JP2008140091A - Analysis data management system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To raise the security performance of analysis data management in a system handling analysis data concerning an analyzing device or a measurement device. <P>SOLUTION: A verification key is embedded in a key storing means in which a license key is embedded. The key storing means is established for every user, and is used as a dongle which can be carried, and (or) a predetermined data preserving area. On the other hand, analysis data, such as analysis conditions and analysis result, are beforehand locked with a lock key. If it is not confirmed that this lock key and a verification key embedded for the key storing means are associated, it prevents from using the analysis data. Since the analysis data cannot be used by other than a user who has a key storing means in which the appropriate verification key is embedded, the secrecy of the analysis data is held even if the analysis data can be revealed. By providing an authority definition part to which makes authority over analysis data to correspond about each of two or more verification keys is prepared, it is also possible to grant the authority according to a user's level. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a system that handles data related to analysis, and more specifically, data such as analysis conditions and analysis results handled in such a system (in this specification, such data is collectively referred to as “analysis data”). ) Related to a system for enhancing security.

  In recent years, in order to ensure the reliability of foods, pharmaceuticals, cosmetics, etc., an electronic record / signature rule called FDA21 CFR Part 11 (FDA: Food and Drug Administration, CFR: Code of Federal Regulations) has been introduced. FDA21 CFR Part 11 has strict data security standards, and measures to prevent inadvertent or intentional alteration or loss of data are required. As one of the countermeasures, security analysis is performed at various levels in the conventional analytical instrument, and for example, a user who is not permitted in advance cannot perform user registration and authority level setting. .

  As a measure for enhancing such security, a password is currently required together with a user ID in order to start an OS or specific application software. According to this, unless a user having a user ID permitted in advance inputs a password that only the user knows, the computer does not operate or a desired function cannot be used, and high security is ensured.

  As an example of conventional technology related to data security, Patent Document 1 describes an analyzer having a security function corresponding to manufacturing management and quality control defined by GLP (Good Laboratory Practice) and GMP (Good Manufacturing Practice). ing. In this analyzer, an operator name, a corresponding screen, and a prohibited command are registered in the access right table as a unit. When a command is issued, the command taker intercepts the command, and the command is passed to the issue destination only when the entry corresponding to the command does not exist in the access right table. If it is determined that access by the intercepted command is not permitted, the command is not executed because it is not passed to the issuing program. Therefore, it is possible to appropriately manage data access to analysis conditions and analysis results.

  Another example of the prior art is disclosed in Patent Document 2. According to this, in the device analysis data management apparatus that performs file management of analysis data by a combination of ID and password, when a mismatch is detected a predetermined number of times or more, an e-mail having a preset content is set as a predetermined destination. A configuration that immediately transmits and prohibits subsequent activation is disclosed. As a result, an appropriate response can be taken to an attempt to illegally enter the system, and strict security can be ensured.

Japanese Unexamined Patent Publication No. 7-319815 JP 2002-334020 A

  However, in the conventional general analysis data management system, if analysis data leaks through a network or media, or if the analysis data is taken out because the computer storing the data itself is stolen, There was a danger that the contents of confidential information (analysis data) could be viewed by the three parties using the same application software.

  The present invention has been made in order to solve the above-mentioned problems, and the object of the present invention is in a system that handles analysis data related to an analysis device or a measurement device, rather than security based on a conventional general user ID and password. It is to provide a stronger data security system.

The analytical data management system according to the present invention configured as described above,
In an analysis data management system for managing one or a plurality of analysis data, which is data related to analysis and locked by a predetermined lock key,
A key storage means provided for each user, in which a license key for the system and an authentication key for unlocking the analysis data are embedded;
Key reading authentication means for requesting predetermined key reading authentication when reading the license key and / or authentication key embedded in the key storage means;
When the key reading authentication by the key reading authentication means is completed, the authentication key is read from the key storage means based on the input of the analysis data use request or at a predetermined timing, and set to the authentication key and the analysis data Authentication key verification means for enabling use of the analysis data when the received lock key is appropriate,
It is characterized by comprising.

