Analysis information management method and analysis information management system

Abstract

To provide an analysis information management method and an analysis information management system that uses one or a plurality of computers to manage information associated with analysis by an analyzer.SOLUTION: An analysis information management method includes: S2 gathering work log information related to use of an analyzer as inclusive log information; S3 using at least part of the gathered inclusive log information to calculate the numbers of times of execution by a plurality of kinds of work including manual analyzing work and batch analyzing work; S4 presenting information on the numbers of times of execution by the kinds of work obtained through the calculation to a user; S5 receiving one or more kinds of work selected from among the plurality of kinds of work from the user; and S6 presenting work log information on the kinds of work received from the user to the user.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to an analysis information management method and system for managing information related to analysis using an analyzer.

Background Art

[0002] In recent years, in fields such as research and development of pharmaceuticals, food and beverages, or quality control of products, an analysis system in which a plurality of analyzers such as liquid chromatographs and mass spectrometers, a computer having a server function, and further a computer as an operation terminal are interconnected through a network line has been widely used. Such an analysis system is equipped with various functions for ensuring the reliability of analysis results obtained by analyzing data and raw data. For example, as described in Patent Documents 1, 2, etc., in an existing analysis system, all operations and tasks for all devices (analyzers, computers, etc.) included in the system are registered without omission as log information in a database.

[0003] Particularly, in an analysis system used in the field of pharmaceuticals, etc., in order to ensure the safety and effectiveness of products, it is required to fully comply with various laws and regulations, and data integrity is essential. In order to confirm that data integrity is ensured, an audit person such as a supervisor at the analysis site or a person in charge of quality assurance periodically or irregularly checks log information as audit evidence data and then approves it. That is, the audit person checks the content of the log information generated during a predetermined audit period, and for example, confirms that various illegal or inappropriate acts such as intentional data falsification, acquisition of data by analysis under inappropriate analysis conditions, and re-analysis of inappropriate analysis have not been performed, and approves a series of analysis operations during that audit period if there is no problem.

Prior Art Documents

Patent Documents

[0004] [Patent Document 1] International Publication No. 2017 / 098599 [Patent Document 2] International Publication No. 2017 / 098650 [Overview of the project] [Problems that the invention aims to solve]

[0005] In conventional analysis systems, auditors must individually review each piece of log information being audited on a computer screen. However, in analysis systems involving numerous analysis devices, the amount of accumulated log information is enormous. Furthermore, multiple analysts may each perform numerous analyses, or a single analyst may perform analyses on multiple analysis devices simultaneously. As a result, the content of the log information accumulated in the database is quite complex. Consequently, the auditing process by auditors is extremely cumbersome, time-consuming, and costly. Moreover, this increases the likelihood of audit omissions and errors, which undermines the reliability of the audit.

[0006] This invention was made to solve these problems, and its main objective is to provide an analytical information management method and system that can reduce the burden on auditors, thereby reducing the effort and cost required for audits, and improve the accuracy of data integrity by reducing audit omissions and errors. [Means for solving the problem]

[0007] One aspect of the analytical information management method according to the present invention, which was developed to solve the above problems, is a method for managing information related to analysis by an analytical device using one or more computers, The first step is to collect work log information regarding the use of the aforementioned analytical device as comprehensive log information, A second step involves using at least a portion of the comprehensive log information collected in the first step to calculate the number of times each of several work types, including manual analysis work and batch analysis work, is performed. A third step involves presenting to the user the information on the number of times each type of work has been performed, obtained in the second step, A fourth step in which the user inputs one or more work types selected from the aforementioned plurality of work types, Step 5 involves presenting the user with work log information regarding the type of work received from the user, Includes.

