JP4385396B2 - Measurement data management device - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a measurement data management apparatus that takes in an electronic file of measurement data output from a recording apparatus and processes the electronic file.
[0002]
[Prior art]
[0003]
Conventionally, a measurement result of a recording device used for monitoring a manufacturing process of a pharmaceutical product or the like has been required to have reliability for responding to inspection by a public institution. Specific examples include storage of measurement condition data for determining measurement conditions and writing of a signature at the time of measurement data authentication, which are requested by the US Food and Drug Administration for audits to pharmaceutical manufacturers, and these are called audit trails.
However, in the conventional storage device that records the digitized measurement data that has become mainstream recently, it has been impossible to record the above-mentioned required items for the stored measurement data.
Therefore, the U.S. Food and Drug Administration cited in the example does not respond sufficiently to the audit trail requested by the pharmaceutical manufacturer, and the signature of the user who has authenticated the measurement data on the chart paper still recorded by the chart recorder At present, it is adopted as the measurement result.
This will be specifically described with reference to a conventional example.
[0004]
FIG. 6 is a diagram showing a configuration example of a conventional recording apparatus.
[0005]
In FIG. 6, an input signal such as a voltage is converted into electronic data by the measurement circuit 1, and the measured value from the memory start to the memory stop is transmitted to the internal memory 3 via the control means 2 at a preset period. Stored. The measurement data stored in the internal memory is stored in the storage medium 4 in a file format when the memory is stopped. The storage medium 4 is an external memory.
[0006]
Conventionally, information stored in the storage medium 4 includes measurement data, information for displaying the waveform of the measurement data, information on alarms and messages generated during measurement, and who has performed the memory start and memory stop. There was only some information.
[0007]
In the recording apparatus of FIG. 6, since the function is specialized for recording display of measurement data, the display screen is relatively small, and the processing mode for measurement data must be limited. Therefore, in order to expand these functions, there has been a measurement data management device that takes in an electronic file of measurement data output from a recording device and processes it.
When editing the measurement condition data with the measurement data management device, the measurement condition data held by the recording device is taken into the computer and edited. In a conventional measurement data management device, a measurement condition file output from a recording device is taken as original data and edited.
However, there were the following problems, and the handling of measurement conditions and the security for printed matter were not perfect.
(A) The original file was not protected and could be overwritten.
(B) When the original file is read and the measurement conditions are printed after the editing is started, it is unclear which editing time the file belongs to.
[0009]
[Problems to be solved by the invention]
The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a measurement data management apparatus that can handle electronic data as formal data in correspondence with storage of measurement condition data. And
[0010]
[Means for Solving the Problems]
The present invention is a measurement data management apparatus configured as follows.
[0011]
(1) In a measurement data management apparatus that takes in an electronic file of measurement data output from a recording device and processes the electronic file,
Measurement condition file storage means for storing measurement condition data for determining measurement conditions as a measurement condition file;
Mode setting means for setting the measurement condition file to an editable mode;
An editing means for generating a new measurement condition file based on an existing measurement condition file when the measurement condition file is set to an edit mode, and editing measurement condition data on the new measurement condition file;
Additional information control means that does not print the file creation time when printing while the measurement condition file is open in edit mode, and prints the file creation time when the edited measurement condition file is closed and then printed A measurement data management device characterized by comprising:
[0012]
(2) The measurement data management apparatus according to (1), wherein the measurement condition data is at least one of data defining a measurement range and a measurement channel.
[0017]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be described in detail with reference to the drawings.
FIG. 1 is a block diagram showing an embodiment of the present invention. In FIG. 1, the same reference numerals are assigned to the same parts as those in the previous figure.
In FIG. 1, the recording apparatus 20 takes in and stores measurement signals such as temperature and pressure as input signals. Measurement data, measurement condition data, registered user data, and the like are recorded in the storage medium 4. By attaching the storage medium 4 to a personal computer (PC) 10, the PC 10 takes in data of the recording device 20. The PC 10 takes in the measurement condition data from the recording device 20 and edits it. The edited measurement condition data is fed back to the recording device 20. If sufficient network security can be ensured, the PC 10 and the recording device 20 may be connected via a network.
[0018]
In the PC 10, the measurement condition file storage unit 11 stores measurement condition data for determining the measurement conditions as a measurement condition file. The measurement condition data is data such as a measurement range and a measurement channel, for example.
The mode setting unit 12 sets the measurement condition file to an edit mode in which edit is possible and a view mode in which edit is not possible. In the browse mode, the contents of the measurement condition file can be viewed on the screen, but the file contents cannot be changed.
When the measurement condition file is set to the edit mode, the editing unit 13 generates a new measurement condition file based on the existing measurement condition file, and edits the measurement condition data on the new measurement condition file. Do.
[0019]
The edited measurement condition file is fed back to the recording device 20. For example, the recording device 20 determines the measurement data of which measurement channel based on the measurement channel data included in the measurement condition file.
The additional information control means 15 does not print the additional information about the file when printing while the measurement condition file is opened in the edit mode, and prints the additional information about the file when the edited measurement condition file is closed and printed. .
The sign-in means 16 inputs an electronic signature when measuring data is authenticated.
The user authentication means 17 inputs a user authentication failure when the electronic signature input input by the sign-in means 16 is an unregistered user's electronic signature input, and is input when the number of user authentication failures reaches a predetermined number. Disable a user. Registered user data is stored in the storage means 4.
The history storage unit 18 stores the operation history when the user is invalidated by the user authentication unit 17 in the history file 19.
The printer 40 prints the contents of the measurement condition file.
[0020]
