EP3997636A1 - Système d'archivage et procédé pour archiver des données électroniques - Google Patents

Système d'archivage et procédé pour archiver des données électroniques

Info

Publication number
EP3997636A1
EP3997636A1 EP20734479.7A EP20734479A EP3997636A1 EP 3997636 A1 EP3997636 A1 EP 3997636A1 EP 20734479 A EP20734479 A EP 20734479A EP 3997636 A1 EP3997636 A1 EP 3997636A1
Authority
EP
European Patent Office
Prior art keywords
data
work step
component
archiving
weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20734479.7A
Other languages
German (de)
English (en)
Inventor
Mirko Nowak
Reinhard Nowak
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Glatt GmbH
Original Assignee
Glatt GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Glatt GmbH filed Critical Glatt GmbH
Publication of EP3997636A1 publication Critical patent/EP3997636A1/fr
Pending legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
    • G06F16/10—File systems; File servers
    • G06F16/11—File system administration, e.g. details of archiving or snapshots
    • G06F16/113—Details of archiving
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
    • G06F16/90—Details of database functions independent of the retrieved data types
    • G06F16/93—Document management systems
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063—Operations research, analysis or management
    • G06Q10/0631—Resource planning, allocation, distributing or scheduling for enterprises or organisations
    • G06Q10/06316—Sequencing of tasks or work
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
    • G06Q10/063—Operations research, analysis or management
    • G06Q10/0639—Performance analysis of employees; Performance analysis of enterprise or organisation operations
    • G06Q10/06398—Performance of employee with respect to a job function
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00—Administration; Management
    • G06Q10/08—Logistics, e.g. warehousing, loading or distribution; Inventory or stock management
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00—Information and communication technology [ICT] specially adapted for implementation of business processes of specific business sectors, e.g. utilities or tourism
    • G06Q50/04—Manufacturing
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P90/00—Enabling technologies with a potential contribution to greenhouse gas [GHG] emissions mitigation
    • Y02P90/30—Computing systems specially adapted for manufacturing

Definitions

  • the invention relates to an archiving system for archiving electronic data, the archiving system having storage means for storing the electronic data, a data processing system for processing the electronic data and a work step recording system for recording work steps carried out in a process, the work step recording system with the data processing system and the storage means is connected via communication means for data transmission, and wherein the data processing system is configured to convert the work steps recorded by the work step recording system into electronic data.
  • the invention also relates to a method for archiving electronic data.
  • the invention also relates to a use of an archiving system for archiving electronic data in the pharmaceutical industry.
  • Archiving systems and methods for archiving electronic data have long been state of the art.
  • data is digitized and then stored on a computer.
  • the invention is therefore based on the object of providing a method and a device for revision-proof archiving of electronic data, in particular for methods and processes in the pharmaceutical industry, which allow paper masses that are otherwise necessary for documentation of this type and sometimes entire rooms Avoid fogging up and thus protect the environment while reducing costs and storage space.
  • revision-proof refers to the revision-proof archiving for electronic archiving systems. The term is based on the understanding of the revision from an economic point of view and relates to information and documents that are required to be kept or are worth keeping.
  • archived in a revision-proof manner basically means that the stored data are protected from subsequent modification, for example by a user, and that the data in the archiving system is not manipulated.
  • the data is archived in the archiving system in a traceable, findable, unchangeable and falsification-proof manner.
  • the requirements for audit-proof archiving are laid down in the principles for the proper management and storage of books, records and documents in electronic form and for data access (GoBD).
  • Audit-proof archiving includes the concept of revision security. This relates to the verifiability of the process used and contains: a) proof of procedural documentation, b) proper use, c) safe process, d) safe operation and e) organization of the user company.
  • Audit security is not limited to the technology or software, but always includes the entire archiving process.
  • the ten principles for revision security of electronic data are defined as follows: l) All data (e-documents) are archived in the archiving system and cannot be changed.
  • Electronic archiving systems must be designed so that migration to new platforms, media, software versions and components is possible without any loss of information. io)
  • the archiving system must offer the user the opportunity to ensure the legal provisions (e.g. BDSG, HGB, AO etc.) as well as the operating provisions of the user with regard to data security and data protection over the life of the archiving system.
  • the data from the archiving system may be destroyed at the earliest after the retention period has expired.
  • An archiving system with a tamper-proof archiving system has the advantage that all steps of a process, whereby these are, for example, monitored by state authorities and can be checked at any time, such as B. the produc- tion of drugs in the pharmaceutical industry, ma can be archived tamper-proof.
