Patent ID: 12197380

DETAILED DESCRIPTION

FIG.1shows a basic flow diagram of a preferred archiving system for the audit-proof archiving of electronic data for use on assembling facility parts.

The archiving system1comprises an acquisition system2which is comprises a working step acquisition unit2aand a component acquisition unit2b. The acquisition system2, in particular the working step acquisition unit2aand component acquisition unit2bis preferably designed as a sensor, particularly preferably as an optical sensor, very particularly preferably as a camera, in particular as a video camera.

In the most preferred form, the acquisition system2, in particular the working step acquisition unit2ais designed as smartglasses which comprise a video camera. By way of this, the working step acquisition unit2arecognises the working steps which are carried out by an operating person in the acquisition field of the working step acquisition unit2afor example at his workplace. A location-fixed, stationary installation of the acquisition system2is also conceivable, for example as a camera which is arranged on the body (bodycam), wherein preferably the component acquisition unit2bis designed in such a fashion. By way of this, it is advantageously always possible to acquire the components which are available at the workplace to the operating person for the individual working steps.

The acquisition system2which is shown in the embodiment example, with the working step acquisition unit2aand the component acquisition unit2bcomprises two acquisition systems2which as video cameras are independent of one another. The acquisition system2is suitable for acquiring raw data3, in particular for acquiring working step raw data3aand component raw data3b.

The working step raw data3aand component raw data3bwhich is detected by the working step acquisition unit2aand component acquisition unit2bis transferred to a data processing system5via communication means4, such as for example a data transmission cable, strip conductors, radio networks or the like, wherein the data processing system5is configured to convert the raw data3which is acquired by the acquisition system2into acquired, electronic actual value data6. Hereby, the working steps raw data3ais converted into acquired, electronic working step actual value data6aand the component raw data3binto acquired, electronic component actual value data6b.

In the embodiment example, the data processing system5of the archiving system1comprises memory means7, comparator means8and evaluation means9.

On the one hand the electronic actual value data6which is obtained by the conversion from the raw data, in particular the working step actual value data6aand the component actual value data6bcan be stored on the memory means7, in particular on the batch records which are designed at least as part of the memory means, and on the other hand further electronic data can be additionally deposited on the memory means7. For example, all types of documents, in particular however desired value data10, preferably working step desired value data10awhich is to be worked off by an operating person on assembling the facility component, here a nozzle, belong to this further electronic data. Likewise, there is the possibility of storing a list of the components which are necessary on assembly, preferably of the components which are necessary for each working step, as component desired value data10bon memory means7as stored, electronic desired value data10. Component storage location data10dcan also be stored on the memory means7as electronic data.

All raw data3, actual value data6and desired value data10as well as additional electronic data is archived in the preferred archiving system1in a non-changeable manner. Hereby, all data, in particular the raw data3and the actual value data6and desired value data10are stored on the memory means7and for the indexation are provided for example with metadata for the unambiguous identification, so that the electronic data can be retrieved again at all times during the duration of the safekeeping period. All electronic data must be able to be displayed and printed on retrieval in precisely the same form as these have been acquired.

The comparator means8are suitable for comparing the acquired electronic actual value data6which is stored on the memory means7and the stored electronic desired value data10with one another. Hereby, the working step actual value data6ais compared to the working step desired value data10aand the component actual value data6bwith the component desired value data10b.

The evaluation means9are configured to evaluate the comparison between stored, acquired electronic actual value data6and deposited electronic desired value data10, said comparison being carried out in the comparator means8, and to determine or provide an evaluation result11. In particular, a so-called working step evaluation result11aresults from the comparison of working step actual value data6aand working step desired value data10aas well as a so-called component evaluation result11bfrom the comparison of component actual value data6band component desired value data10b.

Furthermore, the archiving system1of the embodiment example comprises a position acquisition means12for acquiring location data6dof a current location of an operating person, said position acquisition means being connected to the data processing system5via communication means4for data transfer. However, this is not absolutely necessary. The position acquisition means12is suitable for providing a location evaluation result lid by way of a comparison of the location data6cof the current location of the operating person and of the components storage location data10d, said comparison being carried out by the comparator means and evaluation means7,8.

