Archive System and Method for Archiving Electronic Data

Abstract

The present invention relates to an archive system 1 that archives electronic data and a method for archiving electronic data in the archive system 1 that belongs to the archive system 1.

Description

Technical Field

[0001] The present invention relates to an archiving system for archiving electronic data, the archiving system having storage means for storing electronic data, a data processing system for processing the electronic data, and a work process detection system for detecting work processes carried out in the process, the work process detection system being connected to the data processing system and the storage means via communication means for data transmission, and the data processing system being configured to convert the work processes detected by the work process detection system into electronic data.

[0002] Furthermore, the present invention relates to a method for archiving electronic data.

[0003] In addition, the present invention relates to a method of using an archiving system for archiving electronic data in the pharmaceutical industry.

Background Art

[0004] Archiving systems and methods for archiving electronic data have been prior art for a long time. In particular, data is digitized and then stored in a computer.

Summary of the Invention

Problems to be Solved by the Invention

[0005] From the above, the problem of the present invention is, particularly with regard to methods and processes in the pharmaceutical industry, to prevent large amounts of paper, some of which monopolize an entire room, which would otherwise be necessary for this type of document management, and in so doing, to make it possible to cherish the environment by simultaneously reducing costs and storage space, and to provide a method and apparatus for archiving electronic data in a version-secured form.

Means for Solving the Problems

[0006] This problem is solved in an archive system of the type described at the beginning, by configuring the archive system to archive electronic data in a version-secured form in the storage means of the archive system. The term "securing a version" is related to archiving in a version-secured form with respect to an electronic archive system. Here, this term is intended to understand the version from an economic perspective and is related to information and documents subject to an obligation to store or worth storing.

[0007] Therefore, in this context, "archiving in a version-secured form" basically means that the stored data is protected against subsequent changes by, for example, the user, so that the data in the archive system is not tampered with. At the same time, the data is archived in the archive system in a form that can be re-verified, found, not changed, and secure against tampering. The requirements for archiving in a version-secured form are defined in the Principles for the Proper Handling and Storage of Books, Records, and Documents in Electronic Form and for Data Access (GoBD). Archiving in a version-secured form encompasses the concept of "securing a version". This is related to the verifiability of the method employed, a) Verification of the document management method, b) Proper use, c) Secure flow, d) Secure operation, and e) Organization of the user enterprise including.

[0008] That is, "securing a version" does not refer only to technology or software but always encompasses the entire archiving method. Ten principles regarding the securing of versions of electronic data are defined as follows. 1) All data (E-documents) are archived in the archive system in an unchangeable form. 2) Electronic data must not be lost on the way to the archive system or within the archive system itself. 3) All electronic data must be retrievable again by suitable techniques (e.g., by indexing the metadata). 4) The required data must be retrieved accurately again. 5) The data must not be destroyed during the retention period. 6) All data must be able to be redisplayed and printed in the same form as when it was accurately detected. 7) All data must be retrievable again in a time-ordered manner. 8) All operations in the archive system that cause changes in the organization and structure must be logged so that the original state can be restored. 9) The electronic archive system is designed such that migration to new platforms, media, software versions, and components is possible without loss of information. 10) The archive system must provide the user with a method to ensure compliance with legal regulations regarding data security and data protection (e.g., BDSG, HGB, AO, etc.) and the regulations of the user's company over the lifetime of the archive system.

[0009] In Germany, archives that ensure a version of the electronic archive system must comply with multiple criteria. The legal requirements for this are a) German Commercial Code (§239, 257 HGB), b) Tax Code (§146, 147 AO), and c) New principles regarding the proper handling, storage, and data access of electronic books, records, and materials, abbreviated as GoBD (previously GoBS and GDPdU). derived from.

[0010] In summary, the following criteria for judgment can be derived. a) Compliance with the rules. Each document must be archived regularly based on legal and organizational internal requirements. b) Be complete. None of the archived documents shall be lost either on the path to the archive system or within the archive system itself. c) Be verifiable. The log of each change operation must be saved in a verifiable form in the electronic archive system. d) Be inspectable. The entire archiving method (organizationally and technically) must be inspectable by a third party with expertise at any time. e) The entire method is secure. All data must be archived at the earliest possible organizational point in time. f) Be protected against changes and tampering. All electronically archived data must match the original data. g) Be secure against loss. All data must be both retrievable and reproducible. h) Be accessible only to authorized persons. Only authorized users are permitted to view the archived data. i) Comply with the retention period. Data is permitted to be deleted from the archive system at the earliest after the expiration of the retention period. j) Document the method. Compliance with all the previously mentioned principles, and furthermore, any possible changes in the archive system, must always be documented.

[0011] An archive system that archives while ensuring the version has the advantage that all steps of the method in, for example, the manufacture of pharmaceuticals in the pharmaceutical industry (these are monitored by, for example, national institutions and are always inspectable) are archived in a form protected against tampering. Such an archive system further has the advantage that a large amount of paper that would otherwise be required for this type of document management and that would occupy an entire room no longer occurs. As a result, on the one hand, it is environmentally friendly, and on the other hand, it can save costs and storage space related to paper.

[0012] Advantageously, this data processing system has storage means. This storage means is preferably a normal data memory such as, for example, a hard disk or a device equivalent thereto. The electronic data is preferably stored in so-called batch records. Advantageously, in the storage means of the archive system, one or more of the work steps to be performed in the process as work step target value data, the components required for the work steps to be performed in the process as component target value data, the amount of the content (components) to be administered as weight target value data, and the component storage location of the components as component storage location target value data are stored in the form of electronic data.

[0013] In an additional embodiment of this archive system, the archive system has a detection system configured as a component detection unit and / or a weight detection unit, and these component detection units and / or weight detection units are connected to the data processing system and the storage means via communication means for data transmission. This component detection unit is preferably configured to detect component load data, and whether these component load data are the components present in the work steps to be performed in the process, or this weight detection unit is preferably configured to detect weight load data, and whether these weight load data (mass load data) are the weights of the components or the content to be processed in the work steps to be performed in the process, or both.

[0014] Particularly advantageously, one or more of these process detection units, component detection units, and weight detection units are configured as part of a detection system or a detection system. Advantageously, one or more of these detection systems, process detection units, component detection units, and weight detection units are configured as sensors, advantageously as optical sensors, particularly advantageously as cameras, and most advantageously as video cameras. Such a detection system can accurately detect one or more of individual processes, individual components, and the mass of the components (contents), and advantageously, the detected data can be stored or saved in an archive system in a version-secured form.

[0015] This data processing system is advantageously configured to convert component load data into component actual value data in the form of electronic data. The data processing system of this archive system can convert the data detected by the detection system into electronically evaluable data such as images or videos.

[0016] Furthermore, this archive system has a comparison means connected to the data processing system via communication means for data transmission. Advantageously, this comparison means is configured to perform one or more of the comparison of actual value data and target value data, particularly the comparison of process actual value data and process target value data, the comparison of component actual value data and component target value data, and the comparison of weight actual value data and weight target value data. In an advantageous variant, the data processing system has this comparison means.