[0008] One aspect of the analytical information management system according to the present invention is a system for implementing the analytical information management method of the above aspect, and is an analytical information management system for managing information related to analysis in an analytical instrument, An information collection unit collects work log information related to the use of the aforementioned analytical device as comprehensive log information, A statistical processing unit, which uses at least a portion of the comprehensive log information collected by the information collection unit to calculate the number of times each of several work types, including manual analysis work and batch analysis work, is provided. A first information display unit presents to the user information on the number of times each type of work has been performed, obtained by the statistical processing unit, A work type receiving unit that receives input from the user for one or more work types selected from the aforementioned plurality of work types, A second information presentation unit, upon receiving a user's selection input at the aforementioned work type reception unit, creates a list of work log information for the selected work type and presents it to the user. It is equipped with. [Effects of the Invention]

[0009] In this invention, users (primarily auditors) can easily identify tasks that would not normally be performed, or are unlikely to be performed, based on the number of times each task type was performed, i.e., if the analysis work were carried out according to the appropriate procedures in accordance with the manual. They can then perform a detailed check of the work log information, focusing on those tasks. In other words, the work log information to be audited can be narrowed down to a certain extent, thereby enabling the audit to be carried out efficiently while reviewing the work log information. As a result, this invention reduces the burden on auditors and lowers the effort and cost required for audits. Furthermore, this invention reduces audit omissions and errors, and further improves the accuracy of data integrity. [Brief explanation of the drawing]

[0010] [Figure 1] A schematic diagram of one embodiment of an analysis system including an analysis information management system according to the present invention. [Figure 2] This diagram shows the workflow and processing flow during the auditing of work log information in the analysis system of this embodiment. [Figure 3] This figure shows an example of a graph illustrating the results of a statistical analysis of the work log information that is subject to audit. [Figure 4] A diagram showing an example of a list of work log information corresponding to a specified work type. [Figure 5] A diagram illustrating the work procedure during batch analysis. [Figure 6] A diagram illustrating the work procedure for manual analysis. [Modes for carrying out the invention]

[0011] [Procedure for analytical work using analytical equipment] Before describing one embodiment of the analytical information management method and system according to the present invention, we will first briefly describe the procedure for analysis using an analytical instrument such as a liquid chromatograph. It should be noted that this is a standard analytical procedure and does not limit the present invention in any way. FIG. 5 is a flowchart showing a standard operation procedure during batch analysis, and FIG. 6 is a flowchart showing a standard operation procedure during manual analysis.

[0012] Batch analysis is a method of automatically analyzing a large number of pre-prepared samples in sequence. First, the analyst creates a method file that details the analysis conditions, etc. (step S10). Note that the method file is not always created by the analyst; often, it is created by technicians or administrators who are proficient in the analysis. In particular, in analysis outsourcing companies or large manufacturers that contract out the analysis work, the analyst is often just an operator of the device and does not have the authority to create or edit the method file.

[0013] Next, the analyst creates a batch file that determines the analysis order of the samples and the method file to be used for analyzing each individual sample (step S11). After creating the batch file, the analyst instructs the analysis to be executed. The analysis device that receives this instruction executes the analysis for each sample in sequence according to the set batch file (step S12). Depending on the analysis device, usually, a series of analyses according to the batch file are automatically performed, so there is no need for the analyst to be beside the analysis device to perform any operations or work. For example, during nights, holidays, etc., analyses for a large number of samples can be completed.

[0014] When the analysis of a certain sample is completed and data is obtained during the execution process of the above-described batch analysis, for example, on a personal computer connected to the analysis device, data analysis is automatically performed according to the specified analysis conditions, and for example, qualitative analysis or quantitative analysis is carried out (step S13). Of course, it is also possible to perform the data analysis collectively after all the sample analyses are completed instead of performing the data analysis sequentially. In this way, the analyst can obtain the analysis results and the analysis results almost without performing any work during the analysis execution or data analysis (step S14).

[0015] On the one hand, in manual analysis, the analyst appropriately sets the analysis conditions (step S20), and operates the analyzer so as to analyze the target sample under the set analysis conditions. As a result, the analyzer performs the analysis on the target sample according to the set analysis conditions (step S21). When the analysis is completed and data is obtained, the analyst sets predetermined analysis conditions on a personal computer connected to the analyzer and performs data analysis (step S22). As a result, the analyst can obtain the analysis result and the analysis result for the target sample (step S23).

