 1 includes a computer 2, which is a computer system for recording a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps.

[0071] The system for recording a process 1 may include other terminal devices instead of the computer 2. For example, a different computer 2 may be used for each user. In this case, the various processes describedlater are executed by any one or any combination of the computer 2 and other included terminals or devices.

[0072] The computer 2 may be implemented with a single terminal device, multiple terminal devices, or a virtual device such as a cloud computer.

[0073] Examples of the computer 2 include a desktop computer, a laptop computer, a server, a mobile device such as a smartphone or a tablet, or a wearable device such as a head-mounted display like smart glasses or a smartwatch.

[0074] The computer 2 includes a control unit provided with a CPU (Central Processing Unit), GPU (Graphics Processing Unit), RAM (Random Access Memory), ROM (Read Only Memory), and other components.

[0075] The computer 2 includes a storage unit for data storage such as a hard disk, a semiconductor memory, a recording medium, or a memory card. Data may be stored in a cloud service or a database.

[0076] The computer 2 includes a communication unit provided with a device that has a capability of communication with other terminals or devices. The communication method may be wireless or wired.

[0077] The computer 2 shall be equipped with the necessary functions as an input unit to operate the computer 2. As examples of implementing input, the input unit can include a liquid crystal display with touch panel functionality, a keyboard, a mouse, a pen tablet, hardware buttons on the device, and a microphone for voice recognition. The present disclosure is not particularly limited in functionality by the input method.

[0078] The computer 2 shall be equipped with the necessary functions as an output unit to operate the computer 2. As examples of implementingoutput, the output unit can include a liquid crystal display, a PC display, a projector for projection, and an audio device for audio output. The present disclosure is not particularly limited in functionality by the output method.

[0079] The control unit implements a conversion unit 22, a blockchain formation unit 24, and a hash generation unit 25 in cooperation with the processing unit. The control unit also implements the acquisition unit 21 and the record output unit 23 in cooperation with the processing unit and the communication unit. The control unit also implements the learning unit 26 in cooperation with the processing unit and the storage unit.

[0080] Process recording screen generation process

[0081] The process recording screen generation process executed by the computer 2 is described below with reference to FIG. 3. FIG. 3 is a flowchart of the process recording screen generation process executed by the computer 2. As shown in FIG. 3, the process recording screen generation process consists of Steps Sil to S24, which is executed in the above-mentioned Steps Si to S3.

[0082] The acquisition unit 21 of the computer 2 acquires one or more procedure manual data 100 in a first format (e.g., MS-Word®, PDF) from a user terminal 3 in the order of steps of a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment as many as necessary for recording the process of manufacturing the pharmaceutical or the pharmaceutical raw material or of conducting the life science experiment (Step Sil). The procedure manual data 100 is data of production or experiment that is stipulated by law. The pharmaceutical or pharmaceutical raw material includespharmaceutical ingredients, lowmolecular drugs, high-molecular drugs, biopharmaceuticals, cells produced through bioprocesses, antibodies, vaccines, and mRNA.

[0083] As shown in FIG. 8, the procedure manual data 100 is composed of document data that includes a title 102, a heading 104, a text 106, 108, and a table 110. The text 106 may include an image link for displaying an image.

[0084] In the above-mentioned Step Sil, the acquisition unit 21 of the computer 2 may acquire the preferred language of a user from the user terminal 3. The user refers to the user of the user terminal 3. Specifically, the acquisition unit 21 may acquire the language set in the operating system, browser, keyboard, etc., of the user terminal 3 as the user's preferred language.

[0085] The conversion unit 22 of the computer 2 reads out the procedure manual data 100 in a first format (e.g., MS'Word®, PDF) acquired in Step Sil line by line and classifies the read-out line into a title 102, a heading 104, a text 106, 108, and a table 110 (Step S12).

