Recording quality control system and quality control method applied to clinical test center laboratory

Abstract

The invention discloses a record quality control system and quality control method applied to a clinical test center laboratory, and the method comprises the steps: receiving an inspection request initiated by a target account, the inspection request comprising a target item number and a target record type; searching the target project number in a knowledge base, and obtaining an authorization account corresponding to the target project number; if the authorized account is consistent with the target account, searching a target record abstract corresponding to a target record type under the target item number from a knowledge base, and displaying the target record abstract in an interface corresponding to the target record type; and when a record viewing request initiated by the target account based on the target record abstract is detected, reading a target technical record corresponding to the target record abstract from the knowledge base, and displaying the target technical record. According to the technical scheme, the function of technical record query through the project dimension is achieved, and compared with technical record retrieval through the bar code dimension, the technical record batch retrieval through the project dimension can improve the record consulting and quality control efficiency.

Description

Technical Field

[0001] This invention relates to the field of clinical trials, and more particularly to a record quality control system and method for use in clinical trial central laboratories. Background Technology

[0002] In clinical trials, to assess the efficacy and safety of drugs, auditing agencies typically commission specialized clinical trial center laboratories to conduct biological sample testing and analysis. These center laboratories are specifically established in multi-center clinical trials to ensure the consistency and stability of test data. Their test results play a crucial role in evaluating the effectiveness and safety of clinical trials. As the sponsor of the clinical trial, the auditing agency bears direct responsibility for the data collected during the trial. To ensure high-quality test records and guarantee the consistency, accuracy, and traceability of test results, the sponsor will either organize its own audits or commission professional research institutions to conduct rigorous audits of the center laboratory.

[0003] To ensure that data is authentic, accurate, complete, and traceable, and to meet the requirements of drug / device registration and regulatory review, it is crucial to systematically collect, organize, verify, store, and maintain all data generated during clinical trials (including source data, case report forms, and document records). This process is called the clinical trial record management process.

[0004] Electronic records generated during clinical trial record management are typically maintained using Excel. When an audit request is submitted, quality control personnel must first search for the document name in Excel, then search for and open the corresponding document in the electronic record database. This process requires constantly switching between interfaces, resulting in low efficiency. Summary of the Invention

[0005] This invention provides a record quality control system and method for clinical trial center laboratories to solve the problem of low efficiency in querying technical records in the prior art.

[0006] According to a first aspect of the present invention, a record quality control system for use in a clinical trial center laboratory is provided. The record quality control system is connected to a pre-created knowledge base, which stores technical records of one or more record types that have undergone standardization. The record types include original records and public records. Original records refer to original technical records with unique identifiers, and public records refer to public technical records without the unique identifiers. Each technical record is pre-marked with a corresponding project number.

[0007] The record quality control system includes: an original record processing module, a public record processing module, an authorization module, and an audit module;

[0008] The original record processing module is used to determine the list of original record summaries to be recycled and to display the list of original record summaries to the quality control personnel, so as to prompt the quality control personnel to improve the original records corresponding to the original record summary list in the knowledge base;

[0009] The public record processing module is used to determine the list of public record summaries to be processed;

[0010] The authorization module is used to authorize a project number based on the project number from the list of recovered original record summaries or the list of public record summaries. The authorization includes at least assigning account information that can audit the project number.

[0011] The audit module is used to, upon receiving an audit request containing a target project number initiated by a target account, query the target record summary list corresponding to the target project number in the knowledge base after completing the permission verification, and display the target record summary list to the target account.

[0012] According to a second aspect of the present invention, a method for quality control using a record quality control system is provided, the method comprising:

[0013] Receive an audit request initiated by the target account, the audit request including the target project number and the target record type;

[0014] Search the knowledge base for the target project number to obtain the authorized account corresponding to the target project number;

[0015] If the authorized account is the same as the target account, then the target record summary corresponding to the target record type under the target project number is retrieved from the knowledge base, and the target record summary is displayed in the interface corresponding to the target record type;

[0016] When a record viewing request initiated by the target account based on the target record summary is detected, the target technical record corresponding to the target record summary is read from the knowledge base and the target technical record is displayed.

[0017] According to a third aspect of the present invention, an electronic device is provided, the electronic device comprising:

[0018] At least one processor; and

[0019] A memory communicatively connected to the at least one processor; wherein,

[0020] The memory stores a computer program that can be executed by the at least one processor, the computer program being executed by the at least one processor to enable the at least one processor to perform the above-described method.

[0021] According to a fourth aspect of the present invention, a computer-readable storage medium is provided, characterized in that the computer-readable storage medium stores computer instructions for causing a processor to execute the above-described method.

[0022] The present invention has the following beneficial effects:

[0023] In this embodiment, the record quality control system processes the original records through the original record processing module, determines the list of original record summaries to be recycled, and displays the list of original record summaries to the quality control personnel to prompt them to complete the original records corresponding to the original record summary list in the knowledge base. This provides real-time monitoring to improve the recycling efficiency and completeness of technical records, avoiding the problems of low efficiency and poor completeness caused by manual monitoring of record recycling.

[0024] Meanwhile, the record quality control system determines the list of public record summaries to be processed through the public record processing module, and authorizes project numbers based on project numbers from the recovered original record summary list or public record summary list through the authorization module. This authorization prepares for subsequent audits. The record quality control system receives audit requests containing target project numbers from target accounts through the audit module. After verifying the target account's permissions, it queries the knowledge base for the target record summary list corresponding to the target project number and displays the target record summary list to the target account. This enables the function of querying technical records by project dimension. Compared to searching for technical records one by one by barcode, batch searching of technical records by project dimension improves the efficiency of record review and quality control.

[0025] Furthermore, the auditing party (such as the applicant, pharmaceutical company, or a third party commissioned by the applicant) can query the technical records of the corresponding project by entering the project number into the system. Compared with repeatedly searching through Excel files and then searching the knowledge base, which causes constant switching of the user interface, this can further improve auditing efficiency and provide a better user experience.

[0026] In clinical trial projects, information confidentiality and project access control are of paramount importance. The authorization module can meet the access control requirements and prevent leaks caused by auditors accidentally opening unrelated materials during audits.

[0027] In addition, this record quality control system allows customers to access technical records online, meeting their needs for confidentiality and security when they need to access a large amount of laboratory technical data during business negotiations, project audits, and other stages.

[0028] It should be understood that the description in this section is not intended to identify key or essential features of the embodiments of the present invention, nor is it intended to limit the scope of the invention. Other features of the invention will become readily apparent from the following description. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 This is a structural block diagram of a recording quality control system according to an embodiment of the present invention;

[0031] Figure 2 This is a structural block diagram of another recording quality control system according to an embodiment of the present invention;

[0032] Figure 3 This is a structural block diagram of another recording quality control system according to an embodiment of the present invention;

[0033] Figure 4 This is a flowchart illustrating the steps of a method for quality control using a record-keeping quality control system, as provided in this invention.

