Analysis information management device and analysis information management method

Abstract

To provide an analysis information management device and analysis information management method that facilitate an appropriate audit of an analysis device.SOLUTION: A receiving section 1 receives selection of a batch file that causes an analysis device to successively analyze a sample. An analysis result acquisition section 3 acquires batch analysis data that indicates an analysis result and corresponds to the batch file, of which selection is received, from a database device 20. A standard information acquisition section 4 acquires standard information for verifying validity of an analysis by the analysis device, which corresponds to the batch file, of which selection is received, from the database device 20. A creation section 5 creates a report in which the analysis result indicated by the batch analysis data and an evaluation result regarding the validity of the analysis by the analysis device are described on the basis of the acquired batch analysis data and standard information.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to an analytical information management device and an analytical information management method. [Background technology]

[0002] In the analytical information management system, a database server, one or more analytical instruments, and client terminals are connected to each other via a network. In the database server, analytical data files of samples analyzed by the analytical instruments and audit trail report files showing various log information related to the analytical data files are registered in a corresponding state (see, for example, Patent Document 1).

[0003] When the user selects the desired analysis data file and instructs the creation of a report set, the selected analysis data file and the corresponding audit trail report file are sent from the database server to the client terminal. A final result record report is created in the client terminal, which describes the contents of the analysis data file and the audit trail report file. The created final result record report is registered in the database. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 6699669 Summary of the Invention [Problem to be solved by the invention]

[0005] In the analytical information management system described in Patent Document 1, the contents of the audit trail report file are recorded in the final result record report. Therefore, by presenting the final result record report created in the audit of the analytical equipment, it is possible to prove that the analytical results were obtained through correct operation. However, merely presenting the above-mentioned final result record report is not sufficient to audit the analytical equipment.

[0006] An object of the present invention is to provide an analytical information management device and an analytical information management method that facilitate appropriate auditing of analytical devices. [Means for solving the problem]

[0007] One aspect of the present invention relates to an analytical information management device capable of communicating with a database device in which batch files for causing an analytical device to perform continuous sample analysis are registered, wherein batch analysis data indicating analysis results corresponding to the batch files obtained by the analytical device and reference information for ensuring the validity of the analysis by the analytical device are registered in the database device so as to correspond to the batch files, and the analytical information management device includes a reception unit that receives a selection of the batch files registered in the database device, an analysis result acquisition unit that acquires from the database device the batch analysis data corresponding to the batch file whose selection is accepted by the reception unit, a reference information acquisition unit that acquires from the database device the reference information corresponding to the batch file whose selection is accepted by the reception unit, and a creation unit that creates a report including the analysis results indicated by the batch analysis data and an evaluation result regarding the validity of the analysis by the analytical device, based on the batch analysis data acquired by the analysis result acquisition unit and the reference information acquired by the reference information acquisition unit.

[0008] Another aspect of the present invention relates to an analytical information management method that communicates with a database device in which batch files that cause an analytical device to perform continuous sample analysis are registered, wherein batch analysis data indicating analysis results corresponding to the batch files obtained by the analytical device and reference information for ensuring the validity of the analysis by the analytical device are registered in the database device so as to correspond to the batch files, and the analytical information management method includes a step of accepting a selection of the batch file registered in the database device, a step of acquiring from the database device the batch analysis data corresponding to the batch file whose selection has been accepted, a step of acquiring from the database device the reference information corresponding to the batch file whose selection has been accepted, and a step of creating a report that describes the analysis results indicated by the batch analysis data and an evaluation result of the validity of the analysis by the analytical device based on the acquired batch analysis data and reference information. Effect of the Invention

[0009] According to the present invention, it becomes possible to easily carry out an appropriate audit of an analytical device. [Brief description of the drawings]