[0086] In the above-mentioned Step S12, if the language of the procedure manual data 100 acquired in the above-mentioned Step Sil is different from the user's preferred language, the conversion unit 22 of the computer 2 may automatically translate the procedure manual data 100 into the user's preferred language as reading out the procedure manual data 100 line by line or may predict the user's preferred language version of the procedure manual data 100 in the user's preferred language based on the trained model generated by the learning unit 26 of the computer 2. The read-out procedure manual data 100 and the automatically translated orpredicted user's preferred language version of the procedure manual data 100 may be used to retrain the trained model by the learning unit 26.

[0087] If the line read out in the above-mentioned Step S12 is a title 102 or a heading 104, the conversion unit 22 generates a new section (Step SIS). Specifically, the conversion unit 22 creates a section by enclosing the read-out title 102 or heading 104 in a section tag in HTML format, which is the second format.

[0088] If the line read out in the above-mentioned Step S12 is a text 106 or 108, the conversion unit 22 judges whether or not the text 100 or 108 contains an image link (Step S14). Specifically, the conversion unit 22 judges whether or not the text read-out is the text 106 that contains an image link.

[0089] In the above-mentioned Step S14, if the text 100 or 108 contains an image link (Step S14 YES), the conversion unit 22 of the computer 2 captures the image and adds the file path information as text to the current section (Step S15). Specifically, if the text read out is a text 106 containing an image link (Step S14 YES), the conversion unit 22 captures the image and stores the captured image in the storage unit of the computer 2. Then, the conversion unit 22 adds the file path information indicating the storage location of the image to the current section generated in the above-mentioned Step S 13, grouping the file path information using an HTML tag such as a div tag.

[0090] On the other hand, in the above-mentioned Step S14, if the text does not contain an image link (Step S14 NO), the conversion unit 22 of the computer 2 adds the text to the current section (Step S16).Specifically, if the text read out is a text 108 not containing an image link(Step S14 NO), the conversion unit 22 adds the read-out text 108 to the current section generated in the above-mentioned Step S13, grouping the text 108 using an HTML tag such as a p or div tag.

[0091] If the line read out in the above-mentioned Step S12 is a table 110, the conversion unit 22 of the computer 2 judges whether or not the line is the first row of the table 110 (Step S17). Specifically, the conversion unit 22 judges whether or not the line read out is the first row of a table 110.

[0092] In the above-mentioned Step Si 7, if the line read out is the first row of table 110 (Step S17 YES), the conversion unit 22 of the computer 2 generates a new table 110 in the current section and adds the row read out in the above-mentioned Step S12 (Step S18). Specifically, if the row read out is the first row of a table 110 (Step S17 YES), the conversion unit 22 generates a new table 110 in the current section generated in the above-mentioned Step S13, using a table tag in HTML format, and adds the row read out in the above-mentioned Step S12 to the table 110.

[0093] In the above-mentioned Step Si 7, if the line read out is not the first row of table 110 (Step S17 NO), the conversion unit 22 of the computer 2 adds the row read out in the above-mentioned Step S12 to the current table 110 (Step S19). Specifically, if the row read out is not the first row of a table 110 (Step S17 NO), the conversion unit 22 adds the row read out in the above-mentioned Step S12 to the table 110 generated in the above-mentioned Step S 18.

[0094] The conversion unit 22 of the computer 2 judges whether or not the line read out in the above-mentioned Step S12 is the last line (Step S20). Specifically, the conversion unit 22 judges whether or not the line read out is the last line of the procedure manual document 100.

[0095] In the above-mentioned Step S20, if the line read out is not the last line (Step S20 NO), the conversion unit 22 of the computer 2 executes the above-mentioned Steps S12 to S19 again.

[0096] In the above-mentioned Step S20, if the line read out is the last line (Step S20 YES), the conversion unit 22 of the computer 2 adds a free description field between texts 106, 108 and tables 110 (Step S21).Specifically, as shown in FIG. 9, the conversion unit 22 adds a free description field 112 in HTML format for inputting a record content between the texts 106 and 108 grouped and the tables 110 identified by table tags. As a result, the free description field 112 is provided for each step.

