Whole-process verification method, mistake proofing method and system for medicine

Abstract

The invention discloses a full-process verification method, a mistake proofing method and a system thereof for medicines. The verification method comprises the following steps: obtaining a verification main file set of all verification objects; performing real-time monitoring and maintenance on the verification period, and screening the verification main archives in the verification main archive set according to the verification period or verification project requirements; formulating a first-year verification total plan according to the screened verification main file, and formulating a second-year verification total plan according to the department verification plan; and according to an early warning mechanism, regularly sending the to-do list to the verification sub-archive principal in advance, executing the verification plan, and after the verification plan is completed, updating the archive library. Electronic full-process verification system closed-loop management is realized, verification management efficiency is greatly improved, and manual operation omissions are reduced; according to the error proofing method based on main data management, the quality and service interruption risk is effectively avoided, the traceability requirement of laws and regulations on the whole verification process is met, and the verification management efficiency and normalization are greatly improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of full-process verification of pharmaceuticals, in particular to a full-process verification method of pharmaceuticals, an error-proofing method and a system thereof. BACKGROUND

[0002] Verification management is an important part of the quality management system of pharmaceutical production enterprises. Unlike general quality management, it mainly undertakes the confirmation of the equipment and methods used in each stage of pharmaceutical production, proves that the equipment and process used in pharmaceutical production can continuously achieve the expected effect, and ensures product quality.

[0003] Previously, the verification management of pharmaceutical production enterprises mainly adopted an offline management mode, and the validity period control and process statistics of each verification object were performed through manual checking, but there were disadvantages of long time consumption, high error rate and high risk. Currently, some enterprises on the market have gradually adopted electronic verification management systems, which mainly perform independent statistics on verification schemes, records and reports, but the system structure has not been designed from the perspective of covering the whole life cycle of verification, and the validity period of verification has not been evaluated and warned based on risk, which has the risk of not following up in time. At the same time, the verification systems on the market are mostly independent systems, and the verification system is not deeply associated with other quality management systems to achieve deep integration between systems. The different stages and dimensions of pharmaceutical quality management are still mainly maintained by manual means, which has the risk of communication discontinuity and delayed quality information transmission. SUMMARY

[0004] The existing pharmaceutical verification management has the problems of unclosed loop of the whole life cycle, complicated work prone to errors, high risk of discontinuity in each stage, insufficient compliance, no early warning mechanism, and no error correction for verification management.

[0005] In view of the above problems, a full-process verification method of pharmaceuticals, an error-proofing method and a system thereof are proposed. The verification master file set and the verification sub-file set are constructed to obtain a verification file, the validity period of the verification master file is monitored and maintained in real time, all verification master files within the screening period or associated with the verification project are selected according to the early warning mechanism, an annual verification total plan is formulated, the to-do list is sent to the person in charge of the verification sub-file in advance at regular intervals, and the file library is updated after the verification plan is completed. The electronic full-process verification system closed-loop management is realized, the verification management efficiency is greatly improved, and the manual operation omission is reduced. The error-proofing method based on master data management not only effectively avoids the risk of quality and business interruption, but also meets the requirements of regulations on the traceability of the whole process of verification, greatly improves the verification management efficiency and standardization, and solves the problems of unclosed loop of the whole life cycle, complicated work prone to errors, high risk of discontinuity in each stage, insufficient compliance, no early warning mechanism, and no error correction for verification management in the existing pharmaceutical verification management.

[0006] The first aspect is a whole-process validation method of a drug, comprising: Step 100, obtaining validation object entities, constructing a validation master file for each of the validation object entities, and obtaining a validation master file set of all validation objects; Step 200, setting a validation validity period for each of the validation master files, and performing real-time monitoring and maintenance on the validation validity period, screening the validation master files in the validation master file set according to the validation validity period or a validation project requirement, and obtaining all validation master files within the validation validity period or associated with the validation project; Step 300, formulating a first annual validation overall plan according to the screened validation master files, and distributing the first annual validation overall plan to department heads, wherein the department heads formulate a department validation plan according to the first annual validation overall plan, formulate a second annual validation overall plan according to the department validation plan, and approve the second annual validation overall plan, wherein the formulation of the department validation plan comprises creating a validation sub-file, and obtaining a validation sub-file set, and wherein the validation master file set and the validation sub-file set constitute a file library; Step 400, after the second annual validation overall plan is approved and takes effect, sending to-do items to validation sub-file responsible persons in advance in a timely manner according to a pre-warning mechanism, executing a validation plan, updating the file library after the validation plan is completed, and obtaining an annual validation summary report according to the executed validation sub-file.

[0007] In a first possible implementation manner of the whole-process validation method of the drug according to the first aspect of the present application, the step 100 comprises: Step 110, determining validation object entities, and determining a validation range according to the validation object entities; Step 120, creating and generating a validation master file according to master data information of the validation object entities determined according to the validation range.

