Generation method, management method and management system of controlled file template

Abstract

The invention discloses a generation method, a management method and a management system for a controlled file template, and relates to the technical field of file management.The management method comprises the following steps that the controlled file template is generated through an approval process, and one or more applicable personnel are arranged in the controlled file template; an authority for receiving the controlled file template is configured for the applicable personnel; the controlled file template is sent to each applicable person, the applicable person sends a file use request after receiving the controlled file template, any one or more pieces of assessment data in the assessment database are extracted, the extracted assessment data are sent to the applicable person sending the file use request, and if the applicable person passes the assessment, the application person sends out the file use request; if yes, the permission of using the controlled file template is obtained, and otherwise, the applicable personnel cannot use the controlled file template.

Description

[0001] This application is a divisional application of the invention patent application with Chinese patent application number 202310377699.2, application date April 11, 2023, and invention name “A method for generating, managing and managing a controlled document template”. Technical Field

[0002] The present invention relates to the technical field of file management, and in particular to a generation method, a management method and a management system for a controlled file template. Background Art

[0003] The business scope of pharmaceutical companies includes laboratory research and development (GLP), clinical trials (GCP) and production preparation (GMP). Compared with other industries, the documents generated in the process of pharmaceutical laboratory research and development, clinical trials and production preparation are the core assets of pharmaceutical companies. Pharmaceutical companies have more stringent control requirements on the management and use of such documents to ensure the security of documents and avoid the abuse of documents;

[0004] The available file templates of the currently used OA / project management systems are generally uploaded directly by the administrator in the background, and do not have a file approval and effectiveness process, and cannot guarantee the security and correctness of the files. Although the software systems suitable for the pharmaceutical industry have a certain degree of file approval and control, they lack control over users, and there is a possibility that files may be used by inappropriate personnel. Summary of the invention

[0005] The technical problem to be solved by the present invention is to control such files and the people who use such files, so that both the files and the users are under control, thereby improving the security of the files. The purpose is to provide a method for generating, managing and managing a controlled file template.

[0006] The present invention is achieved through the following technical solutions:

[0007] A first aspect provides a method for managing a controlled document template, comprising the following steps:

[0008] A controlled document template is generated through the approval process, wherein one or more applicable personnel are set in the controlled document template, and the applicable personnel are configured with the authority to receive the controlled document template;

[0009] The above-mentioned controlled document template is sent to each applicable person. After receiving the controlled document template, the above-mentioned applicable person issues a file use request, extracts any one or more assessment data from the assessment database, and sends the extracted assessment data to the applicable person who issued the file use request. If the applicable person passes the assessment, he / she obtains the authority to use the controlled document template, otherwise the applicable person shall not use the controlled document template.

[0010] The above-mentioned controlled document template is generated through an approval process, so that the controlled document template can be managed and controlled during the generation process. The above-mentioned controlled document template is set with corresponding applicable personnel. No one except the applicable personnel can receive the controlled document template. A screening mechanism is further set up based on the applicable personnel. Applicable personnel who pass the screening can open the use rights of the controlled document template. Applicable personnel who fail the screening need to be re-assessed and screened until the assessment is passed before they can open the use rights of the controlled document template. Otherwise, the controlled document template cannot be used. The controlled document template is used within the minimum authority scope to prevent file loss or damage during offline management, which also improves the quality of personnel using the controlled document template, reduces the risk of abuse of the controlled document template, and improves the security of the file, meets the controlled management process of document data and personnel training that pharmaceutical companies regard as core assets in the pharmaceutical industry, and at the same time prevents competitors or potential competitors from copying similar technologies to form unhealthy competition.

[0011] Furthermore, after the controlled document template is generated through the approval process, a training course will be compiled and sent to each applicable person, and the above-mentioned applicable person will study after receiving the training course.

[0012] The above-mentioned training tutorials and controlled document templates are sent to applicable personnel, so that applicable personnel have the potential conditions to open the permission to use the controlled document template. Applicable personnel generally do not have the ability to use the controlled document template when they first receive it, and need training and learning to understand and know how to use the controlled document template.