The component storage location data10dis achieved by way of inventory of the components and an unambiguous deposition of the components, by way of microchips, in particular radio-frequency identification (RFIF) which are built on the components. Hereby, further information can also be stored with the components storage location data, such as for example status data, for example cleaned, validated or the like.

For the display of the evaluation result11, the preferred archiving system1comprises a display system13. Preferably, the display system13comprises display units14,14band14dwhich preferably reproduce the evaluation results11, the working step evaluation result11a, the component evaluation result11band the location evaluation result lid. Advantageously, for example the status data are also shown, so that the operating person always has a complete overview of the process situation. The display system12is preferably designed as a monitor, particularly preferably however as a smartglasses which comprise a projection surface for the display of the evaluation result11. By way of this, it is possible for example for the working step evaluation result11ato be displayed in the projection surface of the data, apart from the other information. The location evaluation result is preferably displayed on the display system13as a path to the component storage location.

The first embodiment example of a preferred method for archiving electronic data is explained by way of the assembly of a nozzle, wherein the method can analogously be applied for the archiving of electronic data on assembly of other facility parts.

On assembly of the nozzle, the operating person at his workplace wears smartglasses which are provided with a video camera, as an acquisition system2. The acquisition system2as working step acquisition unit2aand component acquisition unit2bon the one hand acquires the working steps which are carried out by the operating person on assembly of the nozzle, as working step raw data3aand on the other hand the components which are present at the workplace for the assembly of the nozzle, as component raw data3b. Subsequently, the acquired raw data3is transferred via communication means4to the data processing system5, for example to a computer or the like. The data processing system5converts the acquired raw data3into actual value data6, specifically into working step actual value data6aand component actual value data6b. The raw data3as well as the actual value data6is stored on the memory means7which are assigned to the data processing system5, in an audit-proof manner.

Furthermore, desired value data10, in particular working step desired value data10aas well as component desired value data10bcan be stored on the memory means7.

A list of the individual working steps which are to be carried out is stored on the memory means7as working step data.

Preferably, pre-trained pictures of a CAD model by way of industrial picture processing software, for example Halcon 8.0 of MVTec Software GmbH are used as component desired value data10b. The software recognises3D-objects in space in arbitrary positions and orientations by way of shape-based matching, thus by way of a comparison with a pre-trained CAD model.

Comparator means8access the actual value data6, working step actual value data6aand component actual value data6bwhich is stored on the memory means and is obtained from the raw data3, and compare this to the desired value data10, working step desired value data10band component desired value data10b. The comparison is subsequently evaluated in the evaluation means9and an evaluation result11is provided in the form of a working step evaluation result11aand a component evaluation result11b. A positive evaluation result11confirms an error-free working procedure to the operating person, in contrast to a negative evaluation result11. If the working step evaluation result11ais positive, then the individual working step was carried out correctly, for example all parts are correctly built on one another. If the component evaluation result11bis positive, then adequate components for the working step which is to be carried out on assembly of the nozzle or for the complete assembly of the nozzle are present at the workplace.

The evaluation result11in the form of a working step evaluation result11aand a component evaluation result11bis displayed to the operating person on a display unit14of the display system which is designed as a projection surface of the smartglasses or as a monitor. Additionally, there is the possibility providing the operating person with an acoustic signal, for example via headphones.

Thus, it is possible for the operating person, for example by way of the display of a negative working step evaluation result11a, to immediately recognise an error which occurs on assembly during the running process and to correct this. By way of this, each nozzle is constructed equally, and the assembly procedure is simultaneously yet deposited in the archiving system1in an audit-proof manner, for example for the authorities. Given an incorrect assembly of the nozzle, there is the possibility of interrupting the further assembly of the nozzle for example by way of cutting off the current to the tool which is necessary for the assembly. As soon as the correction of the assembly of the nozzle has been effected by the operating person, then the further assembly of the nozzle can be effected.