[0016] Generally, manual analysis is often carried out when it is necessary to finely adjust the analysis conditions because the appropriate analysis conditions for analyzing the target sample are unknown, or when carefully analyzing a small number of samples. Therefore, for example, although manual analysis is frequently carried out at research and development sites in universities and companies, it is rarely carried out at large-scale analysis sites such as analysis contracting companies as described above.

[0017] [Configuration of the analysis system of the present embodiment] Next, an embodiment of an analysis system including an analysis information management system for implementing the analysis information management method according to the present invention will be described with reference to the accompanying drawings. FIG. 1 is an overall configuration diagram of the analysis system of the present embodiment.

[0018] The analysis system of the present embodiment has a configuration in which a server 1 whose entity is a relatively high-performance computer, a client terminal 2 whose entity is a personal computer (or a portable information terminal), etc., and a personal computer (PC) 5 connected to the analyzer 4 and mainly responsible for controlling the analyzer 4 and analyzing the data collected by the analyzer 4 are interconnected via a network line 3 such as a LAN. The network line 3 may be connected to an external Internet or the like, but is often separated from the external network when emphasizing security.

[0019] In the example shown in Figure 1, one analysis device 4 is connected to each PC 5, but it is also possible for multiple analysis devices 4 to be connected to a single PC 5. Furthermore, the functions of the PC 5 may be effectively incorporated into the analysis device 4, and the analysis device 4 may be directly connected to the network line 3. The number of PC 5s and client terminals 2 connected to the network line 3 can also be determined as appropriate. Moreover, the server 1 is not necessarily a single computer, and its functions may be distributed across multiple computers.

[0020] Server 1 includes, as functional blocks, an analysis data collection unit 10, a log information collection unit 11, a data storage unit 12, an audit work support unit 13, an input / output processing unit 14, and the like. The audit work support unit 13 includes, as lower functional blocks, an audit period specification processing unit 130, an audit target log collection unit 131, a statistics processing unit 132, a statistical result graph creation unit 133, an audit target item instruction reception unit 134, a work log list creation unit 135, and a work log data disclosure unit 136. The data storage unit 12 is a type of database and stores various data files created on the computers included in this system, such as analysis data files, work log data files, and analysis result report files.

[0021] As described above, since Server 1 is essentially a computer, the functional blocks described above are realized by dedicated analytical information management software (programs) pre-installed on the computer running on that computer. Such analytical information management programs can be provided to the user by being stored on various non-temporary recording media readable by the computer. Furthermore, if Network Line 3 is connected to an external network, the above programs can be provided to the user in the form of data transfer over such a network. In addition, when a user newly installs the system, the above programs can be provided pre-installed on the computer that is part of the system.

[0022] As described later, the client terminal 2 can display various information on its screen by exchanging data with the server 1 via the network line 3, and it also has the function of giving various instructions and responses through the keyboard and pointing device attached to the terminal 2. However, in the system of this embodiment, these functions are performed using a standard web browser installed on the client terminal 2, and do not require the installation of any special, or dedicated, software. Of course, it is also possible to install dedicated software on the client terminal 2 to achieve the same functions.

[0023] Each PC 5 connected to the analyzer 4 is equipped with dedicated control and processing software for controlling the analyzer 4 and for collecting and analyzing the data obtained from the analyzer 4. This software also has the function of exchanging predetermined data with the server 1.

[0024] On server 1, the analysis data collection unit 10 collects analysis data obtained by performing analysis on samples with each analysis device 4, analysis data obtained by analyzing that analysis data on PC 5, and various information related to the analysis (analysis conditions, etc.) via the network line 3, and stores it in the data storage unit 12 as an analysis data file. Such an analysis data file may include, for example, sample information such as sample name and sample volume, an instrument ID to identify the analysis device 4 used for the analysis, the date and time the analysis was performed, a user ID to identify the person in charge of the analysis, analysis conditions (method file name, etc.), analysis data obtained by the analysis, and various calculated values ​​and related information obtained by the analysis processing based on the analysis data (e.g., calibration curve, etc.).

