Drug data management control system, method and server

Abstract

The invention provides a medicine data management control system and method and a server, and relates to the field of medicine quality management.The system comprises a personnel risk management module, an equipment risk management module, a material risk management module, a regulation risk management module, an environment risk management module and a detection risk management module which are arranged in the system; according to the technical scheme, risk management can be carried out on personnel, equipment, materials, laws and regulations, environments and detection related to drug data in the whole drug production process, digital quality management and control over the whole drug production process are achieved, repeated problems can be found and processed in time, the drug quality risk continuous improvement capacity is improved, and the accurate quality risk management and control process is achieved.

Description

Technical Field

[0001] The present invention relates to the field of drug quality management, and in particular to a drug data management control system, method and server. Background Art

[0002] The current process of building the quality management system of pharmaceutical companies is mainly based on the Good Manufacturing Practice for Pharmaceuticals, covering the entire process from drug development, registration, review, production, inspection, and sales, and detailed requirements for material management, supplier management, production management, equipment management, quality assurance management, quality control management, change deviation management, risk management, management review, internal review, drug vigilance, shipment, and recall. The quality management system is complete but complex, and quality management matters are systematic but cumbersome. The quality management process mainly adopts the offline paper record management model. When faced with the complex and cumbersome drug quality management work, if it only relies on human experience and experience to manage, it is inevitable that there will be a situation of losing sight of one thing while focusing on another.

[0003] Since the quality management system of existing pharmaceutical manufacturers is mainly based on manual management, facing thousands of quality management documents, it is very challenging for the ability and experience of quality management personnel. Its defects are mainly reflected in: Quality management is highly subjective: the level of quality management is highly dependent on the experience and ability of quality management personnel. Changes in key personnel may have a phased impact on the operation of the quality management system. Lack of timeliness in quality management: Due to the numerous factors that affect product quality, it is difficult to identify the fluctuation of key factors at the first time. The fluctuation of quality-influencing factors often leads to fluctuation of product quality, which is not conducive to the stability of production quality. Insufficient inheritance of quality management: After a quality problem is solved, it will occur again in the future, and the corrective and preventive measures for quality incidents are not fully consolidated and continuously inherited. Summary of the invention

[0004] In view of this, the purpose of the present invention is to provide a drug data management and control system, method and server. The system can perform risk management on personnel, equipment, materials, regulations, environment and testing involved in drug data throughout the entire drug production process through built-in personnel risk management module, equipment risk management module, material risk management module, regulatory risk management module, environmental risk management module and testing risk management module, thereby realizing digital quality control of the entire drug production process, facilitating timely discovery and handling of repeated problems, improving the ability to continuously improve drug quality risks, and realizing a precise quality risk control process.

[0005] In a first aspect, an embodiment of the present invention provides a drug data management and control system, the system comprising: a personnel risk management module, an equipment risk management module, a material risk management module, a regulatory risk management module, an environmental risk management module, a detection risk management module, and a comprehensive risk management module; Among them, the comprehensive risk management module is connected with the personnel risk management module, the equipment risk management module, the material risk management module, the regulatory risk management module, the environmental risk management module and the detection risk management module respectively; The personnel risk management module is used to obtain the first risk data corresponding to the key personnel associated with the drug data; the equipment risk management module is used to obtain the second risk data corresponding to the equipment change scenario associated with the drug data; the material risk management module is used to obtain the third risk data corresponding to the supplier associated with the drug data; the regulatory risk management module is used to obtain the fourth risk data corresponding to the process associated with the drug data; the environmental risk management module is used to obtain the fifth risk data corresponding to the market environment associated with the drug data; the detection risk management module is used to obtain the sixth risk data corresponding to the detection process associated with the drug data; The comprehensive risk management module is used to determine the risk control strategy corresponding to the drug data based on the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

[0006] Optionally, the personnel risk management module is further connected to the equipment risk management module, the detection risk management module and the environmental risk management module; the personnel risk management module is used to generate first risk data corresponding to key personnel associated with the drug data according to the first equipment risk data, the first detection risk data and the first environmental risk data corresponding to the drug data; The equipment risk management module is also connected to the detection risk management module, the regulatory risk management module and the material risk management module; the equipment risk management module is used to generate second risk data corresponding to the equipment change scenario associated with the drug data according to the first personnel risk data, the first regulatory risk data, the second detection risk data and the first material risk data corresponding to the drug data; The material risk management module is also connected to the regulatory risk management module, the environmental risk management module and the detection risk management module; the material risk management module is used to generate third risk data corresponding to the supplier associated with the drug data according to the second equipment risk data, the second regulatory risk data, the third detection risk data and the second environmental risk data corresponding to the drug data; The regulatory risk management module is also connected to the detection risk management module and the environmental risk management module; the regulatory risk management module is used to generate fourth risk data corresponding to the process flow associated with the drug data according to the third equipment risk data, the third environmental risk data, the fourth detection risk data, and the second material risk data corresponding to the drug data; The environmental risk management module is also connected to the detection risk management module; the environmental risk management module is used to generate fifth risk data corresponding to the market environment associated with the drug data according to the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data corresponding to the drug data; The detection risk management module is used to generate sixth risk data corresponding to the detection process associated with the drug data based on the fourth regulatory risk data, third personnel risk data, fourth equipment risk data, fourth environmental risk data, and fourth material risk data corresponding to the drug data.

[0007] Optionally, the personnel risk management module includes: key personnel management unit, skill training management unit, innovation review management unit and knowledge base construction management unit; The key personnel management unit is used to update the first risk data according to the major problem prompt data and key matter approval data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The skill training management unit is used to update the first risk data according to the repeated problem warning data, knowledge inheritance learning data and process processing overdue reminder data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The innovative review management unit is used to update the first risk data based on the data trend analysis data, regulatory change identification data, problem handling overdue reminder data, and key matter approval data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data, and the first environmental risk data; The knowledge base construction management unit is used to update the first risk data according to the knowledge inheritance learning data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data.

[0008] Optionally, the equipment risk management module includes: an equipment change management unit, a computerized system management unit, a data modeling management unit, and a closed-loop control management unit; The equipment change management unit is used to update the second risk data according to the repeated problem warning data, major problem prompt data, problem handling overdue reminder data and key matter approval data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data and the first material risk data; The computerized system management unit is used to update the second risk data according to the first personnel risk data, the first regulatory risk data, the second detection risk data, the knowledge inheritance learning data corresponding to the equipment change scenario determined by the first material risk data, the regulatory change identification data, and the process processing overdue reminder data; The data modeling management unit is used to update the second risk data according to the data trend analysis data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data, and the first material risk data; The closed-loop control management unit is used to update the second risk data based on the data trend analysis data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data, and the first material risk data.

[0009] Optionally, the material risk management module includes: supplier management unit, sample approval management unit, material selection management unit and intermediate monitoring management unit; The supplier management unit is used to update the third risk data according to the repeated problem warning data, problem handling overdue reminder data and key matter approval data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data and the second environmental risk data; The signature review management unit is used to update the third risk data according to the major problem prompt data, regulatory change identification data and process processing overdue reminder data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data and the second environmental risk data; The material selection management unit is used to update the third risk data according to the trend analysis data and knowledge inheritance learning data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data; The intermediate monitoring management unit is used to update the third risk data according to the trend analysis data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data.

[0010] Optionally, the regulatory risk management module includes: technology transfer management unit, regulatory change management unit, process optimization management unit and standard optimization management unit; The technology transfer management unit is used to update the fourth risk data according to the process processing overdue reminder data and key matter approval data corresponding to the process determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data; The regulatory change management unit is used to update the fourth risk data according to the third equipment risk data, the third environment risk data, the fourth detection risk data and the major problem prompt data corresponding to the process flow determined by the second material risk data and the regulatory change identification data; The process optimization management unit is used to update the fourth risk data according to the data trend analysis data, repeated problem warning data, knowledge inheritance learning data, problem handling overdue reminder data and key matter approval data corresponding to the process flow determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data; The standard optimization management unit is used to update the fourth risk data according to the data trend analysis data and key matter approval data corresponding to the process flow determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data.