[0013] Furthermore, after the controlled document template is generated through the approval process, a plurality of assessment data and reference data will be compiled, each of the above assessment data will be associated with one or more reference data, and the plurality of the above assessment data and reference data will be stored in the assessment database.

[0014] In order to ensure that the controlled document template is used correctly and improve the security of the controlled document template, the personnel who use the controlled document template are assessed. Only those who pass the assessment are given the authority to use the controlled document template. If they fail the assessment, they need to study and take the assessment again until they pass the assessment and are granted the right to use the controlled document template. This improves the quality of the personnel who use the controlled document template, solves the abuse of the controlled document template from the root, and improves the security of the controlled document template.

[0015] Furthermore, after receiving a file use request, the above-mentioned assessment database extracts one or more assessment data from the assessment database, and sends the extracted assessment data to the applicable person who issued the file use request. The above-mentioned applicable person gives reply data based on the assessment data. If the reply data is the same as any one or more of the reference data associated with the assessment data, the applicable person passes the assessment, otherwise the applicable person fails the assessment.

[0016] Each assessment data in the above-mentioned assessment database has corresponding reference data, and the reference data is used as the judging standard to determine whether the applicable personnel participating in the assessment have passed the assessment. If the reply data given by the applicable personnel is consistent with the reference data or is within the range specified by the reference data, the assessment is passed and the right to use the controlled document template is obtained; if the reply data given by the applicable personnel is inconsistent with the reference data or exceeds the range specified by the reference data, the assessment is failed. If the applicable personnel needs to obtain the right to use the controlled document template, they need to re-participate in the assessment of the controlled document template until the assessment is passed.

[0017] A second aspect provides a management system for a controlled document template, the management system is used to implement the above-mentioned method for managing a controlled document template, the management system comprises: a generation module and a use module, the generation module and the use module are connected,

[0018] The generation module is used to generate a controlled document template through an approval process, and to set one or more applicable personnel in the controlled document template, and to configure the permissions for the applicable personnel to receive the controlled document template;

[0019] The above-mentioned usage module is used to send the above-mentioned controlled file template to each applicable person. After receiving the controlled file template, the above-mentioned applicable person issues a file usage request, extracts any one or more assessment data in the assessment database, and sends the extracted assessment data to the applicable person who issued the file usage request. If the applicable person passes the assessment, he / she obtains the authority to use the controlled file template, otherwise the applicable person shall not use the controlled file template.

[0020] The above-mentioned generation module is connected to the use module. The generation module is used to generate a controlled document template through an approval process, so that the controlled document template can be managed and controlled during the generation process. The above-mentioned controlled document template is provided with corresponding applicable personnel, and no one except the applicable personnel can receive the controlled document template; the above-mentioned use module is used to further set a screening mechanism based on the applicable personnel. Applicable personnel who pass the screening can open the use rights of the controlled document template, and applicable personnel who fail the screening need to be re-assessed and screened until the assessment is passed before the use rights of the controlled document template can be opened. Otherwise, the controlled document template cannot be used. The controlled document template is used within the minimum authority range to prevent file loss or damage during offline management, which also improves the quality of personnel using the controlled document template, reduces the risk of abuse of the controlled document template, and improves the security of the file.

[0021] Furthermore, the generation module includes a file generation module, a training course generation module and an assessment data generation module, and the file generation module, the training course generation module and the assessment data generation module are all connected to the use module.

[0022] The above-mentioned file generation module is used to generate a controlled file module;

[0023] The training course generation module is used to compile a training course and send the training course to each applicable person;

[0024] The assessment data generation module is used to compile a plurality of assessment data and reference data, each of the assessment data is associated with one or more reference data, and the plurality of assessment data and reference data are stored in the assessment database.

[0025] The above-mentioned controlled document template, training course and assessment content are compiled, and the training course is sent to the usage module for applicable personnel to study, so that applicable personnel have the potential conditions to pass the controlled document template assessment and obtain the right to use the controlled document template.

