Procedures for verifying measurement results

Abstract

This document describes a method for verifying measurement results from samples measured using a measuring device. This method prevents subsequent manipulation of the obtained measurement results without detectability.

Description

[0001] The invention relates to a method for verifying measurement results according to the features of claim 1.

[0002] Measuring instruments are used to measure samples. After the samples have been measured with such an instrument, the measurement results are usually provided to the user in the form of reports. It is standard practice to calibrate and, if necessary, adjust the measuring instrument before actually measuring the samples.

[0003] Such a measuring device could be, for example, a tablet tester, which can be used to measure pharmaceutical products such as tablets or granules. A tablet tester can measure parameters such as the length, width, mass, and hardness of pharmaceutical products. It can also determine the quality of samples. After the measurements have been taken, the results are provided in the form of a report.

[0004] Previously, it was common practice to simply export the report containing the measurement results to another external device, such as a PC, or to print it out. However, the results obtained in this way could easily be manipulated afterwards, for example by changing them on the PC.

[0005] The object of the present invention is therefore to provide a method by which manipulation of measurement results is prevented.

[0006] This problem is solved by a method according to the features of claim 1.

[0007] This describes a procedure for verifying measurement results.

[0008] This procedure for verifying measurement results comprises the following sequential steps: As a first step, a measuring device is provided for measuring samples, and this device includes user management software. In the following, "sample" refers to both a large number of test objects to be measured and the measurement of a single test object.

[0009] The measuring device can be a tablet testing device used to measure pharmaceutical products, such as tablets or granules. Such a tablet testing device has at least one measuring station arrangement, comprising at least one measuring station. In this at least one measuring station arrangement, a property of these pharmaceutical products (samples) can be measured. Preferably, this tablet testing device has several measuring station arrangements so that multiple properties of these samples can be measured. For example, a tablet testing device with several measuring station arrangements can measure not only the mass of these pharmaceutical products but also their quality, width, length, and hardness. For instance, a measuring station arrangement in which the mass of a sample is to be measured can include a measuring station in the form of a scale.If the quality of a sample is to be determined, this can be done in a measuring station arrangement that has several measuring stations, each measuring station being equipped with a camera or an NIR sensor.

[0010] Since tablet testing devices are known, they will not be described in detail below.

[0011] In a second step, a first person (= the user) who wishes to measure at least one or more samples (hereinafter also referred to as "samples" for the sake of simplicity) with the measuring device must, after switching on the device, have at least one biometric characteristic recorded for the first time using a designated identification device. This recorded biometric characteristic is then stored in the measuring device by saving it in the user management software.

[0012] Suitable biometric characteristics include, for example, a fingerprint, retina scan, or signature. In most cases, it should suffice for the first person to register only one biometric characteristic with the measuring device. However, if higher security requirements apply, it may be necessary to register multiple biometric characteristics.

[0013] In a third step, the measuring device stores this one biometric characteristic or the several stored biometric characteristics in the user management software.

[0014] After at least one biometric characteristic has been saved and thus stored in the measuring device, the measuring device is activated in a fourth step for measuring the samples.

[0015] At this point, a person can provide the samples to be measured to the measuring device. The samples can then be measured in a fifth step. In this step, the samples pass through at least one measuring station arrangement one after the other, with a measurement being obtained for each sample in that arrangement. If the measuring device has multiple measuring station arrangements, a measurement is obtained for each sample in each arrangement.

[0016] In a sixth step, a measurement result, in the form of at least one measured value from the measured samples, is stored as a report in the measuring device. For each measuring station configuration, a measurement result is thus obtained, consisting of at least one measured value from one sample. If several samples are measured in the corresponding measuring station configuration, the measurement result consists of multiple measured values, namely one measured value for each sample. If the samples are measured in a measuring device that has, for example, four measuring station configurations, four measurement results are obtained for each sample. These measurement results are stored as a report in the measuring device. The report therefore contains at least one measurement result.

[0017] After the samples have been measured, or at least one sample has been measured, at least one biometric characteristic must be recorded a second time and then stored in the measuring device. This storage of at least one biometric characteristic in the measuring device is again done by saving it in the user management software. As a rule, this biometric characteristic, recorded a second time, will also originate from the first person.

[0018] This biometric characteristic, captured for the second time and stored in the user management software, is compared by the measuring device's user management software with the biometric characteristic of the first person that was initially recorded. If the two stored characteristics are identical, the measuring device allows further processing of the report. It is therefore clear that the biometric characteristic recorded for the first time and the biometric characteristic recorded for the second time must be identical, meaning that the biometric characteristics must also originate from the same person. Should the biometric characteristic recorded for the second time originate from a different person, this will be detected by the user management software.If at least one biometric characteristic is not identical, the measuring device refuses to process the report further.

[0019] Further processing of the report means, for example, that a person can either print the report for the samples just measured in paper form or export it to an external device, such as a PC. Because the measurement results remain stored in the measuring device and have been verified by recording the biometric characteristics, any manipulation of the measurement results or the entire report can be detected at any time, for example, on a PC.

