System update method and device

Abstract

The present application provides a system update method and device, which are applied to a drug vigilance system. The method includes: obtaining a change event, which is used to indicate a change in the organizational structure of the drug vigilance system, or a change in a regulatory document, wherein the regulatory document is a legal document; generating a risk warning according to the change event, the risk warning includes a risk location and a recommended modification plan, and the risk warning is used to prompt the user to modify the risk location according to the recommended modification plan to update the drug vigilance system. The technical solution of the present application can automatically generate a risk warning according to changes in the organizational structure or legal documents in the drug vigilance system to assist users in completing the update of the drug vigilance system.

Description

Technical Field

[0001] The present application relates to the field of medical technology, and in particular to a system updating method and device. Background Art

[0002] The pharmacovigilance system will change with the changes in the internal organizational structure (such as organizational personnel structure, organizational assets) of the enterprise (such as pharmaceutical enterprises), as well as the changes in the published legal documents and other information. However, in the prior art, when the organizational structure of the enterprise and / or the legal documents related to pharmacovigilance change, the pharmacovigilance system will become invalid, and professionals will need to rebuild or update the pharmacovigilance system, resulting in low efficiency and high complexity in updating the pharmacovigilance system. Summary of the invention

[0003] In view of this, the embodiments of the present application provide a system update method and device, which can improve the update efficiency of the drug vigilance system and reduce the complexity of the update of the drug vigilance system.

[0004] In a first aspect, an embodiment of the present application provides a system update method for a drug vigilance system, comprising: obtaining a change event, where the change event is used to indicate a change in the organizational structure within the drug vigilance system, or a change in a regulatory document, where the regulatory document is a legal document; generating a risk warning based on the change event, where the risk warning includes a risk location and a recommended modification plan, and the risk warning is used to prompt a user to modify the risk location according to the recommended modification plan to update the drug vigilance system.

[0005] In certain embodiments of the present application, change events include changes in organizational structure, and changes in organizational structure include changes in organizational personnel structure and changes in operating standard documents. Generating risk warnings based on change events includes: determining, based on the change events, regulatory documents corresponding to the change events; and comparing the change events with the regulatory documents to determine risk warnings.

[0006] In certain embodiments of the present application, the change event includes a change in the organizational personnel structure, and the regulatory documents include organizational personnel structure regulations, wherein the change event is compared with the regulatory documents to determine a risk warning, including: comparing the changed organizational personnel structure with the organizational personnel structure regulations; when the changed organizational personnel structure does not comply with the organizational personnel structure regulations, generating a risk warning, wherein the risk warning includes deleting or adding corresponding organizational personnel.

[0007] In certain embodiments of the present application, the change event includes a change in an operating standard document, and the regulatory document includes an operating regulation, wherein the change event is compared with the regulatory document to determine a risk warning, including: comparing the changed operating standard document with the operating regulation; when the changed operating standard document does not comply with the provisions of the operating regulation, generating a risk warning.

[0008] In certain embodiments of the present application, the change event includes a change in a regulatory document, and the change in the regulatory document includes changing the original regulatory document to a new regulatory document, wherein generating a risk warning based on the change event includes: comparing the new regulatory document with the organizational structure within the drug vigilance system to generate a risk warning.

[0009] In certain embodiments of the present application, the organizational structure includes an organizational personnel structure, and the new regulatory documents include new organizational personnel structure regulations, wherein the new regulatory documents are compared with the organizational structure within the drug vigilance system to generate a risk warning, including: comparing the new organizational personnel structure regulations with the organizational personnel structure; when the organizational personnel structure does not comply with the new organizational personnel structure regulations, generating a risk warning.

[0010] In certain embodiments of the present application, the organizational structure includes an operating standard document, and the new regulations document includes new operating regulations, wherein the new regulations document is compared with the organizational structure within the drug vigilance system to generate a risk warning, including: comparing the new operating regulations with the operating standard document; when the operating standard document does not comply with the new operating regulations, generating a risk warning.

[0011] In certain embodiments of the present application, obtaining a change event includes: detecting the organizational structure within the drug vigilance system to obtain a change event, wherein the organizational structure includes an organizational personnel structure and operating standard documents; or detecting a new regulatory document to obtain a change event, wherein the new regulatory document is a legal document.

[0012] In certain embodiments of the present application, the method further includes: building a display interface of the user terminal according to the intelligent recommendation prompt, and the display interface displays a risk prompt.

[0013] In the second aspect, an embodiment of the present application provides a system update device for a drug vigilance system, comprising: an acquisition module, used to acquire change events within the drug vigilance system, the change events are used to indicate changes in the organizational structure within the drug vigilance system, or changes in regulatory documents, where the regulatory documents are legal documents; a risk warning module, used to generate risk warnings based on change events, where the risk warnings include risk locations and recommended modification plans, and the risk warnings are used to prompt users to modify the risk locations according to the recommended modification plans to update the drug vigilance system.