[0008] In a second possible implementation manner of the first possible implementation manner of the first aspect of the present application, the step 200 comprises: Step 210, monitoring a validation validity period state of the validation master file in real time, and initiating a validity period reminder according to a pre-warning mechanism; Step 220, judging a validation range type, and initiating a corresponding overdue evaluation and maintenance process according to the validation range type; Step 230, after the overdue evaluation and maintenance process is completed, updating process information to the corresponding validation master file, wherein the process information comprises an association relationship of an additional maintenance process and an updated validation state.

[0009] In a third possible implementation manner of the second possible implementation manner of the first aspect of the present application, the step 220 comprises: Step 221, if the verification range type is the equipment type, then the equipment type is graded step by step: whether the use has been overdue, whether to continue the extension of use, and whether to hang the overdue card are evaluated, and the corresponding processing flow is started according to the evaluation result; Step 222, if the verification range type is the process type, then the process type is graded step by step: whether the product quality is affected, whether the control measures are needed are evaluated, and the corresponding processing flow is started according to the evaluation result.

[0010] In combination with the third possible implementation manner of the first aspect of the present application, in the fourth possible implementation manner, the step 300 comprises: Step 310, all verification master files in the archive whose verification validity period is within the specified period are screened, an annual verification total plan template is automatically generated according to the screening result, and the annual verification total plan template is sent to the verification administrator; Step 320, the verification administrator revises and confirms the annual verification total plan template to obtain a first annual verification total plan, and the first annual verification total plan is distributed to the department heads.

[0011] In combination with the fourth possible implementation manner of the first aspect of the present application, in the fifth possible implementation manner, the step 300 further comprises: Step 330, the information of the person in charge of a single verification matter corresponding to the verification master file, the plan completion time information, and the verification reason information are obtained; Step 340, a verification sub-file corresponding to the single verification matter is created and generated according to the information of the person in charge, the plan completion time information, and the verification reason information.

[0012] In combination with the fifth possible implementation manner of the first aspect of the present application, in the sixth possible implementation manner, the step 300 further comprises: Step 350, all department verification plans are summarized, and the second annual verification total plan is formulated by the verification administrator according to all the department verification plans; Step 360, the second annual verification total plan is pushed into the management system, and the second annual verification total plan is approved.

[0013] The second aspect is a full-process verification error prevention method of a drug to prevent the full-process verification method of the first aspect from being wrong, comprising: Step 500, a management data set is constructed, the management data set comprising verification range master data, verification object master data, and attachment master data; Step 600, obtaining the entity type of the verification object entity, associating the corresponding verification range master data according to the entity type, using the verification range master data to generate the corresponding verification master file number and verification sub-file number when creating the verification master file and the verification sub-file, automatically initiating the file to-do and generating the document number during the verification activity execution, and synchronously pushing the verification master file number, the verification sub-file number and the document number to the document management module; Step 700, when the verification master file is created, the verification object master data of the verification object entity is associated, and the verification object master data is updated according to the data update of the verification file, and is synchronously updated to other management modules of the system, and the updating of the verification object master data includes updating the verification state and the verification validity period in the verification object master data; Step 800, when the verification is executed, the general attachment in the document management module is called by associating the attachment master data.

[0014] The third aspect is a whole-process verification system of a drug, which adopts the whole-process verification method of the drug in the first aspect, and includes: A first creation module obtains verification object entities, constructs a verification master file for each verification object entity, and obtains a verification master file set of all verification objects; A screening module is configured to screen the verification master files in the verification master file set according to the verification validity period and the verification project requirements, and obtain all verification master files within the verification validity period or associated with the verification project; A plan making module is configured to make a first annual verification total plan according to the screened verification master files, and distribute the first annual verification total plan to department heads, the department heads make department verification plans according to the first annual verification total plan, make a second annual verification total plan according to the department verification plans, the making of the department verification plans includes creating verification sub-files to obtain a verification sub-file set, and the verification master file set and the verification sub-file set constitute a file library; An execution module is configured to send to-do items to verification sub-file responsible persons in advance according to a pre-warning mechanism after the second annual verification total plan is approved and takes effect, execute the verification plans, update the file library after the verification plans are completed, and obtain an annual verification summary report according to the executed verification sub-files.

[0015] The fourth aspect is an error-proof system of a whole-process verification of a drug, which adopts the whole-process verification error-proof method of the drug in the second aspect, and includes: A second creation module is configured to create a management data set, the management data set including verification range master data, verification object master data and attachment master data; The verification range error-proofing module is configured to acquire an entity type of a verification object entity, associate corresponding verification range master data according to the entity type, generate corresponding verification master file numbers and verification sub-file numbers when creating a verification master file and a verification sub-file by using the verification range master data, automatically initiate a file to-do list and generate a document number during verification activity execution, and synchronously push the verification master file number, the verification sub-file number, and the document number to a document management module. The verification object error-proofing module is configured to associate verification object master data of a verification object entity when creating a verification master file, update the verification object master data according to update data of the verification file, and synchronously update the verification object master data to other management modules. The updating of the verification object master data includes updating a verification state and a verification expiration date in the verification object master data.