In the recording device 20, the measurement data creating means 21 stores the measurement condition data sent from the PC 10 in correspondence with the measurement data obtained under the measurement conditions defined by the measurement condition data in the storage means 4.
The user registration means 21 registers a user who gives authority for measurement operation.
The sign-in means 22, the user authentication means 23, the history storage means 24, and the history file 25 are the same means as the sign-in means 16, the user authentication means 17, the history storage means 18, and the history file 19.
The measurement data creation unit 261 of the control unit 26 records the measurement data and the signature data authenticated by the user authentication unit 23 in association with each other in the storage medium 4.
[0021]
FIG. 2 is a flowchart showing the procedure for editing the measurement condition file.
A description will be given according to the processing procedure of the flowchart.
(S1) The original file (measurement condition file) in the measurement condition file storage means 11 is read. At this time, the viewing mode is set, and the editing operation cannot be performed. Also, data cannot be saved to a file.
(S2) The measurement condition data of the read file is displayed.
(S3) It is determined whether to edit data.
(S4) When editing data, it is determined whether or not the editing mode is set.
(S5) If the editing mode is set, the editing is executed.
(S6) When not editing data, it is determined whether or not to print.
(S7) If the determination S6 is Yes, printing is executed. At this time, additional information regarding the file such as the file creator and the creation time is printed together with the measurement condition data. The additional information is printed as header information, for example. This printing is printing in the browsing mode.
(S8) When not printing, it is determined whether to save the file.
(S9) When saving the file, it is determined whether or not the editing mode is set. If the edit mode is not set, the process returns to step S2.
(S10) In the edit mode, it is determined whether there is a file with the same name. If there is a file with the same name, the process returns to step S2.
(S11) If there is no file with the same name, the file is saved. This prevents the file from being overwritten.
(S12) After saving, the mode is changed to the browsing mode.
(S13) If the file is not saved, it is determined whether to switch to the edit mode.
(S14) When switching to the edit mode, the file name is changed and additional information related to the file is deleted. If printing is performed at this time, the additional information is not printed. Since the measurement condition data can be changed in the edit mode, the additional information is not printed because it is unclear when the file was created.
(S15) It is determined whether to close the file. If it is closed, the editing is terminated. If it is not closed, the process returns to step S2.
[0022]
FIG. 3 shows an example of a screen displaying a list of contents of the measurement condition file.
In FIG. 3, the set “range”, “span”, etc. are listed for each measurement channel “CH01, CH02,...”.
[0023]
FIG. 4 is a schematic flowchart showing an example of a user authentication procedure. In this example, a case where the number of authentications is set to 3 will be described. This process is performed by the user authentication means 23.
First, a user ID is input to determine whether they match. In the case of “No”, it is determined whether or not the user ID input has failed three times. If the user ID has not failed three times, the user ID is re-entered. And exit.
If the determination of whether the user IDs match is “Yes”, the process proceeds to input of a password and determines whether the passwords match. In the case of “No”, it is determined whether or not the password input has failed three times, and if it has not failed three times, the process returns to the re-input of the user ID. Perform invalid write processing and exit.
If the determination of whether the passwords match is “Yes”, the electronic signature processing is performed and the process ends.
[0024]
FIG. 5 is a display example showing an operation history.
History No. “00000001” indicates that the user “A” performed the operation content “setting change” with the type “key input” at the time “2001/09/06 10: 31: 15.625”. In addition, history No. In “00000012”, it can be recognized from the description of the operation content “password invalid” that the user invalidation process has been performed due to the above-mentioned three failed password inputs.
[0025]
【The invention's effect】
According to the present invention, the following effects can be obtained.
[0026]
In the present invention , when the measurement condition file is set to the edit mode, a new measurement condition file is generated based on the existing measurement condition file, and the measurement condition data is edited with respect to the new measurement condition file. For this reason, it is possible to protect the contents by prohibiting overwriting the existing measurement condition file.
[0027]
Also , when printing is performed in a state where the measurement condition data is frequently changed during the edit mode, the creation time for the file is not printed. When editing is finished and the file is closed and then printed, the creation time for the file is printed. Thus, since the creation time is printed after editing is confirmed, it is possible to clarify when the file is created.
[0031]
As described above, according to the present invention, data reliability is ensured by prohibiting overwriting of existing measurement condition data to protect the measurement condition data. This can accommodate audits by the US Food and Drug Administration in the pharmaceutical industry, for example.
[Brief description of the drawings]
FIG. 1 is a configuration diagram showing an embodiment of the present invention.
FIG. 2 is a flowchart showing a procedure for editing a measurement condition file.
FIG. 3 is a diagram showing an example of a screen displaying a list of contents of a measurement condition file.
FIG. 4 is a schematic flowchart showing an example of a user authentication procedure.
FIG. 5 is a display example showing an operation history.
FIG. 6 is a diagram illustrating a configuration example of a conventional recording apparatus.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Measurement circuit 4 Storage medium 11 Measurement condition file storage means 12 Mode setting means 13 Editing means 15 Additional information control means 21 User registration means 16, 22 Sign-in means 17, 23 User authentication means 18, 24 History storage means 19, 25 History File 40 Printer 261 Measurement data creation means

Claims (2)

In a measurement data management device that takes in an electronic file of measurement data output from a recording device and processes it,
Measurement condition file storage means for storing measurement condition data for determining measurement conditions as a measurement condition file;
Mode setting means for setting the measurement condition file to an editable mode;
An editing means for generating a new measurement condition file based on an existing measurement condition file when the measurement condition file is set to an edit mode, and editing measurement condition data on the new measurement condition file;
Additional information control means that does not print the file creation time when printing while the measurement condition file is open in edit mode, and prints the file creation time when the edited measurement condition file is closed and then printed A measurement data management device characterized by comprising:   The measurement data management apparatus according to claim 1, wherein the measurement condition data is at least one of data defining a measurement range and a measurement channel.

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