[0017] In an advantageous embodiment, this archive system has evaluation means connected to a data processing system via communication means for data transmission. Advantageously, this evaluation means is configured to evaluate the comparison performed by the comparison means. This evaluation means is optimally configured to provide, by the evaluation, one or more of the evaluation results, in particular, the work process evaluation result, the component comparison result, and the weight evaluation result. Particularly advantageously, the data processing system has this evaluation means.

[0018] In a further advantageous embodiment, this archive system has a display system with a display unit connected to a data processing system via communication means for data transmission. In a particularly advantageous embodiment, this display system is configured as a monitor and / or data glasses. More advantageously, this display system is configured to display one or more of the evaluation results provided by the evaluation means, advantageously, the work process evaluation result, the component comparison result, the weight evaluation result, and the location evaluation result.

[0019] By the comparison means and the evaluation means of this archive system, the data detected by the detection system can be compared with, for example, the data already stored in the storage means of the archive system and evaluated, and as a result, it is advantageous that the evaluation result is provided for further processing in the archive system and for the archive in a version-secured form.

[0020] In a further improved configuration of this archive system, the archive system has position detection means for detecting the current position of the operating operator connected to a data processing system via communication means for data transmission. Correspondingly, advantageously, this archive system is configured to display the route to the component storage location on the display system. Thereby, when, for example, there is a shortage of components, the operating operator can have the fastest route and / or the shortest route to the nearest component displayed by the display system, and as a result, time losses during production are minimized.

[0021] Furthermore, in the method of the form described at the beginning, this method for archiving electronic data has an archiving system, the archiving system having storage means for storing electronic data, a data processing system for processing the electronic data, and a detection system configured as a work process detection unit for detecting work process load data, these work process load data being the work processes implemented in the process, this work process detection unit being connected to the data processing system and the storage means via communication means for data transmission, this data processing system being configured to convert the work process load data detected by the work process detection unit into work process actual value data in the form of electronic data, the method having a step of detecting, by the work process detection system, the implemented work process in the form of the work process load data of the process, a step of converting the detected work process load data of the process into work process actual value data in the form of electronic data, a step of transmitting these work process actual value data to the storage means, and a step of archiving these work process actual value data in a form in which the version is secured in the storage means of the archiving system.

[0022] The method by an archiving system that archives in a form in which the version is secured has the advantage that all steps of this method, such as the assembly of components used in the pharmaceutical industry, such as nozzles or equivalents thereof (which are, for example, monitored by state agencies and can be inspected at any time), are archived in a form protected against tampering. Such a method further has the advantage that, otherwise, there will no longer be a large amount of paper that occupies the entire room as required for such document management. As a result, on the one hand, the environment is cherished, and on the other hand, the costs and storage space related to paper can be saved.

[0023] In an embodiment related to this method, in the storage means of the archive system, the target value data of the working process of the process is stored as electronic data, the archive system has a comparison means for comparing the stored target value data of the working process with the actual value data of the working process, the archive system has an evaluation means for evaluating the comparison between the target value data of the working process of the process and the actual value data of the working process implemented by the comparison means, and this method includes a step of comparing the target value data of the working process of the process with the actual value data of the working process, a step of evaluating the comparison between the target value data of the working process and the actual value data of the working process implemented by this comparison means, and a step of providing the evaluation result of the working process.

[0024] In a further improved configuration of this method, the component target value data and / or the weight target value data are stored in the storage means, and this method includes a step of transmitting these component target value data and / or weight target value data to a data processing system, a step of comparing the component target value data and / or weight target value data of the process with the component actual value data and / or weight actual value data of the process, a step of evaluating the comparison between the component target value data of the process and the component actual value data and / or the weight target value data and the weight actual value data implemented by the comparison means, and a step of providing the component evaluation result.

[0025] Advantageously, this archival system has a component detection unit and / or a weight detection unit, and this method has a step of detecting component load data and a step of converting these component load data into component actual value data in the form of electronic data, or a step of detecting weight load data and a step of converting these weight load data into weight actual value data in the form of electronic data, or both. Particularly advantageously, component target value data and / or weight target value data are stored in a storage means, and this method has a step of transmitting component actual value data and / or weight actual value data to a data processing system, a step of performing a comparison between the component target value data and / or weight target value data of the process and the component actual value data and / or weight actual value data, a step of evaluating the comparison between the component target value data and / or weight target value data of the process and the component actual value data and / or weight actual value data performed by a comparison means, and a step of providing a component evaluation result and / or a weight evaluation result.

[0026] This has the advantage that both the work process evaluation result and the component evaluation result and / or the weight evaluation result are available for further processing.

[0027] In a further improved configuration of this method, this archival system has a display system for displaying one or more of the evaluation results provided by an evaluation means, advantageously the work process evaluation result and / or the component evaluation result, and the component storage location for the required components stored in a storage means, and this method has a step of displaying the evaluation results provided by the evaluation means on the display system.

[0028] Advantageously, this archive system has position detection means for detecting the then current standing position of the operating operator, and this method has a step of displaying a path from the then current standing position of the operating operator to the component storage location. Thereby, when, for example, there is a shortage of components, the operating operator is displayed by the display system with the fastest path and / or the shortest path to the nearest component, and as a result, temporal losses during production are minimized.

[0029] Particularly advantageously, the electronic data individually generated in the steps of this method are archived in a version-secured form.

[0030] Furthermore, it is advantageous to use an archive system for archiving electronic data in the pharmaceutical industry, and this archive system is based on any one of claims 1 to 20.

[0031] Hereinafter, the present invention will be described in detail based on the accompanying drawings.

Brief Description of the Drawings

[0032]

Figure 1

Figure 2

Figure 3

Modes for Carrying Out the Invention

[0033] FIG. 1 illustrates a basic flowchart of an advantageous archive system 1 for archiving electronic data used when assembling components of equipment in a version-secured form.

[0034] This archive system 1 has a detection system 2 including a work process detection unit 2a and a component detection unit 2b. This detection system 2, particularly the work process detection unit 2a and the component detection unit 2b, are preferably configured as sensors, more preferably as optical sensors, and most preferably as cameras, particularly as video cameras.

[0035] In most advantageous forms, this detection system 2, particularly the work process detection unit 2a, is configured as a data glasses with a video camera. Thereby, the work process detection unit 2a enables an operator to detect the work process carried out within the detection area of the work process detection unit 2a, for example, in its working space. It is also conceivable to install this detection system 2 stationary at a fixed position, for example, configured as a camera (body cam) arranged on the body, and preferably the component detection unit 2b is configured in such a form. Thereby, it is preferably possible to always detect components that can be used with respect to the individual work processes in the operator's working space.

[0036] The detection system 2 consisting of the work process detection unit 2a and the component detection unit 2b illustrated in this embodiment has two independent detection systems 2 as video cameras. This detection system 2 is suitable for detecting raw data 3, particularly for detecting work process raw data 3a and component raw data 3b.