[0010] [Figure 1] 1 is a diagram showing a configuration of an analysis system including an analysis information management device according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a diagram illustrating a configuration of the analysis information management device of FIG. [Diagram 3] FIG. 13 is a diagram showing an integrated report created by the analysis information management device. [Figure 4] 13 is a flowchart showing an example of an algorithm of a report creation process executed by the analysis information management device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] (1) Analysis system configuration An analytical information management device and an analytical information management method according to an embodiment of the present invention will be described in detail below with reference to the drawings. FIG. 1 is a diagram showing a configuration of an analytical system including an analytical information management device according to an embodiment of the present invention. As shown in FIG. 1, the analytical system 100 includes an analytical information management device 10, a database device 20, and a plurality of analytical devices 30. The analytical information management device 10, the database device 20, and each analytical device 30 are connected to a network 110 so as to be able to communicate with each other. A plurality of analytical information management devices 10 may be connected to the network 110.

[0012] The analytical information management device 10 is realized by an information processing device such as a personal computer, and includes, for example, a CPU (Central Processing Unit) and a memory. The analytical information management device 10 generates a batch file for executing an analytical sequence of a sample by the analytical device 30. The analytical information management device 10 can also set a one-off analytical method of a sample that is different from the batch file.

[0013] Furthermore, the analytical information management device 10 sets standard information for ensuring the validity of the analysis by the analytical device 30. The standard information includes system suitability information and QA (quality assurance) / QC (quality control) information. The system suitability information is information that specifies the stability of the analytical device 30, and includes the range of parameters (e.g., the temperature of the analytical column or the pressure of the liquid delivery pump) for the components of the analytical device 30. The QA / QC information is information that specifies the reliability of the analysis results, and includes, for example, the range of the quantitative value of the sample.

[0014] Furthermore, the analytical information management device 10 sets various information such as sample information indicating the type or concentration of the analytical sample, the configuration of the analytical information management device 10, a processing method for analytical data indicating the analysis results obtained by the analytical device 30, and the analyst. The analytical information management device 10 can also create various reports indicating the analytical conditions of the sample, the operation history of the analytical information management device 10, the analysis results of the sample, the stability of the analytical device 30, or the reliability of the analysis results. The analytical information management device 10 creates an integrated report that integrates multiple reports. Details of the analytical information management device 10 will be described later.

[0015] An operation unit 11 and a display unit 12 are connected to the analytical information management device 10. The operation unit 11 includes, for example, a pointing device such as a mouse and a keyboard, and is operated by a user to perform various settings on the analytical information management device 10, instruct the generation of batch files, or instruct the creation of various reports. The display unit 12 includes, for example, an LCD (liquid crystal display) panel or an organic EL (electroluminescence) panel, and displays the analysis results obtained by the analysis device 30, various reports, an integrated report, and the like.

[0016] The database device 20 includes a large-capacity storage device such as a server. Batch files generated by the analytical information management device 10 are registered in the database device 20. Analysis data obtained by the analysis device 30 is also registered in the database device 20. Furthermore, reference information and various batch-related information associated with the batch files are registered in the database device 20. The batch-related information includes sample information, an operation history of the analytical information management device 10, the configuration of the analytical information management device 10, a data processing method, an analyst, and an analysis date and time.

[0017] Each of the analytical devices 30 includes a gas chromatograph, a liquid chromatograph, a mass spectrometer, or the like. The types of the multiple analytical devices 30 may be the same or different. Each analytical device 30 performs continuous analysis of samples (hereinafter referred to as batch analysis) according to a batch file registered in the database device 20. In addition, each analytical device 30 can also perform one-off analysis of samples (hereinafter referred to as single analysis) according to an analysis method generated by the analysis information management device 10.

[0018] (2) Analysis information management device Fig. 2 is a diagram showing the configuration of the analytical information management device 10 of Fig. 1. As shown in Fig. 2, the analytical information management device 10 includes, as functional units, a reception unit 1, a related information acquisition unit 2, an analysis result acquisition unit 3, a reference information acquisition unit 4, and a creation unit 5. The functional units of the analytical information management device 10 are realized by the CPU of the analytical information management device 10 executing a report creation program stored in memory. Some or all of the functional units of the analytical information management device 10 may be realized by hardware such as electronic circuits.