[0016] The drug full-process verification method, the error-proofing method, and the system thereof according to the present application can realize closed-loop management of an electronic full-process verification system, greatly improve verification management efficiency, and reduce manual operation errors. The error-proofing method based on master data management can effectively avoid quality and business interruption risks, meet verification full-process traceability requirements of regulations, greatly improve verification management efficiency and standardization, and solve problems in existing drug verification management, such as non-closed-loop full life cycle, complicated work, high risk of stage discontinuity, insufficient compliance, no early warning mechanism, and no error correction for verification management. BRIEF DESCRIPTION OF DRAWINGS

[0017] To more clearly illustrate the technical solutions in the embodiments of the present application, the following will briefly introduce the drawings needed in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort based on these drawings.

[0018] Figure 1 A specific implementation example of the drug full-process verification method according to the present application; Figure 2 A specific implementation example of step 100 in the method according to the present application; Figure 1 A specific implementation example of step 200 in the method according to the present application; Figure 3 A specific implementation example of step 200 in the method according to the present application; Figure 1 A specific implementation example of step 200 in the method according to the present application; Figure 4 A specific embodiment of step 220 in FIG. 2 is shown in FIG. 3. Figure 3 A specific embodiment of step 220 in FIG. 2 is shown in FIG. 3. Figure 5 A specific embodiment of step 300 in FIG. 3 is shown in FIG. 4. Figure 1 A specific embodiment of step 300 in FIG. 3 is shown in FIG. 4. Figure 6 A specific embodiment of step 320 in FIG. 3 is shown in FIG. 5. Figure 5 A specific embodiment of step 320 in FIG. 3 is shown in FIG. 5. Figure 7 A specific embodiment of step 340 in FIG. 3 is shown in FIG. 6. Figure 6 A specific embodiment of step 340 in FIG. 3 is shown in FIG. 6. Figure 8 A specific embodiment of the full-process validation error-proofing method for a drug in the present application is shown in FIG. 7. Figure 9 A specific embodiment of the information hierarchy of the validation file in the present application is shown in FIG. 8. Figure 10 A specific embodiment of the validation process for a single validation object in the present application is shown in FIG. 9. Figure 11 A specific embodiment of the validation process for a single validation object in the present application is shown in FIG. 9. Figure 12 A specific embodiment of the main data management process in the full-process validation error-proofing method for a drug in the present application is shown in FIG. 10. Figure 13 A specific embodiment of the structure of the full-process validation system for a drug in the present application is shown in FIG. 11. Figure 14 A specific embodiment of the structure of the full-process validation error-proofing system for a drug in the present application is shown in FIG. 12. DETAILED DESCRIPTION

[0019] The technical solutions in the present application will be described below in conjunction with the drawings in the present application. Obviously, the described embodiments are only some of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, other embodiments obtained by those of ordinary skill in the art without creative effort fall within the scope of the present application.

[0020] Reference herein to“an embodiment” means that a particular feature, structure, or characteristic described in conjunction with an embodiment can be included in at least one embodiment of the application. Appearances of the phrase“in an embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are they necessarily mutually exclusive of one another. Those of ordinary skill in the art will readily recognize that the embodiments described herein can be combined with other embodiments.

[0021] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains; the terminology used herein in the specification of the application is for the purpose of describing particular embodiments only and is not intended to limit the application; the terms “comprising” and “having”, and any variations thereof, in the specification, claims, and foregoing description of the drawings of this application are intended to cover non-exclusive inclusion.

[0022] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, "multiple" means two or more, unless otherwise explicitly specified.

[0023] Existing drug validation management suffers from several problems, including a lack of closed-loop management throughout the entire drug lifecycle, complex and error-prone work, high risk of generational gaps at each stage, insufficient compliance, lack of early warning mechanisms, and failure to correct errors in validation management.

[0024] To address the above issues, a full-process verification method, error prevention method, and system for pharmaceuticals are proposed.

[0025] Firstly, a full-process validation method for a drug, such as... Figure 1 , Figure 1 This is a schematic diagram illustrating a specific embodiment of a full-process validation method for a drug according to the present invention; including: In this embodiment of the application, a full-process closed-loop verification control method is adopted. The connection and information interaction between archive entities are carried out in the method process, and the entire life cycle management of the process system is realized through electronic process control. First, the verification master archive of the verification object entity is created, the verification validity period of the verification master archive is monitored in real time, and the verification process is triggered in a timely manner according to the early warning mechanism to carry out closed-loop control of planning, division of labor, execution, closure and summary.