If for example by way of the display of a negative evaluation result11bduring the running process it is displayed to operating person that insufficient components for the assembly of the nozzle at the workplace of the operating person are present, then there is the possibility of the operating person obtaining these, by way of ordering or himself fetching them from the component storage. Hereby, there is also the possibility of already comparing the components for the next or the next but one operating step, so that a uninterrupted working of the operating person is made possible. At the same time, given the absence of components, an automatic ordering and delivery is likewise conceivable.

A position acquisition means12acquires the precise location of the operating person, for example by way of a GPS sensor which is built into the smartglasses. In the case of absent components for a working step at the workplace of the operating person, the position acquisition means12is suitable for providing the operating person with a location evaluation result lid by way of a comparison of the component storage location data10dwhich is stored in the memory means7and of the location data6dof the current location of the operating person, and of displaying a path to the respective component in the closest component storage place to the operating person.

It is possible for the operating person to retrieve the currently valid standard operating procedure (SOP) at any time during the assembly of the nozzle and of having this displayed in the display system13. By way of the mentioned procedures, a documentation corresponding to good manufacturing practise (GMP) is ensured on assembly of the nozzle.

All data which is generated during the method is archived on the memory means7of the archiving system1in an audit-proof manner. Not only can the aforementioned method and the associated archiving system be used with the assembly of facility components, but also on assembling facilities themselves, preferably in the field of the pharmaceutical industry, since here very high demands are placed on the documentation of the data. The method can be carried out analogously to the fitting, in particular to the installation of tools, facility components, such as tablet presses, packaging machines or the like.

A basic flow diagram of a preferred archiving system1for the audit-proof archiving of electronic data for use on weighing in ingredients of medications is shown inFIG.2.

The archiving system1comprises an acquisition system2which comprises a working step acquisition unit2a, a component acquisition unit2band a weight acquisition unit2c. The acquisition system2, in particular the working step acquisition unit2a, the component acquisition unit2band the weight acquisition unit2cis preferably designed as a sensor, particularly preferably as an optical a sensor, very particularly preferably as a camera, in particular as a video camera. Furthermore, optionally the scales can communicate directly with the memory means7for a possible additional control or a second validation and/or documentation.

In the form, which is most preferred, the acquisition system2, in particular the working step acquisition unit2ais designed smartglasses which have a video camera. By way of this, the working step acquisition unit2arecognises the working steps which are carried out by an operating person in the field of acquisition of the working step acquisition unit2afor example at his workplace. The location-fixed, stationary installation of the acquisition system2is also conceivable, for example designed as a camera (bodycam) which is arranged on the body, wherein preferably the component acquisition unit2band the weight acquisition unit2care designed in such a manner. By way of this, it is advantageously always possible for the components which are available to the operating person at the workplace for the individual working steps to be acquired by the component acquisition unit2band the weight, for example of ingredients (active ingredients or adjuvants) which are weighed on scales for medication preparation, by the weight acquisition unit2con a weight display of the scales and/or with a label of the packaging, e.g. batch number, active ingredient, date of expiry, etc and to compare these.

The acquisition system2which is shown in the embodiment example, with the working step acquisition unit2a, the component acquisition unit2band the weight acquisition unit2ccomprises three acquisition systems2which are independent of one another as video cameras. The acquisition system2is suitable for the acquisition of raw data3, in particular for acquiring working step raw data3a, component raw data3band weight raw data.

The working step raw data3a, component raw data3band weight raw data3cwhich is acquired by the working step acquisition unit2a, the component acquisition unit2band the weight acquisition unit2cis transferred to a data processing system5via communication means4, such as for example data transmission cables, strip conductors, radio networks or the like, wherein the data processing system5is configured to convert the raw data5which is acquired by the acquisition system2into acquired, electronic actual value data6. Hereby, the working step raw data3ais converted into acquired, electronic working step actual value data6a, the component raw data3binto acquired, electronic component actual value data6band the weight raw data3cinto acquired electronic weight actual value data6c.

In the embodiment example, the data processing system5of the archiving system according to the archiving system1which is described inFIG.1comprises memory means7, comparator means8and evaluation means9.