[0037] The work process load data 3a and component load data 3b detected by these work process detection units 2a and component detection units 2b are transmitted to a data processing system 5 via communication means 4 such as, for example, a data transmission cable, a conductor line, a wireless network, or the like equivalent thereto. This data processing system 5 is configured to convert the load data 3 detected by the detection system 2 into detected electronic actual value data 6. In this case, the work process load data 3a is converted into detected electronic work process actual value data 6a, and the component load data 3b is converted into detected electronic component actual value data 6b.

[0038] In this embodiment, the data processing system 5 of the archive system 1 has a storage means 7, a comparison means 8, and an evaluation means 9.

[0039] In this storage means 7, particularly in the batch record configured as at least a part of the storage means, on the one hand, the electronic actual value data 6 obtained from the load data 3 by conversion, particularly the work process actual value data 6a and the component actual value data 6b, can be stored. On the other hand, additional other electronic data can be stored in this storage means 7. These other electronic data include, for example, all forms of documents, particularly the target value data 10. Advantageously, they include the component of the facility, here the work process target value data 10a to be processed by the operating operator during the assembly of the nozzle. Similarly, this method generates a list of components required for each work process as the component target value data to be stored in the storage means 7 as the stored electronic target value data 10. The component storage location data 10d can also be stored in the storage means 7 as electronic data.

[0040] All raw data 3, actual value data 6, target value data 10 and additional electronic data are archived in an advantageous archive system 1 in an unchangeable form. In this case, all data, in particular, raw data 3, actual value data 6 and target value data 10 are stored in a storage means 7 and are provided with metadata for uniquely identifying, for example, for indexing, as a result of which the electronic data can be retrieved again at any time during the storage period. All electronic data must be retrievable and displayable in exactly the same form as when it was detected and must be printable.

[0041] This comparison means 8 is suitable for comparing the detected electronic actual value data 6 stored in the storage means 7 with the stored electronic target value data 10. In this case, the working process actual value data 6a is compared with the working process target value data 10a, and the component actual value data 6b is compared with the component target value data 10b.

[0042] This evaluation means 9 is configured to evaluate the comparison of the stored, detected electronic actual value data 6 and the stored electronic target value data 10 performed by the comparison means 8 and to identify or provide an evaluation result 11. In particular, from the comparison of the working process actual value data 6a and the working process target value data 10a, a so-called working process evaluation result 11a is obtained, and from the comparison of the component actual value data 6b and the component target value data 10b, a so-called component evaluation result 11b is obtained.

[0043] Furthermore, the archive system 1 of this embodiment has a position detection means 12 for detecting location data 6d of the current position of the operating operator, which is connected to a data processing system 5 via a communication means 4 for data transmission. However, this is not necessarily required. This position detection means 12 is particularly suitable for providing a location evaluation result 11d by comparing the location data 6c of the current position of the operating operator and the component storage location data 10d, which is carried out by the comparison means 7 and the evaluation means 8.

[0044] These component storage location data 10d can be obtained, for example, by inventorying components attached with microchips, particularly by using radio frequency identifiers (RFIDs) for components and uniquely storing the components. In this case, for example, other information such as status data, such as cleaned, verified or equivalent status, can also be stored by the component storage location data.

[0045] This advantageous archive system 1 has a display system 13 for displaying the evaluation results 11. Advantageously, this display system 13 preferably has display units 14a, 14b and 14d for reproducing the evaluation results 11, particularly the work process evaluation result 11a, the component evaluation result 11b and the location evaluation result 11d. Advantageously, for example, status data is also displayed, so that the operator can always have a complete overview of the current situation of the process. This display system 12 is preferably configured as a monitor, but particularly preferably as data glasses with a projection surface for displaying the evaluation results 11. Thereby, in addition to other information, for example, it is possible to display the work process evaluation result 11a on the projection surface of the data glasses. This location evaluation result is preferably displayed on the display system 13 as a route to the component storage location.

[0046] A first embodiment of this advantageous method for archiving electronic data will be described based on the assembly of nozzles, but this method can also be used in the same way for archiving electronic data when assembling components of other facilities.

[0047] When assembling the nozzle, the operator wears, as the detection system 2, for example, data glasses equipped with a video camera in the work space. This detection system 2, as the work process detection unit 2a and the component detection unit 2b, on the one hand, detects the work process carried out by the operator when assembling the nozzle as work process load data 3a, and on the other hand, detects the components for assembling the nozzle present in the work space as component load data 3b.

[0048] Subsequently, the detected load data 3 is transmitted via the communication means 4 to a data processing system 5, such as a computer or a device equivalent thereto. This data processing system 5 converts the detected load data 3 into actual value data 6, that is, work process actual value data 6a and component actual value data 6b. Both of these load data 3 and actual value data 6 are stored in the storage means 7 assigned to the data processing system 5 in a version-secured form.

[0049] Furthermore, target value data 10, particularly work process target value data 10a and component target value data 10b, are stored in the storage means 7.

[0050] As work process data, advantageously, a list of the individual work processes to be carried out is stored in the storage means 7.

[0051] As the component target value data 10b, advantageously, an image of a pre-trained CAD model is used, for example, using industrial image processing software such as Halcon 8.0 from MVTec Software GmbH. This software detects the arbitrary position and orientation of a three-dimensional object in space by shape-based matching, that is, by comparing it with a pre-trained CAD model.

[0052] The comparison means 8 accesses the actual value data 6 (work process actual value data 6a and component actual value data 6b) obtained from the load data 3 stored in the storage means 7, and compares these data with the target value data 10 (work process target value data 10a and component target value data 10b). Then, this comparison is evaluated by the evaluation means 9, and the evaluation result 11 is provided in the form of a work process evaluation result 11a and a component evaluation result 11b. Different from the negative evaluation result 11, the positive evaluation result 11 confirms to the operation operator that the work flow has no room for doubt. When the work process evaluation result 11a is positive, it means that each work process has been correctly implemented. For example, all parts have been correctly assembled with each other. When the component evaluation result 11b is positive, there are sufficient components related to the work process to be performed when assembling the nozzle or for completely assembling the nozzle in the operation space of the operation operator.

[0053] The evaluation result 11 in the form of the work process evaluation result 11a and the component evaluation result 11b is displayed to the operation operator on the display unit 14 of the display system 13 configured as a projection surface of the data glasses or as a monitor. Further, for example, there is also a method of giving an acoustic signal to the operation operator via headphones.

[0054] Therefore, for example, by displaying a negative work process evaluation result 11a during the progress of the process, the operation operator can immediately detect the obstacle that occurred during assembly and correct it. As a result, each nozzle is assembled in the same way, and at the same time, the assembly process is stored in the archive system 1 in a form that ensures the version, for example, for government agencies. If the assembly of the nozzle is incorrect, for example, there is a method of interrupting the further assembly of the nozzle due to a power failure of the tool required for assembly. When the operation operator corrects the assembly of the nozzle, the further assembly of the nozzle can be performed.