[0014] In a third aspect, an embodiment of the present application provides a computer-readable storage medium, the storage medium stores a computer program, and the computer program is used to execute the system update method described in the first aspect above.

[0015] In a fourth aspect, an embodiment of the present application provides an electronic device, comprising: a processor; and a memory for storing processor executable instructions, wherein the processor is used to execute the system update method described in the first aspect above.

[0016] The embodiments of the present application provide a system update method and device, which automatically generates risk warnings by detecting change events, thereby prompting users of risky locations and providing users with recommended update and modification plans to assist users in completing the update of the drug vigilance system, thereby improving the update efficiency of the drug vigilance system and reducing the complexity of the update of the drug vigilance system. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 It is a flowchart of a system updating method provided by an exemplary embodiment of the present application.

[0018] Figure 2 It is a schematic diagram of a risk warning pop-up window provided by an exemplary embodiment of the present application.

[0019] Figure 3 It is a flowchart of a system updating method provided by another exemplary embodiment of the present application.

[0020] Figure 4 It is a flowchart of a system updating method provided by another exemplary embodiment of the present application.

[0021] Figure 5 It is a flowchart of a system updating method provided by yet another exemplary embodiment of the present application.

[0022] Figure 6 It is a flowchart of a system updating method provided by yet another exemplary embodiment of the present application.

[0023] Figure 7 It is a flowchart of a system updating method provided by yet another exemplary embodiment of the present application.

[0024] Figure 8 It is a structural diagram of a system updating device provided by an exemplary embodiment of the present application.

[0025] Fig. 9 It is a block diagram of an electronic device for system update provided by an exemplary embodiment of the present application. DETAILED DESCRIPTION

[0026] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0027] Pharmacovigilance is the scientific research and activities to discover, evaluate, recognize and prevent adverse drug effects or any other drug-related problems. The establishment and operation of a pharmacovigilance system can play a role in ensuring the safe use of drugs in clinical practice. The pharmacovigilance system of the embodiment of the present application can be composed of organizational personnel structure, standard operating procedures (SOP), and drug adverse reaction monitoring departments. It can be seen that the pharmacovigilance system is a highly professional system in the pharmaceutical industry.

[0028] In the prior art, during the construction of the pharmacovigilance system, there is a disconnection between the organizational structure of the enterprise (such as a pharmaceutical enterprise), and the information of the organizational structure can only be reflected in the SOP document. Moreover, when the organizational structure of the enterprise and the legal documents related to pharmacovigilance change, the traditional pharmacovigilance system will become ineffective to a certain extent, and it can only rely on professionals to recompile the SOP documents so that the pharmacovigilance system can be updated according to the recompile SOP documents, making it difficult for the traditional pharmacovigilance system to keep up with the changes and updates of the enterprise's organizational structure and / or the laws related to pharmacovigilance.

[0029] In order to solve the above technical problems, the present application proposes the following drug vigilance system update method.

[0030] Figure 1 It is a flowchart of a system updating method provided by an exemplary embodiment of the present application. Figure 1 The method is performed by a computing device, such as a server or an auxiliary construction system running on the server. Figure 1 As shown, the system updating method includes the following contents.

[0031] 110: Get change events. Change events are used to indicate changes in the organizational structure within the pharmacovigilance system or changes in regulatory documents.

[0032] In one embodiment, the regulatory document is a legal document.

[0033] Specifically, the auxiliary construction system (or server) running on the server can detect the pharmacovigilance system in real time or non-real time to obtain change events. The server can also obtain change events based on the deletion, modification and / or addition operations of users (such as pharmacovigilance personnel or personnel of pharmaceutical companies) in the pharmacovigilance system.

[0034] Change events can be used to indicate changes in regulatory documents, where regulatory documents are legal documents, which can be official laws and regulations such as the "Pharmacovigilance Quality Management Rules" and the "Regulations for the Implementation of the Drug Administration Law". Change events can also indicate changes in the organizational structure within the pharmacovigilance system, where the organizational structure can include organizational personnel structure and operating standard documents (such as SOPs). Changes in the organizational structure can be changes in the organizational personnel structure and changes in operating standard documents. The embodiments of this application do not limit the specific content of the organizational structure.

[0035] For example, the human resources of a pharmaceutical company deletes a person from the organizational personnel structure included in the pharmacovigilance system. At this time, a personnel change will occur in the organizational personnel structure (i.e., organizational personnel structure change), and the organizational personnel structure change can be regarded as a change event.

[0036] 120: Generate risk warnings based on change events. Risk warnings include risk locations and recommended modification plans. Risk warnings are used to prompt users to modify risk locations according to the recommended modification plans to update the drug vigilance system.

[0037] Specifically, the change event can be a change in the organizational structure within the pharmacovigilance system, or a change in regulatory documents (i.e., legal documents). Risk warnings can generate different warning contents and recommended modification plans based on different change events.