[0026] In another embodiment of this application, a verification plan can be manually formulated with the project as the core, and a closed-loop control system of planning, division of labor, execution, closure, and summary can be implemented according to the verification plan.

[0027] Step 100: Obtain the verification object entity, construct a verification master file for each verification object entity, and obtain the verification master file set for all verification objects.

[0028] In one possible implementation, such as Figure 2 , Figure 2 for Figure 1A schematic diagram of a specific implementation of step 100 is shown below; step 100 includes: step 110, determining the verification object entity and determining the verification scope based on the verification object entity; step 120, creating and generating a verification master file based on the master data information of the verification object entity determined by the verification scope.

[0029] In this embodiment, the system consists of multiple individual verification objects. For each individual verification object, its verification file contains a three-layer structure: a main verification file, a sub-verification file, and a verification activity. When a new verification object is introduced, the verification file is created in the order of the main verification file, sub-verification file, and verification activity.

[0030] In practice, the main verification file is created by the system based on the entity being verified, while the sub-verification files are created by the heads of each department according to the progress of the verification process. During the execution of the verification process, key information is closed and transmitted level by level in the order of verification activity items, sub-verification files, and main verification file, thereby achieving closed-loop management of information throughout the entire verification process.

[0031] Step 200: Set the validity period of each verification master file and monitor and maintain the validity period in real time. Filter the verification master files in the verification master file set according to the validity period or verification project requirements to obtain all verification master files within the validity period or associated with the verification project.

[0032] In one possible implementation, such as Figure 3 , Figure 3 for Figure 1 A schematic diagram of a specific implementation of step 200 is shown below; step 200 includes: step 210, real-time monitoring of the verification validity status of the verification master file, and initiating an expiration reminder according to the early warning mechanism; step 220, determining the verification scope type, and initiating the corresponding overdue assessment and maintenance process according to the verification scope type; step 230, after the overdue assessment and maintenance process is completed, updating the process information to the corresponding verification master file, the process information including the association of additional maintenance processes and the updated verification status.

[0033] In this embodiment, after the impact assessment process is closed, the process information will be synchronously archived and updated in the verification master file, including the relationship of additional processes generated due to the maintenance process and the updated verification status, etc. For process information pushed to other systems or modules, it is managed in the form of master data to achieve data unification between modules or systems. For example, when the product is released, the verification master file will automatically show whether there are abnormal events or whether it is within the expiration date based on the relationship in the product batch master data and the variety and specifications in the product master data, to assist in product release and reduce the risk of quality management gaps.

[0034] In one possible implementation, such as Figure 4 , Figure 4 for Figure 3 A schematic diagram of a specific implementation of step 220 is shown below; step 220 includes: step 221, if the verification scope type is equipment type, then assess whether the equipment type has exceeded its expiration date, whether it should continue to be extended, and whether it should be marked as expired, and start the corresponding processing flow according to the assessment results; step 222, if the verification scope type is process type, then assess whether the process type affects product quality and whether control measures are needed, and start the corresponding processing flow according to the assessment results.

[0035] In this embodiment, the monitoring process for overdue maintenance of equipment types includes checking whether the equipment has exceeded its maintenance period. "During the assessment, if the expiration date has passed, a deviation handling process will be initiated. If the expiration date has not passed, a judgment assessment of 'whether to continue the extension' will be triggered. If yes, a deviation handling process will be initiated to investigate the cause of the expiration, assess the risk of the expiration, and formulate corresponding control measures based on the investigation results and risks. If no, a 'whether to display an expired sign' process will be triggered. If yes, on-site photos will be taken. If no, an explanation of the situation will be provided. After the process is completed, the process information will be updated to the verification master file of the device."

[0036] In this embodiment, for the overdue maintenance monitoring process of the process type, in the judgment and evaluation of "whether it affects product quality", if it affects the product quality, the batch information of the affected products is added; if it does not affect the product quality, the judgment and evaluation of "whether control measures are needed" is triggered. If it does, risk control measures are formulated; if it does not, the process ends. After the process ends, the process information is updated to the verification master file of the process.

[0037] Step 300: Based on the selected master verification files, formulate the first year's overall verification plan and distribute it to the heads of each department. Each department head formulates a departmental verification plan based on the first year's overall verification plan, formulates a second year's overall verification plan based on the departmental verification plan, and approves the second year's overall verification plan. Formulating a departmental verification plan includes creating verification sub-files, obtaining a set of verification sub-files, and the master verification file set and the set of verification sub-files constitute the archive.