[0097] The conversion unit 22 of the computer 2 adds a checkbox 114 for recording a timestamp to each line added as a text 108 not including an image (Step S22). Specifically, as shown in FIG. 8, the conversion unit 22 adds a checkbox 114 for recording a timestamp 116 in HTML format to each line of text 108 that includes no image link.

[0098] The conversion unit 22 of the computer 2 adds a checkbox 114 for recording a timestamp to each row of the table 110 and converts the blank spaces in the table to enable to input a text, As the result, the process recording screen 200 is generated in a second format (Step S23).Specifically, as shown in FIG. 9, the conversion unit 22 adds a checkbox 114 for recording a timestamp 116 in HTML format to each row of a table 110. Furthermore, since the cells in the third column of the table 110 in the procedure manual data 100 shown in FIG. 8 are blank, the conversion unit 22 converts the cells of the third column of the table 110 into text input fields, as shown in FIG. 9. As the result, a process recording screen200 in HTML format, where each group of steps indicated by texts 106, 108, and tables 110 is sectioned by a title 102 or a heading 104, is generated.

[0099] The record output unit 23 of the computer 2 outputs the process recording screen 200 generated in the above-mentioned Step S23 to the user terminal 3 (Step S24). Specifically the record output unit 23 outputs the process recording screen 200 in HTML format generated in the above- mentioned Step S23 to the user terminal 3.

[0100] Blockchain formation process

[0101] The blockchain formation process executed by the computer 2 is described below with reference to FIG. 4. FIG. 4 is a flowchart of the blockchain formation process executed by the computer 2. As shown in FIG. 4, the blockchain formation process consists of Steps S31 to S36, which is executed in the above-mentioned Step S4.

[0102] The input unit of the computer 2 receives an input item (Step S31). Specifically, the input unit receives an item input on the process recording screen by a user. The item is data input by a user in a free description field 112, a checkbox 114 for recording a timestamp, and an input cell in a table 110. The free description field 112 and the input cell in a table 110 may accept any data that may include image data or an image link. The checkbox 114 is checked or unchecked by a user.

[0103] The record output unit 23 of the computer 2 executes the timestamp output process (Step S32). Specifically, the record output unit 23 outputs a date and time when a checkbox 114 on the process recording screen 200 was checked as a timestamp 116 to the user terminal 3 as an operation record. If a checkbox 114 is unchecked, the record output unit23 transmits an instruction to hide the timestamp 116 to the user terminal 3. The details of the timestamp output process will be described later. This timestamp output process may be performed at any timing after Step S31.

[0104] The blockchain formation unit 24 of the computer 2 identifies the step corresponding to the input item (Step S33). Specifically the blockchain formation unit 24 identifies which step the item input in the above-mentioned Step S31 corresponds to.

[0105] The blockchain formation unit 24 of the computer 2 groups the items corresponding to the identified step to form a block (Step S34). Specifically the blockchain formation unit 24 forms a data block by grouping data that have been input in the free description fields 112 and in the input cells in the tables 110 and the timestamps 116 when checkboxes 114 were checked or unchecked which correspond to the identified step.

[0106] The blockchain 300. which is composed of a data block formed in the above-mentioned Step S34, is described below with reference to FIG.10. FIG. 10 is a conceptual diagram that shows an example data stored in a blockchain 300. In this embodiment, the blockchain formation unit 24 associates a step with data that have been input in the free description fields 112 and in the input cells in the tables 110 and a timestamp 116 when checkboxes 114 were checked or unchecked, which correspond to the step and stores the associated data block.

[0107] In FIG. 10, the nth block represents the last block of a blockchain 300, and the (n+l)th block represents the block currently being generated, which is intended to be added to the blockchain 300 that has blocksregistered up to the nth block. The nth block includes a hash value, a nonce value specific to the block, a step, data that have been input in the free description fields 112 and in the input cells in a table 110, and the timestamps 116 that were checked or unchecked in the checkboxes 114.