[0026] Furthermore, the use module includes a file use module, a training module and an assessment module. The file use module is connected to the file generation module through the assessment module, the training module is connected to the training course generation module, and the assessment module is connected to the assessment data generation module.

[0027] The above-mentioned file use module is used for applicable personnel to use the controlled file template when obtaining the use authority of the controlled file template;

[0028] The above training modules are used by applicable personnel to study the training course after receiving the training course;

[0029] The above-mentioned assessment module is used to extract one or more assessment data from the assessment database after receiving a file use request, and send the extracted assessment data to the applicable person who issued the file use request. The above-mentioned applicable person gives reply data based on the assessment data. If the reply data is the same as any one or more of the reference data associated with the assessment data, the applicable person passes the assessment, otherwise the applicable person fails the assessment.

[0030] Applicable personnel obtain the training tutorial from the training module for learning, and issue a file use request after learning. At this time, after receiving the file use request, the assessment module randomly extracts assessment data from the assessment database and sends it to the applicable personnel. After receiving the assessment data, the applicable personnel answer and send the reply data to the assessment module. The assessment module extracts reference data that is relevant to the assessment data, and compares the reply data with the reference data. If the reply data is consistent with the reference data or is within the range specified by the reference data, the use permission is opened for the applicable personnel. If the reply data is inconsistent with the reference data or is not within the range specified by the reference data, the applicable personnel needs to re-participate in the assessment to obtain the right to use the controlled file template.

[0031] A third aspect provides a method for generating a controlled document template. The controlled document template mentioned in the above-mentioned controlled document template management system is generated by using this method. The generation method comprises the following steps:

[0032] Step 1: After receiving the application creation signal, create the basic application information;

[0033] Step 2: Review and approve the above basic application information;

[0034] If approved, proceed to step 3; if not approved, return to step 1 and execute again;

[0035] Step 3: Create and compile the document in the database, and obtain the finalized document after the compilation is completed;

[0036] Step 4: Review and approve the above finalized documents;

[0037] If approved, proceed to step 5; if not approved, return to step 3 and execute again;

[0038] Step 5: Approve the finalized document, bind the approved finalized document with the CA signature certificate, and obtain a controlled document template.

[0039] The approval process ensures that the controlled document template itself goes through a controlled process of creation, editing and approval, thereby improving the security of the controlled document template generation.

[0040] Furthermore, after the above basic application information is approved, it is necessary to set up a compilation personnel and configure the compilation personnel with the authority to compile documents.

[0041] Only the compilers who have the authority to compile the controlled document template can participate in the compilation of the controlled document template. Other personnel do not have the authority to compile the controlled document template, which improves the security and standardization of the controlled document template.

[0042] Furthermore, after the above basic application information is approved, it is necessary to set up applicable personnel and configure the applicable personnel with the authority to receive controlled document templates.

[0043] Only applicable personnel with permission to receive the controlled document template can receive the controlled document template. Other personnel do not have permission to receive the controlled document template, which improves the security of the controlled document template and avoids abuse of the controlled document template.

[0044] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0045] The above-mentioned controlled document template is generated through an approval process, so that the controlled document template can be managed and controlled during the generation process. The above-mentioned controlled document template is set with corresponding applicable personnel. No one except the applicable personnel can receive the controlled document template. A screening mechanism is further set up based on the applicable personnel. Applicable personnel who pass the screening can open the use rights of the controlled document template. Applicable personnel who fail the screening need to be re-assessed and screened until the assessment is passed before they can open the use rights of the controlled document template. Otherwise, the controlled document template cannot be used. The controlled document template is used within the minimum authority scope to prevent file loss or damage during offline management, which also improves the quality of personnel using the controlled document template, reduces the risk of abuse of the controlled document template, and improves the security of the file, meets the controlled management process of document data and personnel training that pharmaceutical companies regard as core assets in the pharmaceutical industry, and at the same time prevents competitors or potential competitors from copying similar technologies to form unhealthy competition. BRIEF DESCRIPTION OF THE DRAWINGS

[0046] In order to more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the following briefly introduces the drawings required for use in the embodiments. It should be understood that the following drawings only illustrate certain embodiments of the present invention and should not be regarded as limiting the scope. For those of ordinary skill in the art, other relevant drawings can be obtained based on these drawings without creative work. In the drawings:

[0047] Figure 1 A management system block diagram provided for Example 2;

[0048] Figure 2The method flow chart provided for Example 3.