[0019] The reception unit 1 receives an instruction to create an integrated report. The user can instruct the creation of an integrated report by selecting a desired batch file from the batch files displayed on the display unit 12 and performing a predetermined operation using the operation unit 11. When instructing the creation of an integrated report, the user can further select analysis results obtained from one or more single analyses in addition to the batch file.

[0020] The related information acquisition unit 2 acquires batch related information corresponding to the batch file selected by the reception unit 1 from the database device 20. The analysis result acquisition unit 3 acquires analysis data of the batch analysis (hereinafter referred to as batch analysis data) corresponding to the batch file selected by the reception unit 1 from the database device 20. When the analysis result of a single analysis is selected by the reception unit 1, the analysis result acquisition unit 3 further acquires analysis data indicating the selected analysis result (hereinafter referred to as single analysis data) from the database device 20. The reference information acquisition unit 4 acquires reference information corresponding to the batch file selected by the reception unit 1 from the database device 20.

[0021] The creation unit 5 creates an integrated report based on the batch-related information acquired by the related information acquisition unit 2, the analysis data acquired by the analysis result acquisition unit 3, and the reference information acquired by the reference information acquisition unit 4. The integrated report may be created in a general-purpose file format such as PDF (Portable Document Format). In addition, the creation unit 5 registers the created integrated report in the database device 20. The creation unit 5 may cause the display unit 12 to display the created integrated report.

[0022] Fig. 3 is a diagram showing an integrated report created by the analysis information management device 10. As shown in Fig. 3, the integrated report R includes an analysis condition report R1, an operation history report R2, an analysis result report R3, a QA / QC report R4, and a system suitability report R5. Each of the analysis condition report R1, the operation history report R2, the analysis result report R3, the QA / QC report R4, and the system suitability report R5 may be composed of multiple pages.

[0023] The analysis conditions report R1 lists the file name of the analysis data for each analysis performed in sequence, the analysis date and time, the analyst, the identifier of the analysis data, or the identifier of the analysis device 30. The analysis conditions report R1 also lists the container numbers, types, concentrations, names or identifiers, etc., for the analyzed samples. Furthermore, the analysis conditions report R1 lists the device parameters of each component of the analysis device 30, the method of processing the analysis data, or information indicating the calibration curve generated by the analysis.

[0024] The operation history report R2 describes the operation history of the analytical information management device 10, such as login, logout, file operations, start of analysis, end of analysis, collection of analytical data, start of application, end of application, etc. The analysis result report R3 describes the analysis results, such as chromatograms or mass spectra, for each analysis.

[0025] The QA / QC report R4 describes the pass / fail result of the analysis based on the QA / QC information for each sample. The system suitability report R5 describes the pass / fail result of the stability of the analysis device 30 for each analysis based on the system suitability information. Each of the analysis result report R3, the QA / QC report R4, and the system suitability report R5 may further describe the analysis conditions corresponding to the performed analysis.

[0026] (3) Report creation process 4 is a flowchart showing an example of an algorithm of a report creation process executed by the analysis information management device 10. First, the reception unit 1 determines whether or not the user has instructed the creation of an integrated report R (step S1). When instructing the creation of an integrated report R, the user selects a desired batch file and analysis results of zero or more single analyses. If the creation of an integrated report R has not been instructed, the reception unit 1 waits until the creation of an integrated report R is instructed.

[0027] When an instruction to create an integrated report R is given, the related information acquisition unit 2 acquires batch related information corresponding to the batch file selected in step S1 from the database device 20 (step S2). The analysis result acquisition unit 3 acquires batch analysis data corresponding to the batch file selected in step S1 from the database device 20 (step S3). The reference information acquisition unit 4 acquires reference information corresponding to the batch file selected in step S1 from the database device 20 (step S4).