  • Such an archiving system also has the advantage that paper masses, which are otherwise necessary for documentation of this type and sometimes occupy entire rooms, are no longer required, so that on the one hand the environment is protected and on the other hand, costs and storage space for the paper are saved can be.
  • the data processing system preferably comprises the memory means.
  • the storage means is preferably a conventional data storage, such as. A hard drive or the like.
  • the electronic data are preferably stored in the so-called batch record.
  • the work steps of a process to be carried out are advantageously on the storage means of the archiving system as work step setpoint data and / or components required for the work step of a process as component setpoint data and / or for the mass of an ingredient (component) to be dosed as weight setpoint data and / or components - Storage locations of components stored as component storage location setpoint data in the form of electronic data.
  • the archiving system has a recording system designed as a component recording unit and / or as a weight recording unit, the component recording unit and / or the weight recording unit being connected to the data processing system and the storage means via communication means for data transmission.
  • the component acquisition unit is preferably configured to acquire raw component data, the raw component data being the components available for the work step of a process to be carried out, and / or the weight acquisition unit is preferably configured to acquire raw weight data, the raw weight data (raw mass data) being the for represents the work step to be carried out of a process processing weight of a component or an ingredient.
  • Recording unit, the component recording unit and / or the weight recording unit designed as a recording system or parts of a recording system.
  • the acquisition system and / or the work step acquisition unit and / or the component acquisition unit and / or the Weight detection unit designed as a sensor, preferably as an optical sensor, particularly preferably as a camera, most preferably as a video camera.
  • the data processing system is preferably configured to convert the raw component data into actual component value data in the form of electronic data.
  • the data processing system of the archiving system can convert the data captured by the capture system into electronic data, such as images or films, which can be subsequently evaluated.
  • the archiving system has comparator means connected to the data processing system via communication means for data transmission.
  • the comparator means are preferably configured to match the actual value data and the setpoint data, in particular the work step actual value data and the work step setpoint data and / or component actual value data and the component setpoint data and / or weight actual value data and the weight setpoint data.
  • the data processing system comprises the comparator means.
  • the archiving system has evaluation means connected to the data processing system via communication means for data transmission.
  • the evaluation means are preferably configured for evaluating the comparison made by the comparison means.
  • the evaluation means are optimally configured based on the evaluation, provide an evaluation result, in particular a work step evaluation result and / or a component evaluation result and / or a weight evaluation result.
  • the data processing system particularly preferably comprises the evaluation means.
  • the archiving system has a display system which is connected to the data processing system via communication means for data transmission and has a display unit.
  • the display system is designed as a monitor and / or data glasses.
  • the display system is also advantageously configured to display the evaluation result provided by the evaluation means, preferably the work step evaluation result and / or the component evaluation result and / or the weight evaluation result and / or the location evaluation result.
  • the comparator and evaluation means of the archiving system enable the data recorded by the recording system to be compared and evaluated with, for example, data already stored in the storage means of the archiving system, so that evaluation results are available for further processing and audit-proof archiving in the archiving system .
  • the archiving system has a position acquisition means connected to the data processing system via communication means for data transmission for acquiring a current location of an operator. Accordingly, the archiving system is preferably configured to display a route to the component storage location on the display system. This makes it possible that the operator, for example If a component is missing, the fastest and / or shortest route to the nearest component is indicated by the display system so that there is as little time loss as possible in production.
  • the object is achieved in a method of the type mentioned in that the method for archiving electronic data comprises an archiving system, the archiving system having storage means for storing the electronic data, a data processing system for processing the electronic data and an as Work step acquisition unit has a recording system designed for acquiring work step raw data, the work step raw data being the work steps carried out in a process, and wherein the work step acquisition unit is connected to the data processing system and the storage means via communication means for data transmission, and the data processing system is configured to be processed by the work step acquisition unit to convert the raw work step data acquired into work step actual value data in the form of electronic data, the method comprising the steps of acquisition ng of the work steps carried out in the form of work step raw data of a process by the work step recording system, a conversion of the acquired work step raw data of a process into work step actual value data in the form of electronic data, a transmission of the work step actual value data to the storage means and an audit-proof archiving of the work step actual value data on the storage means of the archiv
  • a method with an archiving system for audit-proof archiving has the advantage that all procedural steps, such as those from state authorities are monitored and can be checked at any time, such as B. the assembly of components used in the pharmaceutical industry, such as nozzles or the like, can be archived tamper-proof.
