JP2004028583A - Measuring instrument compatible with network - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a measuring instrument compatible with a network which is improved in operability and also, results of records of which adapted to an audit trail can be treated as an official data. <P>SOLUTION: The measuring instrument compatible with the network is provided with a key log-in function and a communication log-in function, and constituted such that the measured data is recorded in a recording medium, wherein a user capable of the key log-in and communication log-in is subjected to a unitary administration. <P>COPYRIGHT: (C)2004,JPO

Description

[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a network-compatible measuring device, and more particularly to an improvement in a log-in function in a measuring device such as a recorder that records digitized measurement data in a storage medium.
[Prior art]
[0002]
Recorders, which are a type of measuring device, are also used for monitoring, for example, manufacturing processes of pharmaceuticals and the like. Depending on the use form in monitoring the manufacturing process of pharmaceuticals and the like, a personal computer PC and a plurality of recorders R are connected via a LAN as shown in FIG. And reading the measured data into a personal computer PC.
[0003]
By the way, some network-compatible measuring devices are provided with a login function so that only a pre-registered specific user can operate from the viewpoint of ensuring the security of the measurement system.
[0004]
FIG. 5 is a block diagram showing an example of such a conventional network-compatible measuring device, and shows an example of a recorder. Prior to the operation of the recorder, user information including a user name, a user ID, and a password for giving the authority to log in to the recorder is set using the setting data operation unit 1. This setting data is stored in the setting data area of the internal memory 3 via the arithmetic control unit 2. It should be noted that, as these setting data, a user list having the operation authority from the key login operation unit 4 and a user list having the operation authority from the communication login operation unit 5 are separately stored.
[0005]
When the user performs a login operation from the key login operation unit 4, the arithmetic control unit 2 performs a key login operation in which the user name, user ID, and password input by the key login operation unit 4 are stored in the internal memory 3. It is checked whether the user name, user ID, and password registered in the user list having the operation authority from the unit 4 match. The arithmetic control unit 2 also confirms that there is no user who is currently key-logged in based on the key-login status data stored in another area of the internal memory 3. If the user name, the user ID, and the password match, and there is no user who is currently key-logged in, the key-login of that user is permitted, and operations such as measurement condition setting of the recorder become possible. In the logout state, operations other than the login operation cannot be performed.
[0006]
When the user logs in using the communication login operation unit 5, the arithmetic control unit 2 stores the user name, user ID, and password input by the communication login operation unit 5 in the internal memory 3. It is checked whether the user name, user ID, and password registered in the user list having the operation authority from the communication login operation unit 5 match. The arithmetic control unit 2 also confirms that no user is currently logged in for communication, based on the communication log-in state data stored in another area of the internal memory 3. If the user name, the user ID, and the password match and there is no user currently logged in for communication, the communication log-in of that user is permitted, and operations such as setting of measurement conditions of the recorder become possible. In the logout state, operations other than the login operation cannot be performed.
[0007]
When the measurement is started through a series of log-in procedures, an input signal such as a voltage applied to the input terminal 6 is converted into digital data by the measurement circuit 7, and the digital data is set in advance via the arithmetic control unit 2. The measured data from the memory start to the memory stop is stored in the measurement data area of the internal memory 3 at the set cycle.
[0008]
The measurement data stored in the internal memory 3 is transferred to and stored in the storage medium 8 in a file format when the memory is stopped. In addition, the storage medium 8 stores information for displaying the waveform of the measurement data, information of alarms and messages generated during the measurement, in addition to the measurement data. After the file is saved, the measurement data file is read from the storage medium 8 and the measurement data is referred to on the display unit 9.
[0009]
However, in the conventional measuring device, the management of the key login and the communication login are performed independently and individually. Thereby, it is possible to log in from the communication login operation unit 5 / key login operation unit 4 irrespective of the login / logout state from the key login operation unit 4 / communication login operation unit 5, and to set the measurement device and read the measurement data. Was possible.
[0010]
As described above, by independently and separately managing the key login and the communication login, there is an advantage that the setting and operation of the measuring device can be performed substantially simultaneously, but a user who can set and operate the measuring device simultaneously. There will be more than one.
[0011]
[Problems to be solved by the invention]
However, the simultaneous existence of a plurality of users who can set and operate the measuring apparatus has a problem that the apparatus does not conform to the audit trail described below.
[0012]
That is, the reliability of the measurement results of the recorder used for monitoring the manufacturing process of pharmaceuticals and the like is required to be compatible with inspections by public organizations. Specific examples are the U.S. Food and Drug Administration's requirements for audits of drug manufacturers, such as restricting access to measurement results, storing operation histories, and writing signatures during data authentication, and these are called audit trails. .
[0013]
Therefore, in order to conform to the audit trail, it is conceivable that only the key login function is enabled and the communication login function is disabled. The degree of freedom is greatly limited.
[0014]