[0034] Figure 5 This is a schematic diagram of the structure of an electronic device provided by the present invention. Detailed Implementation

[0035] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0036] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0037] In clinical trials, to assess the efficacy and safety of drugs, inspectors typically entrust clinical trial center laboratories with the testing and analysis of biological samples. Generally, a comprehensive center laboratory may include over 80 types of medical testing technology platforms, involving more than 4,000 testing items. To comply with the record management requirements of the *Good Clinical Practice for Drug Clinical Trials* and to support frequent (e.g., 10-12 times per month) audits by inspectors, clinical trial center laboratories usually have a professional quality control team to comprehensively collect, classify, inspect, digitize, label, and archive the technical records of clinical trial projects, handling over 500,000 pages of records annually. This invention's embodiment configures a record quality control system to manage such a large volume of technical records. This record quality control system can be implemented in hardware and / or software; in one specific embodiment, the record quality control system can be integrated into an electronic device.

[0038] The server-side development framework for the quality control system can use Java 8.0 as the core programming language and build a full-stack technology solution based on the JVM ecosystem. It maximizes code reusability through modular design patterns, ensures system efficiency through GC automatic memory management and JIT just-in-time compilation technology, and optimizes stability under high-concurrency scenarios by combining NIO non-blocking I / O models.

[0039] The microservice architecture of the quality control system can be based on a distributed microservice architecture using Spring Cloud Alibaba, integrating components such as Nacos service registration and discovery, Sentinel traffic management, and RocketMQ message queues. It uses OpenFeign to implement declarative service calls and works with the Gateway to implement multi-dimensional routing strategies, ensuring the system's horizontal scalability and fault tolerance capabilities.

[0040] The database optimization solution for the quality control system can utilize MySQL 8.0 enterprise-grade relational database, implementing ACID transaction characteristics based on the InnoDB storage engine, and constructing a cross-regional data synchronization architecture through multi-source replication technology. It also deeply applies JSON type fields to support complex structured data storage and optimizes information service performance by combining database indexes.

[0041] The cloud infrastructure deployment of the quality control system can adopt Huawei Cloud Stack architecture, using CCE container clusters to achieve elastic service scaling, and the CES cloud monitoring system to track CPU / memory usage in real time, combined with AS automatic scaling strategies to dynamically optimize resource utilization. At the network layer, an ELB load balancer is used to achieve intelligent traffic distribution and ensure service availability.

[0042] To ensure the reliability, consistency, and integrity of the record quality control system and protect product quality and data integrity, Computerized System Validation (CSV) is performed on the system in practice. CSV is a series of planned and documented activities that demonstrate that the design, installation, operation, and performance of the computerized system consistently meet preset goals and regulatory requirements (such as GMP and GCP), ensuring that the data generated by the system is accurate, complete, traceable, and secure. The core of CSV is "proving that the system works well and the data is reliable," avoiding data errors or compliance risks due to system problems. It is a crucial step in the compliant application of computerized systems in fields such as pharmaceuticals and clinical settings. Its objectives include: ensuring compliance: meeting the regulatory requirements of regulatory agencies (such as the FDA and NMPA) for computerized systems and avoiding compliance penalties; ensuring data reliability: verifying that the generation, storage, transmission, and retrieval of system data are unbiased, and that data is traceable and tamper-proof; and confirming system suitability: demonstrating that the system's functions fully match user needs (such as clinical trial data collection and drug production monitoring) and can operate stably. After verification is completed, a CSV verification delivery list can be generated. This CSV verification delivery list can include the verification results of different verification activities at different verification stages. Verification stages may include, for example, the planning and requirements stage, the design and development stage, the testing and validation stage, the pre-launch stage, the operation and maintenance stage, and the system decommissioning stage. Verification activities may include, for example, supplier evaluation, initial risk assessment, functional specifications, design specifications, user requirement specifications, design validation, source code review, unit testing, integration testing, and verification summary report.

[0043] In this embodiment, the record quality control system is connected to a pre-created knowledge base that stores technical records of one or more record types that have undergone standardization.

[0044] Standardization processes may include, but are not limited to: record retrieval, classification and organization, record inspection, record labeling, record digitization, and record archiving. In practice, when archiving records, the quality control team can also predefine naming rules to store technical records of different record types.

[0045] In implementation, the knowledge base can be stored locally or synchronously backed up to a third-party cloud platform. The record quality control system can establish a connection with the knowledge base through a specified API (Application Programming Interface). For example, the specified API may include a NAS (Network Access Server) interface. However, the NAS interface lacks standardization, and direct access is susceptible to network fluctuations and permission issues. Therefore, in this embodiment, the NAS interface is used to back up the knowledge base to a third-party cloud platform according to a set period, preserving the path structure. The record quality control system then obtains the path through the API of the third-party cloud platform. For example, the third-party cloud platform can be Huawei Cloud OBS. The NAS automatically backs up files to OBS every morning at midnight, preserving the path structure, and the record quality control system obtains the path through the OBS API. Additionally, manual backup triggering can be set to handle emergency file backups, thus solving the interface problem while improving stability and security.

[0046] Technical records are generated based on various technical platforms within the laboratory. Technical records have different types. For example, record types can include original records and public records. Original records refer to original technical records with unique identifiers, such as workflow sheets, data exported from instruments and equipment (including electronic and paper data), etc., which are generally traceable to corresponding barcodes or test numbers (i.e., unique identifiers) and can record detailed information about the testing process. Public records refer to common technical records without unique identifiers, such as instrument-related records, reagent-related records, environmental-related records, quality control review reports, interlaboratory quality assessment certificates, etc., which generally do not correspond to specific barcodes or test numbers.

[0047] In practice, most original records can be traced through unique identifiers (such as unique barcodes), while a small number of records require manual conversion of barcodes using resetting laboratory codes. Public records, on the other hand, need to be bound to the unique code of the testing item (referred to as: testing code or item number) so that the testing item can be queried and the corresponding public records can be investigated.

[0048] During the standardization process, the quality control team extracts barcodes from each paper or electronic original record through manual conversion, data entry, or OCR recognition. However, for common records where the corresponding testing codes cannot be directly extracted, quality control personnel need to identify the relevant testing codes. After verification, a dedicated document controller scans the records to create electronic records (scanning is not required if the returned records are already in electronic format). The documents are then named according to standard document naming rules, and both paper and electronic records are archived simultaneously. The standardized naming, barcodes, testing codes, and other information for these documents can be maintained using Excel files.

[0049] During the standardization process of technical records, when labeling records, tags can be added to technical records according to pre-defined fields. These tags can be added manually or automatically generated using an automated tag generation method; this embodiment does not impose any restrictions on this. These tags may include, but are not limited to, project number, laboratory name, department name, record type, record year, master barcode, test details, and file name.

