JP4501146B2 - Recording device - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a recording apparatus for recording digitized measurement data on a storage medium, and more particularly to improving the reliability of recorded data.
[0002]
[Prior art]
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 be reliable for responding to an inspection by a public institution. As a specific example, the US Food and Drug Administration requested to conduct audits to pharmaceutical manufacturers to save the setting contents as the measurement conditions in the digitized measurement data, and the history of setting changes before the memory start These are referred to as audit trails.
However, in the conventional recording apparatus that records the digitized measurement data on the storage medium, the above-mentioned required items cannot be recorded for the stored measurement data.
For this reason, the US Food and Drug Administration cited as an example did not respond sufficiently to the audit trail required for audits to pharmaceutical manufacturers, and the digitized measurement data could not be handled as formal data.
This will be specifically described with reference to a conventional example.
[0003]
FIG. 3 is a diagram showing a configuration example of a conventional recording apparatus.
In FIG. 3, an input value such as a voltage is converted into electronic data by the measurement circuit 1 and stored in the internal memory 3 from the memory start to the memory stop at a preset period via the control means 32. The measurement value stored in the internal memory 3 is stored in the storage medium 4 in a file format when the memory is stopped.
The setting data is only stored in the setting data RAM 6 using the setting data operating means 5, and even if the setting content is changed, the changed content is not saved in the storage medium 4 as a change record such as log data. .
[0004]
[Problems to be solved by the invention]
In this case, in the file stored in the storage medium 4, there is no association of the setting contents with the digitized measurement record required by the above-mentioned pharmaceutical industry etc., and it is not possible to confirm what setting change has been made. For example, there is a problem that it cannot be handled as official data.
[0005]
The present invention has been made in order to solve the above-described problems, and corresponds to associating setting contents with an electronic measurement record and storing a history of setting changes, and requires the reliability necessary to be handled as formal data. It is an object of the present invention to provide a recording apparatus with improved performance.
[0006]
[Means for Solving the Problems]
The present invention is a recording apparatus configured as follows.
[0007]
(1) In a recording device for recording measurement data stored in an internal memory between a memory start and a memory stop on a storage medium in a file format when the memory is stopped.
Consists of control means, internal memory, storage medium and setting data RAM,
Wherein the control means, wherein with the between memory start and the memory stop to prohibit changing the setting value of the recording apparatus, measurement stored setting data stored in the setting data RAM at memory stop to the internal memory Save the data together with the data in a file format,
The setting data changed and confirmed during the memory stop and saved in the setting data RAM, together with the history of the setting data saving operation, correspond to the measurement data saved in the file by subsequent memory start and stop operations. And recording the file in a file format that can be loaded into the recording apparatus.
(2) The control means adds and stores a setting change number to the setting data file saved when the setting is changed, and adds the same number as the setting data file at the time of measurement to the measurement data file. The recording apparatus according to (1), wherein the number information is also stored in the history file.
(3) The recording apparatus according to (1) or (2), wherein the recording medium is provided inside or outside the apparatus.
[0008]
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is a block diagram showing an embodiment of the present invention. In FIG. 1, the same reference numerals are used for the same parts as in the previous figure.
[0009]
When the memory is stopped, the control means 2 stores the measurement data stored in the internal memory 3 and the setting data of the apparatus at that time in the storage medium 4 in a file format.
Specifically, the setting change of the apparatus is prohibited between the memory start and the memory stop, and the setting data at the time of the memory stop is stored in the storage medium 4 together with the measurement data in a file format.
As a result, it is possible to realize an association between the stored measurement data under which the measurement data is measured and recorded.
[0010]
In addition, during the memory stop, the setting data operating means 5 can change the setting of the apparatus, and the setting end processing is performed from the setting end operating means 7, whereby the setting data of the apparatus is determined. The determined setting data is stored in the setting data RAM 6 and further stored in the storage medium 4 in a file format.
Further, the setting data is saved in the storage medium 4 and at the same time, the history of the save operation is saved in the internal memory 3 and the storage medium 4 in a file format.
By associating these files with the measurement data saved in the subsequent memory start / stop operations, it is possible to specify when and who changed the settings before the memory start of the measurement data. .