[0049] Marks and corresponding parts names in the attached drawings:

[0050] 10-Generation module, 11-File generation module, 12-Training tutorial generation module, 13-Assessment data generation module, 20-Usage module, 21-File usage module, 22-Training module, 23-Assessment module. DETAILED DESCRIPTION

[0051] In order to make the objectives, technical solutions and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with embodiments and drawings. The exemplary embodiments of the present invention and their description are only used to explain the present invention and are not intended to limit the present invention.

[0052] The management system of general enterprises directly uploads file templates from the background through the administrator, and does not control the file templates through the approval process. The training system used by pharmaceutical companies includes functions such as courses, learning and assessment, and does not have a file control mechanism. Although the software system of the pharmaceutical industry has a certain degree of approval control, it lacks a training and assessment mechanism, so that the file may be used by inappropriate personnel, and the safety factor is low; the present invention generates a controlled file template through the approval process to ensure that the controlled file template itself is created. The controlled process of editing and approval is ensured by mandatory training, learning and assessment of personnel within the scope of application of the controlled file template to ensure that the personnel using the controlled file template are also in a controlled process, so that the controlled file template and the user are combined to form a closed loop of file control technology.

[0053] Example 1

[0054] This embodiment 1 provides a method for managing a controlled document template, comprising the following steps:

[0055] A controlled document template is generated through the approval process, wherein one or more applicable personnel are set in the controlled document template, and the applicable personnel are configured with the authority to receive the controlled document template;

[0056] The above-mentioned controlled document template is sent to each applicable person. After receiving the controlled document template, the above-mentioned applicable person issues a file use request, extracts any one or more assessment data from the assessment database, and sends the extracted assessment data to the applicable person who issued the file use request. If the applicable person passes the assessment, he / she obtains the authority to use the controlled document template, otherwise the applicable person shall not use the controlled document template.

[0057] The above-mentioned controlled document template is generated through an approval process, so that the controlled document template can be managed and controlled during the generation process. The above-mentioned controlled document template is set with corresponding applicable personnel. No one except the applicable personnel can receive the controlled document template. A screening mechanism is further set up based on the applicable personnel. Applicable personnel who pass the screening can open the use rights of the controlled document template. Applicable personnel who fail the screening need to be re-assessed and screened until the assessment is passed before they can open the use rights of the controlled document template. Otherwise, the controlled document template cannot be used. The controlled document template is used within the minimum authority scope to prevent file loss or damage during offline management, which also improves the quality of personnel using the controlled document template, reduces the risk of abuse of the controlled document template, and improves the security of the file, meets the controlled management process of document data and personnel training that pharmaceutical companies regard as core assets in the pharmaceutical industry, and at the same time prevents competitors or potential competitors from copying similar technologies to form unhealthy competition.

[0058] In a specific implementation example, after a controlled document template is generated through an approval process, a training course is compiled and sent to each applicable person, and the above applicable person studies the training course after receiving it.

[0059] The above-mentioned training tutorials and controlled document templates are sent to applicable personnel, so that applicable personnel have the potential conditions to open the permission to use the controlled document template. Applicable personnel generally do not have the ability to use the controlled document template when they first receive it, and need training and learning to understand and know how to use the controlled document template.

[0060] In a specific embodiment, after a controlled document template is generated through an approval process, a plurality of assessment data and reference data are compiled, each of the assessment data is associated with one or more reference data, and the plurality of the assessment data and reference data are stored in an assessment database.