[0011] Optionally, the environmental risk management module includes: market complaint management unit, pharmacovigilance management unit, external supervision management unit and clean environment management unit; Among them, the market complaint management unit is used to update the fifth risk data according to the repeated problem warning data, regulatory change identification data, and key matter approval data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The pharmacovigilance management unit is used to update the fifth risk data according to the data trend analysis data and major problem prompt data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The external supervision and management unit is used to update the fifth risk data according to the repeated problem warning data, knowledge inheritance learning data, and problem handling overdue reminder data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The clean environment management unit is used to update the fifth risk data according to the trend analysis data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data.

[0012] Optionally, the detection risk management module includes: a trend analysis management unit, a process analysis data management unit, an inspection optimization management unit, and a stability inspection management unit; The trend analysis management unit is used to update the sixth risk data according to the data trend analysis data and process processing overdue reminder data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The process analysis data management unit is used to update the sixth risk data according to the data trend analysis data, major problem prompt data, and key matter approval data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The inspection optimization management unit is used to update the sixth risk data according to the major problem prompt data, regulatory change identification data, problem handling overdue data, and key matter approval data corresponding to the inspection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The stability inspection management unit is used to update the sixth risk data according to the data trend analysis data and repeated problem warning data corresponding to the inspection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data.

[0013] Optional, comprehensive risk management module includes: system certification management unit, self-inspection management unit, change management unit and deviation management unit; The system certification management unit is used to update the risk control strategy based on the regulatory change identification data, process processing overdue reminder data, and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The self-check management unit is used to update the risk control strategy based on the data trend analysis data, repeated problem warning data, major problem prompt data, and problem handling overdue reminder data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The change management unit is used to update the risk control strategy based on the major problem prompt data, knowledge inheritance learning data, regulatory change identification data and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data; The deviation management unit is used to update the risk control strategy based on the repeated problem warning data and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

[0014] In a second aspect, the present invention provides a drug data management and control method, which is applied to the drug data management and control system mentioned in the first aspect; wherein the drug data management and control system at least includes: a personnel risk management module, an equipment risk management module, a material risk management module, a regulatory risk management module, an environmental risk management module, a detection risk management module and a comprehensive risk management module; The method includes: Controlling the comprehensive risk management module to receive the first risk data output by the personnel risk management module, the second risk data output by the equipment risk management module, the third risk data output by the material risk management module, the fourth risk data output by the regulatory risk management module, the fifth risk data output by the environmental risk management module, and the sixth risk data output by the detection risk management module; Controlling the comprehensive risk management module to generate a risk control strategy corresponding to the drug data according to the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data; Obtain the risk value corresponding to the drug data based on the risk control strategy, and use the risk value to update the drug data.

[0015] In a third aspect, an embodiment of the present invention further provides a server, comprising a processor and a memory, wherein the memory stores computer executable instructions that can be executed by the processor, and the processor executes the computer executable instructions to implement the steps of the drug data management and control method provided in the second aspect.

[0016] In a fourth aspect, an embodiment of the present invention further provides a storage medium storing computer executable instructions. When the computer executable instructions are called and executed by a processor, the computer executable instructions prompt the processor to implement the steps of the drug data management and control method provided in the second aspect.

[0017] A drug data management control system, method and server provided by an embodiment of the present invention include: a personnel risk management module, an equipment risk management module, a material risk management module, a regulatory risk management module, an environmental risk management module, a detection risk management module and a comprehensive risk management module. Among them, the comprehensive risk management module is connected to the personnel risk management module, the equipment risk management module, the material risk management module, the regulatory risk management module, the environmental risk management module and the detection risk management module respectively. Specifically, the personnel risk management module is used to obtain the first risk data corresponding to the key personnel associated with the drug data; the equipment risk management module is used to obtain the second risk data corresponding to the equipment change scenario associated with the drug data; the material risk management module is used to obtain the third risk data corresponding to the supplier associated with the drug data; the regulatory risk management module is used to obtain the fourth risk data corresponding to the process associated with the drug data; the environmental risk management module is used to obtain the fifth risk data corresponding to the market environment associated with the drug data; the detection risk management module is used to obtain the sixth risk data corresponding to the detection process associated with the drug data; the comprehensive risk management module is used to determine the risk control strategy corresponding to the drug data according to the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data. Through the built-in personnel risk management module, equipment risk management module, material risk management module, regulatory risk management module, environmental risk management module and testing risk management module, the system can manage the risks of personnel, equipment, materials, regulations, environment and testing involved in drug data throughout the entire drug production process, thereby achieving digital quality control of the entire drug production process, helping to promptly discover and deal with repeated problems, improving the ability to continuously improve drug quality risks, and realizing a precise quality risk control process.

[0018] Other features and advantages of the present invention will be described in the following description, and partly become apparent from the description, or understood by practicing the present invention. The purpose and other advantages of the present invention are realized and obtained by the structures particularly pointed out in the description, claims and drawings.

[0019] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, preferred embodiments are given below and described in detail with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0021] Figure 1 A schematic diagram of the structure of a drug data management and control system provided by an embodiment of the present invention; Figure 2 A schematic diagram of the structure of another drug data management and control system provided by an embodiment of the present invention; Figure 3 A schematic diagram of the structure of a personnel risk management module in a drug data management and control system provided by an embodiment of the present invention; Figure 4 A schematic diagram of the structure of an equipment risk management module in a drug data management and control system provided by an embodiment of the present invention; Figure 5 A schematic diagram of the structure of a material risk management module in a drug data management and control system provided by an embodiment of the present invention; Figure 6 A schematic diagram of the structure of a regulatory risk management module in a drug data management and control system provided by an embodiment of the present invention; Figure 7 A schematic diagram of the structure of an environmental risk management module in a drug data management and control system provided by an embodiment of the present invention; Figure 8 A schematic diagram of the structure of a detection risk management module in a drug data management and control system provided by an embodiment of the present invention; Fig. 9 A schematic diagram of the structure of a comprehensive risk management module in a drug data management and control system provided by an embodiment of the present invention; Fig.10 A functional schematic diagram of a drug data management and control system provided by an embodiment of the present invention; Fig.11 A flowchart of a drug data management control method provided by an embodiment of the present invention; Fig.12 A flowchart of another drug data management and control method provided by an embodiment of the present invention; Fig.13 A schematic diagram of the structure of a server provided in an embodiment of the present invention.

[0022] icon: 100-personnel risk management module; 200-equipment risk management module; 300-material risk management module; 400-regulatory risk management module; 500-environmental risk management module; 600-detection risk management module; 700-comprehensive risk management module; 110-Key personnel management unit; 120-Skills training management unit; 130-Innovation review management unit; 140-Knowledge base construction management unit; 210-equipment change management unit; 220-computerized system management unit; 230-data modeling management unit; 240-closed loop control management unit; 310-supplier management unit; 320-sample approval management unit; 330-material selection management unit; 340-intermediate monitoring management unit; 410-Technology transfer management unit; 420-Regulatory change management unit; 430-Process optimization management unit; 440-Standard optimization management unit; 510- Market Complaint Management Unit; 520- Pharmacovigilance Management Unit; 530- External Supervision and Management Unit; 540- Clean Environment Management Unit; 610-trend analysis management unit; 620-process analysis data management unit; 630-inspection optimization management unit; 640-stability inspection management unit; 710-System certification management unit; 720-Self-inspection management unit; 730-Change management unit; 740-Deviation management unit; 101 - processor; 102 - memory; 103 - bus; 104 - communication interface. DETAILED DESCRIPTION

[0023] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution of the present invention will be clearly and completely described in combination with the embodiments below. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0024] The existing quality management system of pharmaceutical companies is mainly based on the Good Manufacturing Practice for Pharmaceuticals, and refers to relevant requirements such as ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). The quality management system is complete but complex, and the quality management matters are systematic but cumbersome. In the face of complex and cumbersome pharmaceutical quality management work, if we only rely on human experience and experience to manage it, it is inevitable that we will lose sight of one thing while focusing on another.