An object of the present invention is to solve such a problem, and an object of the present invention is to provide a network-compatible measuring device that improves operability and enables a record result to be handled as formal data conforming to an audit trail. .
[0015]
[Means for Solving the Problems]
The invention of claim 1, which achieves such an object,
A network-compatible measuring device that has a key login function and a communication login function, and is configured to record measurement data on a storage medium.
It is characterized in that users capable of key login and communication login are centrally managed.
[0016]
As a result, only one user can log in to the measuring device.
[0017]
According to a second aspect of the present invention, in the network-compatible measuring device according to the first aspect, user information in which a user who has an operation right is registered, operation history of the device, and signature information of a user who has authenticated the measurement data correspond to the measurement data. And recording it on a storage medium.
[0018]
According to a third aspect of the present invention, in the network-compatible measuring device according to the second aspect, the operation history includes identification information of a key login or a communication login.
[0019]
According to a fourth aspect of the present invention, there is provided the network-compatible measuring device according to any one of the first to third aspects, further comprising a signature input unit for performing an electronic signature on the measurement data.
[0020]
According to a fifth aspect of the present invention, in the network-compatible measuring device according to the fourth aspect, input is permitted for a plurality of signature inputs in a set order.
[0021]
According to a sixth aspect of the present invention, in the network-compatible measuring device according to any one of the first to fifth aspects, the storage medium is provided at least inside or outside the device.
[0022]
As a result, a record result that can be handled as formal data conforming to the audit trail is obtained.
[0023]
BEST MODE FOR CARRYING OUT THE INVENTION
FIG. 1 is a block diagram showing an embodiment of the present invention, and portions common to FIG. 5 are denoted by the same reference numerals. The differences between FIG. 1 and FIG. 5 are the data storage form in the internal memory 3 and the configuration of the login operation unit 10.
[0024]
That is, in the internal memory 3, the log-in user list area stores the key log-in and the communication log-in unified without dividing them. In the login control data area, key login status data and communication login status data are unified and stored without being divided as shown in FIG.
[0025]
The login operation unit 10 is also shared without separating the key login operation unit 4 and the communication login operation unit 5 as shown in FIG. 5, and a key input unit 11 and a communication input unit 12 are separately provided as input units.
[0026]
In such a configuration, user information for granting the authority to log in to the measurement device (the recorder in the example of FIG. 1) is input from the setting data operation unit 1, and a log-in user list in the internal memory 3 and a Save in the area of the login control list. The stored contents include a login method, a user name, a user ID and a password, an operable range, and the like. Depending on the login method, it is possible to set, for each user, a method of not being able to log in, being able to log in only from the key, only from the communication, or from the key and the communication.
[0027]
In logging in, a user name, a user ID, and a password are input from the key input unit 11 or the communication input unit 12 of the main unit to the arithmetic and control unit 2 via the login operation unit 10. The arithmetic control unit 2 checks whether the input user name, user ID, and password match the user name, user ID, and password stored in the login control data area, and whether the user has already logged in. . If the user name, user ID, and password match and the user is not logged in, the logged-in data is saved in the login control data area, the entered user enters the login state, and the recorder can be set and operated. become.
[0028]
Here, when logging in from the communication input unit 12, it is possible to select a "setting connection" that can be set and operated and a "monitor connection" that can read only the measured value data.
[0029]
If there is a user who has logged in from the key input unit 11, control is performed to prohibit login by setting connection for communication and to limit only users who can make recorder settings.
[0030]
If there is a user who has logged in from the communication input unit 12 through the setting connection, control is performed so that no user can log in from the key input unit 11.
[0031]
Further, when logging in from the communication input unit 12 through the monitor connection, control is performed so that a user who is logged in through the setting connection from the key input unit 11 and the communication input unit 12 can log in unless the user is the same user. Thereby, the monitoring of the measurement data can be always performed as needed.
[0032]
In the operation history data area, information for discriminating whether the login has been performed from the key input unit 11 or the communication input unit 11 is recorded in addition to the operation content, date and time, and the user name of the operated user.
[0033]
In the logout state, control is performed so that other than the operation for login cannot be performed as in the related art.
[0034]
As a result, users who can operate the recorder can be restricted, and the user who is operating the recorder can be specified, and security of the recorder can be ensured.
[0035]
When the measurement is started through a series of log-in procedures, an input signal such as a voltage applied to the input terminal 6 is converted into digital data by the measurement circuit 7, and the digital data is set in advance via the arithmetic control unit 2. The measured data from the memory start to the memory stop is stored in the measurement data area of the internal memory 3 at the set cycle.
[0036]
The measurement data stored in the internal memory 3 is transferred to and stored in the storage medium 8 in a file format when the memory is stopped. The storage medium 8 includes, in addition to the measurement data, information for displaying a waveform of the measurement data, information on alarms and messages generated during the measurement, and information on who performed the memory start and the memory stop. Is also stored.
[0037]
By adding the user information to the measurement data in this way, only registered users can be given the right to access the data.
[0038]