[0050] For example, in one implementation, labels can be automatically generated for technical records as follows: An automatic labeling model is trained, and the pre-processed technical records (such as image correction and noise reduction) are input into the automatic labeling model. The automatic labeling model can then output the labels for the technical records. This embodiment does not limit the training method of the automatic labeling model; for example, it can be a model obtained by fine-tuning a large model using a dataset from the industry. Furthermore, one or more OCR APIs can be embedded in the automatic labeling model. Combining multiple OCR methods can improve the accuracy of key information extraction, enabling the extraction of key information from different types of documents, such as tabular documents and plain text documents.

[0051] refer to Figure 1 A structural block diagram of a recording quality control system according to an embodiment of the present invention is shown, as follows: Figure 1 As shown, the record quality control system 10 may include: a raw record processing module 110, a public record processing module 120, an authorization module 130, and an audit module 140.

[0052] The original record processing module 110 is used to determine the list of original record summaries to be recycled and display the list of original record summaries to the quality control personnel to prompt them to complete the original records corresponding to the original record summary list in the knowledge base.

[0053] The public record processing module 120 is used to determine the list of public record summaries to be processed.

[0054] Authorization module 130 is used to authorize project numbers based on the project number from the list of reclaimed original record summaries or the list of public record summaries. Authorization includes at least assigning account information that allows auditing the project number.

[0055] The audit module 140 is used to, when receiving an audit request containing a target project number initiated by a target account, query the target record summary list corresponding to the target project number in the knowledge base after completing the permission verification, and display the target record summary list to the target account.

[0056] Specifically, the record quality control system 10 divides the processing of technical records into two parts: a raw record processing module 110 processes raw records, and a common record processing module 120 processes common records. The raw record processing module 110 can determine a list of raw record summaries to be retrieved and display this list to the quality control personnel, prompting them to promptly update the corresponding raw records in the knowledge base, thereby achieving the function of record archiving and monitoring.

[0057] In a further embodiment, for the retrieval and processing of original records, the record quality control system can also be connected to a reporting system, which provides inspection and auditing parties with access to specific test reports. The original record processing module 110 is specifically used for:

[0058] Read the list of key record summaries from the reporting system; determine the list of recovered record summaries; based on the list of key record summaries and the list of recovered record summaries, determine the list of original record summaries to be recovered.

[0059] For example, the key record summary list may include, but is not limited to, the following fields: barcode information, project number, central laboratory number, project name, sampling time, subject information, visit point information, etc. After the original record processing module 110 reads the key record summary list from the reporting system, it compares it with its own maintained list of recovered record summaries according to the project number. The recovered record summary list includes, but is not limited to, the following fields: laboratory name, department name, barcode information, project number, project name, time information, etc. If a project number in the key record summary list is not in the recovered record summary list, the summary information corresponding to that project number is added to the list of original records to be recovered. When the quality inspector queries the list of original records to be recovered, they can perform recovery processing on the original records according to the list of original records to be recovered, thereby monitoring the recovery status of technical records and promptly reminding the quality control personnel to recover any technical records that have not yet been recovered, thus improving the efficiency and coverage of technical record recovery.

[0060] Once the quality control officer has completed the retrieval process for the technical records, the system can be triggered to transfer the record summary corresponding to that technical record from the list of original record summaries to be retrieved to the list of retrieved record summaries.

[0061] In this embodiment, the system supports statistical analysis of testing records by department, outputting the status of testing items and retrieval records. It also determines whether retrieval is complete based on the retrieval logic for each testing item, generating a list of original record summaries to be retrieved. In one implementation, the list of original record summaries to be retrieved can be transferred to the quality control team for manual review. Furthermore, the system can automatically determine whether a testing item requires retesting based on the number of records for that item, automatically generating a retest list, which is then transferred to the quality control team for manual review.

[0062] In a further embodiment, the public record processing module 120 is specifically used for the recycling of public records, including:

[0063] Read the list of public record files in the knowledge base and generate a list of public record summaries to be processed based on the list of public record files.

[0064] Specifically, a directory for storing a list of public record files can be set in the knowledge base. The public record processing module 120 can read the key information of the public record file list and generate a list of public record summaries to be processed. For example, the fields of the public record summary list to be processed may include, but are not limited to: scheme number, project number, detection code, project name, file name, etc.

[0065] In other embodiments, quality control personnel can also add public record summaries in batches to form a public record summary list in the system.

[0066] For the list of recovered original record summaries or public record summaries, project authorization can be completed through the authorization module 130, so that only authorized accounts can access the relevant technical records of the corresponding project, preventing users from accidentally opening irrelevant materials, thereby improving the confidentiality of technical records. In clinical trial projects, information confidentiality and project access control are particularly important.

[0067] When granting authorization, the authorization is based on the project number. For example, this authorization may at least include assigning account information to the project number that allows auditing that project. This embodiment authorizes accounts by project, so that authorized accounts have the right to view the technical records of the corresponding authorized project, but not the technical records of other projects. This ensures data isolation and is more efficient than searching technical records one by one via barcodes.

[0068] The authorization module 130 allows a unified project to be authorized to multiple accounts, enabling multiple roles and accounts to simultaneously perform quality control or auditing on the same project, thus improving query efficiency.

[0069] Once project authorization is complete, the authorized account can conduct project audits through the audit module 140. Specifically, when the audit module 140 receives an audit request containing the target project number from the target account, after completing the permission verification, it queries the target record summary list corresponding to the target project number in the knowledge base and displays the target record summary list to the target account.

[0070] It should be noted that the audit mentioned in this embodiment can be an internal audit, such as an internal quality control audit initiated by internal quality control personnel; or an external audit, such as an audit application submitted by an auditing party. This embodiment does not impose any restrictions on this. When conducting an internal audit, the auditing party can view not only the target record summary list but also other technical documents. Technical documents refer to data obtained by extracting relevant information from existing public records and then performing data structuring processing on that information.

[0071] In one example, when an auditor wants to conduct a project audit, they can submit an audit request in the system. Upon receiving the request, the system assigns an account to the auditor. The auditor can then log in to that account and submit an audit request, which includes the target project number. Upon receiving the request, the system first verifies the auditor's account permissions. If the permissions are verified, the system queries the knowledge base for the target record summary list corresponding to the target project number and displays this list to the target account.

[0072] In one embodiment, the authorization by the authorization module 130 may further include assigning an auditable time period to the project number. When implementing permission verification, the audit module 140 is specifically used for:

[0073] Search for the target project number in the knowledge base to obtain the authorized account corresponding to the target project number; if the authorized account is the same as the target account and the current audit time is within the auditable period, then the permission verification is considered complete.