[0025] The existing drug quality management system covers the entire process from drug development, registration, review, production, inspection, sales, etc., and has detailed requirements for material management, supplier management, production management, equipment management, quality assurance management, quality control management, change deviation management, risk management, management review, internal review, pharmacovigilance, shipment and recall, etc. In the quality management process, the main management mode is offline paper records.

[0026] Take change management as an example. It is necessary to establish relevant change control procedures. According to the requirements of laws and regulations, changes are divided into four categories. Each department shall submit a change application according to business needs and fill in a paper version of the change application approval form, which includes the application department, change name, change reason, detailed description of the change, change risk assessment, change impact, plan, etc. After review and approval by personnel of various departments and levels, the change can be implemented only after signing and agreeing. After the change is implemented, fill in the change assessment approval form, including the implementation of the plan, the effect of the plan implementation and the verification content and conclusion, the risk assessment after the change, the effect evaluation, the specific implementation description, etc., and then need to be reviewed and approved by the quality authorized person, the quality person in charge, etc., and sign and agree. The change can be formally implemented after the change is closed. The whole process requires multiple offline approvals and involves multiple positions. It is highly subjective, has a long cycle, and has many variables, which is not conducive to the rapid identification, control and elimination of quality risks in the change management process. In addition, the above approval records must finally be formed into paper versions of files and stored in the archives room. There are problems such as inconvenient reading, easy loss during circulation, and easy damage during long-term storage, which is not conducive to the inheritance of quality management information.

[0027] It can be seen that since the quality management system of existing pharmaceutical manufacturers is mainly based on manual management, facing thousands of quality management documents, it is very challenging for the ability and experience of quality management personnel. Its defects are mainly reflected in: Quality management is highly subjective: the level of quality management is highly dependent on the experience and ability of quality management personnel. Changes in key personnel may have a phased impact on the operation of the quality management system. Lack of timeliness in quality management: Due to the numerous factors that affect product quality, it is difficult to identify the fluctuation of key factors at the first time. The fluctuation of quality-influencing factors often leads to fluctuation of product quality, which is not conducive to the stability of production quality. Insufficient inheritance of quality management: After a quality problem is solved, it will occur again in the future, and the corrective and preventive measures for quality incidents are not fully consolidated and continuously inherited.

[0028] In relevant quality risk management, risk is a combination of the probability of harm and the severity of harm. Risks are characterized by objectivity, commonality, inevitability, identifiability, loss, uncertainty, and sociality. Risks are sometimes superimposed, amplified, fluid, and permeable. To ensure the safety, effectiveness, and quality control of drugs, the key is to control quality risks at an acceptable level. Therefore, it is necessary to develop a risk-oriented drug data management and control system.

[0029] Based on this, the present invention provides a drug data management and control system, method and server. The system can perform risk management on personnel, equipment, materials, regulations, environment and testing involved in drug data in the entire drug production process through built-in personnel risk management module, equipment risk management module, material risk management module, regulatory risk management module, environmental risk management module and testing risk management module, thereby realizing digital quality control of the entire drug production process, facilitating timely discovery and handling of repeated problems, improving the ability to continuously improve drug quality risks, and realizing a precise quality risk control process.

[0030] To facilitate understanding of this embodiment, a drug data management and control system disclosed in an embodiment of the present invention is first described in detail. Figure 1 As shown, it includes: a personnel risk management module 100, an equipment risk management module 200, a material risk management module 300, a regulatory risk management module 400, an environmental risk management module 500, a detection risk management module 600 and a comprehensive risk management module 700.

[0031] Among them, the comprehensive risk management module 700 is respectively connected to the personnel risk management module 100, the equipment risk management module 200, the material risk management module 300, the regulatory risk management module 400, the environmental risk management module 500 and the detection risk management module 600.

[0032] The personnel risk management module 100 is used to obtain first risk data corresponding to key personnel associated with drug data; the equipment risk management module 200 is used to obtain second risk data corresponding to equipment change scenarios associated with drug data; the material risk management module 300 is used to obtain third risk data corresponding to suppliers associated with drug data; the regulatory risk management module 400 is used to obtain fourth risk data corresponding to the process flow associated with drug data; the environmental risk management module 500 is used to obtain fifth risk data corresponding to the market environment associated with drug data; the detection risk management module 600 is used to obtain sixth risk data corresponding to the detection process associated with drug data; the comprehensive risk management module 700 is used to determine the risk control strategy corresponding to the drug data based on the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

[0033] like Figure 2 In the structural schematic diagram of another drug data management and control system shown, the personnel risk management module 100 is also connected to the equipment risk management module 200, the detection risk management module 600 and the environmental risk management module 500; the personnel risk management module 100 is used to generate first risk data corresponding to key personnel associated with the drug data based on the first equipment risk data, the first detection risk data and the first environmental risk data corresponding to the drug data.

[0034] The equipment risk management module 200 is also connected to the detection risk management module 600, the regulatory risk management module 400 and the material risk management module 300; the equipment risk management module 200 is used to generate second risk data corresponding to the equipment change scenario associated with the drug data based on the first personnel risk data, the first regulatory risk data, the second detection risk data and the first material risk data corresponding to the drug data.

[0035] The material risk management module 300 is also connected to the regulatory risk management module 400, the environmental risk management module 500 and the detection risk management module 600; the material risk management module 300 is used to generate the third risk data corresponding to the supplier associated with the drug data according to the second equipment risk data, the second regulatory risk data, the third detection risk data and the second environmental risk data corresponding to the drug data; The regulatory risk management module 400 is also connected to the detection risk management module 600 and the environmental risk management module 500; the regulatory risk management module 400 is used to generate fourth risk data corresponding to the process flow associated with the drug data based on the third equipment risk data, third environmental risk data, fourth detection risk data, and second material risk data corresponding to the drug data.

[0036] The environmental risk management module 500 is also connected to the detection risk management module 600; the environmental risk management module 500 is used to generate fifth risk data corresponding to the market environment associated with the drug data based on the fifth detection risk data, third regulatory risk data, second personnel risk data, and third material risk data corresponding to the drug data.

[0037] The detection risk management module 600 is used to generate sixth risk data corresponding to the detection process associated with the drug data based on the fourth regulatory risk data, third personnel risk data, fourth equipment risk data, fourth environmental risk data, and fourth material risk data corresponding to the drug data.

[0038] The comprehensive risk management module 700 is used to determine the risk control strategy corresponding to the drug data according to the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

[0039] It can be seen from the drug data management and control system in the above embodiment that the system, through the built-in personnel risk management module, equipment risk management module, material risk management module, regulatory risk management module, environmental risk management module and detection risk management module, collects personnel, equipment, materials, regulations, environment, detection and other comprehensive information in the drug production process to conduct risk assessment management, and realizes digital quality control of the entire drug production process based on the comprehensive risk management module, which helps to timely discover and deal with repeated problems, improves the ability to continuously improve drug quality risks, and realizes a precise quality risk control process.

[0040] Optionally, the personnel risk management module 100 is as follows: Figure 3 As shown, it includes: a key personnel management unit 110, a skill training management unit 120, an innovation review management unit 130 and a knowledge base construction management unit 140; The key personnel management unit 110 is used to update the first risk data according to the major problem prompt data and key matter approval data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The skill training management unit 120 is used to update the first risk data according to the repeated problem warning data, knowledge inheritance learning data and process processing overdue reminder data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The innovation review management unit 130 is used to update the first risk data according to the data trend analysis data, regulatory change identification data, problem handling overdue reminder data and key matter approval data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The knowledge base construction management unit 140 is used to update the first risk data according to the knowledge inheritance learning data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data.

[0041] The key personnel management unit 110 mainly focuses on changes in key personnel in production processes with unstable quality, key quality management personnel (enterprise head, production head, management head, quality authorized person), and key inspection personnel (such as technicians, supervisors, team leaders, technicians, etc.). The key personnel management unit 110 can provide timely reminders of key personnel changes, and regularly sort out and review the correlation between key personnel changes and quality work to ensure that key personnel always have the necessary capabilities or potential for the position.