[0055] For example, during the process, if the display of the negative component evaluation result 11b indicates to the operating operator that there are not enough components in the working space of the operating operator for nozzle assembly, an order or a method for the operating operator to obtain it by taking it out from the component storage can be obtained. In this case, there is also a method of pre-comparing the components related to the next or the next-next working process, and as a result, the operating operator can always work without being interrupted. At the same time, it is also conceivable to automatically place an order and supply it when there are no components.

[0056] The position detection means 12 detects the exact standing position of the operating operator, for example, by a GPS sensor incorporated in the data glasses. This means 12 is suitable for providing the location evaluation result 11d to the operating operator by comparing the component storage location data 10d stored in the storage means 7 with the then standing position of the operating operator when the components related to the working process do not exist in the working space of the operating operator, and displaying to the operating operator the route to the corresponding components in the nearest component storage location.

[0057] The operating operator can call the then effective standard operating procedure (SOP) at any time during nozzle assembly and display it on the display system 13. According to the above-described flow, document management in accordance with the "Good Manufacturing Practice" (GMP) during nozzle assembly is guaranteed.

[0058] All data generated during this method is archived in the storage means 7 of the archive system 1 in a form that ensures the version.

[0059] Advantageously, in the field of the pharmaceutical industry, where very high requirements are imposed on the documentation management of data, the above-described method and the archive system belonging thereto can be used not only during the assembly of the components of the equipment but also during the assembly of the equipment itself. This method can likewise be implemented during the installation of equipment, in particular, the attachment of tools, tableting presses, packaging machines or components of equipment such as equivalent devices.

[0060] FIG. 2 shows a basic flow diagram of an advantageous archive system 1 for archiving electronic data used when weighing the contents of pharmaceuticals in a version-secured form.

[0061] This archive system 1 has a detection system 2 comprising a work process detection unit 2a, a component detection unit 2b and a weight detection unit 2c. This detection system 2, in particular, the work process detection unit 2a, the component detection unit 2b and the weight detection unit 2c are advantageously configured as sensors, particularly advantageously as optical sensors, and most particularly advantageously as cameras, in particular, as video cameras. Further, optionally, this weighing instrument can also communicate directly with the storage means 7 for any additional management or second verification and / or documentation management that may occur.

[0062] In a generally advantageous form, the detection system 2, in particular the work process detection unit 2a, is configured as a data glasses with a video camera. Thereby, the work process detection unit 2a enables an operating operator to detect the work process that the operator performs within the detection area of the work process detection unit 2a, for example, in its work space. It is also conceivable to install the detection system 2 stationary at a fixed position. For example, the detection system is configured as a camera (body cam) arranged on the body, and advantageously, the component detection unit 2b and the weight detection unit 2c are configured in such a way. Thereby, advantageously, based on the weight display of the weighing instrument and / or the label of the package, for example, batch number, active substance, expiration date, etc., the component detection unit 2b detects and compares the components that are always available for the individual work processes in the work space of the operating operator, and the weight detection unit 2c can detect and compare the weight of the content (active substance or auxiliary material) weighed by the weighing instrument, for example, for the preparation of pharmaceuticals.

[0063] The detection system 2 consisting of the work process detection unit 2a, the component detection unit 2b, and the weight detection unit 2c illustrated in this embodiment has three detection systems 2 that are independent of each other as video cameras. This detection system 2 is suitable for detecting the raw data 3, in particular, the work process raw data 3a, the component raw data 3b, and the weight raw data.

[0064] The work process load data 3a, component load data 3b, and weight load data 3c detected by the work process detection unit 2a, component detection unit 2b, and weight detection unit 2c are transmitted to the data processing system 5 via communication means 4 such as, for example, a data transmission cable, conductor line, wireless network, or the like equivalent thereto. This data processing system 5 is configured to convert the load data 3 detected by the detection system 2 into detected electronic actual value data 6. In this case, the work process load data 3a is converted into detected electronic work process actual value data 6a, the component load data 3b is converted into detected electronic component actual value data 6b, and the weight load data 3c is converted into detected electronic weight actual value data 6c.

[0065] In this embodiment, the data processing system 5 of the archive system 1 has a storage means 7, a comparison means 8, and an evaluation means 9 corresponding to the archive system 1 shown in FIG. 1.

[0066] In this storage means 7, particularly in the batch record configured as at least a part of this storage means, on the one hand, the electronic actual value data 6 obtained from the load data 3 by conversion, particularly the work process actual value data 6a, component actual value data 6b, and weight actual value data 6c, can be stored. On the other hand, further other electronic data can be stored in this storage means 7. These other electronic data include, for example, all forms of documents, particularly target value data 10, preferably work process target value data 10a to be processed by the operation operator during the formulation of pharmaceuticals. Similarly, there is a method of storing, as the component target value data 10b, the individual contents (components) of the pharmaceuticals, preferably the list of contents required for each work process, in the storage means 7 as the stored electronic target value data 10. In addition to that, it is also possible to store the weight reference amount regarding the individual contents to be administered. The component storage location data 10d can also be stored in the storage means 7 as electronic data.

[0067] All raw data 3, actual value data 6, target value data 10 and additional electronic data are archived in this advantageous archive system 1 in an unmodifiable form. In this case, all data, in particular, raw data 3, actual value data 6 and target value data 10 are stored in the storage means 7 and are provided with metadata for uniquely identifying, for example, for indexing, and as a result, the electronic data can be retrieved again at any time during the storage period. All electronic data must be retrievable and displayable in exactly the same form as when they were detected and must be printable.

[0068] This comparison means 8 is suitable for comparing the detected electronic actual value data 6 and the stored electronic target value data 10 stored in the storage means 7 with each other. In this case, the working process actual value data 6a is compared with the working process target value data 10a, the component actual value data 6b is compared with the component target value data 10b, and the weight actual value data 6 c is compared with the weight target value data 10c.

[0069] This evaluation means 9 is configured to evaluate the comparison between the stored detected electronic actual value data 6 and the stored electronic target value data 10 performed by the comparison means 8 and to identify or provide an evaluation result 11d. In particular, from the comparison of the working process actual value data 6a and the working process target value data 10a, a so-called working process evaluation result 11a is obtained, from the comparison of the component actual value data 6b and the component target value data 10b, a so-called component evaluation result 11b is obtained, and from the comparison of the weight actual value data 6c and the weight target value data 10c, a so-called weight evaluation result 11c is obtained.

[0070] Furthermore, this archive system 1 has position detection means 12 for detecting location data 6d of the operator's current position, which is connected to a data processing system 5 via communication means 4 for data transmission. This position detection means 12 is particularly suitable for providing a location evaluation result 11d by comparing the location data 10d of the operator's current position and the component storage location data 10d, which is carried out by comparison means 7 and evaluation means 8 respectively.

[0071] These component storage location data 10d can be obtained, for example, by taking inventory of components attached with microchips, particularly radio frequency identification (RFID) tags, and uniquely storing the components. In this case, for example, other information such as status data, such as washed, verified or equivalent status, can also be stored by the component storage location data.