[0074] In one embodiment, the audit module 140 can also be used for:

[0075] When a record viewing request initiated by a target account based on a target record summary is detected, the target technical record corresponding to the target record summary is read from the knowledge base and displayed.

[0076] Specifically, when the target technical record is an original record, the original record is displayed in the original record interface; when the target technical record is a public record, the public record is displayed in the public record interface.

[0077] For example, a "Details" button is displayed after each target record summary in the target record summary list. When the inspector clicks the "Details" button, the corresponding technical record is found in the knowledge base according to the storage path of the target record summary as the target technical record, and the target technical record is displayed to the inspector.

[0078] To further enhance confidentiality, watermarks can be added when displaying technical records.

[0079] To ensure system transparency and traceability, the quality control system can also include an audit module to record operational logs during authorization or inspection processes. These logs are queryable; for example, inspectors can review the logs to understand the entire inspection process and accurately assess the results. In other cases, audit records can provide strong evidence for sponsors when responding to regulatory audits or third-party reviews, demonstrating the compliance and effectiveness of their inspection activities.

[0080] In this embodiment, the record quality control system processes the original records through the original record processing module, determines the list of original record summaries to be recycled, and displays the list of original record summaries to the quality control personnel to prompt them to complete the original records corresponding to the original record summary list in the knowledge base. This provides real-time monitoring to improve the recycling efficiency and completeness of technical records, avoiding the problems of low efficiency and poor completeness caused by manual monitoring of record recycling.

[0081] Meanwhile, the record quality control system determines the list of public record summaries to be processed through the public record processing module, and authorizes project numbers based on project numbers from the recovered original record summary list or public record summary list through the authorization module. This authorization prepares for subsequent audits. The record quality control system receives audit requests containing target project numbers from target accounts through the audit module. After verifying the target account's permissions, it queries the knowledge base for the target record summary list corresponding to the target project number and displays the target record summary list to the target account. This enables the function of querying technical records by project dimension. Compared to searching for technical records one by one by barcode, batch searching of technical records by project dimension improves the efficiency of record review and quality control.

[0082] Furthermore, inspectors can query the technical records of the corresponding project by entering the project number into the system. Compared to repeatedly searching through Excel files and then searching the knowledge base, which results in constant switching of the user interface, this can further improve inspection efficiency and provide a better user experience.

[0083] In clinical trial projects, information confidentiality and project access control are of paramount importance. The authorization module can meet the access control requirements and prevent leaks caused by auditors accidentally opening unrelated materials during audits.

[0084] In addition, this record quality control system allows customers to access technical records online, enabling multiple people to access the same technical record simultaneously without being limited by geographical location. This meets customers' needs for confidentiality and security when they need to access a large amount of laboratory technical data during business negotiations, project audits, and other stages.

[0085] refer to Figure 2 A structural block diagram of another recording quality control system according to an embodiment of the present invention is shown, such as... Figure 2 As shown, the record quality control system 20 may include: a raw record processing module 210, a public record processing module 220, an authorization module 230, an audit module 240, and a quality control report generation module 250.

[0086] The original record processing module 210 is used to determine the list of original record summaries to be recycled and to display the list of original record summaries to the quality control personnel, so as to prompt the quality control personnel to improve the original records corresponding to the original record summary list in the knowledge base.

[0087] The public record processing module 220 is used to determine the list of public record summaries to be processed.

[0088] Authorization module 230 is used to authorize project numbers based on the project number from the list of reclaimed original record summaries or the list of public record summaries. Authorization includes at least assigning account information that allows auditing the project number.

[0089] The audit module 240 is used to, when receiving an audit request containing a target project number initiated by a target account, query the target record summary list corresponding to the target project number in the knowledge base after completing the permission verification, and display the target record summary list to the target account.

[0090] The quality control report generation module 250 is used to generate a quality control plan, which includes target record identifiers and quality control points. Based on the target record identifiers, the module reads the corresponding target technical records and performs quality control on the target technical records according to the quality control points to generate a quality control report.

[0091] In this embodiment, to assist the quality control team in better quality control, the quality control system generates a quality control plan through the quality control report generation module 250. This plan includes target record identifiers, quality control points, etc. Then, the quality control report generation module 250 reads the corresponding target technical record based on the target record identifier, performs quality control on the target technical record according to the quality control points, generates a quality control report, and presents the report to the quality control personnel.

[0092] Among them, the key points of quality control can be the audit points that the quality control team pre-configures for each laboratory.

[0093] The quality control report can also be accessed by external clients.

[0094] For example, a quality control report may include the quality control project number, the extracted barcodes, and the problems found.

[0095] It can also automatically classify and statistically analyze the problems found, and provide inferences based on project characteristics, key points of inspection, key quality points, past experience, etc., and make further inspection suggestions or risk point opinions.

[0096] In a further embodiment, the quality control report generation module 250 is specifically used to: determine the risk level of each laboratory; determine the sampling ratio of each laboratory based on its risk level; determine the sampling quantity based on the sampling ratio; and determine the target record identifier corresponding to the laboratory from the knowledge base based on the sampling quantity.

[0097] Specifically, the system can pre-determine the risk level of each laboratory and set up a level-based sampling ratio correspondence table. The system then looks up the corresponding sampling ratio for each laboratory's risk level in the table. Based on this sampling ratio and the total number of records in the laboratory, the system determines the corresponding sampling quantity and randomly selects one or more target record identifiers from the total number of records corresponding to that laboratory in the knowledge base according to this sampling quantity.

[0098] In one embodiment, the quality control report generation module 250 can determine the risk level of each laboratory in the following manner: for each laboratory, determine the evaluation index value of the laboratory; calculate the risk assessment score of the laboratory based on the evaluation index value of the laboratory and the set weight; and determine the corresponding risk level based on the risk assessment score.

[0099] For example, the evaluation indicators include at least the project submission volume indicator, the management risk indicator, and the problem rectification efficiency indicator. Specifically, the project submission volume indicator reflects the laboratory's project submission volume evaluation score; the management risk indicator reflects the laboratory's management risk evaluation score; and the problem rectification efficiency indicator reflects the laboratory's problem rectification efficiency evaluation score.

[0100] In one embodiment, the quantity of samples submitted for testing can be determined in the following manner:

[0101] Determine the current laboratory's sample submission volume within a set time period; locate the sample submission volume for that project within multiple preset sample submission volume intervals, and determine the sample submission volume interval into which the sample submission volume falls as the target sample submission volume interval; obtain the interval score bound to the target sample submission volume interval, and use it as the sample submission volume index value.

[0102] In one implementation, the number of items submitted for inspection within a set time period can be synchronously obtained by the quality control recording system from a module or system used for recording the number of items submitted for inspection. Of course, the number of items submitted for inspection within the set time period can also be counted and entered into the quality control recording system by quality control personnel; this embodiment does not impose any restrictions on this.

