Quality demand analysis method applied to pharmaceutical enterprise data
By classifying the data sources of pharmaceutical companies and configuring the data and templates of the annual quality review report, the problem of low efficiency and difficulty in ensuring the accuracy of the annual quality review report is solved, and efficient and accurate report production is achieved.
Patent Information
- Application Number
- CN202411549380.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-01
- Publication Date
- 2025-01-21
AI Technical Summary
The production of annual quality review reports in the prior art is inefficient and the accuracy of the reports is difficult to guarantee.
By classifying and storing pharmaceutical company data sources, and configuring the data and report templates for annual quality review reports, data acquisition time is reduced, report writing efficiency is improved, and the accuracy of the report is ensured through multiple reviews.
It improves the production efficiency of annual quality review reports, ensures the accuracy of reports, and reduces data acquisition time and report writing workload.
Smart Images
Figure CN119337854A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of quality requirement analysis, and in particular to a quality requirement analysis method applied to pharmaceutical enterprise data. Background Art
[0002] In the production process of pharmaceutical companies, in order to ensure the reliability of product quality, it is usually necessary to strictly monitor the quality of the drugs produced during the production process. According to the relevant provisions of the "Good Manufacturing Practice for Pharmaceuticals", pharmaceutical companies should follow the operating procedures during the production process and conduct product quality review and analysis of all drugs produced by type every year to confirm the stability and reliability of the process, as well as the applicability of the current quality standards of raw materials, excipients and finished products, to promptly discover adverse trends and determine the direction of product and process improvement. Historical data from previous review and analysis should be considered, and the effectiveness of product quality review and analysis should also be self-checked. Therefore, each pharmaceutical company needs to regularly prepare and submit an annual quality review report.
[0003] The preparation of annual quality review reports usually includes test report collection, test report calibration, statistical analysis, and annual quality review report writing. With the increasing popularity of computer technology, pharmaceutical companies usually use tools such as EXCEL / Minitab in computers to perform statistical analysis on test reports in order to improve the efficiency of preparing product quality review analysis reports during the production process, thereby reducing the amount of calculation and data analysis complexity in the preparation of annual quality review reports.
[0004] However, in the process of making the annual quality review report, the number of reports generated by each pharmaceutical company during the production process is usually large, and the test data is scattered, which makes it difficult to collect and organize the test reports, resulting in a lot of time spent on making the annual quality review report, which increases the production time of the annual quality review report. In addition, when writing the annual quality review report, the data, analysis charts and reports required are usually scattered, and these contents need to be collected and organized during the writing process, which further increases the production time of the annual quality review report and reduces the production efficiency of the annual quality review report; and in the writing process, in order to ensure the accuracy of the annual quality review report, some indicator data need to be recalculated and checked, which increases the complexity of writing the annual quality review report, and the multiple calculations and checks of data indicators make it easy for the indicator data required for the annual quality review report to be modified multiple times, making it difficult to ensure the accuracy of the written annual quality review report. Summary of the invention
[0005] The present invention aims to provide a quality requirement analysis method applied to pharmaceutical company data to solve the technical problems in the prior art that the production efficiency of the annual quality review report is low and the accuracy of the annual quality review report is difficult to ensure.
[0006] To achieve the above object, the present invention adopts the following technical solution: a quality requirement analysis method applied to pharmaceutical enterprise data, comprising the following steps: Step 1: annual quality review report requirement configuration; the annual quality review report requirement configuration includes data configuration of the annual quality review report and report template configuration of the annual quality review report; Wherein, in step 1, when configuring the data of the annual quality review report, the data source information is configured according to the information of the annual quality review report; the data source classifies each data according to the classification information of the pharmaceutical company's product categories, and stores multiple data independently; Step 2: Compile the content of the annual quality review report according to the data configuration and report template configuration of the annual quality review report in step 1; In step 2, when the annual quality review report is written, the data required for the annual quality review report is analyzed according to the data in the data set generated in step 1 to obtain analytical data, and the obtained analytical data is reviewed; Step 3: Review the contents of the annual quality review report prepared in step 2 and generate an annual quality review report file.