[0028] Steps S2, S3, and S4 may be executed first or simultaneously. If the analysis result of the single analysis is selected in step S1, the analysis result acquisition unit 3 further acquires single analysis data indicating the selected analysis result from the database device 20 in step S3.

[0029] The preparation unit 5 prepares an integrated report R based on the batch-related information acquired in step S2, the analysis data acquired in step S3, and the reference information acquired in step S4 (step S5). In step S5, the preparation unit 5 may prepare an analysis condition report R1, an operation history report R2, an analysis result report R3, a QA / QC report R4, and a system suitability report R5 individually, and then prepare the prepared reports by integrating them to prepare the integrated report R. Thereafter, the preparation unit 5 registers the integrated report R prepared in step S5 in the database device 20 (step S6), and ends the report preparation process.

[0030] (4) Effects In the analytical information management device 10 according to this embodiment, the selection of a batch file for causing the analytical device 30 to perform continuous analysis of samples is received by the receiving unit 1. The batch analysis data indicating the analysis results corresponding to the batch file whose selection has been received by the receiving unit 1 is obtained from the database device 20 by the analysis result obtaining unit 3.

[0031] The reference information acquisition unit 4 acquires reference information for ensuring the validity of the analysis by the analysis device 30 corresponding to the batch file whose selection has been accepted by the acceptance unit 1. The creation unit 5 creates an integrated report R based on the batch analysis data acquired by the analysis result acquisition unit 3 and the reference information acquired by the reference information acquisition unit 4.

[0032] According to this configuration, the analysis results indicated by the batch analysis data and the evaluation results regarding the validity of the analysis by the analysis device 30 are included in the integrated report R. Therefore, during an audit of the analysis device 30, the validity of the analysis can be proven by presenting the created integrated report R. Therefore, there is no need to present a separate report for proving the validity of the analysis.

[0033] Furthermore, in the analysis system 100, a single analysis may be performed as a trial analysis separately from the batch analysis. Even in such a case, since the result of the single analysis is included in the integrated report R, it is not necessary to present a separate report showing the result of the single analysis during an audit of the analysis device 30.

[0034] This reduces the effort required for audits, and also prevents mistakes such as presenting a report that does not correspond to the analysis results indicated by the batch analysis data, making it easier to perform appropriate audits of the analysis device 30.

[0035] (5) Other embodiments In the above embodiment, the integrated report R includes the analysis condition report R1, the operation history report R2, the analysis result report R3, the QA / QC report R4, and the system suitability report R5, but the embodiment is not limited to this. The integrated report R does not have to include the analysis condition report R1, and does not have to include the operation history report R2. In addition, the integrated report R does not have to include either the QA / QC report R4 or the system suitability report R5.

[0036] In the above embodiment, the integrated report R includes the results of the single analysis, but the embodiment is not limited to this. The integrated report R does not have to include the results of the single analysis.

[0037] In addition, in the above embodiment, the analysis information management device 10 automatically registers the created integrated report R in the database device 20, but the embodiment is not limited to this. The analysis information management device 10 does not have to register the created integrated report R in the database device 20. Alternatively, the analysis information management device 10 may register the created integrated report R in the database device 20 in response to an instruction from a user.

[0038] (6) Description It will be appreciated by those skilled in the art that the exemplary embodiments described above are examples of the following aspects.

[0039] (1) An analytical information management device according to one aspect includes: An analytical information management device capable of communicating with a database device in which a batch file for causing an analytical device to perform continuous analysis of samples is registered, In the database device, batch analysis data showing an analysis result corresponding to the batch file obtained by the analysis device and reference information for ensuring the validity of the analysis by the analysis device are registered so as to correspond to the batch file, The analysis information management device includes: a reception unit that receives a selection of the batch file registered in the database device; an analysis result acquisition unit that acquires from the database device the batch analysis data corresponding to the batch file whose selection has been accepted by the acceptance unit; a reference information acquisition unit that acquires, from the database device, the reference information corresponding to the batch file whose selection has been accepted by the acceptance unit; The analytical instrument may further include a creation unit that creates a report including an analysis result indicated by the batch analysis data and an evaluation result regarding the validity of the analysis performed by the analytical instrument, based on the batch analysis data acquired by the analysis result acquisition unit and the reference information acquired by the reference information acquisition unit.