[0038] In one embodiment, when the change event is a change in the organizational structure within the pharmacovigilance system, the auxiliary construction system (or server) running on the server can determine the regulatory document corresponding to the change event based on the change event. The auxiliary construction system running on the server can then compare the change event with the regulatory document corresponding to the change event. When the change event does not comply with the regulatory document, the auxiliary construction system running on the server can generate a risk warning.

[0039] In another embodiment, when the change event is a change in a regulatory document (i.e., a new legal provision, such as a new regulatory document, is promulgated), the auxiliary construction system (or server) running on the server can compare the new regulatory document with the organizational structure in the pharmacovigilance system. When the organizational structure does not conform to the new regulatory document, the server can generate a risk warning.

[0040] It should be noted that when constructing the various components of the organizational structure in the pharmacovigilance system, the legal documents corresponding to the various components can be corresponded, that is, the organizational structure in the pharmacovigilance system and the corresponding legal documents are in a one-to-one mapping relationship. For example, the organizational personnel structure in the constructed organizational structure can correspond to the organizational personnel structure regulations, so that the server can quickly extract the legal documents corresponding to the organizational personnel structure.

[0041] The risk warning may include risk location, recommended modification plan, and the number of risks, etc. The specific form of the risk warning is not specifically limited in the embodiment of the present application. The risk warning may be used to remind the user that the current drug vigilance system does not comply with the regulations, so that the user can modify the non-compliant location (i.e., risk location) according to the recommended modification plan to complete the update operation of the drug vigilance system.

[0042] The risk location may be a specific department that is missing in the drug vigilance system, or may be a responsible person that is missing in a specific department in the drug vigilance system. The description of the risk location in the embodiment of the present application is not specifically limited.

[0043] For example, the risk warning may be that no other departments related to pharmacovigilance have been found. Another example is that the risk warning may be that no responsibilities related to collection have been found in the responsibility information of the pharmacovigilance department.

[0044] The recommended modification plan can be a targeted modification plan determined according to the risk location. For example, to ensure the responsibilities of the pharmacovigilance department, it is necessary to have personnel with responsibilities related to "signal detection, risk assessment, risk control, and pharmacovigilance plan".

[0045] In one example, the risk warning may be displayed on the page in the form of a pop-up window, for example, see Figure 2 The specific content of the risk warning can be displayed as there are 2 risks to be processed on the current page, and the specific location information of the 2 risks is listed, and a corresponding "suggested action" control is set after each risk, so that the user can obtain the recommended modification plan for each risk by clicking the control.

[0046] It can be seen that the embodiment of the present application automatically generates risk warnings by detecting change events, thereby prompting users of risky locations and giving users recommended solutions for updating and modifying to assist users in completing updates to the drug vigilance system, thereby improving the update efficiency of the drug vigilance system and reducing the complexity of updating the drug vigilance system.

[0047] Figure 3 It is a flowchart of a system updating method provided by another exemplary embodiment of the present application. Figure 3 The embodiment is Figure 1The examples of the embodiments will not be repeated in detail, and the differences will be described in detail here. Figure 3 As shown, the system updating method includes the following contents.

[0048] In one embodiment, the change event includes a change in the organizational structure, and the change in the organizational structure includes a change in the organizational personnel structure and a change in the operating standard document.

[0049] Specifically, the change event may include a change in the organizational structure within the pharmacovigilance system. The change in the organizational structure may include a change in the organizational personnel structure within the pharmacovigilance system, a change in the operating standard document (such as a SOP change), and a department change, which is not specifically limited in the embodiments of the present application.

[0050] 310: Based on the change event, determine the regulatory documents corresponding to the change event.

[0051] Specifically, the auxiliary construction system (or server) running on the server can retrieve the regulatory documents corresponding to different change events according to different change events. The regulatory documents can be legal documents corresponding to the change event. Among them, the regulatory documents can correspond to their corresponding organizational structures and be saved on the server in advance. The embodiment of the present application does not specifically limit the method for obtaining the regulatory documents. In other words, the server can determine the laws and regulations corresponding to the change event based on the change event.

[0052] 320: Compare change events with regulatory documents to determine risk warnings.

[0053] Specifically, the auxiliary construction system (or server) running on the server may compare the change event with the regulation file corresponding to the change event.

[0054] In one embodiment, when a change event does not comply with a regulatory document corresponding to the change event, the server may generate a risk prompt to prompt the user of the risks existing in the current pharmacovigilance system.

[0055] In another embodiment, when the change event complies with the regulatory document corresponding to the change event, the server does not generate a risk warning.

[0056] It can be seen that the embodiment of the present application automatically detects the legality of the change event by comparing the change event with the legal document corresponding to the change event. In addition, when the change event does not comply with the legal document, a risk warning is generated to assist the user in completing the update of the drug vigilance system, thereby improving the efficiency of the update and simplifying the update operation.

[0057] Figure 4 It is a flowchart of a system updating method provided by another exemplary embodiment of the present application. Figure 4 The embodiment is Figure 1The examples of the embodiments will not be repeated in detail, and the differences will be described in detail here. Figure 4 As shown, the system updating method includes the following contents.