[0108] The hash generation unit 25 of the computer 2 converts the items input for each step into a character string and hashes the character string to generate a hash value for each step. The hash generation unit 25 then adds the hash value of the corresponding step to the block formed for each step (Step S35). Specifically, when attempting to add a new (n+l)th block to a blockchain 300 where blocks up to the nth block have been registered, the hash generation unit 25 calculates to find a nonce value such that the hash value of the new (n+l)th block meets a certain condition through a hash generation process described later. The hash generation unit 25 adds a hash value and a nonce value to the data block formed in the above- mentioned Step S34 based on the calculation result.

[0109] The hash generation unit 25 of the computer 2 adds the block formed in the above-mentioned Step S34 with the hash value generated in the above-mentioned Step S35 to the blockchain 300 (Step S36).Specifically, the block formed in the above-mentioned Step S34 and added with the hash value generated in the above-mentioned Step S35 is added to the blockchain 300, where blocks up to the nth block are registered, as a new (n+l)th block.

[0110] Timestamp output process

[0111] The timestamp output process executed by the computer 2 is described below with reference to FIG. 5. FIG. 5 is a flowchart of the timestamp output process executed by the computer 2. As shown in FIG.5, the timestamp output process consists of Steps S321 to S324, which is executed in the above-mentioned Step S32 of the blockchain formation process.

[0112] The record output unit 23 of the computer 2 judges whether or not the item input on the process recording screen 200 in Step S31 corresponds to a checkbox 114 (Step S321). Specifically, the record output unit 23 judges whether or not the item received by input in Step S31 of the above-mentioned blockchain formation process corresponds to a checkbox 114.

[0113] In the above-mentioned Step S321, if the input received from a user corresponds to a checkbox 114 (Step S321 YES), the record output unit 23 of the computer 2 judges whether the checkbox 114 is checked or unchecked (Step S322).

[0114] On the other hand, in the above-mentioned Step S321, if the input received from a user does not correspond to a checkbox 114 (Step S321 NO), the record output unit 23 of the computer 2 terminates this process.

[0115] In the above-mentioned Step S322, if the checkbox 114 is checked (Step S322 CHECK), the record output unit 23 of the computer 2 outputs the date and time when the checkbox 114 was checked as a timestamp 116 to the user terminal 3 (Step S323) and then terminates this process. As the result, for example, as shown in FIG. 11, the checkboxes 114 for the lines indicating " 1. Bullet point 1" and "2. Bullet point 2" in the text 108 are checked, and the timestamps 116 are displayed, on the user terminal 3.

[0116] On the other hand, in the above-mentioned Step S322, if the checkbox 114 is unchecked (Step S322 UNCHECK), the record output unitdisplay the timestamp (Step S323) and then terminates this process. As the result, for example, as shown in FIG. 12, the checkbox 114 for the line indicating "2. Bullet point 2" in the text 108 is unchecked, and the timestamp 116 for that line is hidden, on the user terminal 2.

[0117] Hash generation process

[0118] The blockchain formation process executed by the computer 2 is described below with reference to FIG. 6. FIG. 6 is a flowchart of the hash generation process executed by the computer 2. As shown in FIG. 6, the hash generation process consists of Steps S351 to S355, which is executed in the above-mentioned Step S35 of the blockchain formation process.

[0119] The hash generation unit 25 of the computer 2 converts the items input for each step into a character string (Step S351). Specifically, the hash generation unit 25 converts data that have been input in the free description fields 112 and in the input cells in tables 110 and timestamps 116 when checkboxes 114 were checked or unchecked, which correspond to the step on the process recording screen 200, into a character string as the record content. For example, as shown on the process recording screen 200 in FIG. 11, the free description fields 112 contain data such as the text "Result A was obtained," a graph image data, and the text "Result B was obtained." Some of the input cells in the table 110 contain the text "Remarks" and the text "Comment 1," and some of the checkboxes 114 are checked with timestamps displayed. Therefore, the record content input for each step is converted into a character string, for example, "2024 / 05 / 04 12: 14:02 2024 / 05 / 04 12: 14:03 Remarks Comment 1 Result A was obtainedPHN2ZyB3aWROaDOiOTYiIGhlaW Result C was obtained".