[0103] The quality control system can pre-set multiple sample submission ranges, each with a corresponding score. After determining the sample submission volume of the current laboratory within a set time period, the sample submission volume range into which the sample submission volume falls can be identified as the target sample submission volume range, and the score of the target sample submission volume range can be used as the sample submission volume index value.

[0104] For example, assuming multiple sample submission ranges include [1, 5000], (5000, 10000], (10000, 20000], (20000, 50000], and greater than 50000, and assuming the sample submission quantity is represented by Q and the sample submission quantity index value is represented by S1, then the sample submission quantity index value S1 can be determined using the following formula:

[0105]

[0106] When Q falls into the first test quantity range, the test quantity index value is S1 equal to 1; when Q falls into the second test quantity range, the test quantity index value is S1 equal to 2, and so on.

[0107] In one embodiment, the management risk indicator value is determined as follows: obtain the current laboratory's operating system score and recording system score; and use the average of the operating system score and the recording system score as the management risk indicator value.

[0108] The operational system score reflects the degree of automation in the current laboratory; a higher degree of automation results in a higher score. Specifically, the operational system refers to the standardization of the testing process and the complexity of its technical implementation. According to regulations, the testing process should prioritize the use of high-precision automated instruments for data acquisition and analysis. By reducing manual intervention, it significantly improves the control of human error, the stability of test results, and repeatability—the core criteria for evaluating an excellent operational system. In other words, a higher degree of automation means less manual operation and lower risk. One implementation method involves pre-setting scoring rules, which quality control personnel use to score the operational system. For example, scoring rules could be as follows: "High degree of automation, few manual steps" receives 3-5 points; "Many manual steps, complex process" receives 1-2 points.

[0109] The record system score reflects the traceability of records; the higher the traceability, the higher the score. Specifically, a comprehensive evaluation mechanism can be established from three dimensions: data integrity, process standardization, and quality control effectiveness. A sound record system can cover the entire process of document management, including pre-test sample information registration, key parameter recording during testing, and post-test result verification. Through a systematic traceability mechanism, it ensures effective avoidance of quality risks caused by missing information or non-standard operations. In other words, the operation process needs specific audit tracking; if there is a record, it means the event occurred. The more complete and standardized the records, the higher the quality and the lower the risk. In one implementation, scoring rules can be pre-set, and quality control personnel can score the record system according to the scoring criteria to obtain a record system score. For example, the scoring rules are as follows: "Complete electronic source, standardized record" gets 3-5 points; "Disorganized record, no source" gets 1-2 points.

[0110] The management risk indicator value can be calculated using the following formula:

[0111] S2=(S 21 +S 22 ) / 2

[0112] Where S2 is the management risk indicator value, S 21 S is the score for the operational system. 22 To record the system score.

[0113] In one embodiment, the problem rectification efficiency index value can be determined in the following way:

[0114] Obtain the number of issues rectified and the number of issues discovered within the current laboratory time period, and use the ratio of the number of issues rectified to the number of issues discovered as the issue rectification efficiency; locate the issue rectification efficiency within multiple preset rectification efficiency intervals, and determine the rectification efficiency interval into which the issue rectification efficiency falls as the target rectification efficiency interval; obtain the interval score bound to the target rectification efficiency interval as the issue rectification efficiency index value.

[0115] In one implementation, the number of issues rectified and the number of issues discovered within a set time period can be synchronously obtained from other modules or systems by the quality control system. Of course, the number of issues rectified and the number of issues discovered within the set time period can also be counted and entered into the quality control system by quality control personnel; this embodiment does not impose any restrictions on this.

[0116] The ratio of the number of problems rectified to the number of problems discovered is used as the problem rectification efficiency, and the problem rectification efficiency index value is determined based on the problem rectification efficiency.

[0117] Specifically, the quality control system can pre-set multiple rectification efficiency intervals, each with a corresponding interval score. After determining the problem rectification efficiency, the rectification efficiency interval to which the problem rectification efficiency falls can be identified as the target rectification efficiency interval, and the interval score bound to the target rectification efficiency interval can be used as the problem rectification efficiency indicator value.

[0118] For example, assuming multiple rectification efficiency ranges include less than 60%, [60%, 69%], [70%, 79%], [80%, 89%], and [90%, 100%], and assuming the problem rectification efficiency is represented by E, and the problem rectification efficiency index value is represented by S3, then the problem rectification efficiency index value S3 can be determined using the following formula:

[0119]

[0120] When E falls into the first test volume range, the problem rectification efficiency index value S3 equals 1; when E falls into the second test volume range, the problem rectification efficiency index value S3 equals 2, and so on.

[0121] After obtaining the project's testing volume index, management risk index, and problem rectification efficiency index, these can be weighted and summed to obtain the current laboratory's risk assessment score.

[0122] That is, the current risk assessment score of the laboratory is calculated using the following formula:

[0123] T = S1*W1 + S2*W2 + S3*W3

[0124] Where T represents the current risk assessment score of the laboratory, and W1, W2, and W3 are the weights corresponding to the project's sample submission volume index, management risk index, and problem rectification efficiency index, respectively. W1, W2, and W3 can be pre-set weights or weights generated according to set dynamic update rules; this embodiment does not impose any restrictions on this. For example, W1, W2, and W3 can be set to 0.2, 0.4, and 0.4, respectively.

[0125] Once the current risk assessment score of the laboratory is obtained, the risk level corresponding to the current risk assessment score can be determined based on the correspondence between the score and the level set in the pre-screening.

[0126] This embodiment dynamically determines the risk level of each laboratory through the above method, thereby guiding the proportion of daily quality control spot checks, making the quality control objectives more aligned with the actual situation of the laboratories, and improving the flexibility of quality control.

[0127] In this embodiment, based on a regularly maintained knowledge base, the quality control system supports internal or external personnel in querying technical records by project dimension and quickly previewing them; it supports remote auditing by customers, allowing them to view only the relevant data by granting specific project permissions; it supports sharing technical materials externally during business negotiations, with shared documents watermarked to prevent leakage and subject to time-limited access; it supports exporting and analyzing data from internal teams, enabling the quality control team to quickly complete record quality control within the system and generate modular quality control reports for the team's reference, reducing the workload of manual quality control and improving quality control efficiency.

[0128] refer to Figure 3 A structural block diagram of another recording quality control system according to an embodiment of the present invention is shown, such as... Figure 3 As shown, the record quality control system 30 may include: an original record processing module 310, a public record processing module 320, an authorization module 330, an audit module 340, and a problem summary module 350.

[0129] The original record processing module 310 is used to determine the list of original record summaries to be recycled and display the list of original record summaries to the quality control personnel to prompt them to complete the original records corresponding to the original record summary list in the knowledge base.

[0130] The public record processing module 320 is used to determine the list of public record summaries to be processed.

