Demand analysis method applied to electronic record of pharmaceutical enterprise
By adopting electronic recording systems and demand analysis methods in pharmaceutical companies, the problem of paper-based office work in pharmaceutical company ledger record management has been solved, paperless office has been realized, and the accuracy of data and production qualification rate have been improved.
Patent Information
- Application Number
- CN202411549367.9
- 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
Existing pharmaceutical companies have paper offices in the management of ledger records, resulting in long recording cycles, easy to damage or loss, and difficult to manage and trace, affecting the production pass rate.
The electronic recording system is adopted to build different types of electronic recording templates through demand analysis methods to achieve digital and automated data collection, storage, processing, and sharing, including online editing, electronic signatures and audit records to ensure compliance and data security.
The paperless office is achieved, reducing the errors of man -filled in, improving the correctness and traceability of the data, saving time and cost, and increasing the production qualification rate of pharmaceutical companies.
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Figure CN119338415A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of pharmaceutical enterprise information technology, and in particular to a demand analysis method applied to electronic records of pharmaceutical enterprises. Background Art
[0002] In pharmaceutical companies, ledger records need to be managed in accordance with SOP regulations. Ledger records themselves need to go through formal drafting, approval, and effectiveness processes before they can be used. When actually using ledger records, they also need to go through the application, printing, issuance, retrieval, and archiving processes. All processes are done in paper offices. Therefore, the entire paper ledger recording cycle is long, time-consuming and labor-intensive.
[0003] In addition, traditional paper ledger records are not written in a standardized manner, and paper ledger records circulate in the hands of multiple people throughout the entire process, which can easily cause paper ledger records to be damaged and lost, making them difficult to manage. At the same time, paper ledgers are prone to recording errors and cannot be traced during the recording process, resulting in erroneous recording data in paper ledger records that cannot be traced in real time, and erroneous records cannot be corrected in time, affecting the production qualification rate of pharmaceutical companies. Summary of the invention
[0004] The present invention aims to provide a demand analysis method for electronic records of pharmaceutical companies. The inventor, based on compliance requirements, data management efficiency improvement, data security assurance, business process optimization, and information construction, conducts management research on paper ledger records and reviews the electronic record system required by regulations. The inventor also collects, stores, processes, and shares data in a digital and automated manner, thereby saving time and costs, improving the accuracy of data, and increasing the production qualification rate of pharmaceutical companies.
[0005] In order to achieve the above object, the present invention adopts the following technical scheme: 1) Requirements analysis methods applied to electronic records of pharmaceutical companies, including: Build different types of electronic record templates based on document structure, and determine the corresponding electronic record templates based on business scenario requirements; Analyze the relevant stakeholders of electronic records according to the target users, design and use electronic records based on the expectations of the relevant stakeholders of electronic records. The electronic record design realizes targeted paperless office through template configuration, template approval and permission control. The use of electronic records realizes online paperless office through online editing, electronic signature and audit records based on the electronic record design.
[0006] The present invention constructs different types of electronic record templates based on two analyses of needs. First, the corresponding electronic record templates are determined through business scenario needs (such as: use of vacuum drying ovens, laboratory inspections, preparation and calibration, QC instrument maintenance and repair, and preparation of test solutions, etc.), and different types of electronic record templates are divided into corresponding to different business scenario needs through document structures (such as: ledgers, checklists, preparation record sheets, text fields, merged cells, complex tables (for example: stability test sample inspection structure registration ledgers), one-to-many (for example: sample distribution records), chapter categories, and scoring categories, etc.), so as to achieve wide adaptation to the needs of pharmaceutical companies to ensure product quality, safety, and compliance.
[0007] The authority control of electronic record templates can control that only authorized users can operate electronic records, and the access records can be effectively tracked to facilitate compliance audits and accountability tracing.