[0061] In order to ensure that the controlled document template is used correctly and improve the security of the controlled document template, the personnel who use the controlled document template are assessed. Only those who pass the assessment are given the authority to use the controlled document template. If they fail the assessment, they need to study and take the assessment again until they pass the assessment and are granted the right to use the controlled document template. This improves the quality of the personnel who use the controlled document template, solves the abuse of the controlled document template from the root, and improves the security of the controlled document template.

[0062] In a specific embodiment, after receiving a file use request, the above-mentioned assessment database extracts one or more assessment data from the assessment database, and sends the extracted assessment data to the applicable person who issued the file use request. The above-mentioned applicable person gives reply data based on the assessment data. If the reply data is the same as any one or more of the reference data associated with the assessment data, the applicable person passes the assessment, otherwise the applicable person fails the assessment.

[0063] Each assessment data in the above-mentioned assessment database has corresponding reference data, and the reference data is used as the judging standard to determine whether the applicable personnel participating in the assessment have passed the assessment. If the reply data given by the applicable personnel is consistent with the reference data or is within the range specified by the reference data, the assessment is passed and the right to use the controlled document template is obtained; if the reply data given by the applicable personnel is inconsistent with the reference data or exceeds the range specified by the reference data, the assessment is failed. If the applicable personnel needs to obtain the right to use the controlled document template, they need to re-participate in the assessment of the controlled document template until the assessment is passed.

[0064] Example 2

[0065] This embodiment 2 provides a management system for controlled document templates, such as Figure 1 As shown, the management system is used to implement the above-mentioned method for managing a controlled document template. The management system includes: a generation module 10 and a use module 20. The generation module 10 and the use module 20 are connected.

[0066] The generation module 10 is used to generate a controlled document template through an approval process, and to set one or more applicable personnel in the controlled document template, and to configure the applicable personnel with the authority to receive the controlled document template;

[0067] The above-mentioned usage module 20 is used to send the above-mentioned controlled file template to each applicable person. After receiving the controlled file template, the above-mentioned applicable person issues a file usage request, extracts any one or more assessment data in the assessment database, and sends the extracted assessment data to the applicable person who issued the file usage request. If the applicable person passes the assessment, he / she obtains the authority to use the controlled file template, otherwise the applicable person shall not use the controlled file template.

[0068] The above-mentioned generation module 10 is connected to the use module 20. The generation module 10 is used to generate a controlled document template through an approval process, so that the controlled document template can be managed and controlled during the generation process. The above-mentioned controlled document template is provided with corresponding applicable personnel, and no one except the applicable personnel can receive the controlled document template; the above-mentioned use module 20 is used to further set a screening mechanism based on the applicable personnel. Applicable personnel who pass the screening can open the use rights of the controlled document template, and applicable personnel who fail the screening need to be re-assessed and screened until the assessment is passed before the use rights of the controlled document template can be opened. Otherwise, the controlled document template cannot be used. The controlled document template is used within the minimum authority range to prevent file loss or damage during offline management, which also improves the quality of the personnel using the controlled document template, reduces the risk of abuse of the controlled document template, and improves the security of the file.

[0069] In a specific embodiment, the generation module 10 includes a file generation module 11, a training course generation module 12 and an assessment data generation module 13, and the file generation module 11, the training course generation module 12 and the assessment data generation module 13 are all connected to the use module 20.

[0070] The above-mentioned file generation module 11 is used to generate a controlled file module;

[0071] The training course generation module 12 is used to compile a training course and send the training course to each applicable person;

[0072] The assessment data generating module 13 is used to compile a plurality of assessment data and reference data, each of the assessment data is associated with one or more reference data, and the plurality of assessment data and reference data are stored in an assessment database.

[0073] The above-mentioned controlled document template, training course and assessment content are compiled, and the training course is sent to the use module 20 for applicable personnel to learn, so that applicable personnel have the potential conditions to pass the controlled document template assessment and obtain the right to use the controlled document template.

[0074] In a specific embodiment, the use module 20 includes a file use module 21, a training module 22 and an assessment module 23. The file use module 21 is connected to the file generation module 11 through the assessment module 23, the training module 22 is connected to the training course generation module 12, and the assessment module 23 is connected to the assessment data generation module 13.