[0025] The log information collection unit 11 collects individual work log information via the network line 3, which includes information indicating operations and tasks performed by the user on all analysis devices 4 and computers 1, 2, and 5 included in this system, as well as information indicating the status of devices such as errors issued by the analysis device 4 or PC 5 when performing analysis or processing, and stores it in the data storage unit 12. Each work log data file stores various data and information related to a single task or operation.

[0026] As an example, as shown in Figure 1, a single work log data file includes information such as the operation / task details, the device ID to identify the analysis device 4, PC 5, or client terminal 2 on which the operation / task was performed, the date and time the operation was executed, the user ID to identify the person who performed the operation / task, and the type of work. In addition, if operations related to data files are performed, such as saving, reading, or printing a file, the data ID to identify the data file being operated on is also recorded in the work log data file.

[0027] Here, the work type indicates the type of operation or task performed by the user (e.g., an analyst). In the system of this embodiment, the work types include batch analysis, post-batch analysis data analysis, manual analysis, manual data analysis, method file creation and editing, system-related operations, and report creation and editing. System-related operations include changing the settings of computers 1, 2, and 5 included in this analysis system, installing, uninstalling, and updating software, and also include operations that are not directly related to analysis or interpretation work. These work types correspond to the operations and tasks that are subject to audit, as described later.

[0028] Next, the operations performed by the auditor when reviewing the audit trail in the analysis system of this embodiment, and the corresponding processes executed primarily by Server 1, will be explained with reference to Figures 2 to 4. Figure 2 is a flowchart showing the operations and processing flow during an audit.

[0029] The auditor logs into the system from client terminal 2 (or a user interface attached to server 1, not shown) with auditing authority and performs the prescribed operations. In response to these operations, the audit support unit 13 functions on server 1. First, the audit period specification processing unit 130 displays an input field for the audit period on the display screen of client terminal 2 via the input / output processing unit 14. The auditor enters the period to be audited into that input field. The audit period specification processing unit 130 receives this input and determines the audit period (step S1). Here, for example, the audit period is determined as XX / XX / XX to XX / XX / XX.

[0030] Once the audit period is determined, the audit log collection unit 131 collects numerous work log data files corresponding to that audit period from the data storage unit 12 as comprehensive log information (step S2). Note that this assumes that all work log information for the entire system is stored on server 1. However, in some cases, work log information not yet collected on server 1 may remain on each PC 5 or each client terminal 2. Therefore, the audit log collection unit 131 may access all computers in the system, not just server 1, to collect work log information stored for the relevant period and aggregate it as comprehensive log information.

[0031] The statistical processing unit 132 recognizes the work type for all work log information included in the collected comprehensive log information and counts the log information for each work type to obtain the number of times each operation or task is executed (step S3). As described above, in this example there are work types such as batch analysis work, data analysis work after batch analysis, manual analysis work, manual data analysis work, method file creation / editing work, system-related operations, and report creation / editing work, so the number of executions for each of them can be determined. If work log information corresponding to an unnecessary work type is included in the comprehensive log information, it is not necessary to count the number of executions for that work log information. In other words, the processing in step S3 may be performed by excluding some of the work log information included in the comprehensive log information.

[0032] The statistical results graph generation unit 133 creates a graph in a format that allows for easy comparison of the number of executions of each type of operation / task, and displays the graph on the display screen of the client terminal 2 via the input / output processing unit 14 (step S4). Figure 3 is an example of the graph 100 displayed at this time, which is a bar graph of the number of executions for each type of operation. In this graph, "Audit Type" is the type of operation described above, and from left to right in Figure 3, it corresponds to manual data analysis work, manual analysis work, data analysis work after batch analysis, batch analysis work, method file creation / editing work, system-related operations, and report creation / editing work. This graph allows auditors to compare the number of executions of each type of operation / task at a glance.

[0033] In existing analysis systems, while it was possible for auditors to view a list of work log information, the list would display a mix of work log information corresponding to various work types. Although some systems are known to have functions to filter and display only work log information corresponding to specific work types, it was unclear which work log information was important, so in principle, it was necessary to review all work log information, which was extremely time-consuming.