[0042] The personnel in the skill training management unit 120 are the main body of drug production quality control. The skills of the personnel directly affect the quality control level of drugs. By formulating an annual key training plan and supervising its implementation, systematic management of the annual planned training quantity, training content, completion time, and number to be completed for each department of the base is achieved.

[0043] The innovation review management unit 130 is mainly used to reduce pharmaceutical risks and solve problems in the drug production process. Various rationalization suggestions, lean improvement cases, technological innovations and other problem-solving measures will appear in the daily production process. While encouraging innovation, the necessary quality risk assessment and review that comes with innovative measures are also necessary. The innovation review management unit 130 is used to implement the review and control of various plans by relevant competent departments, and can realize online review and push of case-related departments, specifically by uploading cases, project reports and other pictures, videos, etc. The innovation review management unit 130 realizes the innovation review function, which helps to control product quality risks in the process of enterprise production quality innovation and upgrading.

[0044] Rapid personnel turnover is a common problem currently faced by enterprises. How to avoid the problem of "people leaving and skills being lost" is a difficult problem that needs to be solved urgently. The knowledge base construction management unit 140 can document the problems and accumulated experience encountered by the enterprise in the daily production and manufacturing process, strengthen the accumulation of enterprise manufacturing knowledge, and promote the inheritance of pharmaceutical technology and skills, which is crucial to ensuring the quality of drugs. By building a digital pharmaceutical knowledge base, providing employees with a medium for learning pharmaceutical knowledge and a sharing platform for the inheritance of technical skills and experience, it helps to avoid the recurrence of quality problems and improve the stability of product quality. At the same time, when a quality risk is upgraded, the knowledge base can actively push previous risk disposal measures for quality management personnel to learn from.

[0045] Optionally, the equipment risk management module 200 is as follows: Figure 4As shown, it includes: an equipment change management unit 210, a computerized system management unit 220, a data modeling management unit 230 and a closed-loop control management unit 240; The equipment change management unit 210 is used to update the second risk data according to the repeated problem warning data, major problem prompt data, problem processing overdue reminder data and key matter approval data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data and the first material risk data; The computerized system management unit 220 is used to update the second risk data according to the first personnel risk data, the first regulatory risk data, the second detection risk data, the knowledge inheritance learning data corresponding to the equipment change scenario determined by the first material risk data, the regulatory change identification data, and the process processing overdue reminder data; The data modeling management unit 230 is used to update the second risk data according to the data trend analysis data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data, and the first material risk data; The closed-loop control management unit 240 is used to update the second risk data according to the data trend analysis data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data, and the first material risk data.

[0046] Equipment is one of the key basic conditions supporting drug production, and the stable operation of equipment is the prerequisite for ensuring stable product quality. The advent of the digital age has greatly accelerated the pace of updating and upgrading pharmaceutical equipment, and at the same time has had an impact on drug quality. In order to ensure the positive effect of equipment upgrades on improving drug quality, it is crucial to digitally control the equipment update process. The equipment change management unit 210 can be used to digitally manage the total number of new equipment purchases, changes, repairs, scrapping, etc., the number of completed changes, and the activation time of the company's equipment, and timely push key information on equipment changes.

[0047] The computerized system is the data and information integration center and control brain of the drug production process, and is an important carrier for ensuring that drug production quality information is complete, effective, and traceable. The computerized system management unit 220 can follow up on the verification, status, and update of the computerized system in real time, which helps to control the overall operation status of the computerized system and avoid data integrity risks.

[0048] The application of PAT (Process Analytical Technologies), quality data analysis, process risk warning and other functions are inseparable from the establishment of various data models. The data modeling management unit 230 can monitor the establishment, iteration, and deactivation of data models, which is a new challenge and new requirement for quality management in the digital era.

[0049] Closed-loop control aims to achieve dynamic and autonomous adjustment of key process parameters in the production process, achieve real-time and accurate control of process parameters, and improve the stability of drug quality. The closed-loop control management unit 240 can use a digital system to monitor each closed-loop control system in real time, ensuring dynamic and autonomous adjustment of key process parameters while also enabling continuous optimization of closed-loop control technology.

[0050] Optionally, the material risk management module 300 is as follows: Figure 5 The diagram includes: a supplier management unit 310, a sample approval management unit 320, a material selection management unit 330, and an intermediate monitoring management unit 340; The supplier management unit 310 is used to update the third risk data according to the repeated problem warning data, problem handling overdue reminder data and key matter approval data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data and the second environmental risk data; The signature review management unit 320 is used to update the third risk data according to the second equipment risk data, the second regulatory risk data, the third detection risk data, and the major problem prompt data, regulatory change identification data, and process processing overdue reminder data corresponding to the supplier determined by the second environmental risk data; The material selection management unit 330 is used to update the third risk data according to the trend analysis data and knowledge inheritance learning data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data; The intermediate monitoring management unit 340 is used to update the third risk data according to the trend analysis data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data.

[0051] The supplier management unit 310 can realize the digital management of the company's supplier certificates, quantity, supply types, introduction progress, changes, first batch usage, supplier audits, rectifications and annual evaluations and other major contents. It can upload and store supplier certificates, audit reports, rectification reports and annual evaluation reports of previous years, and can record and prompt key contents including supplier introduction, supplier changes, supplier withdrawal, supplier audits and daily use of supplier materials. The module function aims to strengthen the management of key supplier matters and carry out timely supplier quality risk warnings.

[0052] The functions of the signature and review management unit 320 mainly cover the signature and review samples of product packaging materials, and can realize the electronic storage, historical version tracing and signature and review dynamic reminder of all varieties of packaging signatures of the company.

[0053] The material selection management unit 330 is mainly used to record experimental data related to the new material introduction process, realize digital management of material source data, incoming goods inspection conditions, and usage process conditions, and can actively push new material introduction prompt information to users to control the risks of key material introduction.

[0054] The intermediate monitoring management unit 340 can provide prompts for problems with the quality of intermediates of various varieties in production exceeding trends or standards, and at the same time form process quality management files according to the varieties.

[0055] Optionally, the regulatory risk management module 400 is as follows: Figure 6 As shown, it includes: a technology transfer management unit 410, a regulatory change management unit 420, a process optimization management unit 430 and a standard optimization management unit 440; The technology transfer management unit 410 is used to update the fourth risk data according to the process processing overdue reminder data and key matter approval data corresponding to the process determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data; The regulatory change management unit 420 is used to update the fourth risk data according to the third equipment risk data, the third environment risk data, the fourth detection risk data and the major problem prompt data corresponding to the process flow determined by the second material risk data and the regulatory change identification data; The process optimization management unit 430 is used to update the fourth risk data according to the data trend analysis data, repeated problem warning data, knowledge inheritance learning data, problem processing overdue reminder data and key matter approval data corresponding to the process flow determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data; The standard optimization management unit 440 is used to update the fourth risk data according to the data trend analysis data and key matter approval data corresponding to the process flow determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data.

[0056] The technology transfer management unit 410 is mainly applicable to the technology transfer process of new products. It can record and follow up the name, progress, quantity, time, person in charge and other contents, summarize and analyze and remind technology transfer issues, including the batch number, production line and time of product pilot, pilot and commercial trial production, and at the same time realize the approval of key matters of technology transfer.

[0057] Pharmaceutical laws and regulations are basic guidelines that companies must follow in their daily quality management process. Changes in pharmaceutical-related laws and regulations, guidelines, and standards are becoming more frequent. Regulatory change management unit 420 can accurately identify and directional push new regulations, and is an essential part of risk management in the digital system for pharmaceutical quality management. Regulatory change management unit 420 can screen and collect relevant laws and regulations related to the company's products, connect with third-party websites, download legal and regulatory texts, and digitally manage information screening, compliance evaluation registration, implementation time reminders, and risk change reminders caused by implementation.