[0040] In this analytical information management device, the report contains the analysis results indicated by the batch analysis data and the evaluation results regarding the validity of the analysis performed by the analytical device. Therefore, in an audit of the analytical device, the validity of the analysis can be proven by presenting the created report. Therefore, there is no need to present a separate report to prove the validity of the analysis. In this case, the effort required for the audit is reduced. In addition, the mistake of presenting a report that does not correspond to the analysis results indicated by the batch analysis data is prevented. This makes it possible to easily perform an appropriate audit of the analytical device.

[0041] (2) In the analysis information management device according to the first aspect, The reference information includes system suitability information that defines the stability of the analytical device, The creation section may create the report including a pass / fail result of the stability of the analysis device in the analysis as an evaluation result regarding the validity of the analysis by the analysis device.

[0042] In this case, the validity of the analysis can be easily indicated in the report as to whether the stability of the analysis device in the analysis is acceptable or not.

[0043] (3) In the analysis information management device according to the first or second aspect, The reference information includes quality assurance / quality control information that specifies the reliability of the analysis results; The creation section may create the report including a pass / fail analysis result for the sample as an evaluation result regarding the validity of the analysis performed by the analysis device.

[0044] In this case, the validity of the analysis can be easily indicated in the report as pass / fail results of the analysis of the sample.

[0045] (4) In the analysis information management device according to any one of paragraphs 1 to 3, History information indicating an operation history of the analysis information management device is further registered in the database device, the analysis information management device further includes a history information acquisition unit that acquires, from the database device, the history information corresponding to the batch file whose selection has been accepted by the acceptance unit, The creation unit may create the report further including an operation history indicated by the history information acquired by the history information acquisition unit.

[0046] In this case, the report further shows the operation history of the analytical information management device, which makes it possible to easily perform a more appropriate audit of the analytical device.

[0047] (5) In the analysis information management device according to any one of paragraphs 1 to 4, The database device further registers single analysis data indicating a result of a single analysis of a sample according to a predetermined analysis method; The reception unit further receives a selection of the single analysis data registered in the database device, the analysis result acquisition unit acquires from the database device the single analysis data selected by the acceptance unit; The creation unit may create the report further including an analysis result indicated by the single analysis data acquired by the analysis result acquisition unit.

[0048] According to this configuration, even if a one-off sample analysis is performed separately from the continuous sample analysis according to the batch file, the results of the analysis are included in the report. Therefore, in an audit of the analytical device, there is no need to present a separate report showing the analysis results of the one-off sample. In this case, the effort required for the audit is reduced. In addition, the mistake of presenting a report that does not correspond to the analysis results shown by the batch analysis data is prevented. This makes it possible to easily perform a more appropriate audit of the analytical device.

[0049] (6) Another aspect of the analysis information management method includes: 1. An analytical information management method for communicating with a database device in which a batch file for causing an analytical device to perform continuous analysis of samples is registered, comprising: In the database device, batch analysis data showing an analysis result corresponding to the batch file obtained by the analysis device and reference information for ensuring the validity of the analysis by the analysis device are registered so as to correspond to the batch file, The analysis information management method includes: receiving a selection of the batch file registered in the database device; obtaining the batch analysis data corresponding to the batch file whose selection has been accepted from the database device; acquiring, from the database device, the reference information corresponding to the batch file whose selection has been accepted; The method may further include a step of creating a report based on the acquired batch analysis data and the reference information, the report including the analysis results indicated by the batch analysis data and an evaluation result regarding the validity of the analysis performed by the analysis device.