Moreover, the analysis data management system according to the present invention is preferably,
For each of the plurality of authentication keys, it further has an authority definition section in which authority for analysis data is stored,
The authentication key verification unit reads the authentication key from the key storage unit in a state where the key reading authentication by the key reading authentication unit is completed, and the authentication key and the lock key set in the analysis data correspond to each other. The analysis data may be configured to be usable within the scope of the authority corresponding to the authentication key described in the authority definition unit.

  In the present invention, the key storage means can be a portable dongle.

  In the analysis data management system according to the present invention, analysis data is locked in advance using a lock key. In order to unlock and view or edit analysis data (in this specification, various operations performed on such analysis data are referred to as “use analysis data”) The lock key and the authentication key embedded in the key storage means must correspond. As a result, a user other than the user who has an authentication key for releasing the lock key cannot use the analysis data even if only the analysis data is acquired.

  In addition, since the license key for the system according to the present invention is embedded in the key storage means together with the authentication key, the management of the license key and the management of the authentication key, which are conventionally performed in general, can be performed integrally. This brings about an effect that physical management becomes easy especially when the key storage means is a portable dongle.

When the authentication key is read to use the analysis data, a predetermined key read authentication is required by the key read authentication means. Therefore, the analysis data cannot be used unless this key read authentication is appropriately performed.
In the past, in order to prevent the theft of analysis data, there was a case where a computer was locked or a computer storage was required, but the analysis data management system according to the present invention should be used. This reduces the burden that was previously required to protect the analysis data. In other words, it is possible to reliably protect the analysis data at a low cost.

  Further, with respect to each of the plurality of authentication keys, it further includes an authority definition unit in which authority for analysis data is stored, and the authentication key collating means is within the range of authority corresponding to the authentication key described in the authority definition unit. By adopting a configuration in which analysis data can be used, when a plurality of users use the system, it becomes possible to flexibly control analysis data use authority for each user.

  Embodiments of an analysis data management system according to the present invention will be described below with reference to the drawings. FIG. 1 is an overall configuration diagram showing an example of an analysis system 1 using a network including an analysis data management system according to the present invention, and FIG. 2 is a block diagram showing a functional configuration of the analysis data management system of this embodiment. .

The analysis system 1 according to the present embodiment performs analysis devices A-1 to A-4, analysis control servers AS-1 to AS-3 connected to a network NW such as a LAN, analysis instructions and analysis result display for the analysis devices. A plurality of computers (personal computers) PC-1 to PC-3 that are clients for the system, a system control server SS for controlling the entire system, and a database server DS for storing analysis data that has been analyzed .
The analyzers A-1 to A-4 can be various analyzers and measuring devices, and the types thereof are not limited. In this embodiment, the analysis apparatus, the analysis control server, the personal computer, the system control server, and the database server are connected via the network NW. It is not limited to what is shown, and it is of course possible to connect various things. Of course, the number of connected devices connected to the network NW is not limited.

  In the database server DS, the analysis data acquired by each of the analysis apparatuses A-1 to A-4 is stored in a database so that the files can be shared. In order for the client to use this database, it is necessary to install an analysis data management program (software) on the computer, and in addition to reading and writing database files on this analysis data management program, various processes are performed. Is possible. Of course, it goes without saying that the same operation can be performed from the database server DS.

  Here, the database server DS and the computers PC-1 to PC-3 are analysis data management systems as shown in FIG. That is, the computer in which the analysis data management program is installed. As shown in FIG. 2, a CPU 2, a memory 3, a display unit 4 such as a liquid crystal display, an input unit 5 composed of a keyboard and a mouse, and a storage unit 6 which is a mass storage medium composed of a hard disk and a flash memory are mutually connected. Connected and configured. The storage unit 6 stores an analysis data management program 7 and an OS 8.

  The analysis data management system according to the present invention includes key storage means 9. In the key storage means 9, a software use license key and an authentication key of the system are embedded. “Embedded” means that it is controlled by software or hardware so that only data reading can be performed in a normal usage pattern.