[0058] Continuous improvement is an inevitable need for enterprise development. Technology is the core of drug production. Continuous process optimization is crucial to promoting drug quality improvement. Use process optimization management unit 430 to control drug process optimization, realize digital management of the company's process optimization varieties, brief content, personnel, initiation events, optimization progress, closing time and other contents, and provide title and homepage prompts to authorized personnel to ensure that process document users can understand process changes in a timely manner, strengthen process version traceability, process improvement point records, and process optimization experience summaries, which is of great significance to drug quality risk control.

[0059] Standard Optimization Management Unit 440 can manage the entire life cycle of standard versions and push standard optimization information to relevant personnel in real time. Specifically, Standard Optimization Management Unit 440 can realize digital system management of the drafting, approval, and review personnel, implementation time, change content, and trainees of all statutory and internal quality standards of the company. It can strengthen control prompts when new standards are created or changed, and provide title and homepage prompts to authorized personnel to ensure that all personnel using the standards are aware of changes in the standards and implement risk warnings for abnormal situations caused by standard changes.

[0060] The standard optimization management unit 440 can also compare and summarize the data of all statutory and internal quality standard indicators of the company with the actual inspection results, form a quality inspection data trend analysis report, and implement risk warnings for differences between standard indicator requirements and actual inspection data.

[0061] Optionally, the environmental risk management module 500 is as follows: Figure 7 As shown, it includes: a market complaint management unit 510, a drug vigilance management unit 520, an external supervision management unit 530 and a clean environment management unit 540; Among them, the market complaint management unit 510 is used to update the fifth risk data according to the repeated problem warning data, regulatory change identification data, and key matter approval data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The pharmacovigilance management unit 520 is used to update the fifth risk data according to the data trend analysis data and major problem prompt data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The external supervision and management unit 530 is used to update the fifth risk data according to the repeated problem warning data, knowledge inheritance learning data, and problem handling overdue reminder data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The clean environment management unit 540 is used to update the fifth risk data according to the trend analysis data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data.

[0062] The market complaint management unit 510 can realize expandable archiving of key information such as the time, variety, specification, production line, shift, operator, equipment, season, material supplier, etc. of market complaints; it can extract and summarize data on the complaint department, quantity, and frequency of recurrence; it can screen out common characteristics of complaints from different markets; it can present statistics in a variety of graphics and push the collected and analyzed information to relevant personnel.

[0063] The drug vigilance management unit 520 can record the product varieties, specifications, feedback information, adverse reaction contents, etc. of the company's adverse drug reactions. It can classify the adverse reaction contents of drug vigilance according to the "Adverse Reaction Terminology" MedRA code, and classify the adverse reaction system organ classification into low-level terms LLT. It can actively, comprehensively and effectively collect adverse reactions, automatically sort out drug vigilance reports, and realize real-time push of serious adverse reactions.

[0064] The external supervision management unit 530 is capable of digitally managing the number, type, non-conformities, suggestions, rectification measures and other contents of external supervision information. It can extract and summarize data on the departments, quantities and recurrence frequencies of complaints. The summary results can be presented in a variety of graphics and previous external supervision non-conformities can be regularly pushed out on a departmental basis to warn departments to prevent similar problems from recurring.

[0065] The clean environment management unit 540 can summarize relevant data such as dust particles, temperature and humidity, pressure difference, surface microorganisms, etc. in the clean areas of each production workshop, and realize digital management of the company's clean environment monitoring frequency, monitoring results, result trends, etc. It can upload monitoring data to realize reminders of abnormal clean frequency, abnormal results, and abnormal trends, and send clean environment out-of-trend information to relevant departments in real time.

[0066] Optionally, the detection risk management module 600 is as follows Figure 8 As shown, it includes: a trend analysis management unit 610, a process analysis data management unit 620, a test optimization management unit 630 and a stability inspection management unit 640; The trend analysis management unit 610 is used to update the sixth risk data according to the data trend analysis data and process processing overdue reminder data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The process analysis data management unit 620 is used to update the sixth risk data according to the data trend analysis data, major problem prompt data, and key matter approval data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The inspection optimization management unit 630 is used to update the sixth risk data according to the major problem prompt data, regulatory change identification data, problem handling overdue data, and key matter approval data corresponding to the inspection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The stability inspection management unit 640 is used to update the sixth risk data according to the data trend analysis data and repeated problem warning data corresponding to the inspection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data.

[0067] The trend analysis management unit 610 can realize automatic trend analysis of quality inspection data, and automatically push abnormal situations to relevant departments in combination with OOS / OOT judgment results.

[0068] The process analysis data management unit 620 can integrate the PAT test data of the entire drug production line, collect, analyze and push data in real time, and record and warn of quality risks in the drug production process.

[0069] The inspection optimization management unit 630 can record and archive the quality inspection optimization process data and optimization results, and push them to relevant management personnel for review.

[0070] The stability study management unit 640 can store the types of drugs, specifications, time, quantity, study type, results, etc., support classification retrieval and data analysis based on time, batch number, product name, etc., can summarize and analyze the data that has been studied and not studied, can use a variety of graphics for statistical presentation, and can push stability study warning data to relevant personnel.

[0071] Optionally, the comprehensive risk management module 700 is as follows: Fig. 9 As shown, it includes: a system certification management unit 710, a self-inspection management unit 720, a change management unit 730 and a deviation management unit 740; The system certification management unit 710 is used to update the risk control strategy according to the regulatory change identification data, process processing overdue reminder data, and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The self-check management unit 720 is used to update the risk control strategy based on the data trend analysis data, repeated problem warning data, major problem prompt data, and problem handling overdue reminder data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The change management unit 730 is used to update the risk control strategy according to the major problem prompt data, knowledge inheritance learning data, regulatory change identification data and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data; The deviation management unit 740 is used to update the risk control strategy according to the repeated problem warning data and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

[0072] The system certification management unit 710 can realize the digital system management of system certification cycles such as base drug production license renewal, five-system management certification, CNAS certification, etc. It can upload system certificates and regularly remind the validity period of various certificates.

[0073] The self-inspection management unit 720 realizes data management of various quality inspections of the base content, such as comprehensive records of inspection scope, problem items, responsible departments, corrective and preventive measures, etc., and can extract and summarize data on problem departments, number of problems, and frequency of repeated occurrence of problems.

[0074] The change management unit 730 records the content of base changes, including the number of changes implemented (closed, unclosed), departments, applicants, types of changes, and implementation time of changes in the year, season, and month. It can extract and summarize data on changes that have not been completed or risk assessments have not been conducted. It can automatically capture data from the system for summary analysis. It can prompt the length of the change process and warn of overdue changes and other violations of the change process.

[0075] Deviation management unit 740 can manage the company's deviation data, and can summarize the number of deviations, departments where deviations occur, and completed and pending data for the whole year, quarter, and month, and can present statistics in the form of bar charts. It can provide timely feedback, follow-up, and closure of deviations in the production process, and distinguish deviation levels based on risk assessment. Medium and above batches can be prompted in the system, and minor deviations can be counted and the responsible department can be confirmed; it can follow up on the progress of all deviations and provide risk warnings for deviations that have exceeded the deadline and have not been completed.

[0076] like Fig.10 The functional diagram of a drug data management and control system shown in the figure includes eight major functions, including trend analysis, system certification, self-inspection, change management, deviation management, PAT technology, inspection optimization, and stability inspection. It can identify risks in all aspects of the entire drug production process, including people, machines, materials, methods, environment, and measurement.

[0077] From the drug data management and control system mentioned in the above embodiment, it can be seen that the system can perform risk management on personnel, equipment, materials, regulations, environment, and testing aspects involved in drug data throughout the entire drug production process through the built-in personnel risk management module, equipment risk management module, material risk management module, regulatory risk management module, environmental risk management module, and testing risk management module, thereby realizing digital quality control of the entire drug production process, facilitating timely discovery and resolution of duplicate problems, improving the ability to continuously improve drug quality risks, and realizing a precise quality risk control process.