[0007] Compared with the prior art, in this solution, when preparing the annual quality review report, by classifying and storing the data sources, it is only necessary to obtain relevant data from the corresponding data source when preparing the annual quality review report, avoiding the need to retrieve relevant data from all the data of the pharmaceutical company in the annual quality review report, reducing the time for data acquisition in the process of preparing the annual quality review report, and improving the efficiency of preparing the annual quality review report; and in the process of writing the annual quality review report, the analyzed data is analyzed after the data is analyzed, avoiding errors in the analyzed data, resulting in the need to modify the written annual quality review report multiple times, and increasing the workload of writing the annual quality review report.
[0008] Preferably, as an improvement, in step 1, after obtaining the required data from the configured data source, the obtained data is stored as a data set corresponding to the annual quality review report. This allows the number of accesses to the data source and output transmissions to be reduced during the production of the annual quality review report, ensuring the smoothness of the data source connection line, and ensuring that the data source can be efficiently accessed and data can be obtained during the production of the annual quality review report for multiple products; while the required data is stored in the data set near the end of the annual quality review report, the convenience of querying and obtaining specific data during the production of the annual quality review report is improved, and data acquisition during the data analysis process when the annual quality review report is produced is facilitated.
[0009] Preferably, as an improvement, in step 1, the configured report template is also submitted for review. If the configured report template fails the review, the report template is reselected and configured according to the review result. After the report template is configured, the configured report template is first reviewed to ensure the accuracy of the configured report template and avoid defects or errors in the configured report template, which may affect the quality of the report template.
[0010] Preferably, as an improvement, the existing report templates are updated and upgraded according to the report templates reconfigured after the review, so that the quality of the existing report templates can match the actual needs, avoiding the need to configure and modify multiple report templates multiple times when making the annual quality review report in the future, and improving the production efficiency of the annual quality review report.
[0011] Preferably, as an improvement, in step 2, when compiling the annual quality review report, an annual quality review report instance is created and generated according to the report template configured in step 1.
[0012] Preferably, as an improvement, the report chapters are divided according to the content of the generated annual quality review report instance; and the divided chapters are grouped, and the writing work is carried out simultaneously in each group. By grouping the chapters in the annual quality review report, the content of multiple chapters of the annual quality review report can be written simultaneously in multiple threads, thereby improving the writing efficiency of the annual quality review report. And by grouping the chapter content, the relevant content in the annual quality review report can be divided into the same writing work, ensuring the relevance of the writing of the relevant content.
[0013] Preferably, as an improvement, when compiling the content of each group, after the analysis data is reviewed and approved, the specific content of each group of the annual quality review report is compiled according to the specific content of the analysis data. By reviewing the content of the analyzed data after the data analysis, and using the data after the data review is passed, the accuracy of the data used in the compilation of the annual quality review report is guaranteed, and it is avoided that the analyzed data is reviewed after the compilation of the annual quality review report is completed, resulting in the need to modify the analyzed data, and the content of the compiled annual quality review report needs to be adjusted accordingly, so as to ensure the compilation efficiency of the annual quality review report.
[0014] Preferably, as an improvement, in step three, when the annual quality review report is reviewed, the content written according to the division of each group in step two is reviewed, and when the content of each group is reviewed and passed, the annual quality review report is generated according to the report template in step one. The accuracy of the annual quality review report is ensured by reviewing the content of each chapter after the grouping of the annual quality review report. The annual quality review report is generated after each chapter of the written annual quality review report is reviewed and passed, so as to ensure the accuracy of the content of the generated annual quality review report.