On the one hand the electronic actual value data6, in particular the working step actual value data6a, the component actual value data6band the weight actual value data which are obtained by the conversion from the raw data, and on the other hand additionally further electronic data can be stored on the memory means7, in particular on the batch records which are designed at least as a part of the memory means. For example, all types of documents, in particular however desired value data10, preferably working step desired value data10awhich is to be processed by an operating on preparing medicine, belong to this further electronic data. Likewise, there is the possibility of storing a list of the individual ingredients (components) of the medications, preferably of the ingredients which are necessary for each working step, as component desired value data10bon the memory means7as deposited electronic desired value data10. Furthermore, it is possible for the ingredients which are to be metered individually to also be stored as a weight specification. Component storage location data10dcan also be stored on the memory means7as electronic data.

All raw data3, actual value data6and desired value data10as well as additional electronic data is archived in the preferred archiving system in an unchangeable manner. Hereby, all data, in particular the raw data3and the actual value data6and desired value data10is stored on the memory means and is provided for example with metadata for the unambiguous identification for indexing, so that the electronic data can be retrieved again at all times during the duration of the safekeeping time period. All electronic data must be able to be displayed and printed on request in precisely the same form as these have been acquired.

The comparator means8are suitable for comparing the acquired electronic actual value data6which is stored on the memory means7and the deposited electronic desired value data10with one another. Hereby, the working step actual value data6ais compared with the working step desired value data10a, the component actual value data6bwith the component desired value data10band the weight actual value data6cwith the weight desired value data10c. The evaluation means9are configured to evaluate the comparison between stored, acquired electronic actual value data6and deposited electronic desired value data10, said comparison being carried out in the comparator means8, and to determine or provide an evaluation result11. In particular, a so-called working step evaluation result11aresults from the comparison of working step actual value data6aand working step desired value data10a, a so-called component evaluation result11bfrom the comparison of component actual value data6band component desired value data10bas well as a so-called weight evaluation result11cfrom the comparison of weight actual value data6cand weight desired value data10c.

Furthermore, the archiving system1comprises a position acquisition means12which is connected to the data processing system5via communication means4for the data transfer, for acquiring location data6dof a current location. The position acquisition means12is suitable for providing a location evaluation result lid by way of a comparison of location data6dof the current location of the operating person and of the component storage location data10d, said comparison being carried out in particular by the comparator means7and evaluation means8.

The component storage location data10dis achieved for example by the inventory of the components and an unambiguous deposition of the components, by way of microchips, in particular radio-frequency identification (RFID) which are built on the components. Hereby, further information can be stored with the component storage location data, such as for example status data, for example cleaned, validated or the like.

For the display of the evaluation result11, the preferred archiving system1comprises a display system13. Preferably, the display system13comprises display units14ato14dwhich preferably reproduce the evaluation results11, in particular the working step evaluation result11a, the component evaluation result11b, the weight evaluation result11cand the location evaluation result lid. Advantageously for example the status data is also displayed, so that the operating person always has a complete overview of the process situation. The display system12is preferably designed as a monitor, particularly preferably however as a smartglasses which comprises a projection surface for the display of the evaluation result11. By way of this, it is possible, apart from other information, for example to display working step evaluation result11a, the component evaluation result11band the weight evaluation result11cin the projection surface of the smartglasses. The location evaluation result is preferably displayed on a display system13as a path to the component storage location.

The second embodiment example of a preferred method for archiving electronic data is explained on the basis of a weighing in of ingredients (components) of medication.

On weighing in medications, the operating person at his workspace wears smartglasses as an acquisition system2, said smartglasses being provided with a video camera. The acquisition system2as a working step acquisition unit2a, component acquisition unit2band weight acquisition unit2con the one hand acquires the working steps which are carried out by the operating person on weighing in, as working step raw data3a, and on the other hand the ingredients (components) which are present at the workplace, such as active ingredients and adjuvants, as component raw data3band the weight (mass) of the respective ingredients, as soon as these have been weighed on scales for metering, as weight raw data.