[0038] In one possible implementation, such as Figure 5 , Figure 5 for Figure 1A schematic diagram of a specific implementation of step 300 is shown below; step 300 includes: step 310, screening all verification master files in the archive with verification validity within the specified period, automatically generating an annual verification master plan template based on the screening results, and sending the annual verification master plan template to the verification administrator; step 320, the verification administrator revises and confirms the annual verification master plan template to obtain the first annual verification master plan, and distributes the first annual verification master plan to the heads of each department.

[0039] In this embodiment, the annual verification master plan task is triggered to the verification administrator at regular intervals each year, and all verification master files with a validity period of less than one year in the archive are automatically screened and an annual verification master plan template is automatically generated. After receiving the task, the verification administrator revises and confirms the template to obtain the first year's verification master plan, and distributes the first year's verification master plan to the heads of each department.

[0040] In one possible implementation, such as Figure 6 , Figure 6 for Figure 5 A schematic diagram of a specific implementation method following step 320; step 300 further includes: step 330, obtaining the person in charge information, planned completion time information, and verification reason information for a single verification item in the corresponding verification master file; step 340, creating and generating a verification sub-file for the corresponding single verification item based on the person in charge information, planned completion time information, and verification reason information, such as Figure 11 , Figure 11 This is a schematic diagram of the verification process based on the period in this invention.

[0041] In this embodiment, the first-year verification master plan is distributed to the verification leaders of each department, and the verification leaders of each department formulate the department's annual verification plan, including the creation of verification sub-files, the designation of verification sub-file leaders, and the determination of verification completion time.

[0042] In one possible implementation, such as Figure 7 , Figure 7 for Figure 6 A schematic diagram of a specific implementation method after step 340; step 300 also includes: step 350, summarizing all department verification plans, and the verification administrator formulating the second year verification master plan based on all department verification plans; step 360, pushing the second year verification master plan to the management system and approving the second year verification master plan.

[0043] In this embodiment, the verification plans of each department are automatically aggregated to form the overall verification plan for the second year. The verification administrator confirms the overall verification plan for the second year, and after confirmation, the approval is completed according to the company's internal management requirements, and the overall verification plan for the second year takes effect. Then, according to a customized early warning mechanism, to-do items are sent to the responsible persons of each sub-file in advance at regular intervals, and the notification scope will be gradually expanded if they are not completed before the expiration date. During the verification execution process, process data is recorded simultaneously, and the verification archive database is updated. Every year, the annual verification summary report task is triggered to the verification administrator at regular intervals. The system automatically selects the verification sub-files completed within the set review time range in the archive database, generates the template and verification list of the annual verification summary report, and can quickly identify necessary tags through configuration. For example, when generating the template, the system automatically distinguishes the verification sub-files of each department, and the verification sub-files within or outside the annual plan based on tags. After accepting the task, the verification administrator can revise and confirm the annual verification summary report in the system, complete the approval according to the company's internal management requirements, and make it effective.

[0044] In one possible implementation, when verification of a single verification object entity is required, such as Figure 10 , Figure 10 This is a schematic diagram of the verification process for a single verification object in this invention, and the specific implementation is as follows: For a single verification object, the master file and its associated verification files comprise a three-tiered structure: the master verification file, the sub-verification files, and the verification activities. When introducing a new verification object, verification files are created in the order of master verification file, sub-verification files, and verification activities. During verification management, key information is closed and transmitted level by level in the order of verification activities, sub-verification files, and master verification files, achieving closed-loop management of information throughout the entire verification process.

[0045] Step S11: Confirm the entity to be verified within the system and determine the scope of verification to which the object belongs, such as specific facilities and equipment, product processes, or processing methods for a certain stage. After selecting the verification scope, proceed to step S12 to establish the verification master file: The verification master file is a collection of verification information for the verification object, including static information such as equipment master data / product process master data determined by the verification scope and the attribution information of the verification master file confirmed by the internal division of responsibilities of the enterprise, and dynamic information such as the status information of the master file automatically generated by the system. After the main file is created, proceed to the next step S13 to create a verification sub-file: The verification sub-file is a collection of verification information for a single verification, including static information such as the sub-file person in charge designated by the department, the planned completion time, and the verification reason (such as first verification / periodic re-verification), as well as dynamic information such as the sub-file status automatically generated by the system.

[0046] After the verification sub-file is created, proceed to the next step S14 to establish a verification activity: A verification activity is the basic information of each activity included in a single verification. It is created by the person in charge of the verification sub-file. This includes setting up a verification activity matrix (selecting the activities required for this verification from fixed activity items), static information such as the person in charge of the activity implementation and the planned completion time of the activity, as well as dynamic information such as the number of verification activity items in the verification sub-file automatically updated by the system after the verification activity is established.