[0020] Although it is possible to prepare the samples in the measuring device beforehand, they must be prepared no later than after the device has been activated for measurements. Preparing the samples at this point is also advisable because the measuring device is only activated and measurements can only begin at that time.

[0021] In order for biometric characteristics to be recorded at all, the measuring device has at least one identification device. This identification device allows a specific biometric characteristic to be recorded. For example, the identification device could be a display on which a person has to sign their name.

[0022] It is also possible to use a scanner as an identification device that captures a biometric characteristic through measurement. For example, such a scanner can measure a fingerprint or the retina.

[0023] Depending on the required security standard, the measuring device can also have several identification devices.

[0024] Once at least one biometric characteristic of the first person has been captured and stored in the user management software, at least one biometric characteristic of a second person can be captured for the first time. This characteristic of the second person is then stored in the measuring device by saving it in the user management software. Involving a second person is particularly advantageous when security requirements are very high. The second person then acts as a verifier.

[0025] After the measurements are completed and the measuring device has generated the corresponding report, the first recorded biometric characteristic of the second person must be verified. To do this, the same characteristic must be recorded a second time. This second recorded biometric characteristic is then stored in the measuring device by saving it in the user management software. The device's user management software then compares the first recorded biometric characteristic of the second person with the second recorded biometric characteristic. If the two characteristics are identical, the measuring device allows further processing of the report, provided the characteristics of the first person also match.However, if the usage management software determines that the two characteristics do not match, further processing of the report is not possible because the measuring device blocks the options for further processing of the report.

[0026] If a second person is involved, then not only must at least one biometric characteristic of the second person be identical, but also at least one biometric characteristic of the first person. This results in a double verification of the measurements, making manipulation of the measurement results or even the entire report even more difficult.

[0027] It is clear to an expert that samples must be measured not only during the actual measurement of batches, but also during the adjustment or calibration of the measuring instrument. Therefore, various types of reports can be generated, such as a batch report, a calibration report, or an adjustment report. This process also allows calibration and adjustment reports to be verified and thus protected against manipulation.

Claims

[1] A method for verifying measurement results obtained by measuring samples in a measuring instrument, comprising the following successive steps 1.1 A measuring device for measuring samples is provided, wherein the measuring device comprises at least one identification device, user management software and at least one measuring station arrangement comprising at least one measuring station. 1.2 A first person who wishes to measure the samples with the measuring device must, after switching on the measuring device, have at least one biometric characteristic recorded for the first time by the at least one identification device. 1.3 The at least one biometric characteristic captured by the at least one identification device is stored in the measuring device by saving it in the user management software. 1.4 The measuring device is activated for measuring the samples. 1.5 The measuring device measures the samples, wherein the samples are measured successively in the at least one measuring station arrangement, and a measurement value is obtained for each sample that is measured in the at least one measuring station arrangement. 1.6 For at least one measuring station arrangement, a measurement result in the form of at least one measured value is stored as a report in the measuring device. 1.7 In addition to the first biometric characteristic of the first person being recorded, this biometric characteristic must be captured a second time by the identification device and stored in the user management software. [2] Method according to claim 1, characterized by , that between steps 1.4 and 1.5 the samples to be measured are made available to the measuring device. [3] Method according to claim 1, characterized by, that after step 1.7 the user management software of the measuring device compares whether the biometric characteristic recorded first by the first person is identical to the biometric characteristic recorded second time. [4] Method according to claim 3, characterized by , that the measuring device enables further processing of the report if the first recorded biometric characteristic of the first person is identical to the second recorded biometric characteristic, or the measuring device refuses further processing of the report if the first recorded biometric characteristic of the first person is not identical to the second recorded biometric characteristic. [5] Method according to claim 1, characterized bythat the identification device is a display on which a person must sign. [6] Method according to claim 1, characterized by that the identification device is a scanner that captures at least one biometric characteristic by measurement. [7] Method according to claim 1, characterized by , that after step 1.3 at least one biometric characteristic of a second person is recorded for the first time by the at least one identification device and subsequently stored in the measuring device by saving it in the user management software. [8] Method according to claim 7, characterized by, that after step 1.7, in addition to the first recorded biometric characteristic of the second person, at least one biometric characteristic is recorded a second time by the at least one identification device and stored in the user management software. [9] Method according to claim 8, characterized bythat the user management software of the measuring device compares the first recorded biometric characteristic of the second person with the second recorded biometric characteristic, and that the measuring device enables further processing of the report if the first recorded biometric characteristic of the second person is identical to the second recorded biometric characteristic, or that the measuring device refuses further processing of the report if the first recorded biometric characteristic of the second person is not identical to the second recorded biometric characteristic, and / or if the first recorded biometric characteristic of the first person is not identical to the second recorded biometric characteristic. [10] Measuring device with which the method according to claims 1 to 9 can be carried out. [11] Measuring device according to claim 10, characterized by that the measuring instrument comprises at least one measuring station arrangement which has at least one measuring station, wherein a measured value can be obtained for each sample which is measured in the at least one measuring station arrangement. [12] Measuring device according to claim 10, characterized by that the measuring device has at least one identification device with which a specific biometric characteristic can be detected. [13] Measuring device according to claim 10, characterized by that the measuring device is a tablet testing device.