[0078] The embodiment of the present invention also provides a drug data management and control method, which is applied to the drug data management and control system mentioned in the above embodiment; wherein the drug data management and control system at least includes: a personnel risk management module, an equipment risk management module, a material risk management module, a regulatory risk management module, an environmental risk management module, a detection risk management module and a comprehensive risk management module; like Fig.11 As shown, the method includes: Step S1101, controlling the comprehensive risk management module to receive the first risk data output by the personnel risk management module, the second risk data output by the equipment risk management module, the third risk data output by the material risk management module, the fourth risk data output by the regulatory risk management module, the fifth risk data output by the environmental risk management module, and the sixth risk data output by the detection risk management module; Step S1102, controlling the comprehensive risk management module to generate a risk control strategy corresponding to the drug data according to the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data; Step S1103, obtaining the risk value corresponding to the drug data based on the risk control strategy, and updating the drug data using the risk value.

[0079] Specifically, Fig.12 The flowchart of another drug data management control method shown in the figure involves 8 trigger functions such as data trend analysis, repeated problem warning, major problem prompt, etc., which can identify risks in all aspects of the entire drug production process, including people, machines, materials, methods, environment, and measurement.

[0080] The data trend analysis function is mainly used to collect, analyze and evaluate the quality data in the drug production process. By automatically drawing control charts and other methods, it predicts the changes in quality risks of innovation review units, data modeling units, intermediate monitoring units, etc., and forms a quality data trend change report. It can promptly discover and warn of abnormal changes in quality data such as exceeding the trend and exceeding the warning level. It can prompt potential quality problems and risks through data, helping quality management personnel to promptly discover abnormal changes in drug production quality.

[0081] For example, the duration of the monitoring cycle can be set, and the data q of the quality indicator Q of each batch of the drug production process within the monitoring period can be obtained in turn, such as particle size, moisture, tablet weight difference, hardness, content, etc., and the control charts CL, UCL, and LCL can be calculated respectively.

[0082] CL= ; UCL= ; LCL= ; Area C: , ]; Area B: , ]; Area A: , ]; Judge by the 8 criteria of SPC process abnormality judgment: Criterion 1: 1 point falls outside of Zone A (point exceeds control limit); Rule 2: 9 consecutive points fall on the same side of the center line; Criterion 3: 6 consecutive points increasing or decreasing; Rule 4: In a row of 14 points, adjacent points always alternate up and down; Criterion 5: 2 out of 3 consecutive points fall outside zone B on the same side of the center line; Rule 6: 4 out of 5 consecutive points fall outside Zone C on the same side of the center line; Rule 7: 15 consecutive points fall within the C zone on both sides of the center line; Rule 8: 8 consecutive points fall on both sides of the center line and no point is in area C.

[0083] The repeated problem warning function is used to provide automatic system warning prompts for repeated quality risks and hidden dangers in the drug production process. Through information input and analysis, system monitoring and machine learning are carried out to identify the matching of set procedures, rules, and models. When repeated quality problems are found, the warning program is triggered and detailed information of the repeated problems is sent to designated personnel, which improves the problem discovery capability, handles various quality problems in a timely manner, and avoids further expansion of the problems.

[0084] By analyzing the formula , and obtain the risk classification and early warning model of repeated multiple occurrences in the pharmaceutical process. For the recurrence risk consequence score, Score each indicator. is the weight of each indicator. The score of the consequence value of repeated multiple risk impact is calculated according to the formula. According to the size of the consequence value of repeated risk impact, the severity of the consequence is divided into 5 levels, [70, 100] for extremely large losses, [40, 70] for major losses, [20, 40] for large losses, [10, 20] for general losses, and [0, 10] for minor losses.

[0085] According to the quantified repetitive risk consequence value, the repetitive and multiple risks in the pharmaceutical process are graded, and the warning levels are formulated according to the corresponding risk grades, with level V taking [0, 10], level IV taking [10, 20], level III taking [20, 40], level II taking [40, 70], and level I taking [70, 100], so as to facilitate risk response measures in management.

[0086] The major problem reminder function is used to timely identify, mark and remind key personnel to pay attention to major problems, risks and changes. This function monitors the data, events and employee behavior of the drug production process in real time according to the rules, algorithms and models set by the system through a series of processes such as real-time monitoring, intelligent identification, problem reminders and problem tracking. Once quality risk items that may lead to major problems are found, they will be immediately notified to managers at all levels according to the problem classification so that corrective and preventive measures can be taken in time. The major problem reminder function helps to prevent or reduce the occurrence of problems in the drug production process and improve the stability of drug production quality.

[0087] Taking the tablet weight, a key quality attribute of pharmaceutical tablet intermediates, as an example, the tablet weight process capability index Cpk is calculated: Cpk= ; Among them, C pk is the process capability index, USL is the upper specification limit, LSL is the lower specification limit, μ represents the mean value, To monitor the standard deviation of an object such as tablet weight.

[0088] Specifically, Represents the standard deviation of the monitored object, such as tablet weight, The larger the value, the greater the process fluctuation. pk will decrease as increases. pk The process capability index of the monitored object in the drug production process is calculated by the formula, which is based on the C pk and value 1, when the process capability index of the monitored object deviates significantly from the C value of the previous year or month or before the change pk or 1, the system automatically gives a prompt to remind the management personnel to investigate and take corrective and preventive measures to reduce process fluctuations and prevent non-conformities.

[0089] The knowledge inheritance learning function is used to continuously pass on the knowledge, experience and wisdom accumulated in the drug production process to other drug production quality personnel. Through knowledge entry and hierarchical management, the existing knowledge, technology and skills are shared with relevant drug producers, so that they can further improve their ability to control drug quality risks on this basis and continue to innovate and create drug quality. With the help of a networked drug quality management digital system, drug producers can obtain drug quality risk control knowledge more conveniently, accurately and comprehensively, improve drug quality information literacy and systematic thinking, and promote the continuous accumulation and inheritance of drug production quality knowledge.

[0090] The regulatory change identification function is used to monitor and identify changes such as the addition, revision and abolition of drug-related laws and regulations in real time. By connecting with drug laws and regulations websites, the latest changes in key drug management regulations, standards, and guiding documents are promptly notified to drug production quality management personnel to ensure that drug quality management departments and key personnel are aware of the dynamic changes in laws and regulations in a timely manner, and decompose and implement relevant measures and requirements. The regulatory change identification function can identify the legal and regulatory texts, announcements, and notices issued by drug management agencies at all levels through machine learning and other technical means, and push the updates, revisions, and abolitions of laws and regulations to drug quality management departments and key personnel by email, SMS, pop-up windows, etc. After classification, the changes are pushed to drug quality management departments and key personnel. On this basis, enterprises can also gradually establish and improve the database of drug laws and regulations to achieve real-time monitoring, accurate identification, and system storage of regulatory changes, and improve the compliance of drug production and operation.

[0091] The regulatory change identification function is used to monitor and identify changes such as the addition, revision and abolition of drug-related laws and regulations in real time. By connecting with relevant drug laws and regulations websites, the latest changes in key drug management regulations, standards, and guiding documents are promptly notified to drug production quality management personnel to ensure that drug quality management departments and key personnel are aware of the dynamic changes in laws and regulations in a timely manner, and decompose and implement relevant measures and requirements. The regulatory change identification function can identify the legal and regulatory texts, announcements, and notices issued by drug management agencies at all levels through machine learning and other technical means, and push the updates, revisions, and abolitions of laws and regulations to drug quality management departments and key personnel by email, SMS, pop-up windows, etc. After classification, the changes are pushed to drug quality management departments and key personnel. On this basis, enterprises can also gradually establish and improve the database of drug laws and regulations to achieve real-time monitoring, accurate identification, and system storage of regulatory changes, and improve the compliance of drug production and operation.

[0092] The problem handling overdue reminder is used to follow up the progress of the drug quality risk and problem handling process in real time. When a drug quality risk or problem is not handled or resolved within the prescribed handling time limit, the system automatically issues a warning to the person in charge of the corresponding risk or problem handling, and simultaneously reminds the relevant personnel in the quality management department. The sign of the completion of risk or problem handling can be in various modes such as data, reports or personnel approval. The implementation of the problem handling overdue reminder function module will ensure that drug quality risks and problems are responded to and resolved quickly, avoiding delays and accumulation, thereby improving work efficiency, reducing operational risks, and enhancing the stability of drug quality.