[0131] Authorization module 330 is used to authorize project numbers based on the project number from the list of reclaimed original record summaries or the list of public record summaries. Authorization includes at least assigning account information that allows auditing the project number.

[0132] The audit module 340 is used to, when receiving an audit request containing a target project number initiated by a target account, query the target record summary list corresponding to the target project number in the knowledge base after completing the permission verification, and display the target record summary list to the target account.

[0133] The problem summary module 350 is used to display a problem interface while displaying the target technology record. When a problem is received from the user in the problem interface, the problem is summarized to form a problem list.

[0134] In this embodiment, the issue aggregation module 350 collects questions raised by users during project inquiries, forming an issue list, which is then periodically fed back to the quality control team. For example, the previous month's issue list can be automatically included in the next month's quality control report, allowing the quality control team to manually confirm answers and close the issues.

[0135] In a further embodiment, the quality control system may also include an AI question-and-answer module. Based on the question list collected by the question aggregation module 350, core fields such as testing indicators and medical indicators can be extracted, and then the AI ​​question-and-answer module can be generated based on these core fields. The AI ​​question-and-answer module can support questions and answers related to medical testing knowledge (e.g., if a user wants to monitor blood lipid levels, the AI ​​question-and-answer module will recommend which monitoring items to monitor? Should XX test be performed? What is the stability of XX test? etc.), and can fine-tune the general model using domain data to improve its understanding of professional fields. The system supports internal and external personnel to search and ask questions in the knowledge base.

[0136] In one implementation, the AI ​​question-answering module can adopt the following three-layer closed-loop architecture of "task-knowledge-feedback":

[0137] The data layer uses a combination of vector indexes and graph databases: vectors are responsible for semantic retrieval, while graph databases are responsible for the rapid association of complex relationships between "instruments-methods-standards-projects".

[0138] Access Control and Compliance: RBAC (Role-Based Access Control) dynamic permissions combined with API gateways meet the requirements of GLP (Good Laboratory Practice) / GCP (Good Clinical Practice) for data isolation and audit trails.

[0139] All original records, SOPs (Standard Operating Procedures), historical reports, and raw instrument data (exported from CDS (Chromatography Data System) and LIMS (Laboratory Information Management System)) in the laboratory undergo "data cleaning → metadata extraction → versioned storage".

[0140] The PDF SOP is directly parsed into structured fields (test criteria, acceptance standards, key parameters), reducing manual data entry.

[0141] Organize the decision-making logic of senior SD (Software Development), QA (Quality Assurance), and RA (Regulatory Affairs) into if-then rules or Prompt templates for use by large models.

[0142] Dual-engine mode: General model and industry-specific LoRA fine-tuning. The general model addresses language generalization, while LoRA is fine-tuned using over 100,000 pharmacopoeia entries in the CRO (Contract Research Organization) field, FDA (Food and Drug Administration) / EMA (European Medicine Agency) guidelines, and AOAC (Association of Official Agricultural Chemists) / ISO (International Organization for Standardization) standards to eliminate industry terminology bias.

[0143] Multi-channel recall: using keywords + semantics + knowledge base + online retrieval to ensure that regulatory updates, pharmacopoeia supplements, and the latest guidelines can be retrieved in real time and added to the knowledge base.

[0144] AI response model: NLP (Natural Language Processing) semantic similarity + manual sampling, retraining is triggered when both indicators fall below the threshold.

[0145] All external knowledge undergoes a "compliance filter" before being stored, and a trusted database is jointly built with regulatory agencies to ensure traceability of its source.

[0146] Figure 4 This is a flowchart illustrating the steps of a method for quality control using a record-keeping quality control system, as provided in this embodiment of the invention. Figure 4 As shown, this method can be executed by the aforementioned record quality control system and may include the following steps:

[0147] Step 410: Receive an audit request initiated by the target account. The audit request includes the target project number and the target record type.

[0148] Step 420: Search for the target project number in the knowledge base to obtain the authorized account corresponding to the target project number.

[0149] Step 430: If the authorized account is consistent with the target account, then search the knowledge base for the target record summary corresponding to the target record type under the target project number, and display the target record summary in the interface corresponding to the target record type.

[0150] Step 440: When a record viewing request initiated by the target account based on the target record summary is detected, the target technical record corresponding to the target record summary is read from the knowledge base and the target technical record is displayed.

[0151] For example, when the target technology record is an original record, the original record is displayed in the original record interface, and when the target technology record is a public record, the public record is displayed in the public record interface.

[0152] In one embodiment, when determining that the authorized account matches the target account, before searching the target record summary corresponding to the target record type under the target project number in the knowledge base, the method further includes:

[0153] If the current audit time is determined to be within the preset auditable period, then the authorization verification is considered complete.

[0154] In one embodiment, the record quality control system is connected to the reporting system; the method further includes:

[0155] Read a list of key record summaries from the reporting system;

[0156] Determine the list of reclaimed records summary;

[0157] Based on the key record summary list and the reclaimed record summary list, a list of original record summaries to be reclaimed is determined.

[0158] In one embodiment, the method further includes:

[0159] Read the list of public record files in the knowledge base, and generate a list of public record summaries to be processed based on the list of public record files.

[0160] In one embodiment, the method further includes:

[0161] Generate a quality control plan, which includes target record identifiers and key quality control points;

[0162] Read the corresponding target technical record according to the target record identifier, and perform quality control on the target technical record according to the quality control points to generate a quality control report.

[0163] In one embodiment, the target record identifier is determined in the following manner:

[0164] Determine the risk level of each laboratory;

[0165] The sampling rate for each laboratory is determined based on its stated risk level.

[0166] The sampling quantity is determined according to the sampling ratio.

[0167] The target record identifier corresponding to the laboratory is determined from the knowledge base based on the number of samples extracted.

[0168] In one embodiment, determining the risk level of each laboratory includes:

[0169] For each laboratory, determine the evaluation index values ​​for that laboratory;

[0170] The risk assessment score of the laboratory is calculated based on the assessment index values ​​and the set weights.

[0171] The corresponding risk level is determined based on the risk assessment score.

[0172] In one embodiment, the evaluation index values ​​include at least the project submission volume index value, management risk index value, and problem rectification efficiency index value;

[0173] The quantity of samples submitted for testing for the aforementioned project is determined using the following method:

[0174] Determine the current number of samples submitted for testing in the laboratory within the specified time period;

[0175] The quantity of the item to be submitted is located in a number of preset submission quantity ranges, and the submission quantity range in which the item submission quantity falls is determined as the target submission quantity range.

[0176] Obtain the interval score bound to the target test volume interval, and use it as the test volume index value of the project;

[0177] The management risk indicator values ​​are determined in the following manner:

[0178] Obtain the current laboratory's operation system score and record system score. The operation system score reflects the degree of automation in the current laboratory; the higher the degree of automation, the higher the operation system score. The record system score reflects the traceability of records; the higher the traceability, the higher the record system score.