  • Such a process also has the advantage that paper masses, which are otherwise necessary for such documentation and which sometimes occupy entire rooms, are no longer required, so that on the one hand the environment is protected and on the other hand costs and storage space for the paper can be saved at the same time .
  • work step setpoint data of a process are stored as electronic data on the storage means of the archiving system
  • the archiving system has comparator means for matching the stored work step setpoint data and work step actual value data
  • the archiving system has evaluation means for evaluating the comparison made by the comparison means Has work step setpoint data and work step actual value data of a process
  • the method comprising the steps of performing a comparison of the work step setpoint data and work step actual value data of a process, evaluating the comparison of the work step setpoint data and work step actual value data, and providing a work step evaluation result.
  • component and / or target weight data are stored on the storage means; the method comprises the steps of transmitting the component and / or actual weight data to the data processing system, performing a comparison of the component and / or or weight setpoint data and the component and / or weight actual value data of a process, an evaluation of the This was followed by comparison of the component setpoint data and the component actual value data and / or the weight setpoint data and the weight actual value data of a process and provision of a component evaluation result.
  • the archiving system preferably has a component acquisition unit and / or a weight acquisition unit, the method comprising the step of acquiring raw component data and converting the raw component data into actual component value data in the form of electronic data and / or acquiring raw weight data and converting the raw weight data into actual weight data in the form of electronic data.
  • component setpoint data and / or weight setpoint data are stored on the storage means, the method comprising the steps of transmitting the component actual value data and / or weight actual value data to the data processing system, performing a comparison of the component setpoint data and / or the weight setpoint data and the component actual value data and / or actual weight data of a process, the evaluation of the comparison of the component setpoint data and / or the weight setpoint data and the component actual value data and / or weight actual value data of a process and providing a component evaluation result and / or a weight evaluation result.
  • This has the advantage that both the work step evaluation result and the component and / or weight evaluation result can be used for further processing.
  • the archiving system has a display system for displaying the evaluation result provided by the evaluation means, preferably the work step evaluation result and / or Component evaluation result and / or the component storage space stored on the storage means for required components, the method comprising the
  • the archiving system advantageously has position detection means for detecting a current location of an operator, the method comprising the step of displaying a route from the current location of the operator to the component storage location. This makes it possible for the operator, for example, if a component is missing, to be shown the fastest and / or shortest route to the nearest component by the display system, so that there is as little time loss as possible in production.
  • the individual electronic data generated in the process steps are particularly advantageously archived in a revision-proof manner.
  • an archiving system for archiving electronic data in the pharmaceutical industry is advantageous, the archiving system being an archiving system according to one of Claims 1 to 20.
  • FIG. 1 shows a basic flow diagram of a preferred archiving system for audit-proof archiving of electronic data for use in the assembly of system components
  • FIG. 2 shows a basic flow diagram of a preferred archiving system for the audit-proof archiving of electronic data for use in the weighing-in of ingredients of medicaments
  • FIG. 3 shows a basic flow diagram of a preferred archive
  • Fig. 1 shows a basic flow diagram of a preferred archiving system 1 for the audit-proof archiving of electronic data for use in the assembly of components.
  • the archiving system 1 comprises a detection system 2 having a work step detection unit 2a and a component detection unit 2b.
  • the detection system 2 in particular the work step and component detection unit 2a, 2b, is preferred as a sensor, particularly preferred as an optical sensor, very particularly preferred as Camera, in particular as a video camera, designed.
  • the detection system 2, in particular the work step detection unit 2a is designed as data glasses with a video camera.
  • the work step detection unit 2a recognizes the work steps that are carried out by an operator in the detection field of the work step detection unit 2a, for example at their workplace.
  • a stationary, stationary installation of the detection system 2 is also conceivable, for example designed as a camera (body cam) arranged on the body, the component detection unit 2b preferably being designed in this way. This makes it advantageous always possible to capture the components available for the individual work steps at the operator's workplace.
  • the detection system 2 shown in the exemplary embodiment has, with the work step detection unit 2a and the component detection unit 2b, two detection systems 2 that are independent of one another as video cameras.
  • the acquisition system 2 is suitable for acquiring raw data 3, in particular for acquiring raw work step data 3a and raw component data 3b.
  • the raw work step and component data 3a, 3b captured by the work step and component acquisition unit 2a, 2b are transmitted to a data processing system 5 via communication means 4, such as data transmission cables, conductor tracks, radio networks or the like, where the data processing system 5 is configured to convert the raw data 3 acquired by the acquisition system 2 into acquired electronic actual value data 6.