[0075] The file use module 21 is used for the applicable personnel to use the controlled file template when obtaining the use authority of the controlled file template;

[0076] The training module 22 is used for the applicable personnel to learn the training course after receiving the training course;

[0077] The above-mentioned assessment module 23 is used to extract one or more assessment data from the assessment database after receiving a file use request, and send the extracted assessment data to the applicable person who issued the file use request. The above-mentioned applicable person gives reply data based on the assessment data. If the reply data is the same as any one or more of the reference data associated with the assessment data, the applicable person passes the assessment, otherwise the applicable person fails the assessment.

[0078] The applicable personnel obtains the training tutorial from the training module 22 for learning, and issues a file use request after learning. At this time, after the assessment module 23 receives the file use request, it randomly extracts assessment data from the assessment database and sends it to the applicable personnel. After receiving the assessment data, the applicable personnel answers and sends the reply data to the assessment module 23. The assessment module 23 extracts reference data that is relevant to the assessment data, and compares the reply data with the reference data. If the reply data is consistent with the reference data or is within the range specified by the reference data, the use permission is opened for the applicable personnel. If the reply data is inconsistent with the reference data or is not within the range specified by the reference data, the applicable personnel needs to re-participate in the assessment to obtain the right to use the controlled file template.

[0079] Example 3

[0080] This embodiment 3 provides a method for generating a controlled document template, such as Figure 2 As shown, the controlled document template mentioned in the above-mentioned management system of controlled document templates is generated by this method, and the generation method includes the following steps:

[0081] Step 1: After receiving the application creation signal, create the basic application information, including but not limited to the purpose of creation, controlled scope, applicable personnel and approval personnel;

[0082] Step 2: Review and approve the above basic application information;

[0083] If approved, proceed to step 3; if not approved, return to step 1 and execute again;

[0084] Step 3: Create and compile the document in the database, and obtain the finalized document after the compilation is completed;

[0085] Step 4: Review and approve the above finalized documents;

[0086] If approved, proceed to step 5; if not approved, return to step 3 and execute again;

[0087] Step 5: Approve the finalized document, bind the approved finalized document with the CA signature certificate, and obtain a controlled document template.

[0088] The approval process ensures that the controlled document template itself goes through a controlled process of creation, editing and approval, thereby improving the security of the controlled document template generation.

[0089] In a specific implementation example, after the above basic application information is approved, it is necessary to set up a compilation personnel, and configure the compilation personnel with the authority to compile documents.

[0090] Only the compilers who have the authority to compile the controlled document template can participate in the compilation of the controlled document template. Other personnel do not have the authority to compile the controlled document template, which improves the security and standardization of the controlled document template.

[0091] In a specific implementation example, after the above basic application information is approved, it is also necessary to set up applicable personnel and configure the applicable personnel with the authority to receive the controlled document template.

[0092] Only applicable personnel with permission to receive the controlled document template can receive the controlled document template. Other personnel do not have permission to receive the controlled document template, which improves the security of the controlled document template and avoids abuse of the controlled document template.

[0093] The specific implementation methods described above further illustrate the objectives, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above description is only a specific implementation method of the present invention and is not intended to limit the scope of protection of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the scope of protection of the present invention.

Claims

1. A method for managing a controlled document template, characterized in that: The following steps are involved: A controlled document template is generated through an approval process, wherein one or more applicable personnel are set in the controlled document template, and the applicable personnel are configured with the authority to receive the controlled document template; The controlled document template is sent to each applicable person. After receiving the controlled document template, the applicable person issues a file use request, extracts any one or more assessment data from the assessment database, and sends the extracted assessment data to the applicable person who issued the file use request. If the applicable person passes the assessment, he / she obtains the authority to use the controlled document template. Otherwise, the applicable person shall not use the controlled document template.

2. The method for generating a controlled document template according to claim 1, characterized in that: After the controlled document template is generated through the approval process, a training tutorial will be compiled and sent to each applicable person, who will study the training tutorial after receiving it.