In addition, by saving the settings in a file format that can be loaded by the device, the settings can be easily reproduced on the device.
[0011]
Also, the setting change number is stored by the number adding means 8 in the setting data file saved when the setting is changed, and the measurement data file is the same as the number stored in the setting data file which is the measurement condition. Store things.
Further, by storing the number information in the history file, the correspondence between the measurement data and the setting data can be achieved, and the confirmation work can be facilitated.
[0012]
FIG. 2 is an example of a setting change history file used in the embodiment of the present invention.
The setting change history file is list information of setting data saved in a file, and is constituted by history information such as saving date and time A1, file name A2, user name A3, and setting change number A4.
[0013]
Specifically, it can be seen that the user “ABC” saved the setting data with the file name “XYZ001” on the date “2001/07/05 14:10:16”. Furthermore, a setting change number “0000000001” is added. As described above, by adding the same number to the measurement data (not shown), correspondence between the measurement data and the setting data can be achieved, and the confirmation can be facilitated.
[0014]
As described above, it is possible to realize a recording device that supports the association of setting contents with electronic measurement records and the storage of setting change histories and improves the reliability necessary for handling as formal data, and each setting data The confirmation work can be simplified.
[0015]
In addition, by providing a storage medium outside the device, the data is portable, and data stored in the storage medium can be read and written by another device such as a personal computer at a location away from the measurement site. Confirmation can be performed.
In addition, data tampering can be prevented by storing the check information for detecting tampering of data by binarizing the data, and the data tampering detection method is shared between the device and the personal computer. Can be detected.
[0016]
For example, the US Food and Drug Administration audits in the pharmaceutical industry include not only the audit trail according to the present invention but also the security of the operation of the device and the setting of access rights that allow reading and writing of each data. By combining securing, it can be handled as formal data. This is realized, for example, by registering a user who is given an access right in the user information and providing an access permission means for permitting access to the registered user.
[0017]
Note that the recording device of the present invention may record measurement data for responding to public authentication in other industries as well as the pharmaceutical industry.
[0018]
【The invention's effect】
The present invention has the following effects.
[0019]
According to the first aspect of the present invention, there is provided a recording apparatus capable of handling the association of the setting contents with the electronic measurement record and storing the history of the setting change and improving the reliability required to be handled as formal data. realizable.
[0020]
According to the second aspect of the invention, the measurement data and the setting data can be made to correspond to each other, and the confirmation work can be facilitated to improve workability.
[0021]
According to the third aspect of the present invention, the storage medium is provided outside the apparatus so that the measurement data is portable, and the recorded data can be read, written, and confirmed by another apparatus such as a personal computer. The excellent operability can be realized.
[Brief description of the drawings]
FIG. 1 is a configuration diagram showing an embodiment of the present invention.
FIG. 2 is an example of a setting change history file used in the embodiment of the present invention.
FIG. 3 is a diagram illustrating a configuration example of a conventional recording apparatus.
[Explanation of symbols]
2 Control means 4 Storage medium 5 Setting data operation means 7 Setting end operation means 8 Number addition means

Claims (3)

In the recording device that records the measurement data stored in the internal memory between the memory start and the memory stop on the storage medium in the file format at the time of the memory stop,
Consists of control means, internal memory, storage medium and setting data RAM,
Wherein the control means, wherein with the between memory start and the memory stop to prohibit changing the setting value of the recording apparatus, measurement stored setting data stored in the setting data RAM at memory stop to the internal memory Save the data together with the data in a file format,
The setting data changed and confirmed during the memory stop and saved in the setting data RAM, together with the history of the setting data saving operation, correspond to the measurement data saved in the file by subsequent memory start and stop operations. And recording the file in a file format that can be loaded into the recording apparatus. The control means adds a setting change number to the setting data file stored when changing the setting, and stores the setting data file with the same number as the setting data file at the time of measurement. 2. The recording apparatus according to claim 1, wherein the number information is also stored in the history file.   The recording apparatus according to claim 1, wherein the recording medium is provided in one or both of the inside and the outside of the apparatus.

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