[0058] In one embodiment, the change event includes a change in the organizational personnel structure. The regulatory document includes organizational personnel structure regulations.

[0059] Specifically, the organizational personnel structure may include personnel involved in pharmacovigilance work, such as the person in charge of pharmacovigilance and pharmacovigilance personnel.

[0060] 410: Compare the changed organizational personnel structure with the organizational personnel structure regulations.

[0061] Specifically, the changed organizational personnel structure may be personnel information obtained after a user (eg, personnel and drug vigilance manager, etc.) deletes and / or adds drug vigilance personnel. The embodiment of the present application does not specifically limit the changed organizational personnel structure.

[0062] For example, a changed organizational personnel structure can be an event in which a user deletes a resigned employee in the pharmacovigilance system.

[0063] The organizational personnel structure regulations may be a legal document corresponding to the organizational personnel structure in the pharmacovigilance system. The embodiments of the present application do not specifically limit the organizational personnel structure regulations.

[0064] The auxiliary construction system (or server) running on the server can compare the deleted and / or newly added organizational personnel information (i.e., the changed organizational personnel structure) with the organizational personnel structure regulations, where the organizational personnel structure regulations are legal documents.

[0065] 420: Generate a risk warning when the changed organizational personnel structure does not comply with organizational personnel structure regulations.

[0066] In one embodiment, the risk warning includes deleting or adding corresponding organizational personnel.

[0067] Specifically, when the changed organizational personnel structure does not comply with the organizational personnel structure regulations, the server may generate a risk warning based on the comparison result, wherein the comparison result may be the difference between the changed organizational personnel structure and the organizational personnel structure regulations.

[0068] In one embodiment, the risk warning includes deleting corresponding organizational personnel.

[0069] In another embodiment, the risk warning includes adding corresponding organizational personnel.

[0070] For example, the organizational structure regulations state that the number of people in the pharmacovigilance department must not be less than 5. The organizational structure after the change is 4. At this time, the risk warning is that the pharmacovigilance department is short of one pharmacovigilance person. The recommended modification plan included in the risk warning can be to add one pharmacovigilance person to the pharmacovigilance department.

[0071] It can be seen that the embodiment of the present application automatically generates a risk warning by comparing the changed organizational personnel structure with its corresponding legal documents, so that the user can directly update the existing drug vigilance system according to the content of the risk warning.

[0072] Figure 5 It is a flowchart of a system updating method provided by yet another exemplary embodiment of the present application. Figure 5 The embodiment is Figure 1 The examples of the embodiments will not be repeated in detail, and the differences will be described in detail here. Figure 5 As shown, the system updating method includes the following contents.

[0073] In one embodiment, the change event includes a change in an operating standard document, and the regulation document includes an operating regulation.

[0074] Specifically, the operating standard document may be a SOP. The operating regulations may be a legal document corresponding to the operating standard document. The embodiments of the present application do not specifically limit the specific contents of the operating standard document and the operating regulations.

[0075] 510: Compare the changed operating standard documents with the operating regulations.

[0076] Specifically, the changed operation standard file may be a newly added and / or deleted operation standard file. The changed operation standard file may also be the writing and modification of the newly added and / or original operation standard file. The embodiment of the present application does not specifically limit the changed operation standard file.

[0077] The operation specification may be a legal document corresponding to the operation standard document, and the present application embodiment does not specifically limit the operation specification. For example, the operation specification may be a legal document corresponding to the SOP.

[0078] The auxiliary construction system (or server) running on the server can compare the changed operation standard file with the legal document corresponding to the operation standard file, wherein the legal document corresponding to the operation standard file is the operation regulations.

[0079] 520: When the changed operating standard document does not comply with the provisions of the operating regulations, a risk warning is generated.

[0080] Specifically, when the changed operating standard file does not comply with the legal document corresponding to the operating standard file, the auxiliary construction system (or server) running on the server can generate a risk warning based on the comparison result, wherein the comparison result can be the difference between the changed operating standard file and the legal document corresponding to the operating standard file.

[0081] In one embodiment, when the newly added and / or the modification or writing of the original operation standard file does not comply with the provisions of the operation regulations, the server can generate a risk warning. And / or, when the newly added and / or deleted operation standard file does not comply with the provisions of the operation regulations, the server can generate a risk warning.

[0082] It can be seen that the embodiment of the present application compares the components (such as SOP) within the drug vigilance system with the legal documents of the components and automatically generates risk warnings to remind users that there are risks in the current drug vigilance system, so as to assist users in completing the update of the drug vigilance system.

[0083] In one embodiment of the present application, the change event includes a change in a regulatory document, and the change in the regulatory document includes changing the original regulatory document to a new regulatory document, wherein a risk warning is generated based on the change event, including: comparing the new regulatory document with the organizational structure within the drug vigilance system to generate a risk warning.