[0120] The hash generation unit 25 of the computer 2 judges whether or not the blockchain 300 has the (nth) last block (Step S352). Specifically, the hash generation unit 25 judges whether or not the blockchain 300 has at least one block.

[0121] In the above-mentioned Step S352, if the blockchain 300 has the last block (Step S352 YES), the hash generation unit 25 of the computer 2 concatenates the hash value stored in the last (nth) block of the blockchain 300 with the record content converted in a character string in the above-mentioned Step S351 (Step S353). For example, if the hash value stored in the last (nth) block of the blockchain 300 is "f868a069ff6bbf6c59f8b0bba3929e217717f55bd6208273173eb61e440edl62 ", the hash generation unit 25 concatenates the hash value with the character string "2024 / 05 / 04 12: 14:02 2024 / 05 / 04 12: 14:03 Note Comment 1 Result A was obtained. PHN2ZyB3aWROaDOiOTYiIGhlaW Result C was obtained" into which the record content was converted in the above- mentioned Step S351 to acquire the concatenated character string, for example, "f868a069ff6bbf6c59f8b0bba3929e217717f55bd6208273173eb61e440edl62 2024 / 05 / 04 12: 14:02 2024 / 05 / 04 12: 14:03 Note Comment 1 Result A was obtained PHN2ZyB3aWROaDOiOTYiIGhlaW Result C was obtained".

[0122] The hash generation unit 25 of the computer 2 hashes the data that has been converted to a character string in the above-mentioned Step S353 (Step S354). Specifically, the hash generation unit 25 generates a hash value by hashing the character string data, using a hash function such as SHA-256. For example, the hash generation unit 25 hashes the character string"f868a069ff6bbf6c59f8b0bba3929e217717f55bd6208273173eb61e440edl62 2024 / 05 / 04 12: 14:022024 / 05 / 04 12:i4:03Note Comment 1 Result A was obtained. PHN2ZyB3aWROaDOiOTYiIGhlaW Result C was obtained" into which the record content has been converted in the above-mentioned Step S353, using SHA-256, to generate a hash value, for example, "01690608e04a22243b482b0c33cd09feeb9033340ad784648977af76b0949ea 6".

[0123] On the other hand, in the above-mentioned Step S352, if the blockchain 300 has no last block in (Step S352 NO), the hash generation unit 25 of the computer 2 proceeds to Step S354 and hashes data into which a record content has been converted in the above-mentioned Step S351 (Step S354). Specifically, the hash generation unit 25 generates a hash value by hashing the character string data, using a hash function such as SHA-256. For example, the hash generation unit 25 hashes the character string "2024 / 05 / 04 1204:022024 / 05 / 04 1204:03 Note Comment 1 Result A was obtained. PHN2ZyB3aWROaDOiOTYiIGhlaW Result C was obtained" into which the record content has been converted in the above- mentioned Step S351, using SHA-256, to generate a hash value, for example,nf868a069ff6bbf6c59f8b0bba3929e217717f55bd6208273173eb61e440edl62 fl

[0124] The hash generation unit 25 of the computer 2 adds the hash value generated in the above-mentioned Step S354 to the block formed in the above-mentioned block formation process (Step S355). Specifically, the hash generation unit 25 adds the hash value generated in the above- mentioned Step S354 to the data block formed in Step S34 of the above-mentioned block formation process.

[0125] In the above-mentioned Step S355, when adding a hash value to a block, the record output unit 23 of the computer 2 may output a date and time when the hash value was added to the user terminal.

[0126] Learning process

[0127] The learning process executed by the computer 2 is described below with reference to FIG. 7. FIG. 7 is a flowchart of the learning process executed by the computer 2.

[0128] The acquisition unit 21 of the computer 2 acquires process manual data for learning and a preferred language of a user from the user terminal 3 (Step S41). The procedure manual data for learning may be acquired from another terminal, computer, or device through data communication, etc. The acquisition of a preferred language of a user is described above.

[0129] The learning unit 26 of the computer 2 converts the acquired procedure manual data for learning into the user's preferred language (Step S42). Specifically, the learning unit 26 reads out the acquired procedure manual data for learning line by line and automatically translate the read-out line into the user's preferred language or predicts the user's preferred language version of the read-out line based on a trained model, thereby converting the acquired procedure manual data into the user's preferred language.