[0072] This advantageous archive system 1 has a display system 13 for displaying the evaluation result 11. Advantageously, this display system 13 preferably has display units 14a - 14d for reproducing the evaluation result 11, particularly the work process evaluation result 11a, the component evaluation result 11b, the weight evaluation result 11c and the location evaluation result 11d. Advantageously, for example, status data is also displayed, so that the operator can always have a complete overview of the current state of the process. This display system 12 is preferably configured as a monitor, but particularly preferably as data glasses with a projection surface for displaying the evaluation result 11. Thereby, in addition to other information, for example, the work process evaluation result 11a, the component evaluation result 11b and the weight evaluation result 11c can be displayed on the projection surface of the data glasses. This location evaluation result is preferably displayed on the display system 13 as a route to the component storage location.

[0073] A second embodiment of this advantageous method for archiving electronic data will be described based on the weighing of the contents (components) of pharmaceuticals.

[0074] In the weighing of this pharmaceutical product, the operating operator wears, in his working space, as a detection system 2, for example, data glasses equipped with a video camera. This detection system 2, on the one hand, as a working process detection unit 2a, a component detection unit 2b and a weight detection unit 2c, detects the working process carried out by the operating operator during weighing as working process load data 3a, and on the other hand, detects the contents (components) such as the active substance and auxiliary materials present in the working space as component load data 3b, and detects the weight (mass) of each content weighed for weighing by the weighing instrument as weight load data.

[0075] Subsequently, the detected load data 3 is transmitted via the communication means 4 to a data processing system 5, for example, a computer or a device equivalent thereto. This data processing system 5 converts the detected load data 3 into actual value data 6, that is, working process actual value data 6a, component actual value data 6b and weight actual value data 6c. Both of these load data 3 and actual value data 6 are stored in a storage means 7 assigned to the data processing system 5 in a form that secures the version.

[0076] Furthermore, target value data 10, in particular, working process target value data 10a, component target value data 10b and weight target value data 10c are stored in the storage means 7.

[0077] As working process data, advantageously, a list of the individual working processes to be carried out is stored in the storage means 7. In this second embodiment, furthermore, there is, for example, a method of defining the working processes in a form that does not fix the order, so that the operating operator can freely determine the order in which the contents are added during the preparation of the pharmaceutical product.

[0078] As component target value data 10b, advantageously, pre-trained images of each content are used, and as weight target value data 10c, advantageously, the mass of each individual content, also called a component, is used.

[0079] The comparison means 8 accesses the actual value data 6 obtained from the load data 3 stored in the storage means 7, and compares these data with the target value data 10. Thereafter, this comparison is evaluated by the evaluation means 9, and the evaluation result 11 is provided in the form of a work process evaluation result 11a, a component evaluation result 11b, and a weight evaluation result 11c. Different from the negative evaluation result 11, the positive evaluation result 11 confirms to the operation operator that the work flow has no room for doubt. When the work process evaluation result 11a is positive, it means that each work process has been correctly carried out. For example, all the contents have been correctly administered in a favorable and correct order. When the component evaluation result 11b is positive, it means that there are sufficient components for the preparation (measurement) of the pharmaceutical product in the work space of the operation operator for the work process to be carried out.

[0080] The evaluation result 11 in the form of the work process evaluation result 11a, the component evaluation result 11b, and the weight evaluation result 11c is displayed to the operation operator on the display unit 14 of the display system 13 configured as a projection surface of the data glasses or as a monitor. Different display systems 13 or different display units 14 are conceivable.

[0081] Therefore, for example, by displaying a negative work process evaluation result 11a during the progress of the process, the operation operator can immediately detect the obstacle and correct it, or eliminate the measurement of the incorrectly prepared active substance from the production. Thereby, each pharmaceutical product is manufactured with the same quality, and at the same time, the measurement of the pharmaceutical product is stored in the archive system 1 in a form that ensures the version, for example, for government agencies.

[0082] For example, during the progress of the process, when the display of a negative component evaluation result 11b indicates to the operating operator that there are not enough components (contents) in the working space of the operating operator for the preparation (measurement) of the corresponding pharmaceutical product, an order or a method for the operating operator to obtain it by taking it out from the component storage is obtained. In this case, there is also a method of pre-comparing the components related to the next or the next-next working process, and as a result, it becomes possible for the operating operator to always work without being interrupted. At the same time, when there are no components, it is also conceivable that a third party, for example, an operator in the storage, automatically places an order and supplies it.

[0083] The position detection means 12 detects the exact standing position of the operating operator by, for example, a GPS sensor incorporated in data glasses. This position detection means 12 is suitable for providing the location evaluation result 11d to the operating operator and displaying the route to the corresponding component in the nearest component storage location by comparing the component storage location data 10d stored in the storage means 7 with the location data 6d of the operating operator's standing position at that time when there are no components related to the working process in the working space of the operating operator.

[0084] The operating operator can call the valid standard procedure (SOP) at any time during the measurement of the pharmaceutical product and display it on the display system 13. By the above-described flow, document management according to the "Good Manufacturing Practice" (GMP) during the measurement of the pharmaceutical product is ensured.

[0085] All data generated during this method is archived in the storage means 7 of the archive system 1 in a form that ensures the version.

[0086] Figure 3 illustrates the basic flow of the advantageous archive system 1 for archiving electronic data used in the logistics of pharmaceuticals in a version-secured form. This advantageous archive system 1 and the advantageous method belonging thereto replace the "pick-by-voice" operating mode by the "pick-by-cam" operating mode.

[0087] This archive system 1 is configured in the same way as the archive system 1 shown in FIG. 1.

[0088] A third embodiment of an advantageous method for archiving electronic data is described based on the management of pharmaceutical products in the logistics of pharmaceuticals, and this method can also be used for archiving electronic data in another logistics field other than the pharmaceutical industry.

[0089] When sorting packages, the operating operator wears, as the detection system 2 in his working space, for example, data glasses equipped with a video camera. This detection system 2, as the work process detection unit 2a and the component detection unit 2b, on the one hand, detects the work process carried out by the operating operator when sorting packages consisting of corresponding pharmaceuticals as work process load data 3a, and on the other hand, detects the components (pharmaceuticals) in the working space for sorting packages as component load data 3b.

[0090] Subsequently, the detected load data 3 is transmitted via the communication means 4 to a data processing system 5, for example, a computer or a device equivalent thereto. This data processing system 5 converts the detected load data 3 into actual value data 6, namely, work process actual value data 6a and component actual value data 6b. Both of these load data 3 and actual value data 6 are stored in a version-secured form in the storage means 7 assigned to the data processing system 5.

[0091] Furthermore, target value data 10, in particular work process target value data 10a and component target value data 10b, are stored in the storage means 7.

[0092] As operation process data, advantageously, a list of individual operation processes to be performed is stored in the storage means 7. For example, an order list serves that role, and the operation processes are not processed in a predetermined order. The operation process, here, preparing a package of a predetermined pharmaceutical product in the order list, can be freely selected until all the pharmaceutical products included in the order list are packed in the package.