[0047] After confirming the verification activity items, proceed to the next step S15 to execute the verification activity: The system will periodically send to-do tasks to the responsible persons of each activity according to the defined early warning rules and planned completion time. The responsible persons will initiate the online document drafting and approval process during the verification activity. The system will automatically generate document codes that can be directly indexed into the verification activity items. If necessary, an extension application can be initiated on the system during the verification activity. If the verification activity involves deviations or changes, the deviations and changes can be associated in the verification activity file, and the association will be retained and synchronized to each upper-level solution.

[0048] After the verification report takes effect, proceed to the next step S16 to close the verification activity: The person in charge of implementation can initiate the activity closure on the system, and the verification sub-file will be closed after the approval process is completed by the system's configured approval workflow.

[0049] During the sub-file closure phase S17, the system will trigger a verification validity period assessment action: the person in charge of the verification sub-file will assess the duration of the verification validity period, and the system will automatically generate the verification validity period based on the assessment results and the validity period conversion rules configured by the enterprise, and simultaneously complete the next step S18: update the verification master file information, and return to the initial step to update the verification status of the verification object entity.

[0050] The aforementioned process uses archives at each level as the main information body, covering the entire lifecycle of data, including basic information, status changes, and activity execution / closure. Based on this structured archive management, multi-dimensional analysis of verification data is possible. Data can be configured, ledgers and charts can be output according to management needs, meeting the needs of verification personnel at all levels for summarizing, tracking, and managing verification records. The information structure is as follows: Figure 9 As shown, Figure 9 This is a schematic diagram of the information hierarchy of the verification archive in this invention.

[0051] Step 400: After the second year's overall verification plan is approved and takes effect, according to the early warning mechanism, the to-do items are sent to the person in charge of the verification sub-file in advance, the verification plan is executed, the archive is updated after the verification plan is completed, and the annual verification summary report is obtained based on the executed verification sub-files.

[0052] Secondly, a full-process validation error-proofing method for a drug is provided to prevent errors in the full-process validation method described in the first aspect, such as...Figure 8 , Figure 8 This is a schematic diagram illustrating a specific embodiment of a full-process verification and error-proofing method for a drug according to the present invention; including: Step 500: Construct a management dataset, which includes verification scope master data, verification object master data, and attachment master data. Step 600: Obtain the entity type of the verification object entity, associate the corresponding verification scope master data with the entity type, and use the verification scope master data to generate corresponding verification master file number and verification sub-file number when creating verification master files and verification sub-files. During verification activity execution, automatically initiate document pending tasks and generate document numbers, and synchronously push the verification master file number, verification sub-file number, and document number to the document management module. Step 700: When creating a verification master file, associate the verification object master data of the verification object entity, and update the verification object master data according to the data updates in the verification file. Synchronize this to other management modules in the system. Updating the verification object master data includes updating the verification status and verification validity period. Step 800: During verification execution, call the general attachments in the document management module by associating with the attachment master data.

[0053] In this embodiment, as Figure 12 , Figure 12 This is a schematic diagram of the master data management process in the full-process verification and error prevention method for pharmaceuticals in this invention. It prevents document numbering errors by using verification scope master data. Based on the type of verification object, it associates the corresponding verification scope master data and automatically generates verification master file numbers and verification sub-file numbers according to the verification scope. These are synchronously pushed to the document management module, automatically initiating document pending tasks and automatically generating document numbers during verification activities. It achieves precise management of verification expiration dates through equipment master data or product process master data in the verification object master data. When the master file is created, it is associated with the verification object master data, creating or associating a file for that equipment or process. As the verification file is updated during verification execution, the verification status and expiration date in the equipment master data are updated synchronously, and the data is synchronously pushed to other business systems or management modules. It improves the utilization rate of common attachments through attachment master data: during verification activities, it can associate verification attachment master data with the document management module, synchronously retrieving common attachments stored in the module, such as common equipment calibration certificates, reducing repetitive uploading by personnel and improving efficiency and storage space utilization.

[0054] In this embodiment, validation files are obtained by constructing a master validation file set and a sub-validation file set; the validation validity period of the master validation files is monitored and maintained in real time; all master validation files within the validity period or associated with validation projects are selected according to the early warning mechanism, and an annual validation master plan is formulated; pending tasks are sent to the heads of sub-validation files in advance on a regular basis; and the file database is updated after the validation plan is completed. This achieves closed-loop management of the entire electronic validation system, which greatly improves the efficiency of validation management and reduces human error. The error prevention method based on master data management effectively avoids the risks of quality and business interruption, meets the regulatory requirements for full-process traceability of validation, greatly improves the efficiency and standardization of validation management, and solves the problems in the existing drug validation management, such as the lack of a closed loop throughout the entire life cycle, the complexity and error-proneness of the work, the high risk of generational gaps at each stage, insufficient compliance, the lack of an early warning mechanism, and the lack of error correction in validation management.