  In the present invention, the key storage means 9 can be a dongle that can be carried by the user. A dongle is a medium in which data such as an authentication key can be embedded, and is detachable hardware having a size and weight that can be easily carried by a user. However, the form is not particularly limited. Here, “detachable” means that the analysis data management system according to the present invention accesses a dongle via an interface such as a USB or a non-contact reader, and reads a license key or an authentication key embedded in advance from the dongle. It is possible.

  Further, the key storage means 9 can be a local or network data storage area accessible by the analysis data management system according to the present invention. In the case of this form, as will be described later, the license key and the authentication key embedded in the key storage unit 9 are configured so that they cannot normally be read unless a predetermined authentication is performed. Thereby, leakage of the license key and the authentication key can be prevented.

  The key storage means 9 does not have to be one for one system, and can be provided for each user who uses the system. In this case, a common license key and a common authentication key are embedded in advance in the key storage means 9 used in a certain system. Alternatively, the user ID may be included in the authentication key. Furthermore, in addition to the authentication key, a different ID is further given to each key storage means 9, or the same ID is given to the key storage means 9 of a certain group (a different ID is assigned to each group). You can also

  In the present invention, analysis data output from the analyzer is locked by a predetermined lock key. The method for locking the analysis data is not particularly limited, and the analysis data may be encrypted using a lock key. Analysis data in the locked state cannot be used. In order to release this lock, the authentication key and the lock key need to correspond. Corresponding means that a predetermined condition is met by performing a predetermined calculation or the like. Therefore, the authentication key and the lock key do not have to be the same. A plurality of types of authentication keys and lock keys may be used.

  The key reading authentication means (actually realized by the CPU 2 executing the analysis data management program 7) is free to read the license key and / or the authentication key embedded in the key storage means 9. Key read authentication is requested to prevent the license key and the authentication key from being read. This is because if the license key or the authentication key is freely read, the analysis data can be used immediately after the system is started, and the protection thereof is not sufficient. The key reading authentication may be performed by, for example, inputting a password. In this case, the analysis data cannot be used unless the user knows the predetermined password.

  Further, when a dongle is used as the key storage means 9, the key read authentication may be performed by confirming the dongle connection. In this case, the analysis data cannot be used unless the user who owns the dongle connects the dongle to the system.

Hereinafter, when a user tries to use analysis data stored in the database server DS using the computer PC-1, the CPU 2 executes the analysis data management program 7 (hereinafter also simply referred to as a program). A processing procedure will be described with reference to a flowchart shown in FIG. 4 and an operation conceptual diagram of the analysis data management system according to the present invention shown in FIG. In this embodiment, a dongle that can be connected to the system via the USB port of the computer PC-1 is used as the key storage means 9.
In the present invention, the key reading authentication means and the authentication key collating means are realized by software when the CPU 2 executes the analysis data management program 7.

  First, start-up of the analysis data management program 7 and user authentication, which are executed in the previous stage of using analysis data, will be described. When the user activates the analysis data management program 7 by operating the input unit 5, the CPU 2 causes the display unit 4 to display a dialog requesting input of a user ID and password for user confirmation. When the authentication that the user ID and password input by the user are valid is completed, the CPU 2 checks whether or not a dongle is connected to a predetermined USB port (key read authentication). When the dongle is not connected, the CPU 2 causes the display unit 4 to display a message indicating that the dongle is not connected. When the dongle is connected, the CPU 2 reads the license key embedded in the dongle and checks whether it is a license key predetermined for the program 7. If the license key authentication fails, the CPU 2 displays the fact on the display unit 4 and terminates the program 7 or does not accept input from the user until a dongle in which a valid license key is embedded is connected. . When the authentication of the license key is completed, the CPU 2 displays a predetermined screen on the display unit 4 to indicate that it is in a standby state in which various inputs and commands from the user can be received.