  • the raw work step data 3a are converted into recorded, electronic actual work step value data 6a and the raw component data 3b are converted into recorded, electronic component actual value data 6b.
  • the data processing system 5 of the archiving system 1 comprises storage means 7, comparison means 8 and evaluation means 9.
  • the electronic actual value data 6 obtained by conversion from the raw data 3, in particular the work step actual value data 6a and the component actual value data can be stored on the storage means 7, in particular on the batch records formed at least as part of the storage means 6b, and on the other hand, additional electronic data can be stored on the storage means 7.
  • additional electronic data include, for example, all types of documents, but in particular setpoint data 10, preferably work step setpoint data 10a to be processed by an operator when assembling the system component, here the nozzle.
  • component setpoint data 10b preferably the components required for each work step
  • Component storage location data LOD can also be stored as electronic data on the storage means 7.
  • All raw data 3, actual and setpoint data 6, 10 and additional electronic data are archived in the preferred archiving system 1 and cannot be changed. All data, in particular the raw data 3 and the actual and setpoint data 6, 10 are stored on the storage means 7 and provided with metadata for unambiguous identification, for example, for indexing, so that the electronic data can be found again at any time during the retention period . All electronic data must be displayable and printable on demand in exactly the same form as it was recorded.
  • the comparator means 8 are suitable for comparing the recorded electronic actual value data 6 stored on the memory means 7 and the stored electronic setpoint data 10 with one another.
  • the work step actual value data 6a are compared with the work step setpoint data 10a and the component actual value data 6b with the component setpoint data 10b.
  • the evaluation means 9 are configured to evaluate the comparison carried out in the comparison means 8 between stored, recorded electronic actual value data 6 and stored electronic setpoint data 10 and to determine or provide an evaluation result 11.
  • a so-called work step evaluation result 11a results from the comparison of actual work step value data 6a and target value data 10a
  • a so-called component evaluation result 11b from the comparison of actual component value data 6b and target component value data 10b.
  • the archiving system 1 of the exemplary embodiment includes a position acquisition means 12, connected to the data processing system 5 via communication means 4 for data transmission, for acquiring location data 6d of a current location of an operator.
  • the position detection means 12 is suitable to provide a location evaluation result lld by comparing the location data 6c of the current location of the operator and the component storage location data lOd, carried out in particular by the comparator and evaluation means 7, 8.
  • the component storage location data lOd are achieved, for example, through an inventory of the components and unambiguous storage of the components, through microchips built into the components, in particular radio-frequency identification (RFID).
  • RFID radio-frequency identification
  • further information can also be stored with the component storage location data, such as status data, for example cleaned, validated or the like.
  • the preferred archiving system 1 includes a display system 13.
  • the display system 13 preferably has display units 14a, 14b and 14d, which preferably reproduce the evaluation results 11, in particular the work step evaluation result 11a, the component evaluation result 11b and the location evaluation result lld.
  • the status data are also advantageously displayed, for example, so that the operator can always get a complete overview of the process conditions.
  • the display system 12 is preferably designed as a monitor, but particularly preferably as data glasses that have a projection surface for displaying the evaluation result 11. This makes it possible for the work step evaluation result 11a, for example, to be displayed in the projection area of the data glasses in addition to other information.
  • the Ortaus evaluation result is preferably displayed on a display system 13 as a route to the component storage location.
  • the first exemplary embodiment of a preferred method for archiving electronic data is explained using the assembly of a nozzle, the method also being used analogously for archiving electronic data when assembling other system components.
  • the operator wears, for example, data glasses equipped with a video camera as the acquisition system 2.
  • the acquisition system 2 as a work step and component acquisition unit 2a, 2b, firstly records the work steps performed by the operator when assembling the nozzle raw data 3a as work step and, on the other hand, the components available at the workplace for assembling the nozzle as raw component data 3b.
  • the acquired raw data 3 are transmitted via communication means 4, data processing system 5, for example a computer or the like.
  • the data processing processing system 5 converts the recorded raw data 3 into actual value data 6, namely into work step actual value data 6a and component actual value data 6b. Both the raw data 3 and the actual value data 6 are stored in an audit-proof manner on the storage means 7 assigned to the data processing system 5.
  • setpoint data 10 are stored on the storage means 7, in particular work step setpoint data 10a and component setpoint data 10b.