[0034] In contrast, this analysis system allows us to determine the number of work log entries for each type of work that occurred during the audit period. From this information, we can estimate the types of work that should be the focus of the audit, i.e., those that are highly likely to be related to fraud or inappropriate conduct.

[0035] For example, suppose that the majority of the analyses performed during a certain audit period were batch analyses rather than manual analyses. As mentioned above, batch analyses use method files, and these method files are usually validated so that analysts cannot arbitrarily modify them. In such situations, if a small number of manual analyses are performed, these manual analyses are often intended to cover up errors made by the analysts during the batch analysis, such as incorrect sample placement. It is also possible that the analysis results were not as intended, and the analysis was redone by changing some of the analysis conditions from those defined in the method file. In such cases, the work log information corresponding to the manual analyses is particularly important for auditing.

[0036] In contrast, if the majority of analyses performed during an audited period were manual analyses, with only a few batch analyses, it can be assumed that the analysis focused on samples different from the usual routine analyses, such as test samples under development. In this case, manual analysis should be the standard practice, and it is important to verify whether it was appropriate to perform batch analyses according to a defined method file. Therefore, work log information corresponding to batch analyses is particularly important for auditing.

[0037] Furthermore, as mentioned above, method files used in batch analysis are usually validated, so the task of creating or editing measurement methods should rarely occur. However, if the number of such tasks is unusually high, it is possible that the method files have been modified through some kind of fraudulent activity.

[0038] The above is just one example. Once the number of operations and tasks performed for each type of work is known, it becomes possible to select the types of work that require particular attention to audit based on various assumptions under the environment and circumstances in which the analysis system is used. The auditor then selects one of the multiple types of work on the graph displayed on the screen of client terminal 2. Specifically, they click on or near the bar graph of the type of work they wish to select. The audit target item instruction receiving unit 134 then receives this operation and recognizes the selected type of work (step S5).

[0039] In the graph 100 shown in Figure 3, the auditer selects the method file creation / editing work indicated by the dotted line 101. This is the case, for example, when modification of the method file is suspected, as described above. When one of the work types is selected, the work log list creation unit 135 extracts only the work log information corresponding to the selected work type from the comprehensive log information and creates a list summarizing the main information contained in the extracted work log information in a predetermined format. Then, the work log information list is displayed on the display screen of the client terminal 2 through the input / output processing unit 14 (step S6).

[0040] Figure 4 shows an example of a work log information list that is displayed. In this list, each row corresponds to one piece of work log information. In this table, "PC Name" is the device ID that identifies PC5, "Instrument Name" is the device ID that identifies analysis instrument 4, and "File Name" is the name of the method file. Also, "Audit Trail Versions" is the number of revisions of that method file.

[0041] In this example, it can be seen that the third work log entry from the top has an unusually high number of revisions compared to the others. The auditor, noticing this, clicks on the "Show Details" section in the row corresponding to that work log entry (Step S7). In response to this operation, the work log data disclosure unit 136 displays the detailed contents of the specified work log entry on the display screen of the client terminal 2. The auditor reviews this detailed information and determines whether or not any fraudulent activity has occurred (Step S8).

[0042] Furthermore, if there is suspicion of fraud or inappropriate work in a batch analysis, auditors can check the work log information corresponding to the batch work and also examine the batch file to confirm whether inappropriate samples have been analyzed or inappropriate method files have been selected.

[0043] Furthermore, by reviewing the work log information corresponding to system operations and tasks, auditors can confirm that no configuration changes or new software installations on PC5, which are normally prohibited for analysts, have been performed.

[0044] Furthermore, by reviewing the work log information corresponding to the report creation and editing work, auditors can confirm that the creation and printing of reports showing analysis and interpretation results, which are normally prohibited for analysts to do on their own, have not been carried out.