3. The method for generating a controlled document template according to claim 1, characterized in that: After the controlled document template is generated through the approval process, a plurality of assessment data and reference data will be compiled, each of the assessment data is associated with one or more reference data, and the plurality of the assessment data and reference data will be stored in the assessment database.

4. The method for generating a controlled document template according to claim 3, characterized in that: After receiving the file use request, the assessment database extracts one or more assessment data from the assessment database, and sends the extracted assessment data to the applicable person who issued the file use request. The applicable person gives reply data based on the assessment data. If the reply data is the same as any one or more of the reference data associated with the assessment data, the applicable person passes the assessment, otherwise the applicable person fails the assessment.

5. A management system for controlled document templates, characterized in that: The management system is used to implement a method for managing a controlled document template as claimed in any one of claims 1 to 4, and comprises: a generation module (10) and a use module (20), wherein the generation module (10) and the use module (20) are connected. The generating module (10) is used to generate a controlled document template through an approval process, and to set one or more applicable personnel in the controlled document template, and to configure the applicable personnel with the authority to receive the controlled document template; The use module (20) is used to send the controlled document template to each applicable person. After receiving the controlled document template, the applicable person issues a document use request, extracts any one or more assessment data in the assessment database, and sends the extracted assessment data to the applicable person who issued the document use request. If the applicable person passes the assessment, the applicable person obtains the authority to use the controlled document template. Otherwise, the applicable person is not allowed to use the controlled document template.

6. A management system for controlled document templates according to claim 5, characterized in that: The generating module (10) comprises a file generating module (11), a training course generating module (12) and an assessment data generating module (13), wherein the file generating module (11), the training course generating module (12) and the assessment data generating module (13) are all connected to the using module (20). The file generation module (11) is used to generate a controlled file module; The training course generation module (12) is used to compile a training course and send the training course to each applicable person; The assessment data generation module (13) is used to compile a plurality of assessment data and reference data, each of the assessment data is associated with one or more reference data, and the plurality of assessment data and reference data are stored in an assessment database.

7. A management system for controlled document templates according to claim 5, characterized in that: The use module (20) comprises a file use module (21), a training module (22) and an assessment module (23); the file use module (21) is connected to the file generation module (11) via the assessment module (23); the training module (22) is connected to the training course generation module (12); and the assessment module (23) is connected to the assessment data generation module (13). The file use module (21) is used for the applicable personnel to use the controlled file template when obtaining the use authority of the controlled file template; The training module (22) is used for the applicable personnel to learn the training course after receiving the training course; The assessment module (23) is used to extract one or more assessment data from the assessment database after receiving a file use request, and send the extracted assessment data to the applicable person who issued the file use request, and the applicable person gives reply data based on the assessment data. If the reply data is the same as any one or more of the reference data associated with the assessment data, the applicable person passes the assessment, otherwise the applicable person fails the assessment.

8. A method for generating a controlled document template, characterized in that: The controlled document template mentioned in the management system of a controlled document template as claimed in any one of claims 1 to 4 is generated by using this method, and the generation method comprises the following steps: Step 1: After receiving the application creation signal, create the basic application information; Step 2: Approve and approve the basic information of the application; If approved, proceed to step 3; if not approved, return to step 1 and execute again; Step 3: Create and compile the document in the database, and obtain the finalized document after the compilation is completed; Step 4: review and approve the finalized document; If approved, proceed to step 5; if not approved, return to step 3 and execute again; Step 5: Approve and sign the finalized document, bind the approved finalized document with the CA signature certificate, and obtain a controlled document template.

9. The method for generating a controlled document template according to claim 8, characterized in that: After the basic information of the application is approved, it is necessary to set up a compiler and configure the compiler with the authority to compile documents.

10. The method for generating a controlled document template according to claim 8, characterized in that: After the basic information of the application is approved, it is necessary to set up applicable personnel and configure the applicable personnel with the authority to receive controlled document templates.

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