  • a list of the individual work steps to be carried out is preferably stored in the memory means 7 as work step data.
  • component setpoint data 10b pre-trained images of a CAD model using industrial image processing software, for example Halcon 8.0 from MVTec Software GmbH, are preferably used.
  • the software recognizes 3D objects in space in any positions and orientations using shape-based matching, ie by comparing them with a previously trained CAD model.
  • Comparator means 8 access the actual value data 6, actual work step value data 6a and actual component value data 6b stored on the storage means 7, obtained from raw data 3, and compare these with the setpoint data 10, work step setpoint data 10a and component setpoint data 10b. The comparison is then evaluated in the evaluation means 9 and an evaluation result 11 is provided in the form of a work step evaluation result 11a and a component evaluation result 11b. In contrast to a negative evaluation result 11, a positive evaluation result 11 confirms to the operator that the work process is faultless. If the work step evaluation result 11a is positive, the individual work steps carried out correctly, e.g. all parts correctly installed together. If the component evaluation result 11b is positive, sufficient components are available at the operator's workplace for the work step to be carried out when assembling the nozzle or for the complete assembly of the nozzle.
  • the evaluation result 11 in the form of a work step evaluation result 11a and a component evaluation result 11b is displayed to the operator on a display unit 14 of the display system 13 designed as a projection surface of the data glasses or as a monitor.
  • the operator can also give an acoustic signal, for example via headphones.
  • each nozzle is assembled in the same way and the assembly process is also stored in the archiving system 1 in an audit-proof manner, e.g. for the authorities.
  • nozzle If the nozzle is not assembled correctly, it is possible to interrupt further assembly of the nozzle, for example by disconnecting the tools required for assembly. As soon as the operator has corrected the assembly of the nozzle, further assembly of the nozzle can take place.
  • the operator has the option to procure these by ordering or by collecting them from the component warehouse. There is also the option of aligning the components for the next or the next work step so that the operator can always work without interruption. At the same time, if components are not available, automatic ordering and delivery is also conceivable.
  • a position detection means 12 detects the exact location of the operator, for example by means of a GPS sensor built into the data glasses.
  • the 12 is suitable for the operator, in the case of non-existent components for a work step at the operator's workplace, by comparing the component storage location data lOd stored on the storage means 7 and the location data 6d of the operator's current location, a location evaluation result lld be provided and the Display operator a way to the corre sponding component in the nearest component storage location.
  • the operator can call up the currently valid standard procedure (SOP) at any time during the assembly of the nozzle and have it shown in the display system 13.
  • SOP standard procedure
  • GMP good manufacturing practice
  • the aforementioned method and the associated archiving system can be used not only when assembling system components, but also when assembling systems themselves, preferably in the pharmaceutical industry, as there are very high demands on the documentation of the data.
  • the method can be carried out analogously to the equipping, in particular the installation of tools, plant components such as tablet presses, packaging machines or the like.
  • FIG. 2 shows a basic flow diagram of a preferred archiving system 1 for the audit-proof archiving of electronic data for use in the weighing in of ingredients of drugs.
  • the archiving system 1 comprises a recording unit 2a, a component recording unit 2b and a weight recording unit 2c having recording system 2.
  • the recording system 2 in particular the working, component and weight recording unit 2a, 2b and 2c, is preferred as a sensor , particularly preferably as an optical sensor, very particularly preferably as a camera, in particular as a video camera.
  • the balance can optionally also communicate directly with the storage means 7 for a possible additional control or a second validation and / or documentation.
  • the detection system 2 in particular the work step detection unit 2a, is designed as data glasses with a video camera.
  • the work step detection unit 2a recognizes the work steps that are carried out by an operator in the detection field of the work step detection unit 2a, for example at their workplace.
  • a stationary, stationary installation of the detection system 2 is also conceivable, for example in the form of a camera (body cam) arranged on the body, with the component and weight detection units preferably being used. that is, 2b, 2c are designed in this way. This advantageously makes it possible to always use the components available for the individual work steps at the operator's workplace through the component acquisition unit 2b and the weight, e.g.
  • ingredients active ingredient or auxiliary
  • weighing on a scale through the weight acquisition unit 2c on a weight display the scale and / or with a label on the packaging z.
  • the detection system 2 shown in the exemplary embodiment has, with the work step detection unit 2a, the component detection unit 2b and the weight detection unit 2c, three detection systems 2 that are independent of one another as a video camera.