[0084] Specifically, the change event may include changes in regulatory documents other than the organizational structure within the pharmacovigilance system, where the regulatory documents may be officially promulgated legal documents, for example, the regulatory documents may be the "Drug Administration Law" and the like. The new regulatory document may be a newly promulgated legal document or a revised version of the original regulatory document. The embodiments of this application do not specifically limit the new regulatory document. For example, the original regulatory document is the "Drug Administration Law (2019 Edition)", and the new regulatory document is the "Drug Administration Law (2020 Edition)".

[0085] When the auxiliary construction system (or server) running on the server detects a new regulatory document issued by the official, the new regulatory document can be compared with the organizational structure in the (existing) drug vigilance system. When the organizational structure in the drug vigilance system does not comply with the provisions of the new regulatory document, the server can generate a risk warning. The organizational structure may include an organizational personnel structure and operating standard documents, etc. The embodiment of this application does not specifically limit the organizational structure. It should be noted that the organizational structure and Figure 1 The description of the embodiments is basically the same, please refer to Figure 1 Description of Examples.

[0086] In one embodiment, the organizational structure may be an organizational personnel structure in an existing pharmacovigilance system. The new regulatory document may be a new organizational personnel structure provision. The server may compare the new organizational personnel structure provision with the organizational personnel structure. When the organizational personnel structure does not comply with the new organizational personnel structure provision, the server generates a risk warning.

[0087] In another embodiment, the organizational structure may be an operating standard file in an existing pharmacovigilance system. The new regulation file may be a new operating regulation. The server may compare the new operating regulation with the operating standard file. When the operating standard file does not comply with the provisions of the new operating regulation, a risk warning is generated.

[0088] It can be seen that the embodiment of the present application compares the newly promulgated legal documents with the drug vigilance system, so that the drug vigilance system constructed by the present application can generate risk warnings in real time according to the newly promulgated legal documents, thereby providing a guarantee for the real-time update of the drug vigilance system according to the newly promulgated legal documents.

[0089] Figure 6 It is a flowchart of a system updating method provided by yet another exemplary embodiment of the present application. Figure 6 Example and Figure 4 The embodiments correspond to each other, and the similarities are not repeated here, and the differences are described in detail here. Figure 6 As shown, the system updating method includes the following contents.

[0090] In one embodiment, the organizational structure includes an organizational personnel structure, and the new regulatory document includes provisions for the new organizational personnel structure.

[0091] It should be noted that Figure 4 The embodiment is a case where the server detects and updates the organizational structure of the drug vigilance system when the organizational structure changes. Figure 6 Embodiment) is a situation where when a legal document (i.e., a new organizational personnel structure regulation) changes, the server detects and updates the organizational personnel structure of the pharmacovigilance system.

[0092] 610: Compare the new organizational staff structure regulations with the organizational staff structure.

[0093] Specifically, the auxiliary construction system (or server) running on the server may compare the new organizational personnel structure provisions included in the new regulatory document with the organizational personnel structure in the pharmacovigilance system.

[0094] 620: Generate a risk warning when the organizational personnel structure does not comply with the new organizational personnel structure regulations.

[0095] Specifically, when the organizational structure in the pharmacovigilance system does not comply with the new organizational structure provisions included in the new regulatory document, the server may generate a risk warning based on the comparison result, wherein the comparison result may be the difference between the organizational structure and the new organizational structure provisions.

[0096] For example, the number of people in the organizational structure of the pharmacovigilance system is 4. The new regulatory document changes the number of people in the organizational structure of the pharmacovigilance system indicated in the original regulatory document from 4 to 6. At this time, the risk warning is that the organizational structure of the pharmacovigilance system lacks two pharmacovigilance personnel. The recommended modification plan is to add two pharmacovigilance personnel to the pharmacovigilance department.

[0097] It can be seen that the embodiment of the present application compares the newly issued legal documents with the drug vigilance system and automatically generates risk warnings, so that users can directly update the existing drug vigilance system according to the risk warnings, thereby reducing the complexity of updating the drug vigilance system.

[0098] Figure 7 It is a flowchart of a system updating method provided by yet another exemplary embodiment of the present application. Figure 7 Example and Figure 5 The embodiments correspond to each other, and the similarities are not repeated here, and the differences are described in detail here. Figure 7 As shown, the system updating method includes the following contents.

[0099] In one embodiment, the organizational structure includes an operating standard document, and the new regulation document includes new operating regulations, wherein both the new regulation document and the new operating regulations are legal documents.

[0100] It should be noted that Figure 5 The embodiment is a process of updating the drug vigilance system when the operating standard file changes. Figure 7 Embodiment) is the process of updating the pharmacovigilance system when legal documents (i.e., new operating regulations) change.

[0101] 710: Compare new operating regulations with operating standard documents.

[0102] Specifically, the auxiliary construction system (or server) running on the server may compare the new operation regulations corresponding to the operation standard file with the operation standard file.

[0103] 720: Generate a risk warning when the operating standard document does not comply with the new operating regulations.

[0104] Specifically, when the operating standard file does not conform to the new operating regulations corresponding to the operating standard file, the server can generate a risk warning based on the comparison result, wherein the comparison result can be the difference between the operating standard file in the pharmacovigilance system and the new operating regulations corresponding to the operating standard file.