[0179] The average of the operational system score and the recording system score is used as the management risk indicator value;

[0180] The efficiency index value for the rectification of the aforementioned problems is determined in the following manner:

[0181] The laboratory obtains the number of issues rectified and the number of issues discovered within a set time period, and uses the ratio of the number of issues rectified to the number of issues discovered as the issue rectification efficiency.

[0182] The rectification efficiency of the problem is located within a set of multiple rectification efficiency intervals, and the rectification efficiency interval into which the rectification efficiency of the problem falls is determined as the target rectification efficiency interval.

[0183] Obtain the interval score bound to the target rectification efficiency interval, and use it as the problem rectification efficiency index value.

[0184] In one embodiment, the method further includes:

[0185] While displaying the target technology record, a problem interface is also displayed. When a problem is received from the user in the problem interface, the problem is summarized to form a problem list.

[0186] This embodiment significantly improves the efficiency of internal and external personnel in accessing technical records, changing the working model where client audits could only be conducted on-site. It pioneers an online auditing approach, enabling clinical trial data and supporting original records to be accessed online anytime, anywhere. This change in working model allows laboratories to reduce manpower accompanying client audit activities, allowing clients to complete the process independently and improving their experience. Clients can also reduce travel expenses, and the frequency of audits can be greatly increased, from potentially once a year to once a quarter. This high-frequency project auditing allows for early detection and handling of issues, ensuring the quality of clinical trial project deliverables.

[0187] Figure 5 This is a schematic diagram of the structure of an electronic device provided by the present invention. The electronic device includes the recording quality control system described in the above embodiments, in addition to which, such as... Figure 5 As shown, the electronic device 101 includes at least one processor 11 and a memory, such as a read-only memory (ROM) 12 or a random access memory (RAM) 13, communicatively connected to the at least one processor 11. The memory stores computer programs executable by the at least one processor. The processor 11 can perform various appropriate actions and processes based on the computer program stored in the read-only memory (ROM) 12 or loaded from storage unit 18 into the random access memory (RAM) 13. The RAM 13 can also store various programs and data required for the operation of the electronic device 101. The processor 11, ROM 12, and RAM 13 are interconnected via a bus 14. An input / output (I / O) interface 15 is also connected to the bus 14.

[0188] Multiple components in electronic device 101 are connected to I / O interface 15, including: input unit 16, such as keyboard, mouse, remote control, etc.; output unit 17, such as various types of displays, speakers, etc.; storage unit 18, such as disk, optical disk, etc.; and communication unit 19, such as network card, modem, wireless transceiver, etc. Communication unit 19 allows electronic device 101 to exchange information / data with other devices through computer networks such as the Internet and / or various telecommunications networks.

[0189] Processor 11 can be a variety of general-purpose and / or special-purpose processing components with processing and computing capabilities. Some examples of processor 11 include, but are not limited to, central processing unit (CPU), graphics processing unit (GPU), various special-purpose artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, digital signal processors (DSPs), and any suitable processor, controller, microcontroller, etc. Processor 11 performs the various methods and processes described above, such as a method for quality control using an application record quality control system.

[0190] In some embodiments, a method for quality control using an application recording quality control system may be implemented as a computer program tangibly contained in a computer-readable storage medium, such as storage unit 18. In some embodiments, part or all of the computer program may be loaded and / or installed on electronic device 101 via ROM 12 and / or communication unit 19. When the computer program is loaded into RAM 13 and executed by processor 11, one or more steps of the method for quality control using an application recording quality control system described above may be performed. Alternatively, in other embodiments, processor 11 may be configured to perform a method for quality control using an application recording quality control system by any other suitable means (e.g., by means of firmware).

[0191] Various embodiments of the systems and techniques described above herein can be implemented in digital electronic circuit systems, integrated circuit systems, field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), application-specific standard products (ASSPs), systems-on-a-chip (SoCs), payload-programmable logic devices (CPLDs), computer hardware, firmware, software, and / or combinations thereof. These various embodiments may include implementations in one or more computer programs that can be executed and / or interpreted on a programmable system including at least one programmable processor, which may be a dedicated or general-purpose programmable processor, capable of receiving data and instructions from a storage system, at least one input device, and at least one output device, and transmitting data and instructions to the storage system, the at least one input device, and the at least one output device.

[0192] Computer programs used to implement the methods of the present invention may be written in any combination of one or more programming languages. These computer programs may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device, such that when executed by the processor, the computer programs cause the functions / operations specified in the flowcharts and / or block diagrams to be performed. The computer programs may be executed entirely on a machine, partially on a machine, or as a standalone software package, partially on a machine and partially on a remote machine, or entirely on a remote machine or server.

[0193] In the context of this invention, a computer-readable storage medium can be a tangible medium that may contain or store a computer program for use by or in conjunction with an instruction execution system, apparatus, or device. A computer-readable storage medium may include, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatus, or devices, or any suitable combination thereof. Alternatively, a computer-readable storage medium may be a machine-readable signal medium. More specific examples of machine-readable storage media include electrical connections based on one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fibers, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof.

[0194] To provide interaction with a user, the systems and techniques described herein can be implemented on an electronic device having: a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user; and a keyboard and pointing device (e.g., a mouse or trackball) through which the user provides input to the electronic device. Other types of devices can also be used to provide interaction with the user; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form (including sound input, voice input, or tactile input).

[0195] The systems and technologies described herein can be implemented in computing systems that include backend components (e.g., as data servers), middleware components (e.g., application servers), or frontend components (e.g., user computers with graphical user interfaces or web browsers through which users can interact with implementations of the systems and technologies described herein), or any combination of such backend, middleware, or frontend components. The components of the system can be interconnected via digital data communication of any form or medium (e.g., communication networks). Examples of communication networks include local area networks (LANs), wide area networks (WANs), blockchain networks, and the Internet.

[0196] A computing system can include clients and servers. Clients and servers are generally located far apart and typically interact through communication networks. The client-server relationship is created by computer programs running on the respective computers and having a client-server relationship with each other. The server can be a cloud server, also known as a cloud computing server or cloud host, which is a hosting product within the cloud computing service system to address the shortcomings of traditional physical hosts and VPS services, such as high management difficulty and weak business scalability.

[0197] In one embodiment, the present invention further includes a computer program product, which includes a computer program that, when executed by a processor, implements a method for quality control using an application record quality control system according to any embodiment of the present invention.