[0130] The learning unit 26 of the computer 2 performs machine learning based on the procedure manual data for learning that has been read out in Step S42 and the automatically translated or the predicted user's preferred language version of the procedure manual data for learning(Step S43). Specifically, the learning unit 26 performs supervised learning by using the procedure manual data read out line by line in Step S42 and the user's preferred language version of the procedure manual data for learning, which has been automatically translated or predicted line by line, as the training data. The procedure manual data for learning and the user's preferred language version of the procedure manual data may be learned by deep learning which is automatically defined and learned by a multi-layer neural network.

[0131] The learning unit 26 of the computer 2 generates a trained model for predicting the user's preferred language version of procedure manual data based on the learning results (Step S44). Specifically, the learning unit 26 generates a trained model that incorporates the automatically translated or the predicted user's native language version of procedure manual data for learning line by line.

[0132] The learning unit 26 of the computer 2 stores the generated trained model in the memory unit (Step S45).

[0133] According to the system for recording a process 1, a process recording screen 200 is automatically generated based on the acquired procedure manual data 100. This facilitates to record a process of manufacturing a pharmaceutical or a pharmaceutical raw material and of conducting a life science experiment through multiple steps. For each step, text data as a note, a related file, whether or not an operation was conducted, and a date and time when the operation was conducted are grouped in a block to link to a blockchain 300. As the result, like a paperbased record, such as a laboratory notebook, the entire process of manufacturing a pharmaceutical or a pharmaceutical raw material or ofconducting a life science experiment can be recorded in more detail as electronic data. Furthermore, a user can check the edit history of a record of an operation that the user has input, allowing the user to transparently and accurately understand and to manage the progress of a process and the history of an operation.

[0134] According to the system for recording a process 1, a hash value generated by converting a record of an operation that a user has input for each step to a character string, the character string is hashed to generated a hash value, and the hash value is added to a block linking to a blockchain 300. This enables a blockchain 300 to function as a tamper detection mechanism for an operation record of each step and to maintain the integrity in the record. Additionally, the data on a blockchain 300 is highly transparent, allowing an authorized user to access and verify the data at any time. This enables to share exceptionally reliable information and improve quality assurance and traceability.

[0135] According to the system for recording a process 1, a new hash value is generated in combination with the hash value of a record of the previous operation, and the generated new hash value is stored as the hash value of the current operation record in a block linking to a blockchain 300. This enables further ensure the correct order of the blocks or operations and thereby ensures the integrity and the reliability of a record through multiple steps.

[0136] According to the system for recording a process 1, a date and time when a hash value for each step is added to a block linking to a blockchain 300 is output to indicate when each operation record is incorporated into the blockchain 300. This enable to know whether or notan operation record has been tampered by verifying whether or not a past hash value has been altered. Furthermore, since the time when a hash value is added to a block is later than a timestamp recording a date and time when the operation was conducted, any attempts at unauthorized access or tampering can be easily detected due to the inconsistency in the order of the timestamps.

[0137] According to the system for recording a process 1, if the procedure manual data 100 in the first format (such as MS’Word" or PDF) is different from the preferred language of a user, the procedure manual data is automatically translated into that language, allowing the user to understand the content of the procedure manual more easily and quickly in the user's preferred language. This enables to improve operating efficiency.

[0138] According to the system for recording a process 1, the procedure manual data 100 before and after translation are learned to generate a trained model. This enables to improve the smooth and the accuracy of automatic translation. This enables to translate the procedure manual data 100 that is readable and understandable by a user. Additionally, as time passes, new data is collected, and the trained model is continuously updated. This enables to improve the accuracy of automatic translation.

[0139] According to the system for recording a process 1, automatic translation only needs to be performed once for a specific version of the procedure manual data 100. This enables to save a time for translation processing when the same document is loaded multiple times, allowing a user to access information quickly.