  • the acquisition system 2 is suitable for acquiring raw data 3, in particular for acquiring raw work step data 3a, raw component data 3b and raw weight data.
  • the raw work step, component and weight data 3a, 3b, 3c acquired by the work step, component and weight acquisition unit 2a, 2b, 2c are sent to a communication device 4, such as data transmission cables, conductor tracks, radio networks or the like Data processing system 5 transmitted, the data processing system 5 being configured to convert the raw data 3 acquired by the acquisition system 2 into acquired, electronic actual value data 6.
  • the raw work step data 3a are converted into captured electronic actual work step value data 6a, the raw component data 3b into captured electronic component actual value data 6b and the raw weight data 3c into captured electronic actual weight data 6c.
  • the data processing system 5 of the archiving system 1, corresponding to the archiving system 1 described in FIG. 1, comprises storage means 7, comparison means 8 and evaluation means 9.
  • the storage means 7 in particular on the batch records formed at least as part of the storage means, are the Electronic actual value data 6 obtained by conversion from the raw data 3 can be stored, in particular the work step actual value data 6a, the component actual value data 6b and the raw face data 6c, and on the other hand are on the
  • Storage means 7 can also store further electronic data.
  • additional electronic data include, for example, all types of documents, but in particular target value data 10, preferably working step target value data 10a to be processed by an operator during the preparation of the medicament.
  • target value data 10a preferably working step target value data 10a to be processed by an operator during the preparation of the medicament.
  • component setpoint data 10b a list of the individual ingredients (components) of the medicaments before the ingredients required for each work step as component setpoint data 10b on the storage means 7 as stored, electronic setpoint data 10.
  • Component storage location data 10d can also be stored as electronic data on the storage means 7. All raw data 3, actual and setpoint data 6, 10 and additional electronic data are archived in the preferred archiving system 1 and cannot be changed. Here, all data, in particular the raw data 3 and the actual and setpoint data 6, 10 are stored on the storage means 7 and for indexing, for example, with metadata for unambiguous identification, so that the electronic data can be found again at any time during the retention period. All Electronic data must be displayable and printable on request in exactly the same form in which it was recorded.
  • the comparator means 8 are suitable for comparing the recorded electronic actual value data 6 stored on the storage means 7 and the stored electronic setpoint data 10 with one another.
  • the actual work step value data 6a are compared with the set work step value data 10a, the actual component value data 6b with the setpoint component value data 10b and the actual weight value data 6c with the setpoint weight data 10c.
  • the evaluation means 9 are configured to evaluate the comparison carried out in the comparison means 8 between stored, recorded electronic actual value data 6 and stored electronic setpoint data 10 and to determine or provide an evaluation result 11.
  • a so-called work step evaluation result 11a results from the comparison of actual work step value data 6a and set work step value data 10a
  • a so-called component evaluation result 11b results from the comparison of actual component value data 6b and set component value data 10b
  • a so-called weight evaluation result from the comparison of actual weight value data 6c and target weight data 10c.
  • the archiving system 1 comprises a position detection means 12, which is connected to the data processing system 5 via communication means 4 for data transmission, for the detection of location data 6d of a current location of an operator.
  • the position detection means 12 is suitable by a, in particular by the comparator and evaluation means 7, 8 carried out, comparison of the location data 6d of the current location of the operator and the component storage location data lOd provide a location evaluation result lld.
  • the component storage location data lOd are achieved, for example, through an inventory of the components and unambiguous storage of the components, through microchips built into the components, in particular radio-frequency identification (RFID).
  • RFID radio-frequency identification
  • further information can also be stored with the component storage location data, such as status data, for example cleaned, validated or the like.
  • the preferred archiving system 1 comprises a display system 13.
  • the display system 13 preferably has display units 14a to 14d, which preferably display the evaluation results 11, in particular the work step evaluation result 11a, the component evaluation result 11b, the weight evaluation result 11c and the location value result lld, reproduce.
  • the status data are also advantageously displayed, for example, so that the operator can always get a complete overview of the process conditions.
  • the display system 12 is preferably designed as a monitor, but particularly preferably as data glasses that have a projection surface for displaying the evaluation result 11. This makes it possible for the work step evaluation result 11a, the component evaluation result 11b, the weight evaluation result 11c, for example, to be displayed in the projection surface of the data glasses in addition to other information.
  • the location evaluation result is preferably displayed on a display system 13 as a route to the component storage location.
  • the second embodiment of a preferred method for archiving electronic data is based on Weighing in of ingredients (components) of drugs explained.