[0055] Thirdly, a full-process verification system for a drug, such as... Figure 13 , Figure 13 This is a schematic diagram of the structure of a full-process validation system for a drug according to the present invention; the full-process validation method for a drug according to the first aspect includes: The first creation module obtains the verification object entity, constructs a verification master file for each verification object entity, and obtains the verification master file set of all verification objects. The filtering module is used to filter the validation master files in the validation master file set according to the validation validity period and validation project requirements, so as to obtain all validation master files within the validation validity period or associated with the validation project. The planning module is used to formulate the first year's overall verification plan based on the selected verification master files, and distribute the first year's overall verification plan to the heads of each department. Each head of the department formulates a departmental verification plan based on the first year's overall verification plan, and formulates a second year's overall verification plan based on the departmental verification plan. Formulating a departmental verification plan includes creating verification sub-files, obtaining a set of verification sub-files, and the verification master file set and the set of verification sub-files constitute a file library. The execution module is used to send the pending items to the person in charge of the verification sub-file in advance according to the early warning mechanism after the approval and effective date of the second year verification master plan, execute the verification plan, update the archive after the verification plan is completed, and generate the annual verification summary report based on the executed verification sub-files.

[0056] Fourthly, a full-process verification and error-proofing system for a drug adopts the full-process verification and error-proofing methods of the drug described in the second aspect, such as... Figure 14 , Figure 14 This is a schematic diagram of the structure of a full-process verification and error-proofing system for a drug according to the present invention, comprising: The second creation module is used to create management datasets, which include validation scope master data, validation object master data, and attachment master data. The verification scope error prevention module is used to obtain the entity type of the verification object entity, associate the corresponding verification scope master data according to the entity type, and generate the corresponding verification master file number and verification sub-file number when creating the verification master file and verification sub-file using the verification scope master data. When the verification activity is executed, it automatically initiates the file to be done and generates the document number, and pushes the verification master file number, verification sub-file number and document number to the document management module simultaneously. The verification object error prevention module associates the verification object master data with the verification object entity when the verification master file is created, and updates the verification object master data according to the updated data of the verification file, and synchronizes it to other management modules. Updating the verification object master data includes updating the verification status and verification validity period in the verification object master data.

[0057] This invention discloses a full-process validation method, error prevention method, and system for pharmaceuticals. By constructing a master validation file set and sub-validation file sets to obtain validation files, real-time monitoring and maintenance of the validation validity period of the master validation files, screening all master validation files within the validity period or associated with validation projects based on an early warning mechanism, formulating an annual validation master plan, sending pending tasks to the sub-validation file managers in advance, and updating the file database after the validation plan is completed, this achieves closed-loop management of the entire electronic validation process, significantly improving validation management efficiency and reducing human error. The error prevention method based on master data management effectively avoids quality and business interruption risks while meeting regulatory requirements for full-process traceability of validation, significantly improving validation management efficiency and standardization. It solves the problems existing in current pharmaceutical validation management, such as the lack of a closed-loop system throughout the entire lifecycle, complex and error-prone work, high risk of generational gaps at each stage, insufficient compliance, lack of early warning mechanisms, and lack of error correction in validation management.

[0058] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A method for full-process validation of a drug, characterized in that, include: Obtain the verification object entity, construct a verification master file for each verification object entity, and obtain the verification master file set of all verification objects; Set the validity period for each verification master file and monitor and maintain the validity period in real time. Filter the verification master files in the verification master file set according to the validity period or the requirements of the verification project to obtain all verification master files within the validity period or associated with the verification project. Based on the selected master verification files, a first-year verification master plan is formulated and distributed to the heads of each department. Each department head formulates a departmental verification plan based on the first-year verification master plan, formulates a second-year verification master plan based on the departmental verification plan, and approves the second-year verification master plan. The formulation of the departmental verification plan includes creating verification sub-files to obtain a set of verification sub-files. The set of master verification files and the set of verification sub-files constitute a database. After the second year's overall verification plan is approved and takes effect, the to-do items are sent to the person in charge of the verification sub-files in advance according to the early warning mechanism. The verification plan is executed. After the verification plan is completed, the archive is updated and an annual verification summary report is obtained based on the executed verification sub-files.

2. The method for full-process validation of pharmaceuticals according to claim 1, characterized in that, The construction of a verification master file for each of the verification object entities includes: Determine the entity to be verified, and then determine the scope of verification based on the entity to be verified. A verification master file is created based on the master data information of the verification object entity determined by the verification scope.

3. The method for full-process validation of pharmaceuticals according to claim 1, characterized in that, The real-time monitoring and maintenance of the verification validity period includes: Monitor the validity period status of the main verification file in real time, and initiate validity period reminders according to the early warning mechanism; Determine the verification scope type and initiate the corresponding overdue assessment and maintenance process based on the verification scope type; After the overdue assessment and maintenance process is completed, the process information is updated in the corresponding verification master file. The process information includes the relationship of the additional maintenance process and the updated verification status.