[0015] Preferably, as an improvement, after the annual quality review report is generated, the generated annual quality review report is reviewed as a whole. After the annual quality review report is generated, the report content is reviewed again to ensure the overall quality of the generated annual quality review report, and to avoid insufficient cohesion and relevance between chapters due to simultaneous writing in groups during the writing process, which affects the overall quality of the annual quality review report. BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Figure 1 This is a flowchart of the quality requirement analysis method for pharmaceutical company data in an embodiment of the present invention. DETAILED DESCRIPTION
[0017] The following is further described in detail through specific implementation methods: As attached Figure 1 As shown in the figure, the quality requirement analysis method applied to pharmaceutical enterprise data includes the following steps: Step 1: Configure the requirements for the annual quality review report; the annual quality review report requirements configuration includes configuring the data for the annual quality review report and the report template for the annual quality review report.
[0018] In step one, when configuring the data required for the annual quality review report, first configure the data source information according to the product information of the annual quality review report, so that the data required for the annual quality review report can be obtained from the specified data source. When storing each data source, the data source classifies and processes each data according to the category classification information of the pharmaceutical company's products, so that the data source can independently store multiple data according to the category classification information; the data source of each type of data can be the manual entry of pharmaceutical company data, the import of existing data, and third-party data source adapters and other channels. After the classified data is imported according to each channel, the source data is sorted according to the data storage specification, so that the imported data can be stored in the data source in an orderly manner. The specific content of the data source storage and data sorting is the existing technology, which will not be repeated here. By classifying and storing data of different product types as multiple data sources when storing data, when it is necessary to obtain data for the quality review report of related products during the preparation of the annual quality review report, the data can be quickly obtained according to the classified data sources, thereby improving the efficiency of data acquisition when preparing the annual quality review report; and by storing data through multiple data sources, when preparing the annual quality review report, the data transmission volume of a single data source can be reduced, the data transmission volume of the data transmission line can be reduced, and smooth data transmission can be ensured while reducing the pressure in the data source data query and acquisition process, thereby avoiding the data source being in high-load operation for a long time, resulting in a shortened life of the data source equipment.
[0019] When acquiring the data required for the annual quality review report, the required specific data information is acquired from the configured data source, and the acquired data is stored as the data set corresponding to the annual quality review report. In the process of making the annual quality review report, the number of accesses to the data source and the output transmission times can be reduced, the smoothness of the data source connection line can be ensured, and the data source can be efficiently accessed and data can be acquired in the process of making the annual quality review report for multiple products; the required data is stored in the data set near the end of the annual quality review report, which improves the convenience of querying and acquiring specific data in the process of making the annual quality review report, and facilitates data acquisition in the data analysis process when making the annual quality review report. In addition, only the relevant information of the annual quality review report is stored in the data set, so that in the process of the annual quality review report, only the specific data required for a single time needs to be acquired from the relevant information, which improves the efficiency of data retrieval in the process of making the annual quality review report, avoids the need to retrieve the required specific data from a large amount of data in the annual quality review report, and improves the convenience of making the annual quality review report.
[0020] In step one, when configuring the report template in the annual quality review report requirement, select the corresponding report template according to the content of the annual quality review report to be written, and configure the report template according to the specific content of the annual quality review report, wherein when configuring the report template, the corresponding parameters in the report template can be adjusted according to the product type of the annual quality review report, so that the actual situation of the report template can match the type of the annual quality review report, wherein the configuration content and configuration method of the report template are prior art and will not be repeated here. Wherein, when managing the report template, the required report content is classified according to different types of products and report content, and the corresponding report template is prepared for the report of this type. Wherein, when classifying, it can be classified according to the type of product, production line, and the type of report content. By configuring the report template, the annual quality review report produced can match the specific content of the report, improve the fit between the report content and the template content, and ensure the quality of the annual quality review report produced.
[0021] In step 1, the configured report template is submitted for review, and the relevant staff reviews the configured report template. When the configured report template passes the review, the configured report template is processed for the next step. If the configured report template fails the review, the report template is reselected and configured according to the review result. After the report template is configured, the configured report template is first reviewed to ensure the accuracy of the configured report template and avoid defects or errors in the configured report template, which may affect the quality of the report template.
[0022] In step 1, the existing report template is also updated and upgraded according to the report template that is reconfigured after the audit fails. By updating and upgrading the existing report template based on the content of the reconfigured report template, the quality of the existing report template can match the actual needs, avoiding the need to configure and modify multiple report templates multiple times when making the annual quality review report in the future, thereby improving the production efficiency of the annual quality review report.