[0093] The process processing overdue reminder is used for business process control of risk management processes such as skill training units, sample review units, and system certification units. By presetting the process processing time limit, the system can monitor the process progress in real time, automatically identify process overdues, and send overdue reminders to the drug quality management department and key personnel via emails, text messages, in-site messages, pop-ups, etc., to ensure that relevant personnel can take action as soon as possible to improve the efficiency and quality of business process processing.

[0094] The quality risk management of drug deviation management, change management, technology transfer and other units of the key matters approval function is aimed at ensuring that key matters in the drug production quality management process can be approved and processed in a timely, accurate and efficient manner. In order to improve approval efficiency, reduce decision-making risks, and optimize resource allocation, special approval processes and rules are set up in the digital drug quality management system for business decisions, resource changes, and product expansions that may have a significant impact on drug quality to ensure that key matters are efficiently promoted. Combined with artificial intelligence, big data and other technical means, the system can achieve intelligent management, flexible handling, and full-process traceability of the approval process for key drug matters through processes such as matter identification, process identification, approval execution, and approval monitoring, thereby improving approval efficiency and quality and promoting high-quality operation of the enterprise.

[0095] Combined with the above 8 functions, production quality management personnel can comprehensively carry out risk identification, assessment and control according to the risk triggering situation of the system, and eliminate quality risks in time or reduce them to an acceptable level. Specifically, through the 7 risk management modules of the drug data management and control system and the networked risk assessment of the built-in 28 risk units, the risk level is determined and risk management suggestions are provided in combination with historical data. The recommendations are automatically pushed to the production quality management personnel in the process, and then production quality risk control measures are taken. If the risk has been eliminated, normal production will continue, and the process data will be stored in the database; if the risk has not been eliminated, the system will further remind the production quality management personnel that the risk has not been reduced to an acceptable level, and risk identification, assessment and control will be re-conducted until the risk is acceptable.

[0096] It can be seen from the drug data management and control method mentioned in the above embodiment that this method utilizes the personnel risk management module, equipment risk management module, material risk management module, regulatory risk management module, environmental risk management module and testing risk management module built into the drug data management and control system to perform risk management on personnel, equipment, materials, regulations, environment, and testing aspects involved in drug data throughout the entire drug production process, thereby realizing digital quality control of the entire drug production process, facilitating timely discovery and handling of repeated problems, improving the ability to continuously improve drug quality risks, and realizing an accurate quality risk control process.

[0097] The drug data management and control method provided in the embodiment of the present invention has the same implementation principle and technical effects as those of the aforementioned drug data management and control system embodiment. For the sake of brief description, for matters not mentioned in the device embodiment, reference may be made to the corresponding contents in the aforementioned drug data management and control system embodiment.

[0098] This embodiment also provides a server, the structural diagram of which is as follows: Fig.13 As shown, the device includes a processor 101 and a memory 102; wherein the memory 102 is used to store one or more computer instructions, and the one or more computer instructions are executed by the processor to implement the steps of the above-mentioned drug data management control method.

[0099] Fig.13 The server shown further includes a bus 103 and a communication interface 104 , and the processor 101 , the communication interface 104 and the memory 102 are connected via the bus 103 .

[0100] The memory 102 may include a high-speed random access memory (RAM), and may also include a non-volatile memory, such as at least one disk storage. The bus 103 may be an ISA bus, a PCI bus, or an EISA bus. The bus may be divided into an address bus, a data bus, a control bus, etc. For ease of representation, Fig.13 Only one bidirectional arrow is used in the diagram, but this does not mean that there is only one bus or only one type of bus.

[0101] The communication interface 104 is used to connect to at least one user terminal and other network units through a network interface, and send the encapsulated IPv4 message or IPv4 message to the user terminal through the network interface.

[0102] The processor 101 may be an integrated circuit chip with signal processing capabilities. In the implementation process, each step of the above method can be completed by the hardware integrated logic circuit or software instructions in the processor 101. The above processor 101 can be a general-purpose processor, including a central processing unit (CPU), a network processor (NP), etc.; it can also be a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA) or other programmable logic devices, discrete gates or transistor logic devices, discrete hardware components. The disclosed methods, steps and logic block diagrams in the embodiments of the present disclosure can be implemented or executed. The general-purpose processor can be a microprocessor or the processor can also be any conventional processor, etc. The steps of the method disclosed in conjunction with the embodiments of the present disclosure can be directly embodied as a hardware decoding processor for execution, or a combination of hardware and software modules in the decoding processor for execution. The software module may be located in a storage medium mature in the art, such as a random access memory, a flash memory, a read-only memory, a programmable read-only memory, or an electrically erasable programmable memory, a register, etc. The storage medium is located in the memory 102, and the processor 101 reads the information in the memory 102 and completes the steps of the method of the above embodiment in combination with its hardware.

[0103] An embodiment of the present invention further provides a storage medium on which a computer program is stored. When the computer program is executed by a processor, the steps of the drug data management and control method in the aforementioned embodiment are executed.

[0104] 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. The device embodiments described above are merely schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation. For example, 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 communication interfaces, indirect coupling or communication connection of devices or units, which can be electrical, mechanical or other forms.

[0105] 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.

[0106] In addition, each functional unit in each embodiment of the present invention 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.

[0107] 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 non-volatile computer-readable storage medium that can be executed by a processor. Based on this understanding, the technical solution of the present invention can essentially or in other words, the part that contributes to the prior art or the part of the technical solution can be embodied in the form of a software product. The computer software product is stored in a storage medium and includes several instructions to enable a computer device (which can be a personal computer, a server, or a network device, etc.) to perform all or part of the steps of the method described in each embodiment of the present invention. 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 codes.

[0108] Finally, it should be noted that the above-described embodiments are only specific implementations of the present invention, which are used to illustrate the technical solutions of the present invention, rather than to limit them. The protection scope of the present invention is not limited thereto. Although the present invention is described in detail with reference to the above-described embodiments, ordinary technicians in the field should understand that any technician familiar with the technical field can still modify the technical solutions recorded in the above-described embodiments within the technical scope disclosed by the present invention, or can easily think of changes, or make equivalent replacements for some of the technical features therein; and these modifications, changes or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. A drug data management and control system, characterized in that: The system includes: a personnel risk management module, an equipment risk management module, a material risk management module, a regulatory risk management module, an environmental risk management module, a detection risk management module and a comprehensive risk management module; Wherein, the comprehensive risk management module is respectively connected with the personnel risk management module, the equipment risk management module, the material risk management module, the regulatory risk management module, the environmental risk management module and the detection risk management module; The personnel risk management module is used to obtain first risk data corresponding to key personnel associated with drug data; the equipment risk management module is used to obtain second risk data corresponding to equipment change scenarios associated with the drug data; the material risk management module is used to obtain third risk data corresponding to suppliers associated with the drug data; the regulatory risk management module is used to obtain fourth risk data corresponding to the process associated with the drug data; the environmental risk management module is used to obtain fifth risk data corresponding to the market environment associated with the drug data; the detection risk management module is used to obtain sixth risk data corresponding to the detection process associated with the drug data; The comprehensive risk management module is used to determine the risk control strategy corresponding to the drug data based on the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

2. The drug data management and control system according to claim 1, characterized in that: The personnel risk management module is also connected to the equipment risk management module, the detection risk management module and the environmental risk management module; the personnel risk management module is used to generate first risk data corresponding to key personnel associated with the drug data according to the first equipment risk data, the first detection risk data and the first environmental risk data corresponding to the drug data; The equipment risk management module is also connected to the detection risk management module, the regulatory risk management module and the material risk management module; the equipment risk management module is used to generate second risk data corresponding to the equipment change scenario associated with the drug data according to the first personnel risk data, the first regulatory risk data, the second detection risk data and the first material risk data corresponding to the drug data; The material risk management module is also connected to the regulatory risk management module, the environmental risk management module and the detection risk management module; the material risk management module is used to generate third risk data corresponding to the supplier associated with the drug data according to the second equipment risk data, the second regulatory risk data, the third detection risk data and the second environmental risk data corresponding to the drug data; The regulatory risk management module is also connected to the detection risk management module and the environmental risk management module; the regulatory risk management module is used to generate fourth risk data corresponding to the process flow associated with the drug data according to the third equipment risk data, the third environmental risk data, the fourth detection risk data, and the second material risk data corresponding to the drug data; The environmental risk management module is also connected to the detection risk management module; the environmental risk management module is used to generate fifth risk data corresponding to the market environment associated with the drug data according to the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data corresponding to the drug data; The detection risk management module is used to generate sixth risk data corresponding to the detection process associated with the drug data based on the fourth regulatory risk data, third personnel risk data, fourth equipment risk data, fourth environmental risk data, and fourth material risk data corresponding to the drug data.