4. The method for full-process validation of pharmaceuticals according to claim 3, characterized in that, The process of determining the verification scope type and initiating the corresponding overdue assessment and maintenance process based on the verification scope type includes: If the verification scope type is device type, then proceed step by step for each device type: An assessment of whether the license plate has expired, whether it needs to be extended, and whether the expired license plate is still in use. And initiate the corresponding processing procedure based on the assessment results; If the verification scope type is process type, then the verification is performed level by level for each process type: An assessment of whether it affects product quality and whether control measures are needed. And initiate the corresponding processing procedure based on the evaluation results.

5. The method for full-process validation of pharmaceuticals according to claim 1, characterized in that, The process involves developing a first-year validation master plan based on the selected validation master files, and distributing the first-year validation master plan to the heads of each department, including: The system filters all master verification files in the database whose verification validity period is within the specified period, automatically generates an annual verification master plan template based on the filtering results, and sends the annual verification master plan template to the verification administrator. The verification administrator revises and confirms the annual verification master plan template to obtain the first annual verification master plan, and then distributes the first annual verification master plan to the heads of each department.

6. The method for full-process validation of pharmaceuticals according to claim 5, characterized in that, The creation of the verification sub-file includes: Obtain the person in charge, planned completion time, and verification reason information for the single verification item in the corresponding verification master file; Based on the information of the person in charge, the planned completion time, and the verification reason, a verification sub-file corresponding to the single verification item is created and generated.

7. The method for full-process validation of pharmaceuticals according to claim 6, characterized in that, The formulation of the second-year overall verification plan based on the departmental verification plan includes: The verification administrator summarizes all departmental verification plans and formulates the overall verification plan for the second year based on all the departmental verification plans. The second year's overall verification plan is pushed into the management system for approval.

8. A method for error prevention in the entire process verification of a pharmaceutical product, to prevent errors in the entire process verification method according to any one of claims 1-7, characterized in that, include: Construct a management dataset, which includes verification scope master data, verification object master data, and attachment master data; Obtain the entity type of the verification object entity, associate the corresponding verification scope master data according to the entity type, and generate the corresponding verification master file number and verification sub-file number when creating the verification master file and verification sub-file using the verification scope master data. When the verification activity is executed, automatically initiate the file to be done and generate the document number, and push the verification master file number, verification sub-file number and document number to the document management module simultaneously. When the master verification file is created, the master verification data of the associated master verification object entity is updated, and the master verification data is updated according to the data update of the master verification file and synchronized to other management modules of the system. Updating the master verification data includes updating the verification status and verification validity period in the master verification data. During the verification process, the common attachments in the document management module are called by associating the attachment master data.

9. A full-process validation system for a pharmaceutical product, employing the full-process validation method for a pharmaceutical product as described in any one of claims 1-7, characterized in that, include: The first creation module obtains the verification object entity, constructs a verification master file for each verification object entity, and obtains a set of verification master files for all verification objects. The filtering module is used to filter the verification master files in the verification master file set according to the verification validity period and verification project requirements, so as to obtain all verification master files within the verification validity period or associated with the verification project. The planning module is used to formulate a first-year verification master plan based on the selected verification master files, and distribute the first-year verification master plan to the heads of each department. The heads of each department formulate departmental verification plans based on the first-year verification master plan, and formulate a second-year verification master plan based on the departmental verification plans. The formulation of departmental verification plans includes creating verification sub-files to obtain a set of verification sub-files. The set of verification master files and the set of verification sub-files constitute a file library. The execution module is used to send the pending items to the person in charge of the verification sub-file in advance according to the early warning mechanism after the second year's verification master plan is approved and takes effect, execute the verification plan, update the archive after the verification plan is completed, and obtain the annual verification summary report based on the executed verification sub-files.

10. A full-process verification and error-proofing system for pharmaceuticals, employing the full-process verification and error-proofing method for pharmaceuticals as described in claim 8, characterized in that, include: The second creation module is used to create a management dataset, which includes verification scope master data, verification object master data, and attachment master data. The verification scope error prevention module is used to obtain the entity type of the verification object entity, associate the corresponding verification scope master data according to the entity type, generate the corresponding verification master file number and verification sub-file number when creating the verification master file and verification sub-file using the verification scope master data, automatically initiate file pending and generate document number when the verification activity is executed, and push the verification master file number, verification sub-file number and document number to the document management module simultaneously. The verification object error prevention module associates the verification object master data with the verification object entity when the verification master file is created, and updates the verification object master data according to the update data of the verification file, and synchronizes it to other management modules. Updating the verification object master data includes updating the verification status and verification validity period in the verification object master data.

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