[0050] According to this analysis information management method, the validity of the analysis can be proven by presenting the created report during an audit of the analytical device. Therefore, there is no need to present a separate report to prove the validity of the analysis. In this case, the effort required for the audit is reduced. Also, the mistake of presenting a report that does not correspond to the analysis results indicated by the batch analysis data is prevented. This makes it possible to easily perform an appropriate audit of the analytical device. [Explanation of symbols]

[0051] 1...reception unit, 2...related information acquisition unit, 3...analysis result acquisition unit, 4...reference information acquisition unit, 5...creation unit, 10...analysis information management device, 11...operation unit, 12...display unit, 20...database device, 30...analysis device, 100...analysis system, 110...network, R...integrated report, R1...analysis condition report, R2...operation history report, R3...analysis result report, R4...QA / QC report, R5...system suitability report

Claims

1. An analytical information management device capable of communicating with a database device in which a plurality of batch files for causing an analytical device to perform continuous analysis of samples is registered, a plurality of batch analysis data showing analysis results corresponding to the plurality of batch files obtained by the analysis of the analysis device, and a plurality of reference information corresponding to the plurality of batch files for ensuring the validity of the analysis by the analysis device are registered in the database device; The analysis information management device includes: a reception unit that receives a selection of the plurality of batch files registered in the database device; an analysis result acquisition unit that acquires from the database device the plurality of batch analysis data corresponding to the plurality of batch files whose selections have been accepted by the acceptance unit; a reference information acquisition unit that acquires, from the database device, the plurality of pieces of reference information corresponding to the plurality of batch files whose selections have been accepted by the acceptance unit; and a creation unit that creates a report including analysis results indicated by the plurality of batch analysis data and an evaluation result regarding the validity of the analysis by the analysis device, based on the plurality of batch analysis data acquired by the analysis result acquisition unit and the plurality of reference information acquired by the reference information acquisition unit.

2. The reference information includes system suitability information that defines the stability of the analytical device, The analytical information management device according to claim 1 , wherein the creation unit creates the report including a pass / fail result of stability of the analytical device in the analysis as an evaluation result regarding the validity of the analysis by the analytical device.

3. The reference information includes quality assurance / quality control information that defines the reliability of the analysis results; 3. The analytical information management device according to claim 1, wherein the creation section creates the report including a pass / fail result of the analysis of the sample as an evaluation result regarding the validity of the analysis by the analysis device.

4. History information indicating an operation history of the analysis information management device is further registered in the database device, the analysis information management device further includes a history information acquisition unit configured to acquire from the database device a plurality of pieces of history information corresponding to the plurality of batch files selected by the acceptance unit, 4. The analysis information management device according to claim 1, wherein the creation unit creates the report further including an operation history indicated by the plurality of pieces of history information acquired by the history information acquisition unit.

5. The database device further registers single analysis data indicating a result of a single analysis of a sample according to a predetermined analysis method; The reception unit further receives a selection of the single analysis data registered in the database device, the analysis result acquisition unit acquires from the database device the single analysis data selected by the acceptance unit; 5. The analysis information management device according to claim 1, wherein the creation unit creates the report further including an analysis result indicated by the single analysis data acquired by the analysis result acquisition unit.

6. 1. An analytical information management method for communicating with a database device in which a plurality of batch files for causing an analytical device to perform continuous analysis of samples is registered, comprising: a plurality of batch analysis data showing analysis results corresponding to the plurality of batch files obtained by the analysis of the analysis device, and a plurality of reference information corresponding to the plurality of batch files for ensuring the validity of the analysis by the analysis device are registered in the database device; The analysis information management method includes: receiving a selection of the plurality of batch files registered in the database device; acquiring from the database device the plurality of batch analysis data corresponding to the plurality of batch files whose selection has been accepted; acquiring, from the database device, the plurality of pieces of reference information corresponding to the plurality of batch files whose selection has been accepted; and creating a report based on the acquired plurality of batch analysis data and the plurality of reference information, the report including analysis results indicated by the plurality of batch analysis data and an evaluation result regarding the validity of the analysis performed by the analytical device.

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