  • the operator When weighing medication, the operator wears, for example, data glasses equipped with a video camera as the acquisition system 2.
  • the acquisition system 2 records the work steps performed by the operator as a work step, component and weight acquisition unit 2a, 2b and 2c the initial weight as raw work step data 3a, on the other hand the ingredients (components) present at the workplace, such as active ingredients and auxiliaries, as raw component data 3b and the weight (mass) of the respective ingredients as soon as they are weighed on a scale for dosing as raw weight data.
  • the recorded raw data 3 are transmitted via communication means 4, data processing system 5, for example a computer or the like.
  • the data processing system 5 converts the recorded raw data 3 into actual value data 6, namely into work step actual value data 6a, component actual value data 6b and weight actual value data 6c. Both the raw data 3 and the actual value data 6 are stored in an audit-proof manner on the storage means 7 assigned to the data processing system 5.
  • setpoint data 10 are stored in the storage means 7, in particular work step setpoint data 10a as well as component setpoint data 10b and weight setpoint data 10c.
  • a list of the individual work steps to be carried out is preferably stored on the memory means 7 as work step data.
  • Pre-trained images of the respective ingredient are preferably used as component setpoint data 10b, and the masses of the individual ingredients, also referred to as components, are preferably used as weight setpoint data 10c.
  • Comparator means 8 access the actual value data 6 obtained from raw data 3 and stored on the storage means 7 and compare them with the setpoint data 10. The comparison is then evaluated in the evaluation means 8 and an evaluation result 11 is provided in the form of a work step evaluation result 11a, a component evaluation result 11b and a weight evaluation result 11c.
  • a positive evaluation result 11 confirms the operator, in contrast to a negative evaluation result 11, that the work flow is flawless. If the work step evaluation result 11a is positive, the individual work step was carried out correctly, for example all ingredients were metered in, preferably even correctly in the correct order. If the component evaluation result 11b is positive, there are sufficient ingredients (components) available at the operator's workplace for the preparation of medicaments (initial weight) for the work step to be carried out.
  • the evaluation result 11 in the form of a work step evaluation result 11a, a component evaluation result 11b and a weight evaluation result 11c is displayed to the operator on a display unit 14 of the display system 13 which is designed as a projection surface of the data glasses or as a monitor. shows.
  • a display unit 14 of the display system 13 which is designed as a projection surface of the data glasses or as a monitor. shows.
  • Different display systems 13 or different display units 14 are conceivable.
  • each drug is produced with consistent quality and the drug weight is also stored in the archiving system 1 in an audit-proof manner, for example for the authorities.
  • the operator If the operator is shown, for example by displaying a negative component evaluation result 11b during the ongoing process, that there are not enough components (ingredients) for the preparation (weighed-in) of the corresponding drug at the operator's workplace, the operator has the option to obtain these by ordering or collecting them from the component warehouse. There is also the possibility of already aligning the components for the next or the next but one work step so that the operator can always work without interruption. Simultaneously, in the absence of components, automatic ordering and delivery by third parties, e.g. B. warehouse workers, conceivable.
  • third parties e.g. B. warehouse workers
  • a position detection means 12 detects the exact location of the operator, for example by means of a GPS sensor built into the data glasses.
  • the position detection means 12 is suitable for the operator, in the event that components are not available, for a work step at the operator's workplace, by comparing the data on the storage means 7
  • the stored component storage location data lOd and the location data 6d of the current location provide the operator with a location evaluation result lld and display the operator a route to the corresponding component in the nearest component storage location.
  • Fig. 3 shows a basic flow diagram of a preferred archiving system 1 for audit-proof archiving of electronic data for use in pharmaceutical logistics.
  • the preferred archiving system 1 and the associated preferred method are intended to replace a "Pick by Voice" mode of operation with a "Pick by Cam” mode of operation.
  • the archiving system 1 is designed in accordance with the archiving system 1 described in FIG.
  • the third exemplary embodiment of a preferred method for archiving electronic data is explained using the control of a pharmaceutical product in pharmaceutical logistics, the method also being used analogously for archiving electronic data in other logistics areas besides the pharmaceutical industry .
  • the operator wears, for example, data glasses equipped with a video camera as the acquisition system 2.
  • the acquisition system 2 as a work step and component acquisition unit 2a, 2b, records on the one hand the work steps carried out by the operator when assembling the package with corresponding drugs as raw work step data 3a and, on the other hand, the components (drugs) available at the workplace for equipping the package as raw component data 3b.