[0045] As described above, in the analysis system of this embodiment, the audit support unit 13 provides information for selecting important work types to be audited, and the auditor can use this information to select work types and then carefully check the work log information corresponding to those work types. As a result, when conducting an audit using work log information, instead of spending an equal amount of time checking each piece of work log information, specific work log information can be checked intensively, allowing for more efficient audit execution. Furthermore, it becomes easier to detect fraud or inappropriate operations and work, reducing audit omissions and errors.

[0046] In the analysis system of the above embodiment, the work log data disclosure unit 136 may provide the following functions. When an auditor selects, for example, one of the work log pieces of information related to the creation and editing of a method file as described above, and then selects multiple versions of that file revision, the work log data disclosure unit 136 reads the different versions of the method file and examines the changes. It then displays the contents of each method file on the display screen of the client terminal 2, clearly indicating the changes. This allows the auditor to easily find out which analysis conditions in the method file have been changed (tampered with).

[0047] In the analysis system of this embodiment, the type of analyzer 4 is not limited. Furthermore, various types of analyzers can be combined as analyzer 4. In particular, this analysis system is suitable for systems that include analyzers that have the function of automatically analyzing a large number of pre-prepared samples, such as liquid chromatographs and gas chromatographs equipped with autosamplers.

[0048] Furthermore, the above embodiments are merely examples of the present invention, and it is clear that they can be appropriately modified or altered within the scope of the spirit of the present invention.

[0049] [Various forms] Those skilled in the art will understand that the exemplary embodiments described above are specific examples of the following embodiments.

[0050] (Section 1) One aspect of the analytical information management method according to the present invention is a method for managing information related to analysis by an analytical device using one or more computers, The first step is to collect work log information regarding the use of the aforementioned analytical device as comprehensive log information, A second step involves using at least a portion of the comprehensive log information collected in the first step to calculate the number of times each of several work types, including manual analysis work and batch analysis work, is performed. A third step involves presenting to the user the information on the number of times each type of work has been performed, obtained in the second step, A fourth step in which the user inputs one or more work types selected from the aforementioned plurality of work types, Step 5 involves presenting the user with work log information regarding the type of work received from the user, Includes.

[0051] (Clause 8) Another aspect of the analytical information management system according to the present invention is an analytical information management system for managing information related to analysis in an analytical instrument, An information collection unit collects work log information related to the use of the aforementioned analytical device as comprehensive log information, A statistical processing unit, which uses at least a portion of the comprehensive log information collected by the information collection unit to calculate the number of times each of several work types, including manual analysis work and batch analysis work, is provided. A first information display unit presents to the user information on the number of times each type of work has been performed, obtained by the statistical processing unit, A work type receiving unit that receives input from the user for one or more work types selected from the aforementioned plurality of work types, A second information presentation unit, upon receiving a selection input from the user at the aforementioned work type reception unit, creates a list of work log information for the selected work type and presents it to the user. It is equipped with.

[0052] According to the analytical information management method described in paragraph 1 and the analytical information management system described in paragraph 8, auditors can analyze the work log information subject to audit in detail, focusing on items that warrant particular attention, specifically those suspected of fraud or those highly likely to be work errors or mistakes, thereby efficiently reviewing the work log information and conducting audits. As a result, the present invention reduces the burden on auditors and lowers the effort and cost required for audits. Furthermore, the present invention reduces audit omissions and errors, and improves the accuracy of data integrity.

[0053] Furthermore, one embodiment of an analytical information management program for implementing the analytical information management method described in paragraph 1 is an analytical information management program for managing information related to analysis in an analytical instrument using one or more computers, wherein the one or more computers include The first step is to collect work log information regarding the use of the aforementioned analytical device as comprehensive log information, A second step involves using at least a portion of the comprehensive log information collected in the first step to calculate the number of times each of several work types, including manual analysis work and batch analysis work, is performed. A third step involves presenting to the user the information on the number of times each type of work has been performed, obtained in the second step, A fourth step in which the user inputs one or more work types selected from the aforementioned plurality of work types, Step 5 involves presenting the user with work log information regarding the type of work received from the user, This is what causes it to execute.