[0105] It can be seen that the embodiment of the present application compares the newly issued legal documents with the operating standard documents (such as SOP) in the pharmacovigilance system, so that the pharmacovigilance system can be updated as the newly issued legal documents are updated, thereby avoiding the problem that the pharmacovigilance system is difficult to keep up with legal changes.

[0106] In one embodiment of the present application, obtaining a change event includes: detecting an organizational structure within a drug vigilance system to obtain a change event, wherein the organizational structure includes an organizational personnel structure and an operating standard document; or detecting a new regulatory document to obtain a change event, wherein the new regulatory document is a legal document.

[0107] Specifically, obtaining the change event may be that the auxiliary construction system or the server running on the server detects the internal organizational structure of the pharmacovigilance system in real time or non-real time to obtain the change event in the pharmacovigilance system. The organizational structure may be the various components of the pharmacovigilance system, such as the organizational personnel structure.

[0108] In one embodiment, the auxiliary construction system running on the server detects the internal organizational structure of the drug vigilance system in real time or non-real time. When it is detected that a user (such as personnel) has modified the drug vigilance system, an event corresponding to the modification is used as an acquired change event.

[0109] The change event can also be obtained by obtaining new regulatory documents on the Internet through an algorithm such as a crawler algorithm, and then comparing the new regulatory documents with the pharmacovigilance system to obtain the change event. It should be noted that the description of the new regulatory documents is basically the same as that in the above embodiment, and please refer to the records of the above embodiment for details.

[0110] It should be noted that the above two methods of obtaining change events can be executed simultaneously during actual application, and the embodiments of the present application do not make specific limitations on this.

[0111] It can be seen that the embodiments of the present application obtain change events in a variety of ways, which provides a guarantee for timely updating of the drug vigilance system during actual application.

[0112] In one embodiment of the present application, the method further includes: building a display interface of the user terminal according to the intelligent recommendation prompt, and the display interface displays a risk prompt.

[0113] Specifically, the interface of the user terminal (such as a mobile phone, a computer, etc.) may include a display interface, and the risk warning may appear in the form of a pop-up window on the display interface, for example, see Figure 2 .

[0114] Before setting up the display interface, the drug vigilance system can be associated with the company's organizational structure. Specifically, in the process of setting up the drug vigilance system, the company's organizational structure information can be directly selected in the drug vigilance system. For example, when setting up the organizational personnel structure information in the drug vigilance system, you can click the "drop-down box" or jump node and other controls at the location of the drug vigilance personnel in the display interface to directly select the company personnel in the company's organizational structure, so as to prevent the construction of the drug vigilance system from being out of touch with the company's organizational structure.

[0115] In addition, the display interface can be built step by step according to the intelligent recommendation prompts and guidance. When the user builds the drug vigilance system, the intelligent recommendation prompts can recommend the recommended solution corresponding to the current building steps of the user to ensure the legality of the drug vigilance system built by the user (such as an enterprise).

[0116] For example, when a user is building the position information of the organizational personnel structure in the drug vigilance system, the intelligent recommendation prompt can recommend the job responsibilities corresponding to the position information, as well as the qualifications that the person responsible for the job responsibilities needs to have, and the intelligent recommendation prompt can also display the recommended personnel for user reference.

[0117] It should be noted that the embodiments of the present application can be implemented in Figure 1 Before step 110, the server or the auxiliary construction system running on the server detects change events in the drug vigilance system.

[0118] It can be seen that the embodiment of the present application guides the user to build a drug vigilance system step by step through the intelligent recommendation prompt, thereby avoiding situations in which the user does not comply with legal regulations when building a drug vigilance system independently.

[0119] Figure 8 FIG. 8 is a schematic diagram of the structure of a system updating device 800 provided by an exemplary embodiment of the present application. Figure 8 As shown, the system updating device 800 includes: an acquisition module 810 and a risk warning module 820.

[0120] The acquisition module 810 is used to obtain change events within the drug vigilance system. The change events are used to indicate changes in the organizational structure within the drug vigilance system, or changes in regulatory documents, where regulatory documents are legal documents; the risk warning module 820 is used to generate risk warnings based on change events, where risk warnings include risk locations and recommended modification plans, and risk warnings are used to prompt users to modify risk locations according to the recommended modification plans to update the drug vigilance system.

[0121] The embodiments of the present application provide a system update method and device, which automatically generates risk warnings by detecting change events, thereby prompting users of risky locations and providing users with recommended update and modification plans to assist users in completing the update of the drug vigilance system, thereby improving the update efficiency of the drug vigilance system and reducing the complexity of the update of the drug vigilance system.

[0122] According to an embodiment of the present application, the change event includes a change in the organizational structure, and the change in the organizational structure includes a change in the organizational personnel structure and a change in the operating standard document. The risk warning module 820 is used to determine the regulatory document corresponding to the change event based on the change event; compare the change event with the regulatory document to determine the risk warning.