[0093] As the component target value data 10b, advantageously, images of pre-trained pharmaceutical products in corresponding amounts (volume, mass or equivalent amounts) stored in software are used. This software detects any position and orientation of a three-dimensional object in space by shape-based matching, i.e., by comparing with pre-trained images.

[0094] The comparison means 8 accesses the actual value data 6 (operation process actual value data 6a and component actual value data 6b) obtained from the load data 3 stored in the storage means 7, and compares these data with the target value data 10 (operation process target value data 10a and component target value data 10b). Then, this comparison is evaluated by the evaluation means 9, and an evaluation result 11 is provided in the form of an operation process evaluation result 11a and a component evaluation result 11b. Different from a negative evaluation result 11, a positive evaluation result 11 confirms to the operation operator that it is a work flow without doubt. When the operation process evaluation result 11a is positive, it means that the individual operation processes have been correctly performed, for example, all the pharmaceutical products have been packed. When the component evaluation result 11b is positive, it means that there are sufficient components (pharmaceutical products) related to the operation processes to be performed when preparing the package in the work space of the operation operator.

[0095] The evaluation result 11 in the form of the operation process evaluation result 11a and the component evaluation result 11b is displayed to the operation operator on the display unit 14 of the display system 13 configured as a projection surface of data glasses or as a monitor.

[0096] Therefore, for example, by displaying a negative work process evaluation result 11a during the process, it is possible to immediately detect and correct the obstacles that occur when the operation operator arranges the luggage. As a result, each piece of luggage is arranged in accordance with the standard, and at the same time, data is stored in the archive system 1 in a form that ensures the version, for example, for government agencies. If the arrangement of the luggage is incorrect, there is a method of displaying the obstacle to the operation operator by an acoustic signal and / or an optical signal.

[0097] For example, by displaying a negative component evaluation result 11b during the process, if the operation operator is to be informed that there are not enough components in the operation operator's work space to arrange the luggage, a method can be obtained for the operation operator to obtain it by ordering or retrieving it from the component storage. In this case, there is also a method of comparing in advance the components related to the next or the next next work process, and as a result, it is always possible for the operation operator to work without being interrupted. At the same time, it is also conceivable that when there are no components, the operator in the storage automatically orders and supplies them.

[0098] The position detection means 12 detects, for example, the exact standing position of the operator by means of a GPS sensor incorporated in the data glasses. When there are no components related to the work process in the work space of the operator, this position detection means 12 provides the operator with a location evaluation result 11d by comparing the component storage location data 10d stored in the storage means 7 with the location data 6d of the operator's standing position at that time, and is suitable for displaying to the operator a route to the corresponding component in the nearest component storage location. Therefore, it is also possible for the operator to directly sort the goods in the storage in the form of "pick and drop" instead of in the work space. By means of the position detection means 12 and the display system 13, the operator is always optically and / or acoustically shown a direct route to the component to be packed.

[0099] By means of the flow described above, document management in accordance with the "Good Manufacturing Practice" (GMP) when sorting goods is ensured.

[0100] All data generated during this method is archived in the storage means 7 of the archive system 1 in a form that ensures versioning.

[0101] Said method and the archive system belonging thereto thereby achieve an improvement in the safety of the correct sorting process, and can thus be used not only when sorting pharmaceutical goods in the pharmaceutical industry, but also during the packing process of other objects.