[0054] The analysis information management program described above may be provided to the user by being stored on a computer-readable non-temporary recording medium such as a CD-ROM, DVD-ROM, memory card, or USB memory (dongle). Alternatively, the program may be provided to the user via data transfer over a communication line such as the Internet. Furthermore, the program may be pre-installed on the computer (more precisely, the storage device that is part of the computer) that is part of the system when the user purchases the system.

[0055] (Paragraph 2) The analysis information management method described in Paragraph 1 may further include the step of extracting work log information for the type of work received from the user from the comprehensive log information.

[0056] (Clause 9) In addition, in the analysis information management system described in paragraph 8, the second information presentation unit may perform a process to extract work log information for the work type received by the work type reception unit from the comprehensive log information.

[0057] According to the analysis information management method described in paragraph 2 and the analysis information management system described in paragraph 9, it is possible to collect work log information corresponding to the target work type without any omissions from the collected comprehensive log information.

[0058] (3) The analysis information management method described in paragraph 1 may further include, in the first step, a step of having the user specify the period for which work log information will be collected as comprehensive log information, and accepting this specification.

[0059] (Clause 10) The analysis information management system described in paragraph 8 may further include a period specification unit that allows the user to specify the period for which the information collection unit will collect work log information as comprehensive log information, and accepts this specification.

[0060] According to the analytical information management method described in paragraph 3 and the analytical information management system described in paragraph 10, auditors can easily conduct audits of work log information collected over a desired period.

[0061] (Article 4) In the analysis information management method described in any one of paragraphs 1 to 3, the work type may include operations related to the system.

[0062] (Clause 11) Similarly, in the analytical information management system described in any one of paragraphs 8 to 10, the work type may include operations related to the system.

[0063] System operations include, for example, changing computer settings within the system, installing, uninstalling, and updating software. For instance, in the case of an analysis system used by an analysis service provider, it is often prohibited for analysts to change computer settings without following the manual or other guidelines.

[0064] According to the analytical information management method described in paragraph 4 and the analytical information management system described in paragraph 11, auditors can easily identify an unusually high number of system operations that should normally occur very infrequently. This allows auditors to recognize unintended or intentional modifications to the system.

[0065] (Article 5) In the analytical information management method described in any one of paragraphs 1 to 4, the work type may include report creation work, which involves creating a report relating to analytical work or data analysis work.

[0066] (Paragraph 12) Similarly, in the analytical information management system described in any one of paragraphs 8 to 11, the work type may include report creation work, which involves creating reports relating to analytical work or data analysis work.

[0067] For example, in the case of analytical systems used by companies that provide analytical services, the creation and output of reports are usually not done at the discretion of the analyst, but rather according to a manual. According to the analytical information management method described in Section 5 and the analytical information management system described in Section 12, auditors can easily identify an unusually high number of operations related to report creation, which should ideally occur very infrequently. This allows auditors to check for actions such as analysts performing report creation work in violation of the manual or taking printed reports outside the premises.

[0068] (Article 6) In the analysis information management method described in any one of Articles 1 to 5, the work type may include method creation and editing work.

[0069] (Clause 13) Similarly, in the analysis information management system described in any one of paragraphs 8 to 12, the work type may include method creation and editing work.

[0070] Here, a method is a file that specifies the conditions for analysis in detail. For example, in the case of analysis systems used by companies that provide analysis services, it is often prohibited for analysts to create methods on their own or to edit existing methods. According to the analytical information management method described in paragraph 6 and the analytical information management system described in paragraph 13, auditors can check, for example, that the method has been edited and the analytical conditions are different from what they were originally intended.

[0071] (Section 7) The analytical information management method described in any one of Sections 1 to 6 may further include a step of accepting a selection by the user on the list of work log information presented in Step 5, obtaining detailed information about the selected work log information, and presenting it to the user.

[0072] (Clause 14) Similarly, the analysis information management system described in any one of paragraphs 7 to 13 may further include a detailed information display unit that accepts a selection by the user on a list of work log information presented by the second information display unit, and obtains and presents detailed information about the selected work log information to the user.