[0123] According to an embodiment of the present application, the change event includes a change in the organizational personnel structure, the regulatory document includes organizational personnel structure regulations, and the risk warning module 820 is used to compare the changed organizational personnel structure with the organizational personnel structure regulations; when the changed organizational personnel structure does not comply with the organizational personnel structure regulations, a risk warning is generated, wherein the risk warning includes deleting or adding corresponding organizational personnel.

[0124] According to an embodiment of the present application, the change event includes a change in an operating standard file, and the regulation file includes operating regulations. The risk warning module 820 is used to compare the changed operating standard file with the operating regulations; when the changed operating standard file does not comply with the provisions of the operating regulations, a risk warning is generated.

[0125] According to an embodiment of the present application, the change event includes a change in a regulatory document, and the change in a regulatory document includes changing an original regulatory document to a new regulatory document. The risk warning module 820 is used to compare the new regulatory document with the organizational structure within the drug vigilance system to generate a risk warning.

[0126] According to an embodiment of the present application, the organizational structure includes the organizational personnel structure, the new regulations document includes the new organizational personnel structure regulations, and the risk warning module 820 is used to compare the new organizational personnel structure regulations with the organizational personnel structure; when the organizational personnel structure does not comply with the new organizational personnel structure regulations, a risk warning is generated.

[0127] According to an embodiment of the present application, the organizational structure includes an operating standard file, the new regulations file includes new operating regulations, and the risk warning module 820 is used to compare the new operating regulations with the operating standard file; when the operating standard file does not comply with the new operating regulations, a risk warning is generated.

[0128] According to an embodiment of the present application, the acquisition module 810 detects the organizational structure within the drug vigilance system to obtain change events, wherein the organizational structure includes the organizational personnel structure and the operating standard document; or detects a new regulatory document to obtain a change event, wherein the new regulatory document is a legal document.

[0129] According to an embodiment of the present application, the risk warning module 820 is used to build a display interface of the user terminal according to the intelligent recommendation prompt, and the display interface displays a risk warning.

[0130] It should be understood that the specific working process and functions of the acquisition module 810 and the risk warning module 820 in the above embodiment can refer to the above Figures 1 to 7 To avoid repetition, the description of the system updating method provided in the embodiment will not be repeated here.

[0131] Fig. 9 is a block diagram of an electronic device 900 for system updating provided by an exemplary embodiment of the present application.

[0132] Reference Fig. 9 , the electronic device 900 includes a processing component 910, which further includes one or more processors, and a memory resource represented by a memory 920 for storing instructions executable by the processing component 910, such as an application. The application stored in the memory 920 may include one or more modules, each corresponding to a set of instructions. In addition, the processing component 910 is configured to execute instructions to perform the above-mentioned system update method.

[0133] The electronic device 900 may also include a power supply component configured to perform power management of the electronic device 900, a wired or wireless network interface configured to connect the electronic device 900 to a network, and an input / output (I / O) interface. The electronic device 900 may be operated based on an operating system stored in the memory 920, such as Windows Server 2008. TM , Mac OSX TM , Unix TM , Linux TM , FreeBSD TM or similar.

[0134] A non-temporary computer-readable storage medium, when the instructions in the storage medium are executed by the processor of the above-mentioned electronic device 900, enables the above-mentioned electronic device 900 to execute a system update method, including: obtaining a change event, the change event is used to indicate the change of the organizational structure within the drug vigilance system, or the change of the regulatory document, wherein the regulatory document is a legal document; generating a risk warning according to the change event, the risk warning includes a risk location and a recommended modification plan, and the risk warning is used to prompt the user to modify the risk location according to the recommended modification plan to update the drug vigilance system.

[0135] All the above optional technical solutions can be arbitrarily combined to form optional embodiments of the present application, and will not be described one by one here.

[0136] Those of ordinary skill in the art will appreciate that the units and algorithm steps of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond the scope of this application.

[0137] Those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working processes of the systems, devices and units described above can refer to the corresponding processes in the aforementioned method embodiments and will not be repeated here.

[0138] In the several embodiments provided in the present application, it should be understood that the disclosed systems, devices and methods can be implemented in other ways. For example, the device embodiments described above are only schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation, such as multiple units or components can be combined or integrated into another system, or some features can be ignored or not executed. Another point is that the mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of devices or units, which can be electrical, mechanical or other forms.

[0139] The units described as separate components may or may not be physically separated, and the components shown as units may or may not be physical units, that is, they may be located in one place or distributed on multiple network units. Some or all of the units may be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0140] In addition, each functional unit in each embodiment of the present application may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.

[0141] If the functions are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present application can be essentially or partly embodied in the form of a software product that contributes to the prior art. The computer software product is stored in a storage medium, including several instructions to enable a computer device (which can be a personal computer, server, or network device, etc.) to perform all or part of the steps of the methods described in each embodiment of the present application. The aforementioned storage medium includes: U disk, mobile hard disk, read-only memory (ROM, Read-Only Memory), random access memory (RAM, Random Access Memory), disk or optical disk, and other media that can store program check codes.