  Next, when the user inputs a request to use certain analysis data by operating the input unit 5 (step S11), the CPU 2 (key reading authentication means) checks whether or not the dongle is connected (key reading). Authentication). If the above-described license key authentication is always performed (that is, the program 7 according to the present invention can be used only while the dongle 9 is connected), an analysis data use request is input. There is no need to check the dongle connection again. When the dongle 9 is not connected (No in step S12), as shown in FIG. 3A, the CPU 2 rejects the analysis data use request and displays a predetermined message on the display unit 4.

  If the dongle 9 is connected in step S22 (Yes in step S12), it is assumed that the key read authentication by the key read authentication means is completed, and the CPU 2 authenticates the dongle as shown in FIG. 3 (b). The key is read (step S13). Further, the CPU 2 reads the lock key specified in the analysis data use request and embedded in the analysis data to be used (step S14). In addition, the execution order of step S13 and step S14 is not ask | required.

  Next, the CPU 2 (authentication key collating means) compares the authentication key read from the dongle with the lock key set in the analysis data, and confirms whether or not they correspond (step S15). If the authentication key and the lock key do not match (No in step S15), the CPU 2 rejects the analysis data use request and displays a predetermined message on the display unit 4.

  When the authentication key and the lock key correspond to each other (Yes in step S15), the CPU 2 permits the analysis data use request input from the input unit 5 (step S16). As a result, the user can use the analysis data (see FIG. 3C).

  The present invention is not limited to this embodiment. In the present invention, when an analysis data use request is input from the input unit as described above, the CPU 2 (authentication key verification means) verifies whether it can be used for each analysis data. Alternatively, when an analysis data use request is input from the input unit, each of the analysis data can be used for a plurality of analysis data (for example, all listed in the display unit) at a time. You may make it collate. Further, the CPU 2 (authentication key verification means) authenticates from the key storage means 9 at a predetermined timing (for example, when the key reading authentication is completed) without waiting for the input of the analysis data use request from the input unit by the user. The key may be read to verify whether one or more analysis data is available.

When the analysis data management system according to the present invention is used by a plurality of users, a user who can see only a part of information related to analysis data, a user who can see only a report related to analysis data, and a user who analyzes There are cases where it is desirable to change the authority to use analysis data depending on the user's position, such as a user who can perform approval processing on data and reports.
Another embodiment of the present invention corresponding to such a use form will be described below as a second embodiment. The basic configuration of the second embodiment is the same as that described in the first embodiment unless otherwise specified.

  FIG. 5 shows an operation conceptual diagram of the present embodiment. In this embodiment, the authority definition unit 10 is provided in a part of the storage unit 6 or the like. The authority definition unit 10 can be provided in each client, or can be provided only in the database server DS so as to be accessible from each client.

The authority definition unit 10 stores the authority for the analysis data in association with each authentication key. That is, in this embodiment, the authentication key plays the role of an ID that determines authority.
For example, the authority definition section describes that an authentication key with access rights as “user” can only view analysis data, and an authentication key with access rights as “administrator” can view analysis data. It is described that the analysis data can be corrected or corrected (in addition to being capable of being used with an authentication key to which the user authority is given).

  In this embodiment, in order to determine the authority of a user for analysis data, an authentication key corresponding to the authority of the user is embedded in advance in a key storage means provided for each user. Of course, from the viewpoint of security, it is necessary that a normal user be configured not to embed or change the authentication key.

  Hereinafter, referring to FIG. 6 which is a flowchart, when a user tries to use analysis data stored in the database server DS using the computer PC-1, the CPU 2 manages analysis data according to the present embodiment. Processing performed by executing the program 7 will be described. Also in this embodiment, a dongle that can be connected to the system via the USB port of the computer PC-1 is used as the key storage means 9.

Since steps S21 to S25 of the program flow in the present embodiment are the same as steps S11 to S15 in the first embodiment, only the processing after step S26 will be described here.
If the authentication key read from the dongle corresponds to the lock key read from the analysis data (Yes in step S25), the CPU 2 (authentication key verification means) accesses the authority definition unit 10 and the authentication already read in step S23. The authority corresponding to the key is read (step S26).