In addition, by storing the operation history, it is possible to leave evidence of who did what, when, and what at the time of measurement.
[0039]
Note that the contents of the above-mentioned storage files may be stored together in one file, or may be stored individually in a file format corresponding to the measurement data file.
[0040]
After the file is saved, the measurement data file is read from the storage medium 8 and the measurement data is referred to on the display unit 9.
[0041]
FIG. 2 is a block diagram showing another embodiment of the present invention, showing an example in which a signature is input from the signature input unit 13 as data authentication. When the signature is input, the signature information is added to the file read via the arithmetic control unit 2 and stored in the storage medium 8. The details of the signature information include the name of the user who signed, the time, the determination of the availability of the measurement data, and the comment.
[0042]
Furthermore, by giving the sign input of a plurality of users and the restriction of the priority order for the sign input, for example, after the operator's sign input, the administrator can input the sign, thereby achieving thorough data management. .
[0043]
As described above, it is possible to realize a recorder that supports access restriction, operation history storage, signature writing, etc., for digitized data, and can receive the same treatment as measurement records recorded with conventional chart recorders. did.
[0044]
Further, by providing the storage medium outside the device, the measurement data can be read out by another device such as a personal computer and a signature can be input. At this time, by using the user information stored in the external storage medium, it is possible to permit only the user registered in the recorder to access the measurement data.
[0045]
In addition, binarization of data prevents easy data tampering, and saves check information to detect data tampering and standardizes the data tampering detection method between the recorder and personal computer. It can also be detectable.
[0046]
FIG. 3 is a flowchart showing an example of a procedure for opening a file on a personal computer and inputting a signature. A description will be given according to the processing procedure of this flowchart.
(S1) Enter a user name.
(S2) It is determined whether the user name is registered in the file.
(S3) If the determination in S2 is "Yes", the user inputs a user ID and a password. If the determination in S2 is "No", the process ends.
(S4) It is determined whether the user ID and the password are correct.
(S5) If the determination in S5 is "Yes", the file is opened. If the determination in S5 is "No", the user ID and password are re-entered.
(S6) A signature is input.
[0047]
In the present invention, portability of measurement data can be realized by providing a storage medium outside the device.
Thus, excellent operability such as performing an electronic signature after confirming the measurement data with another device at a location away from the measurement site can be realized.
[0048]
Note that the recorder of the present embodiment may record measurement data for complying with public certification in other industries as well as the pharmaceutical industry.
[0049]
Further, the remote control operation by the remote control terminal occurs and operates even when the user is not logged in to the measuring device. In the conventional apparatus, the operation history records the state at that time (user information when logged in, unknown when not logged in).
[0050]
On the other hand, by adding a mode that allows remote control operation only when the user is logged in to the measuring device, the user must be logged in to the measuring device when performing remote operation, and recording in the measuring device Audit trail of remote operation based on the operation history to be performed becomes possible.
Note that the operation history (key, communication, remote) information is stored in the operation history, so that the operation methods can be distinguished.
[0051]
Further, in the above-described embodiment, an example in which the measuring device is a recorder has been described. However, the present invention is not limited to a recorder, and the present invention can be applied to any device that records measurement results as electronic data such as a data logger.
[0052]
【The invention's effect】
As described above, according to the present invention, it is possible to realize a network-compatible measuring device that can improve operability and handle recorded results as formal data conforming to an audit trail. Can also respond.
[Brief description of the drawings]
FIG. 1 is a block diagram showing an embodiment of the present invention.
FIG. 2 is a block diagram showing another embodiment of the present invention.
FIG. 3 is a flowchart showing an example of a procedure for inputting a signature by another apparatus of the present invention.
FIG. 4 is a connection example diagram of a network-compatible measuring device.
FIG. 5 is a block diagram showing an example of a conventional network-compatible measuring device.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Setting data operation part 2 Operation control part 3 Internal memory 6 Input terminal 7 Measurement circuit 8 Storage medium 9 Display part 10 Login operation part 11 Key input part 12 Communication input part 13 Signature input part

Claims (6)

A network-compatible measuring device that has a key login function and a communication login function, and is configured to record measurement data on a storage medium.
A network-compatible measuring device that centrally manages users who can perform key login and communication login. 2. A network compatible device according to claim 1, wherein user information in which a user who has operation authority is registered, operation history of the apparatus, and signature information of the user who has authenticated the measurement data are recorded in a storage medium in correspondence with the measurement data. Shape measuring device. 3. The network-compatible measuring device according to claim 2, wherein the operation history includes information for distinguishing between key login and communication login. 4. The network-compatible measurement device according to claim 1, further comprising a signature input unit for performing an electronic signature on the measurement data. 5. The network-compatible measuring device according to claim 4, wherein input is permitted for a plurality of signature inputs in a set order. The network-compatible measuring device according to any one of claims 1 to 5, wherein the storage medium is provided at least inside or outside the device.

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