[0142] It should be noted that, in the description of this application, the terms "first", "second", "third", etc. are used for descriptive purposes only and cannot be understood as indicating or implying relative importance. In addition, in the description of this application, unless otherwise specified, the meaning of "plurality" is two or more.

[0143] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent substitutions, etc. made within the spirit and principles of the present application shall be included in the protection scope of the present application.

Claims

1. A system update method for a pharmacovigilance system, characterized in that: include: Detecting the internal organizational structure of the pharmacovigilance system to obtain a change event, or detecting a new regulatory document to obtain the change event, wherein the change event is used to indicate that the organizational structure of the pharmacovigilance system has changed, or the regulatory document has changed, wherein the regulatory document is a legal document, and the new regulatory document is the legal document, and the organizational structure includes an organizational personnel structure and an operating standard document; generating a risk prompt according to the change event, wherein the risk prompt includes a risk location and a recommended modification plan, and the risk prompt is used to prompt the user to modify the risk location according to the recommended modification plan to update the pharmacovigilance system; Wherein, the change event includes the change of the organizational structure, and the change of the organizational structure includes the change of the organizational personnel structure and the change of the operating standard document, wherein the generating of the risk warning according to the change event includes: determining the regulatory document corresponding to the change event according to the change event; comparing the change event with the regulatory document to determine the risk warning; or, The change event includes a change in the regulatory document, and the change in the regulatory document includes changing the original regulatory document to a new regulatory document, wherein generating a risk warning based on the change event includes: comparing the new regulatory document with the organizational structure in the drug vigilance system to generate the risk warning.

2. The system updating method according to claim 1, characterized in that: The change event includes the change of the organizational personnel structure, and the regulatory document includes the organizational personnel structure regulations. Wherein, comparing the change event with the regulatory document to determine the risk warning includes: Compare the changed organizational personnel structure with the organizational personnel structure regulations; When the changed organizational personnel structure does not comply with the organizational personnel structure regulations, the risk warning is generated, wherein the risk warning includes deleting or adding corresponding organizational personnel.

3. The system updating method according to claim 1, characterized in that: The change event includes the change of the operating standard document, and the regulation document includes the operating regulations. Wherein, comparing the change event with the regulatory document to determine the risk warning includes: Compare the changed operating standard documents with the operating regulations; When the changed operating standard document does not comply with the provisions of the operating regulations, the risk warning is generated.

4. The system updating method according to claim 1, characterized in that: The organizational structure includes an organizational personnel structure, and the new regulatory document includes provisions for a new organizational personnel structure. Wherein, comparing the new regulatory document with the organizational structure within the pharmacovigilance system to generate the risk warning includes: Comparing the new organizational personnel structure regulations with the organizational personnel structure; When the organizational personnel structure does not comply with the new organizational personnel structure regulations, the risk warning is generated.

5. The system updating method according to claim 1, characterized in that: The organizational structure includes operating standard documents, and the new regulations documents include new operating regulations. Wherein, comparing the new regulatory document with the organizational structure within the pharmacovigilance system to generate the risk warning includes: Comparing the new operating regulations with the operating standard documents; When the operation standard document does not comply with the new operation regulations, the risk warning is generated.

6. The system updating method according to any one of claims 1 to 5, characterized in that: The method further comprises: A display interface of the user terminal is built according to the intelligent recommendation prompt, and the display interface displays the risk prompt.

7. A system updating device for a drug vigilance system, characterized in that: include: an acquisition module, used for detecting the organizational structure within the pharmacovigilance system to obtain a change event, or detecting a new regulatory document to obtain the change event, wherein the change event is used to indicate a change in the organizational structure within the pharmacovigilance system, or a change in a regulatory document, wherein the regulatory document is a legal document, the new regulatory document is the legal document, and the organizational structure includes an organizational personnel structure and an operating standard document; a risk prompt module, configured to generate a risk prompt according to the change event, wherein the risk prompt includes a risk location and a recommended modification plan, and the risk prompt is configured to prompt the user to modify the risk location according to the recommended modification plan to update the pharmacovigilance system, Wherein, the change event includes the change of the organizational structure, and the change of the organizational structure includes the change of the organizational personnel structure and the change of the operating standard document. The risk warning module is used to determine the regulatory document corresponding to the change event according to the change event; compare the change event with the regulatory document to determine the risk warning; or, The change event includes a change in the regulatory document, and the change in the regulatory document includes changing the original regulatory document to a new regulatory document. The risk warning module is used to compare the new regulatory document with the organizational structure in the drug vigilance system to generate the risk warning.

8. A computer-readable storage medium storing a computer program, wherein the computer program is used to execute the system updating method according to any one of claims 1 to 6.

9. An electronic device, comprising: processor; a memory for storing instructions executable by the processor, Wherein, the processor is used to execute the system updating method described in any one of claims 1 to 6 above.

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