  • the recorded raw data 3 are transmitted via communication means 4, data processing system 5, for example a computer or the like.
  • the data processing system 5 converts the acquired raw data 3 into actual value data 6, namely into work step actual value data 6a and component actual value data 6b. Both the raw data 3 and the
  • Actual value data 6 are stored in an audit-proof manner on the storage means 7 assigned to the data processing system 5.
  • setpoint data 10 are stored in the storage means 7, in particular work step setpoint data 10a and component setpoint data 10b.
  • a list of the individual work steps to be carried out is preferably stored on the memory means 7 as work step data.
  • An order list for example, can be used for this purpose, whereby the work steps do not have to be processed in a specific order.
  • the work steps here the loading of a package with a certain drug from an order list, can be freely selected until all the drugs on the order list are stored in the package.
  • Pre-trained images of a medicament stored in software are preferably used as component setpoint data 10b used in the appropriate size (volume, mass or the like).
  • the software recognizes 3D objects in space in any position and orientation using shape-based matching, ie by comparing them with a pre-trained image.
  • Comparator means 8 access the actual value data 6, work step actual value data 6a and component actual value data 6b obtained from raw data 3 stored on the storage means 7 and compare these with the setpoint data 10, work step setpoint data 10a and component setpoint data 10b. The comparison is then evaluated in evaluation means 8 and an evaluation result 11 is provided in the form of a work step evaluation result 11a and a component evaluation result 11b. In contrast to a negative evaluation result 11, a positive evaluation result 11 confirms to the operator that the work process is faultless. If the work step evaluation result 11a is positive, the individual work step was carried out correctly, for example all medicaments packed in the package. If the component evaluation result 11b is positive, sufficient components (drugs) are available at the operator's workplace for the work step to be carried out when loading the package.
  • the evaluation result 11 in the form of a work step evaluation result 11a and a component evaluation result 11b is displayed to the operator on a display unit 14 of the display system 13 designed as a projection surface for the data glasses or as a monitor.
  • each package is assembled according to the specification and, at the same time, the data is also stored in the archiving system 1 in an audit-proof manner, for example for the authorities. If the package is not loaded correctly, the operator can indicate the error by means of acoustic and / or optical signals.
  • a position detection means 12 detects the exact location of the operator, for example by means of a GPS sensor built into the data glasses.
  • the position detection means 12 is suitable for the operator, in the event that components are not available for a work step at the operator's workstation, by comparing the component storage location data lOd stored on the storage means 7 and the location data 6d of the current location of the operator and providing the operator with a location evaluation result to show the operator a route to the corresponding component in the nearest component storage location. This makes it possible for the operator to put the package together not at the workplace, but directly in the warehouse using "pick and drop". position detection means 12 and the display system 13, the operator is always optically and / or acoustically indicated the direct route to the next component to be packaged.
  • All data generated during the process are archived in a revision-safe manner on the storage means 7 of the archiving system 1.
  • the aforementioned method and the associated archiving system can be used not only when loading or assembling packages with medicines in the pharmaceutical industry, but also in other packaging processes for objects, since this increases the reliability of the correct assembling process.
  • Another example of the use of the archiving system 1 is the incoming goods inspection and the correct labeling of the goods in the incoming goods area.
  • the work steps during the incoming goods inspection are recorded by the work step acquisition unit 2a and the label of the goods is also labeled
  • the electronic data are compared with the delivery data of the goods and then stored in the archiving system 1 in an audit-proof manner.

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Abstract

L'invention concerne un système d'archivage (1) pour archiver des données électroniques et un procédé associé pur archiver des données électroniques sur le système d'archivage (1).
EP20734479.7A 2019-07-09 2020-06-18 Système d'archivage et procédé pour archiver des données électroniques Pending EP3997636A1 (fr)

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DE102019210085.6A DE102019210085A1 (de) 2019-07-09 2019-07-09 Archivierungssystem und Verfahren zur Archivierung von elektronischen Daten
PCT/EP2020/066906 WO2021004744A1 (fr) 2019-07-09 2020-06-18 Système d'archivage et procédé pour archiver des données électroniques

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WO2021004744A1 (fr) 2021-01-14
BR112022000238A2 (pt) 2022-03-08
DE102019210085A1 (de) 2021-01-14
US20220269646A1 (en) 2022-08-25
CA3145975A1 (fr) 2021-01-14
JP2022540088A (ja) 2022-09-14

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