[0023] Step 2: According to the data configuration and report template configuration of the annual quality review report in step 1, the content of the annual quality review report is written; specifically, when writing the annual quality review report, create and generate an annual quality review report instance according to the report template configured in step 1, and divide the report chapters according to the content of the generated annual quality review report instance; and when writing the annual quality review report, group the chapters according to the content relevance of each chapter, and write the work of each group synchronously. When dividing the chapters of the annual quality review report, the chapters can be divided and grouped according to the content of the report template, wherein the specific content of dividing the chapters of the annual quality review report and grouping the divided chapters is the prior art, which will not be repeated here. By grouping the chapters of the annual quality review report, the content of multiple chapters of the annual quality review report can be written in multiple threads at the same time, thereby improving the writing efficiency of the annual quality review report. And by grouping the chapter content, the relevant content in the annual quality review report can be divided into the same writing work, ensuring the relevance of the writing of the relevant content.
[0024] In step two, when writing the annual quality review report, the data required for the annual quality review report is analyzed according to the data in the data set generated in step one to obtain analytical data. Specifically, when analyzing the data, the corresponding data analysis model is selected according to different data analysis types and dimensions, and the corresponding data is analyzed by the data analysis model according to the data analysis requirements. When analyzing the data, the data analysis model also generates chart results of the data analysis results (such as trend charts, pie charts, bar charts, etc.) according to the dimensions of the data analysis. The specific content of analyzing the data through the data analysis model is the existing technology and will not be described in detail here. When acquiring and analyzing the data, the data required for each chapter is synchronously acquired according to the divided chapter contents. The specific content of acquiring and analyzing the data of the data set is the existing technology and will not be described in detail here.
[0025] The analysis data obtained after the analysis is reviewed, and the relevant staff reviews the relevance of the analysis data to the annual quality report and the accuracy of the analysis results. When the analysis data is reviewed and approved, the specific contents of each chapter of the annual quality review report are written according to the specific contents of the analysis data. When writing the specific contents of each chapter of the annual quality review report, the specific contents in the report template are modified according to the data analysis results of the data analysis model through the data results analyzed in step 2 or the generated chart results, and the chapter content is generated in combination with the generated chart results. The specific steps of generating the report content according to the data analysis results and the report template content are prior art and will not be repeated here. When the analysis data review fails, the data is re-analyzed according to the review feedback content. By reviewing the analyzed data content after the data analysis, and using the data after the data review is passed, the accuracy of the data used in the writing of the annual quality review report is guaranteed, and the analyzed data is reviewed after the writing of the annual quality review report is completed. When the analyzed data needs to be modified, the content of the written annual quality review report needs to be adjusted accordingly to ensure the writing efficiency of the annual quality review report.
[0026] Step 3: Annual quality review report review. When the content of the annual quality review report passes the review, an annual quality review report file is generated. When the content of the annual quality review report fails the review, the review result is sent to step 2. Step 2 modifies the content of the annual quality review report based on the review result.
[0027] Wherein, in step three, when reviewing the annual quality review report, first review the contents written according to the chapters and groups divided in step two. When the contents of each chapter or group are reviewed and approved, the annual quality review report is generated according to the report template for the reviewed contents of each chapter, and the generated annual quality review report is reviewed. When some chapters or distributions in each chapter or group are not reviewed and approved, the review results are fed back to step two, and step two modifies the corresponding chapter or group content according to the review results. Wherein, when reviewing each chapter or group, the specific contents such as the written text description and chart content of each chapter can be reviewed; when reviewing the generated annual quality review report, the assembly of each chapter, the completeness of the content and other information can be reviewed. Wherein, the specific contents of the review of each chapter or group and the generated annual quality review report are not in the prior art, and will not be repeated here. By reviewing the chapters of the annual quality review report and the generated report content separately, the accuracy of the annual quality review report is ensured. After the chapters of the annual quality review report are reviewed and approved, the annual quality review report is generated to ensure the accuracy of the content of the generated annual quality review report. This avoids the need to modify the content of each chapter after the annual quality review report is generated, resulting in the need to generate the annual quality review report twice, which increases the complexity of the annual quality review report production and ensures the production efficiency of the annual quality review report.