[0102] Another example of using this archive system 1 is goods receipt management and the correct labeling of goods during goods receipt that occurs at that time. The work process during goods receipt management is detected by the work process detection unit 2a, and furthermore, the labeling and / or coding display of the goods is detected, for example, using the component detection unit 2b. These electronic data are compared with the delivery data of the goods and are then stored in the archive system 1 in a form that ensures versioning. Although this application relates to the invention described in the claims, it includes the following from other viewpoints. 1. An archive system (1) for archiving electronic data, This archive system (1) includes a storage means (7) for storing electronic data, a data processing system (5) for processing electronic data, and a detection system (2) configured as a work process detection unit (2a) for detecting work process load data (3a). These work process load data (3a) are work processes implemented in the process. This work process detection unit (2a) is connected to the data processing system (5) and the storage means (7) via a communication means (4) for data transmission. In this archive system, this data processing system (5) is configured to convert the work process load data (3a) detected by the work process detection unit (2a) into work process actual value data (6a) in the form of electronic data. This archive system (1) is characterized in that these electronic data are archived in the storage means (7) of this archive system (1) in a form that ensures the version. 2. In the archive system (1) described in 1 above, The archive system (1) is characterized in that the data processing system (5) has the storage means (7). 3. In the archive system (1) described in 1 or 2 above, In the storage means (7) of this archive system (1), The work process to be implemented in the process as work process target value data (10a), The components required for the work process to be implemented in the process as component target value data (10b), The weight target value data (10c) required for the component to be administered, The component storage location of the component as component storage location target value data (10d), The archive system (1) is characterized in that one or more of them are stored as electronic data. 4. In the archive system (1) described in any one of 1 to 3 above, This archive system (1) has a detection system (2) configured as a component detection unit (2b) and / or a weight detection unit (2c), and the component detection unit (2b) and / or the weight detection unit (2c) are connected to the data processing system (5) and the storage means (7) via communication means (4) for data transmission. The archive system (1) is characterized by this. 5. In the archive system (1) described in 4 above, the component detection unit (2b) is configured to detect component load data (3b), and these component load data (3b) are components existing with respect to the work steps to be carried out in the process, and the weight detection unit (2c) is configured to detect weight load data (3c), and these weight load data (3c) are the weights of the components or contents to be processed with respect to the work steps to be carried out in the process, and The archive system (1) is characterized by one or more of the above. 6. In the archive system (1) described in 1 and 4 above, the work step detection unit (2a), the component detection unit (2b) and / or the weight detection unit (2c) are configured as a detection system (2) or a part of the detection system (2). The archive system (1) is characterized by this. 7. In the archive system (1) described in any one of 1 to 6 above, one or more of the detection system (2), the work step detection unit (2a), the component detection unit (2b) and the weight detection unit (2c) are configured as sensors, preferably as optical sensors, particularly preferably as cameras, most preferably as video cameras. The archive system (1) is characterized by this. 8. In the archive system (1) described in any one of 5 to 7 above, the data processing system (5) is configured to convert component load data (3b) and / or weight load data (3c) into component actual value data (6b, 6c) in the form of electronic data. The archive system (1) is characterized by this. 9. In the archive system (1) described in any one of 1 to 8 above, An archive system (1), characterized in that it has a comparison means (8) connected to a data processing system (5) via a communication means (4) for data transmission. 10. In the archive system (1) according to the above item 9, The archive system (1), characterized in that the comparison means (8) is configured to compare actual value data (6) with target value data (10). 11. In the archive system (1) according to the above item 9 or 10, The archive system (1), characterized in that the data processing system (5) has the comparison means (8). 12. In the archive system (1) according to any one of the above items 1 to 11, An archive system (1), characterized in that it has an evaluation means (9) connected to a data processing system (5) via a communication means (4) for transmission. 13. In the archive system (1) according to the above item 12, The archive system (1), characterized in that the evaluation means (9) is configured to evaluate the comparison performed by the comparison means (8). 14. In the archive system (1) according to the above item 13, The archive system (1), characterized in that the evaluation means (9) is configured to provide an evaluation result (11) by the evaluation. 15. In the archive system (1) according to any one of the above items 12 to 14, The archive system (1), characterized in that the data processing system (5) has the evaluation means (9). 16. In the archive system (1) according to any one of the above items 1 to 15, An archive system (1), characterized in that it has a display system (13) provided with a display unit (14) connected to a data processing system (5) via a communication means (4) for data transmission. 17. In the archive system (1) according to the above item 16, The archive system (1), characterized in that the display system (13), preferably the display unit (14), is configured as a monitor and / or data glasses. 18. In the archive system (1) according to the above item 16 or 17, The archive system (1) is characterized in that the display system (13) described above is configured to display one or more of the evaluation results (11) provided by the evaluation means (9), preferably the work process evaluation result (11a), the component evaluation result (11b), the weight evaluation result (11c), and the location evaluation result (11d). 19. In the archive system (1) according to any one of the above items 1 to 18, The archive system (1) is characterized in that it has a position detection means (12) for detecting the current position of the operating operator, which is connected to a data processing system (5) via a communication means (4) for data transmission. 20. In the archive system (1) according to any one of the above items 16 to 19, The archive system (1) is characterized in that the display system (13), preferably the display unit (14), is configured to display the route to the component storage location. 21. An electronic data archiving method having an archive system (1), The archive system (1) has a storage means (7) for storing electronic data, a data processing system (5) for processing electronic data, and a detection system (2) configured as a work process detection unit (2a) for detecting work process load data (3a). These work process load data (3a) are work processes implemented in the process. The work process detection unit (2a) is connected to the data processing system (5) and the storage means (7) via a communication means (4) for data transmission. The data processing system (5) is configured to convert the work process load data (3a) detected by the work process detection unit (2a) into work process actual value data (6a) in the form of electronic data. In the method, A step of detecting the work process to be implemented in the form of work process load data (3a) of the process by the work process detection unit (2a); A step of converting the detected work process load data (3a) of these processes into work process actual value data (6a) in the form of electronic data; A step of transmitting these work process actual value data (6a) to the storage means (7); A method having a step of archiving these work process actual value data (6a) in the storage means (7) of the archive system (1) in a form with a version secured. 22. In the method according to 21 above, the process operation step target value data (10a) is stored as electronic data in the storage means (7) of the archive system (1), the archive system (1) has a comparison means (8) for comparing the stored process operation step target value data (10a) with the process operation step actual value data (6a), the archive system (1) has an evaluation means (9) for evaluating the comparison of the process operation step target value data (10a) and the process operation step actual value data (6a) performed by the comparison means (8), and this method includes a step of comparing the process operation step target value data (10a) with the process operation step actual value data (6a), a step of evaluating the comparison of the process operation step target value data (10a) and the process operation step actual value data (6a) performed by the comparison means (8), and a step of providing a process evaluation result (11a). The method is characterized by this. 23. In the method according to 21 or 22 above, the said archive system (1) has a component detection unit (2b) and / or a weight detection unit (2c), and this method includes a step of detecting component load data (3b) and / or weight load data (3c), and a step of converting these component load data (3b) and / or weight load data (3c) into component actual value data (6b) and / or weight actual value data (6c) in the form of electronic data. The method is characterized by this. 24. In the method according to 23 above, component target value data (10b) and / or weight target value data (10c) are stored in the storage means (7), and this method includes a step of transmitting the component actual value data (6b) and / or the weight actual value data (6c) to the data processing system (5), a step of comparing the component target value data (10b) and / or the weight target value data (10c) of the process with the component actual value data (6b) and / or the weight actual value data (6c), a step of evaluating the comparison of the component target value data (10b) and / or the weight target value data (10c) of the process with the component actual value data (6b) and / or the weight actual value data (6c) performed by the comparison means (8), and a step of providing a component evaluation result (11b) and / or a weight evaluation result (11c). The method is characterized by this. 25. In the method according to any one of 22 to 24 above, the archive system (1) has a display system (13) for displaying one or more of the evaluation results (11) provided by the evaluation means (9), in particular, the work process evaluation result (11a), the component evaluation result (11b), and the weight evaluation result (11c), and this method has a step of displaying the evaluation result (11) provided by the evaluation means (9) on the display system (13). The method is characterized by this. 26. In the method according to 25 above, the archive system (1) has position detection means (12) for detecting the current position of the operation operator, and this method has a step of displaying the route from the current position of the operation operator to the component storage location. The method is characterized by this. 27. In the method according to any one of 21 to 26 above, each electronic data generated in the steps of this method is archived in a form that ensures the version. The method is characterized by this. 28. In a method of using an archive system (1) for archiving electronic data in the pharmaceutical industry, the archive system (1) is the archive system (1) according to any one of 1 to 20 above. The method of use is characterized by this.

Claims

1. An archiving system (1) for archiving electronic data, wherein this archiving system (1) has a storage means (7) for storing electronic data, a data processing system (5) for processing electronic data, and a detection system (2) configured as a camera, wherein the detection system (2) is configured as a work process detection unit (2a) for detecting the work processes carried out in the process as work process load data (3a), this work process detection unit (2a) is connected to the data processing system (5) and the storage means (7) via a communication means (4) for data transmission, in this archiving system, this data processing system (5) is configured to convert the work process load data (3a) detected by the work process detection unit (2a) into work process actual value data (6a) in the form of electronic data so as to be able to compare it with work process target value data (10a), this archiving system (1) is configured to archive electronic data including the work process load data (3a), the work process actual value data (6a), and the work process target value data (10a) in the storage means (7) of this archiving system (1), and the archived data is protected against subsequent changes, in the storage means (7) of this archiving system (1), · the work process target value data (10a) as the work process to be carried out in the process, · component target value data (10b) as the components required for the work process to be carried out, · weight target value data (10c) required for the components to be administered, · component storage location target value data (10d) as the component storage location of the components, one or more of which are stored as electronic data, characterized in that it is an archiving system (1).

2. In the archiving system (1) according to Claim 1, characterized in that the data processing system (5) has the storage means (7).

3. In the archiving system (1) according to Claim 1 or 2, This archive system (1) has a detection system (2) configured as a component detection unit (2b) and / or a weight detection unit (2c), and the component detection unit (2b) and / or the weight detection unit (2c) are connected to the data processing system (5) and the storage means (7) via communication means (4) for data transmission. The archive system (1) is characterized by this.

4. In the archive system (1) according to claim 3, the component detection unit (2b) is configured to detect component load data (3b), and these component load data (3b) are components existing with respect to the work steps to be performed in the process, and the weight detection unit (2c) is configured to detect weight load data (3c), and these weight load data (3c) are the weights of the components to be processed with respect to the work steps to be performed in the process, and The archive system (1) is characterized by one or more of the above.