[0198] In the implementation of a computer program product, computer program code for performing the operations of this invention can be written in one or more programming languages ​​or a combination thereof. Programming languages ​​include object-oriented programming languages ​​as well as conventional procedural programming languages. The program code can be executed entirely on the user's computer, partially on the user's computer, as a standalone software package, partially on the user's computer and partially on a remote computer, or entirely on a remote computer or server. In cases involving remote computers, the remote computer can be connected to the user's computer via any type of network—including a local area network (LAN) or a wide area network (WAN)—or can be connected to an external computer (e.g., via the Internet using an Internet service provider).

[0199] It should be understood that the various forms of processes shown above can be used, with steps reordered, added, or deleted. For example, the steps described in this invention can be executed in parallel, sequentially, or in different orders, as long as the desired result of the technical solution of this invention can be achieved, and this is not limited herein.

[0200] The specific embodiments described above do not constitute a limitation on the scope of protection of this invention. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this invention should be included within the scope of protection of this invention.

Claims

1. A record quality control system for use in a clinical trial center laboratory, characterized in that, The record quality control system is connected to a pre-created knowledge base, which stores technical records of one or more record types that have undergone standardization. The record types include original records and public records. The original records refer to original production technical records with unique identifiers, and the public records refer to public technical records without such unique identifiers. Each of the aforementioned technical records is pre-marked with a corresponding project number; The record quality control system includes: an original record processing module, a public record processing module, an authorization module, and an audit module; The original record processing module is used to determine the list of original record summaries to be recycled and to display the list of original record summaries to the quality control personnel, so as to prompt the quality control personnel to improve the original records corresponding to the original record summary list in the knowledge base; The public record processing module is used to determine the list of public record summaries to be processed; The authorization module is used to authorize a project number based on the project number from the list of recovered original record summaries or the list of public record summaries. The authorization includes at least assigning account information that can audit the project number. The audit module is used to, upon receiving an audit request containing a target project number initiated by a target account, query the target record summary list corresponding to the target project number in the knowledge base after completing the permission verification, and display the target record summary list to the target account.

2. The recording quality control system according to claim 1, characterized in that, The audit module is also used for: When a record viewing request initiated by the target account based on the target record summary is detected, the target technical record corresponding to the target record summary is read from the knowledge base and displayed. When the target technical record is an original record, the original record is displayed in the original record interface, and when the target technical record is a public record, the public record is displayed in the public record interface.

3. The recording quality control system according to claim 1 or 2, characterized in that, The authorization also includes assigning auditable time periods to the project number; the audit module is specifically used for: Search the knowledge base for the target project number to obtain the authorized account corresponding to the target project number; If the authorized account is the same as the target account and the current audit time is within the auditable period, then the permission verification is considered complete.

4. The recording quality control system according to claim 1, characterized in that, The record quality control system is connected to the reporting system; the raw record processing module is specifically used for: Read a list of key record summaries from the reporting system; Determine the list of reclaimed records summary; Based on the key record summary list and the reclaimed record summary list, a list of original record summaries to be reclaimed is determined.

5. The recording quality control system according to claim 1, 2, or 4, characterized in that, The public record processing module is specifically used for: Read the list of public record files in the knowledge base, and generate a list of public record summaries to be processed based on the list of public record files.

6. The recording quality control system according to claim 1, 2, or 4, characterized in that, The record quality control system establishes a connection with the pre-created knowledge base through a NAS interface. The NAS interface is used to back up the knowledge base to a third-party cloud platform according to a set period and retain the path structure. The record quality control system obtains the path through the API of the third-party cloud platform.

7. The recording quality control system according to claim 1, characterized in that, The record quality control system also includes: The quality control report generation module is used to generate a quality control plan, which includes a target record identifier and quality control points. The module reads the corresponding target technical record according to the target record identifier and performs quality control on the target technical record according to the quality control points to generate a quality control report.

8. The recording quality control system according to claim 7, characterized in that, The quality control report generation module is specifically used for: Determine the risk level of each laboratory; The sampling rate for each laboratory is determined based on its stated risk level. The sampling quantity is determined according to the sampling ratio. The target record identifier corresponding to the laboratory is determined from the knowledge base based on the number of samples extracted.

9. The recording quality control system according to claim 8, characterized in that, The quality control report generation module determines the risk level of each laboratory in the following manner: For each laboratory, determine the evaluation index values ​​for that laboratory; The risk assessment score of the laboratory is calculated based on the assessment index values ​​and the set weights. The corresponding risk level is determined based on the risk assessment score.

10. The record quality control system according to claim 9, wherein the evaluation index values ​​include at least the project submission quantity index value, management risk index value, and problem rectification efficiency index value; The quantity of samples submitted for testing for the aforementioned project is determined using the following method: Determine the current number of samples submitted for testing in the laboratory within the specified time period; The quantity of the item to be submitted is located in a number of preset submission quantity ranges, and the submission quantity range in which the item submission quantity falls is determined as the target submission quantity range. Obtain the interval score bound to the target test volume interval, and use it as the test volume index value of the project; The management risk indicator values ​​are determined in the following manner: Obtain the current laboratory's operational system score and record system score, among which, The operational system score reflects the degree of automation in the current laboratory; the higher the degree of automation, the higher the operational system score. The record system score is used to reflect the traceability of records; the higher the traceability, the higher the record system score. The average of the operational system score and the recording system score is used as the management risk indicator value; The efficiency index value for the rectification of the aforementioned problems is determined in the following manner: The laboratory obtains the number of issues rectified and the number of issues discovered within a set time period, and uses the ratio of the number of issues rectified to the number of issues discovered as the issue rectification efficiency. The rectification efficiency of the problem is located within a set of multiple rectification efficiency intervals, and the rectification efficiency interval into which the rectification efficiency of the problem falls is determined as the target rectification efficiency interval. Obtain the interval score bound to the target rectification efficiency interval, and use it as the problem rectification efficiency index value.

11. The recording quality control system according to claim 2, characterized in that, The record quality control system also includes: The problem summary module is used to display a problem interface while showing the target technology record. When a problem is received from the user in the problem interface, the problem is summarized to form a problem list.

12. A method for quality control using the record quality control system according to any one of claims 1-11, characterized in that, The method includes: Receive an audit request initiated by the target account, the audit request including the target project number and the target record type; Search the knowledge base for the target project number to obtain the authorized account corresponding to the target project number; If the authorized account is the same as the target account, then the target record summary corresponding to the target record type under the target project number is retrieved from the knowledge base, and the target record summary is displayed in the interface corresponding to the target record type; When a record viewing request initiated by the target account based on the target record summary is detected, the target technical record corresponding to the target record summary is read from the knowledge base and the target technical record is displayed.

13. An electronic device, characterized in that, The electronic device includes: At least one processor; and A memory communicatively connected to the at least one processor; wherein, The memory stores a computer program that can be executed by the at least one processor to enable the at least one processor to perform the method of claim 12.

14. A computer-readable storage medium, characterized in that, The computer-readable storage medium stores computer instructions that cause a processor to execute the method of claim 12.

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