[0073] For example, if a user clicks on a list of work log information displayed on the screen, the detailed information display unit can receive this operation, read the content of the corresponding work log information, and display it on the screen. Furthermore, if a user specifies multiple work log entries and instructs the system to extract the differences between them, the detailed information display unit may receive this operation, read the contents of the corresponding multiple work log entries, examine the differences between them (for example, differences in parameter values ​​of analysis conditions), and extract and display only the information that shows differences.

[0074] According to the analytical information management method described in paragraph 7 and the analytical information management system described in paragraph 14, auditors can easily perform detailed analyses of work log information suspected of containing fraudulent or inappropriate conduct and check whether it is acceptable. [Explanation of Symbols]

[0075] 1…Server 10…Analysis Data Collection Department 11…Log Information Collection Department 12...Data storage section 13…Audit Support Department 130…Audit Period Designation Processing Unit 131... Audited Log Collection Department 132...Statistical Processing Section 133...Statistical Results Graph Creation Department 134… Department for Receiving Instructions on Audit Items 135...Work Log List Creation Department 136...Work Log Data Disclosure Department 14… Input / Output Processing Unit 2…Client terminals 3…Network connection 4…Analyzer 5…PC

Claims

1. 1. A method for managing information related to analysis by an analytical device using one or more computers, comprising: a first step of collecting work log information relating to the use of the analytical device as comprehensive log information; a second step of calculating the number of times each of a plurality of task types, including manual analysis tasks and batch analysis tasks, has been performed by using at least a portion of the comprehensive log information collected in the first step; a third step of presenting to a user information on the number of times each task type has been performed, obtained in the second step; a fourth step of receiving, from a user, an input of one or more work types selected from the plurality of work types; a fifth step of presenting to the user work log information regarding the work type received from the user; A method for managing analytical information, including:

2. The analysis information management method according to claim 1 , further comprising the step of extracting work log information for a work type received from a user from the comprehensive log information.

3. 2. The analysis information management method according to claim 1, further comprising a step of having a user specify a period for collecting work log information as the comprehensive log information and accepting the specification in the first step.

4. The analysis information management method according to claim 1 , wherein the work type includes an operation related to a system.

5. The analysis information management method according to claim 1 , wherein the task type includes a report creation task for creating a report related to an analysis task or a data analysis task.

6. The analytical information management method according to claim 1 , wherein the work type includes a method creation / editing work.

7. The analysis information management method of claim 1, further comprising a step of accepting a user selection from the list of work log information presented in the fifth step, obtaining detailed information about the selected work log information, and presenting it to the user.

8. An analysis information management system for managing information related to analysis by an analysis device, an information collection unit that collects work log information related to the use of the analysis device as comprehensive log information; a statistical processing unit that calculates the number of times each of a plurality of task types, including manual analysis tasks and batch analysis tasks, is performed by using at least a portion of the comprehensive log information collected by the information collection unit; a first information presentation unit that presents to a user information on the number of times each task type has been performed, which information is obtained by the statistical processing unit; a task type receiving unit that receives, from a user, an input of one or more task types selected from the plurality of task types; a second information presentation unit that receives a selection input operation by a user in the work type reception unit, creates a list of work log information for the selected work type, and presents the list to the user; An analytical information management system equipped with:

9. The analysis information management system according to claim 8 , wherein the second information presenting unit performs a process of extracting work log information about the work type accepted by the work type accepting unit from the comprehensive log information.

10. The analysis information management system according to claim 8 , further comprising a period designation unit that allows a user to designate and accepts a period for collecting work log information as the comprehensive log information in the information collection unit.

11. The analysis information management system according to claim 8 , wherein the work type includes an operation related to a system.

12. The analysis information management system according to claim 8 , wherein the work type includes a report creation work for creating a report related to an analysis work or a data analysis work.

13. The analytical information management system according to claim 8 , wherein the work type includes a method creation / editing work.

14. The analysis information management system described in claim 8, further comprising a detailed information presentation unit that accepts a user selection from the list of work log information presented by the second information presentation unit, obtains detailed information about the selected work log information, and presents it to the user.

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