5. In the archive system (1) according to claim 3, the work step detection unit (2a), the component detection unit (2b) and / or the weight detection unit (2c) are configured as the detection system (2) or a part of the detection system (2). The archive system (1) is characterized by this.

6. In the archive system (1) according to any one of claims 3 to 5, one or more of the detection system (2), the work step detection unit (2a), the component detection unit (2b) and the weight detection unit (2c) are configured as a sensor, or as an optical sensor, or as a camera, or as a video camera. The archive system (1) is characterized by this.

7. In the archive system (1) according to any one of claims 4 to 6, The archive system (1) is characterized in that the above-described data processing system (5) is configured to convert component load data (3b) into component actual value data (6b) in the form of electronic data so as to be able to compare it with component target value data (10b), and convert weight load data (3c) into weight actual value data (6c) in the form of electronic data so as to be able to compare it with weight target value data (10c).

8. In the archive system (1) according to any one of Claims 1 to 7, the archive system (1) is characterized by having comparison means (8) connected to a data processing system (5) via communication means (4) for data transmission.

9. In the archive system (1) according to Claim 8, the above-described comparison means (8) is configured to compare actual value data (6) with target value data (10), which is a feature of the archive system (1).

10. In the archive system (1) according to Claim 8 or 9, the above-described data processing system (5) has the above-described comparison means (8), which is a feature of the archive system (1).

11. In the archive system (1) according to any one of Claims 1 to 10, the archive system (1) is characterized by having evaluation means (9) connected to a data processing system (5) via communication means (4) for transmission.

12. In the archive system (1) according to Claim 11, the above-described evaluation means (9) is configured to evaluate the comparison performed by the above-described comparison means (8), which is a feature of the archive system (1).

13. In the archive system (1) according to Claim 12, the above-described evaluation means (9) is configured to provide an evaluation result (11) based on the above-described evaluation, which is a feature of the archive system (1).

14. In the archive system (1) according to any one of Claims 11 to 13, the above-described data processing system (5) has the above-described evaluation means (9), which is a feature of the archive system (1).

15. In the archive system (1) according to any one of Claims 1 to 14, An archive system (1) characterized by having a display system (13) equipped with a display unit (14), which is connected to a data processing system (5) via communication means (4) for data transmission.

16. In the archive system (1) according to claim 15, the archive system (1) characterized in that the display system (13) equipped with the display unit (14) is configured as a monitor or data glasses.

17. In the archive system (1) according to claim 15 or 16, the archive system (1) characterized in that the display system (13) is configured to display one or more of the evaluation results (11) provided by the evaluation means (9), namely, the work process evaluation result (11a), the component evaluation result (11b), the weight evaluation result (11c), and the location evaluation result (11d).

18. In the archive system (1) according to any one of claims 1 to 17, the archive system (1) characterized by having position detection means (12) for detecting the current position of the operating operator, which is connected to a data processing system (5) via communication means (4) for data transmission.

19. In the archive system (1) according to any one of claims 15 to 18, the archive system (1) characterized in that it is configured to display the route to the component storage location on the display system (13) equipped with the display unit (14).

20. An electronic data archiving method having an archive system (1), wherein this archive system (1) has storage means (7) for storing electronic data, a data processing system (5) for processing electronic data, and a detection system (2) configured as a camera, the detection system (2) being configured as a work process detection unit (2a) for detecting the work process implemented in the process as work process load data (3a), and this work process detection unit (2a) being connected to the data processing system (5) and the storage means (7) via communication means (4) for data transmission. This data processing system (5) is configured to convert the work process load data (3a) detected by the work process detection unit (2a) into work process actual value data (6a) in the form of electronic data so that it can be compared with the work process target value data (10a). In the method, a step of detecting, by the work process detection unit (2a), the work process being performed in the form of the work process load data (3a) of the process; a step of converting the detected work process load data (3a) of these processes into work process actual value data (6a) in a form of electronic data that can be evaluated thereafter; a step of transmitting these work process actual value data (6a) to the storage means (7); a step of archiving these work process actual value data (6a) in the storage means (7) of the archive system (1), wherein the archived work process actual value data (6a) is protected against subsequent changes, the archiving step; and has the above-mentioned electronic data includes the work process load data (3a), the work process actual value data (6a), and the work process target value data (10a); in the storage means (7) of the above-mentioned archive system (1), · the work process target value data (10a) as the work process to be performed in the process, · component target value data (10b) as the components required for the work process to be performed in the process, · weight target value data (10c) required for the component to be administered, · component storage location target value data (10d) as the component storage location of the component, one or more of which are stored as electronic data; Method.

21. In the method according to claim 20, the work process target value data (10a) of the process is stored in the storage means (7) of the archive system (1) as electronic data, the archive system (1) has a comparison means (8) for comparing the stored work process target value data (10a) with the work process actual value data (6a), and the archive system (1) has an evaluation means (9) for evaluating the comparison of the work process target value data (10a) and the work process actual value data (6a) of the process performed by the comparison means (8), and this method includes a step of comparing the work process target value data (10a) and the work process actual value data (6a) of the process; A step of evaluating the comparison between the operation process target value data (10a) and the operation process actual value data (6a) performed by the comparison means (8); A step of providing an operation process evaluation result (11a), characterized by a method.

22. In the method according to claim 20 or 21, The archive system (1) has a component detection unit (2b) and / or a weight detection unit (2c), This method is A step of detecting component load data (3b) and / or weight load data (3c); A step of converting these component load data (3b) into component actual value data (6b) in the form of electronic data so as to be comparable with component target value data (10b); and a step of converting weight load data (3c) into weight actual value data (6c) in the form of electronic data so as to be comparable with weight target value data (10c), characterized by a method.

23. In the method according to claim 22, Component target value data (10b) and / or weight target value data (10c) are stored in the storage means (7), and this method is A step of transmitting component actual value data (6b) and / or weight actual value data (6c) to the data processing system (5); A step of performing a comparison between the component target value data (10b) and / or weight target value data (10c) of the process and the component actual value data (6b) and / or weight actual value data (6c); A step of evaluating the comparison between the component target value data (10b) and / or weight target value data (10c) of the process and the component actual value data (6b) and / or weight actual value data (6c) performed by the comparison means (8); A step of providing a component evaluation result (11b) and / or a weight evaluation result (11c), characterized by a method.

24. In the method according to any one of claims 21 to 23, The archive system (1) has a display system (13) for displaying one or more of the evaluation results (11) provided by the evaluation means (9), in particular, the operation process evaluation result (11a), the component evaluation result (11b), and the weight evaluation result (11c), and this method has a step of displaying the evaluation result (11) provided by the evaluation means (9) on the display system (13), characterized by a method.

25. In the method according to claim 24, wherein the archive system (1) has position detection means (12) for detecting the current position of the operating operator, and the method comprises the step of displaying a route from the current position of the operating operator to the component storage location. A method characterized by having.

26. In the method according to any one of claims 20 to 25, individual electronic data generated in the steps of this method are archived, and the archived data is protected against subsequent changes. A method characterized by that.

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