  The CPU 2 gives permission to use the analysis data included in the analysis data use request input from the input unit 5 within the authority read in step S26 (step S27). As a result, the user can use the analysis data within the authority range corresponding to the authentication key embedded in the dongle (see FIG. 5).

  The analysis data management system according to the present invention has been described above with an example. However, the described embodiment is merely an example, and it goes without saying that modifications, improvements, and modifications can be appropriately made within the spirit of the present invention. Yes.

  For example, the analysis data management system according to the present invention may be configured to further include analysis data lock means for locking analysis data with a predetermined lock key corresponding to the authentication key (see FIG. 7). As a result, the data output from the analyzer and the newly created method data (ie, analysis data) are automatically issued or when a predetermined command is issued from the user via the input unit. Analytical data can be locked. In order to reduce the risk of data leakage as much as possible, it is desirable to lock the analysis data with a lock key when the analysis data is registered in the database server DS or at an earlier stage.

  In the above embodiment, a server / client type network system has been described as an example. However, the present invention can also be applied to a stand-alone type or a file sharing distributed type system in which no server is prepared.

1 is an overall configuration diagram illustrating an example of an analysis system using a network including an analysis data management system according to the present invention. The block diagram which shows the functional structure of the analysis data management system of embodiment. (a) When the dongle is not connected, (b) When the authentication key of the dongle and the lock key of the analysis data are incompatible, (c) When the authentication key and the lock key are appropriate, the analysis data management system according to the present invention FIG. The flowchart of an analysis data management program. The operation | movement conceptual diagram of the other structure of the analysis data management system which concerns on this invention. The flowchart of an analysis data management program. The operation | movement conceptual diagram of an analysis data lock means.

Explanation of symbols

1 ... Analysis system 2 ... CPU
3 ... Memory 4 ... Display unit 5 ... Input unit 6 ... Storage unit 7 ... Analysis data management program 8 ... OS
9 ... dongle 10 ... authority definition part A-1 to A-4 ... analysis device AS-1 to AS-4 ... analysis control server SS ... system control server DS ... database server PC-1 to PC-3 ... computer

Claims (6)

In an analysis data management system for managing one or a plurality of analysis data, which is data related to analysis and locked by a predetermined lock key,
A key storage means provided for each user, in which a license key for the system and an authentication key for unlocking the analysis data are embedded;
Key reading authentication means for requesting predetermined key reading authentication when reading the license key and / or authentication key embedded in the key storage means;
When the key reading authentication by the key reading authentication means is completed, the authentication key is read from the key storage means based on the input of the analysis data use request or at a predetermined timing, and set to the authentication key and the analysis data Authentication key verification means for enabling use of the analysis data when the received lock key is appropriate,
An analytical data management system comprising: For each of the plurality of authentication keys, it further has an authority definition section in which authority for analysis data is stored,
The authentication key verification unit reads the authentication key from the key storage unit in a state where the key reading authentication by the key reading authentication unit is completed, and the authentication key and the lock key set in the analysis data correspond to each other. The analysis data management system according to claim 1, wherein the analysis data can be used within a range of authority corresponding to the authentication key described in the authority definition unit.   The analysis data management system according to claim 1 or 2, further comprising analysis data lock means for locking analysis data with a predetermined lock key corresponding to the authentication key.   The analysis data management system according to claim 1, wherein the key storage means is a portable dongle.   The analysis data management system according to any one of claims 1 to 3, wherein the key storage means is a local or network data storage area accessible by the analysis data management system. A program for use in an analysis data management system for managing one or a plurality of analysis data that is data related to analysis and is locked by a predetermined lock key,
A computer that is provided for each user and that can access a key storage means in which a license key for the system and an authentication key for unlocking the analysis data are embedded;
Key reading authentication means for requesting predetermined key reading authentication when reading the license key and / or authentication key embedded in the key storage means;
When the key reading authentication by the key reading authentication means is completed, the authentication key is read from the key storage means, and the analysis data can be used when the authentication key corresponds to the lock key set in the analysis data. Authentication key verification means to
Analytical data management program characterized by functioning

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