[0140] The computer (including CPU, an information processor, andvarious terminals) reads and executes a predetermined program to achieve the above-mentioned means and functions. For example, the program may be provided by a computer (SaaS: Software as a Service) through a network or a cloud service. The program may be provided in a form recorded in a computer-readable recording medium, for example. In this case, the computer reads a program from the recording medium, and forwards it to an internal or external storage, records it in the storage, and executes it. The program may be previously recorded in a storage (recording medium) and provided from the storage to the computer through a communication line.

[0141] Embodiments of the present disclosure are described above, but the present disclosure is not limited thereto. Moreover, the effects described in Embodiments of the present disclosure are only the most suitable ones produced from the present disclosure. Moreover, the effects described in Embodiments of the present disclosure are only the most suitable ones produced from the present disclosure.

[0142] Description of reference numerals

[0143] 1:system for recording a process, 2'- computer, 3:user terminal, 21: acquisition unit, 22: conversion unit, 23:record output unit, 24: blockchain formation unit, 25:hash generation unit, 26:learning unit, 100: procedure manual data, 102: title, 104:heading, 106, 108: text, 110: table, 112: free description field, 114: checkbox, 116: timestamp, 200: process recording screen, 300:blockchain

Claims

WHAT IS CLAIMED IS:

1. A computer for recording a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps, comprising: an acquisition unit that acquires one or more procedure manual data in a first format from a user terminal in the order of steps of a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment as many as necessary for recording the process of manufacturing the pharmaceutical or the pharmaceutical raw material or of conducting the life science experiment, the procedure manual being stipulated by law! a conversion unit that converts the first format to a second format! a record output unit that outputs a record in the second format to a user terminal, the record being associated with: for each procedure manual,(A) a procedure of each step, the procedure being indicated by the procedure manual data,(B) a free description field for inputting a record content!(C) a checkbox for indicating that an operation was conducted for each step, and(D) a timestamp for recording a date and time when the operation was conducted; and a blockchain formation unit that forms a blockchain by grouping an item input for each step into a block and linking the block to the blockchain.

2. The computer for recording a process according to claim 1, further comprising: a hash generation unit that generates a hash value by converting the input item into a character string and hashing the character string when the block is formed, wherein the blockchain formation unit adds the hash value to the formed block.

3. The computer for recording a process according to claim 2, wherein the hash generation unit concatenates the character string into which the item has been converted with the hash value of the last block of the blockchain and hashes the concatenation, when generating the hash value.

4. The computer for recording a process according to claim 2, wherein the record output unit outputs a date and time when the hash value was added to the block by the blockchain formation unit to the user terminal.

5. The computer for recording a process according to claim 1, wherein the acquisition unit acquires a preferred language of a user from the user terminal, and the conversion unit translates the procedure manual data into the preferred language of the user and converts the translated procedure manual data into the second format if the acquired preferred language ofthe user is different from the language of the procedure manual data.

6. The computer for recording a process according to claim 5, further comprising: a learning unit that generates a trained model by learning the procedure manual data and the translated procedure manual data.

7. The computer for recording a process according to claim 5, wherein the conversion unit predicts the procedure manual data in the preferred language of the user based on the trained model and converts the predicted procedure manual data into the second format.

8. A method for recording a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment through multiple steps, the method being executed by a computer, comprising the steps of acquiring one or more procedure manual data in a first format from a user terminal in the order of steps of a process of manufacturing a pharmaceutical or a pharmaceutical raw material or of conducting a life science experiment as many as necessary for recording the process of manufacturing the pharmaceutical or the pharmaceutical raw material or of conducting the life science experiment, the procedure manual being stipulated by law! converting the first format to a second format; outputting a record in a second format to the user terminal, the record being associated with:0144 for each procedure manual,(A) a procedure of each step, the procedure being indicated by the procedure manual data,(B) a free description field for inputting a record content;(C) a checkbox for indicating that an operation was conducted for each step, and(D) a timestamp for recording a date and time when the operation was conducted; and forming a blockchain by grouping an item input for each step into a block and linking the block to the blockchain.

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