Subsequently to this, the acquired raw data3is transferred to a data processing system5, for example to a computer or the like via communication means4. The data processing system5converts the acquired raw data3into actual value data6, specifically into working step actual value data6a, component actual value data6band weight actual value data6c. The raw data3as well as the actual value data6are stored on the memory means7which are assigned to the data processing system, in an audit-proof manner. Furthermore, desired value data10, in particular working step desired value data10aas well as component desired value data10band weight desired value data10cis stored on the memory means7. Preferably, a list of the individual working steps which are to be carried out is stored on the memory means7as working step data. Concerning the second embodiment example, there is further the possibility of specifying the working steps without a fixed sequence, so that the operating person can freely decide on the sequence of the addition of the ingredients on preparing medication. Preferably, pre-trained pictures of the respective ingredient are used as component desired value data10band preferably the masses of the individual ingredients which are also designated as components are used as weight desired value data10c.

Comparator means8access the actual value data6which is obtained from the raw data3and is stored in the memory means7and compares this to the desired value data10. The comparison is subsequently evaluated in the evaluation means8and an evaluation result11is provided in the form of a working step evaluation result11a, a component evaluation result11band weight evaluation result11c. A positive evaluation result11in contrast to a negative evaluation result11confirms a correct working procedure to the operating person. If the working step evaluation result11ais positive, the individual working step was carried out correctly, for example all ingredients admetered correctly, preferably even in the correct sequence. If the component evaluation result11bis positive, then adequate ingredients (components) for the preparation of medication (weigh-in) are present at the workplace of the operating person for the working step which is to be carried out.

The evaluation result11in the form of a working step evaluation result11a, component evaluation result11band a weight evaluation result11cis displayed to the operating person on a display unit14of the display system13which is designed as a projection surface of the smartglasses or as a monitor. Different display systems13or different display units14are conceivable.

Thus, during the running process, it is possible for the operating person, for example by way of the display of a negative working step evaluation result11a, to immediately recognise an error and to correct this or to remove the incorrectly prepared ingredient weight out of the production. By way of this, each medication is manufactured with a constant quality and the medication weight is simultaneously deposited in the archiving system1in an audit-proof manner, for example for the authorities.

If it is displayed to the operating person, for example by way of the display of a negative component evaluation result11bduring the running operation, that inadequate components (ingredients) are present for the preparation (weigh-in) of the respective medication at the workplace of the operating person, there is the possibility of the operating person obtaining these by way of ordering or by way of fetching this himself from the component store. Hereby, there is also the possibility of already comparing components for the next or next but one working step, so that an uninterrupted working of the operating person is rendered possible. Simultaneously, given the absence of components, an automatic ordering and delivery by third parties, e.g., store workers, is also conceivable.

A position acquisition means12acquires the precise location of the operating person, for example by way of a GPS sensor which is built into the smartglasses. In the case of absent components for a working step at the workplace of the operating person, the position acquisition means12is suitable for providing the operating person with a location evaluation result lid by way of a comparison of the component storage location data10dwhich is stored on the memory means7and of the location data6dof the current location of the operating person and for displaying a path to the respective component in the closest component storage space to the operating person.

It is possible at all times during the weighing of the medication for the operating person to retrieve the currently valid standard operating procedure (SOP) and for this to be represented in the display system13. By way of the aforementioned sequences, a documentation according to good manufacturing practise (GMP) is ensured on weighing in the medicine.

All data which is generated during the method is archived on the memory means7of the archiving system1in an audit-proof manner.FIG.3shows a basic flow diagram of a preferred archiving system1for the audit-proof archiving of electronic data for use in pharmaceutical logistics. The preferred archiving system1and the associated preferred method are to replace a “pick by voice” working procedure by a “pick by cam” working procedure.

The archiving system1is designed according to the archiving system1which is described inFIG.1.

The third embodiment example of a preferred method for archiving electronic data is explained by way of the control of a pharmaceutical product in pharmaceutical logistics, wherein the method can be applied analogously also to the archiving of electronic data in other fields of logistics, apart from the pharmaceutical industry.

On equipping the packages, the operating person at his workplace carries for example smartglasses which are provided with a video camera, as an acquisition system2. The acquisition system2as a working step acquisition unit2aand a component acquisition unit2bon the one hand acquires the working steps which are carried out by the operating person on equipping the package with respective medication, as working step raw data3aand on the other hand the components (medications) which are present at the workplace and which are for equipping the package, as component raw data3b. Subsequently to this, the acquired raw data3is transferred for example to a computer or the like via communication means4. The data processing system5converts the acquired raw data3into actual value data6, specifically into working step actual value data6aand component actual value data6b. The raw data3as well as the actual value data6is stored on the memory means7which are assigned to the data processing system5, in an audio-proof manner.