[0028] In step three, after the generated annual quality review report file is reviewed and approved, the annual quality review report file can also be shared. Specifically, when sharing the annual quality review report file, the annual quality review report file is generated into PDF, HTML and other easy-to-view files for sharing, so that the generated annual quality review report can be more conveniently sent to relevant personnel for browsing or use, thereby improving the convenience of viewing or using the generated annual quality review report.
[0029] Compared with the prior art, in this solution, when making the annual quality review report, by classifying and storing the data sources, it is only necessary to obtain relevant data from the corresponding data sources when making the annual quality review report, avoiding the need to retrieve and obtain relevant data from all the data of the pharmaceutical company in the annual quality review report, reducing the time for data acquisition in the process of making the annual quality review report, and improving the production efficiency of the annual quality review report; and in the process of writing the annual quality review report, after analyzing the data, the analyzed data is analyzed to avoid errors in the analyzed data, resulting in the need to modify the written annual quality review report for many times, increasing the workload of writing the annual quality review report. And in this solution, by reviewing the report template, analysis data, writing content and generated report for many times in the process of writing the annual quality review report, the accuracy of each step in the process of making the annual quality review report is ensured, which is convenient for the smooth development of the next step of the annual quality review report, avoiding the need to modify and adjust the content of the relevant steps in the production process, resulting in the need for a large number of adjustments to the content of the subsequent steps, and increasing the steps and workload of the annual quality review report; and improving the production efficiency of the annual quality review report while ensuring the efficiency of the produced annual quality review report.
[0030] It should be pointed out that for those skilled in the art, several modifications and improvements can be made without departing from the technical solution of the present invention, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The protection scope required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.
Claims
1. The quality requirement analysis method applied to pharmaceutical enterprise data is characterized by: The following steps are involved: Step 1: annual quality review report requirement configuration; the annual quality review report requirement configuration includes data configuration of the annual quality review report and report template configuration of the annual quality review report; Wherein, in step 1, when configuring the data of the annual quality review report, the data source information is configured according to the information of the annual quality review report; the data source classifies each data according to the classification information of the pharmaceutical company's product categories, and stores multiple data independently; Step 2: Compile the content of the annual quality review report according to the data configuration and report template configuration of the annual quality review report in step 1; In step 2, when the annual quality review report is written, the data required for the annual quality review report is analyzed according to the data in the data set generated in step 1 to obtain analytical data, and the obtained analytical data is reviewed; Step 3: Review the contents of the annual quality review report prepared in step 2 and generate an annual quality review report file.
2. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 1 is characterized by: In step one, after obtaining the required data from the configured data source, the obtained data is stored as a data set corresponding to the annual quality review report.
3. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 1 is characterized by: In step one, the configured report template is also submitted for review. If the configured report template fails the review, the report template is reselected and configured based on the review result.
4. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 3 is characterized by: Update and upgrade the existing report templates based on the reconfigured report templates after review.
5. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 1 is characterized by: In step 2, when compiling the annual quality review report, an annual quality review report instance is created and generated according to the report template configured in step 1.
6. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 5 is characterized by: The report chapters are divided according to the content of the generated annual quality review report example; the divided chapters are grouped and each group carries out writing work simultaneously.
7. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 6 is characterized by: When compiling the contents of each group, after the analysis data is reviewed and approved, the specific contents of each group of the annual quality review report will be compiled based on the specific contents of the analysis data.
8. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 6 is characterized by: In step three, when reviewing the annual quality review report, the content written by each group divided in step two is reviewed. When the content of each group is reviewed and passed, the annual quality review report is generated based on the report template in step one.
9. The quality requirement analysis method applied to pharmaceutical enterprise data according to claim 8 is characterized by: After the annual quality review report is generated, the entire report will be reviewed.