3. The drug data management and control system according to claim 2, characterized in that: The personnel risk management module includes: a key personnel management unit, a skill training management unit, an innovation review management unit and a knowledge base construction management unit; The key personnel management unit is used to update the first risk data according to the major problem prompt data and key matter approval data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The skill training management unit is used to update the first risk data according to the repeated problem warning data, knowledge inheritance learning data and process processing overdue reminder data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The innovation review management unit is used to update the first risk data according to the data trend analysis data, regulatory change identification data, problem handling overdue reminder data and the key matter approval data corresponding to the key personnel determined by the first equipment risk data, the first detection risk data and the first environmental risk data; The knowledge base construction management unit is used to update the first risk data according to the knowledge inheritance learning data corresponding to the key personnel determined according to the first equipment risk data, the first detection risk data and the first environmental risk data.

4. The drug data management and control system according to claim 2, characterized in that: The equipment risk management module includes: an equipment change management unit, a computerized system management unit, a data modeling management unit and a closed-loop control management unit; The equipment change management unit is used to update the second risk data according to the repeated problem warning data, major problem prompt data, problem processing overdue reminder data and key matter approval data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data and the first material risk data; The computerized system management unit is used to update the second risk data according to the first personnel risk data, the first regulatory risk data, the second detection risk data, the knowledge inheritance learning data corresponding to the equipment change scenario determined by the first material risk data, the regulatory change identification data, and the process processing overdue reminder data; The data modeling management unit is used to update the second risk data according to the data trend analysis data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data, and the first material risk data; The closed-loop control management unit is used to update the second risk data according to the data trend analysis data corresponding to the equipment change scenario determined by the first personnel risk data, the first regulatory risk data, the second detection risk data, and the first material risk data.

5. The drug data management and control system according to claim 2, characterized in that: The material risk management module includes: a supplier management unit, a sample approval management unit, a material selection management unit and an intermediate monitoring management unit; The supplier management unit is used to update the third risk data according to the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data, the repeated problem warning data, the problem processing overdue reminder data, and the key matter approval data corresponding to the supplier; The signature review management unit is used to update the third risk data according to the second equipment risk data, the second regulatory risk data, the third detection risk data, and the major problem reminder data, regulatory change identification data, and process processing overdue reminder data corresponding to the supplier determined by the second environmental risk data; The material selection management unit is used to update the third risk data according to the trend analysis data and knowledge inheritance learning data corresponding to the supplier determined by the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data; The intermediate monitoring management unit is used to update the third risk data according to the trend analysis data corresponding to the supplier determined based on the second equipment risk data, the second regulatory risk data, the third detection risk data, and the second environmental risk data.

6. The drug data management and control system according to claim 2, characterized in that: The regulatory risk management module includes: a technology transfer management unit, a regulatory change management unit, a process optimization management unit and a standard optimization management unit; The technology transfer management unit is used to update the fourth risk data according to the process processing overdue reminder data and key matter approval data corresponding to the process determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data; The regulatory change management unit is used to update the fourth risk data according to the third equipment risk data, the third environment risk data, the fourth detection risk data and the major problem prompt data corresponding to the process flow and the regulatory change identification data determined by the second material risk data; The process optimization management unit is used to update the fourth risk data according to the data trend analysis data, repeated problem warning data, knowledge inheritance learning data, problem handling overdue reminder data and the key matter approval data corresponding to the process flow determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data; The standard optimization management unit is used to update the fourth risk data according to the data trend analysis data and the key matter approval data corresponding to the process flow determined by the third equipment risk data, the third environment risk data, the fourth detection risk data and the second material risk data.

7. The drug data management and control system according to claim 2, characterized in that: The environmental risk management module includes: a market complaint management unit, a pharmacovigilance management unit, an external supervision management unit and a clean environment management unit; The market complaint management unit is used to update the fifth risk data according to the repeated problem warning data, regulatory change identification data, and key matter approval data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The pharmacovigilance management unit is used to update the fifth risk data according to the data trend analysis data and major problem prompt data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The external supervision and management unit is used to update the fifth risk data according to the repeated problem warning data, knowledge inheritance learning data, and problem handling overdue reminder data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data; The clean environment management unit is used to update the fifth risk data according to the trend analysis data corresponding to the market environment determined by the fifth detection risk data, the third regulatory risk data, the second personnel risk data, and the third material risk data.

8. The drug data management and control system according to claim 2, characterized in that: The detection risk management module includes: a trend analysis management unit, a process analysis data management unit, an inspection optimization management unit and a stability inspection management unit; The trend analysis management unit is used to update the sixth risk data according to the data trend analysis data and process processing overdue reminder data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The process analysis data management unit is used to update the sixth risk data according to the data trend analysis data, major problem prompt data, and key matter approval data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The inspection optimization management unit is used to update the sixth risk data according to the major problem prompt data, regulatory change identification data, problem handling overdue data, and key matter approval data corresponding to the inspection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data; The stability assessment management unit is used to update the sixth risk data according to the data trend analysis data and repeated problem warning data corresponding to the detection process determined by the fourth regulatory risk data, the third personnel risk data, the fourth equipment risk data, the fourth environmental risk data, and the fourth material risk data.

9. The drug data management and control system according to claim 1, characterized in that: The comprehensive risk management module includes: system certification management unit, self-inspection management unit, change management unit and deviation management unit; The system certification management unit is used to update the risk control strategy according to the regulatory change identification data, process processing overdue reminder data, and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The self-check management unit is used to update the risk control strategy according to the data trend analysis data, repeated problem warning data, major problem prompt data, and problem handling overdue reminder data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The change management unit is used to update the risk control strategy according to the major problem prompt data, knowledge inheritance learning data, regulatory change identification data and key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data; The deviation management unit is used to update the risk control strategy according to the repeated problem warning data and the key matter approval data determined by the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data and the sixth risk data.

10. A drug data management and control method, characterized in that: The method is applied to the drug data management and control system according to any one of claims 1 to 9; wherein the drug data management and control system comprises at least: a personnel risk management module, an equipment risk management module, a material risk management module, a regulatory risk management module, an environmental risk management module, a detection risk management module and a comprehensive risk management module; The method comprises: Controlling the comprehensive risk management module to receive the first risk data output by the personnel risk management module, the second risk data output by the equipment risk management module, the third risk data output by the material risk management module, the fourth risk data output by the regulatory risk management module, the fifth risk data output by the environmental risk management module, and the sixth risk data output by the detection risk management module; Controlling the comprehensive risk management module to generate a risk control strategy corresponding to the drug data according to the first risk data, the second risk data, the third risk data, the fourth risk data, the fifth risk data, and the sixth risk data; The risk value corresponding to the drug data is obtained based on the risk control strategy, and the drug data is updated using the risk value.

11. A server, characterized in that: It comprises a processor and a memory, wherein the memory stores computer executable instructions that can be executed by the processor, and the processor executes the computer executable instructions to implement the steps of the drug data management control method described in claim 10.

Images