Furthermore, desired value data10, in particular working step desired value data10asuch as components desired value data10bis stored in the memory means7.

As working step data, preferably a list of the individual working steps which are to be carried out are stored on the memory means7. By way of example, an order list can serve for this, wherein the working steps are not to be worked off in a certain sequence. The working steps, here the equipping of a package with a certain medication of an order list, can be freely selected until all medications which are contained on the order list are deposited in the package.

Preferably, pre-trained pictures of a medication which are stored in software are used in a suitable size (volume, mass or the like) as component desired value data10b. The software recognises3D objects in space in arbitrary positions and orientations by way of shape-based matching, thus by way of a comparison with a pre-trained picture.

Comparator means8access the actual value data6, working step actual value data6aand component actual value data6bwhich is obtained from the raw data3and is stored on the memory means7and compare this to the desired value data10, working step desired value data10aand component desired value data10b. The comparison is subsequently evaluated in the evaluation means8and an evaluation result11is provided in the form of a working step evaluation result11aand a component evaluation result11. A positive evaluation result11in contrast to at negative evaluation result11confirms a correct working procedure to the operating person. If the working step evaluation result11ais positive then the individual working step was carried out correctly, for example all medications were packaged in the package. If the component evaluation result11bis positive, then adequate components (medications) for the working step to be carried out are present at the workplace of the operating person on equipping the package. The evaluation result11in the form of a working step evaluation result11and a component evaluation result11bis displayed to the operating person on a display unit14of the display system13, said display unit being designed as a projection surface of the smartglasses or as a monitor.

Hence during the running process, it is possible for the operating person, for example by way of the display of a negative working step result11a, to immediately recognise errors on putting together the package and to correct this. By way of this, each packet is equipped according to the specification and the data is simultaneously yet stored in an audit-proof manner, for example for the authorities, in the archiving system1. Given an incorrect equipping of the packet, there is the possibility of indicating the error to the operating person by way of acoustic and/or optical signals.

Should it be displayed to the operating person, for example by way of the display of a negative component evaluation result11b, that insufficient components for the equipping of the package are present at the workplace of the operating person, then there is the possibility of the operating person obtaining these, by way of ordering or fetching them himself from the component store. Hereby, there is also the possibility of already comparing the components for the next or next but one working step, so that an uninterrupted working of the operating person is rendered possible. At the same time, given the absence of components, an automatic ordering and delivery by the store worker is also conceivable.

A position acquisition means12acquires the precise location of the operating person, for example by way of a GPS sensor which is built into the smartglasses. In the case of absent components for a working step at the workplace of the operating person, the position acquisition means12is suitable for providing the operating person with a location evaluation result lid by way of a comparison of the component storage location data10dwhich is stored in the memory means7and of the location data6dof the current location of the operating person and to display to the operating person a path to the respective component in the closest component storage space. It is hence possible for the operating person to also not put the package together at the workplace, but per “pick and drop” directly in the store. On account of the position acquisition means12and the display system13, the direct path to the next component to be packaged is optically and/or acoustically displayed to the operating person.

On account of the aforementioned sequences, a documentation corresponding to the “good manufacturing practise” (GMP) is ensured on putting together the package.

All data which is generated during the method is archived on the memory means7of the archiving system1in an audit-proof manner. Not only can the aforementioned method and the associated archiving system be used on equipping and putting-together packages with medications in the pharmaceutical industry, but also analogously with other packaging procedures, since by way of this an increased reliability of the correct composition procedure is achieved.

A further example for the use of the archiving system1is incoming goods inspection and the correct labelling of the good at the goods input which hereby occurs. The working steps are acquired by the working step acquisition unit2aat the goods input control and additionally the inscribing of the label of the goods and/or the coding of the goods are acquired by way of the component acquisition unit2b. The electronic data is compared to delivery data of the goods and is subsequently deposited in the archiving system1in an audit-proof manner.