[0008] Secondly, the electronic record design and use in the electronic record template are set based on the expectations of the relevant stakeholders of the electronic records. For example, the relevant stakeholders of the electronic records are the production department, and the expectations of the production department are: 1. Draft and configure templates through electronic records; 2. Review the content of electronic records; 3. Designate roles to issue electronic records; 4. Audit and track records; 5. Print, download, and preview the content of electronic records; 6. Archive electronic records by time or content; 7. Perform report analysis through electronic records.
[0009] Therefore, according to the expectations of the production department, the template configuration, template approval and authority control in the electronic record design are set to achieve targeted paperless office. The electronic record is used based on the electronic record design to realize online paperless office with online editing, electronic signature and audit records. The paper ledger records are managed and reviewed in an electronic record system required by regulations. Data collection, storage, processing and sharing are realized in a digital and automated manner, thereby saving time and cost, improving data accuracy and increasing the production qualification rate of pharmaceutical companies. Data monitoring and data analysis are realized through electronic record design and use. Pharmaceutical companies can discover problems in a timely manner and make adjustments to achieve continuous improvement and optimization of the production process.
[0010] 2) The method for analyzing the needs of electronic records of pharmaceutical companies according to 1), wherein: The expectations of the electronic record-related stakeholders have a demand priority matrix, where the core business component has a value of 3, the important auxiliary parts of the core business, which cannot run smoothly without it, have a value of 2, and the marginal business can run smoothly even without this expectation, has a value of 1.
[0011] The present invention sets a demand priority matrix in the expectations of the stakeholders related to electronic records, and realizes the setting of the characteristics of the stakeholders related to electronic records and the way of using electronic records through the demand priority matrix, so as to realize one-to-one precise satisfaction of the needs of the stakeholders related to electronic records, for example: the stakeholders related to electronic records are production operators, and the production operators have a value of 3 for the core business component. Therefore, the characteristics of the stakeholders related to electronic records are online editing, signing, and applying for electronic records. Typical representatives, the main users of computer systems; can be trained and used, and it is impossible to confirm whether their projects are equipped with computers and pads, depending on different situations. Therefore, the present invention can realize the precise design of electronic records according to the different demand priority matrices expected by the stakeholders related to electronic records to meet different needs.
[0012] 3) The method for analyzing the needs of electronic records of pharmaceutical companies according to 2), wherein: The expectations of the requirements priority matrix include query, online editing, electronic signature, data retrieval, application template, drafting template, configuration template, review electronic records, issuance template, audit trail, print download preview, archiving, reporting, review template and upload document; Among them, the query, online editing, electronic signature, drafting template, configuration template, review of electronic records, issuance template, audit tracking and review template are value 3 in the demand priority matrix, the application template, print download preview and archiving are value 2 in the demand priority matrix, and the retrieval of data, report and upload of documents are value 1 in the demand priority matrix.
[0013] The present invention refines the expectations of stakeholders related to electronic records in electronic record design in more detail, and prioritizes each electronic record design. During the design process, the electronic record templates required by stakeholders related to electronic records can be designed according to different priority levels in the demand priority matrix, which is more precise and reduces human filling errors.
[0014] 4) The method for analyzing the needs of electronic records of pharmaceutical companies according to 1), wherein: The target users include the person filling out the ledger records, the approver and the file administrator. The person filling out the ledger records is responsible for filling out and submitting the ledger records in the system; the approver is responsible for reviewing and approving the ledger record templates and specific ledger records; the file administrator is responsible for designing and configuring electronic spreadsheets, managing ledger templates and maintaining the system.
[0015] The present invention classifies and analyzes the relevant stakeholders of electronic records by refining target users, thereby classifying the relevant stakeholders of electronic records and designing electronic record templates; at the same time, it can realize data tracking through electronic signatures and filling through the cooperation of target users and relevant stakeholders of electronic records, and can trace the data in electronic records, so that the relevant stakeholders of electronic records can correct erroneous records in time.
[0016] 5) According to the method for analyzing the needs of electronic records for pharmaceutical companies described in 1), the analysis of stakeholders related to electronic records based on target users includes: Stakeholder names, stakeholder descriptions and expectations, where the stakeholder names include production operators, production department quality management personnel, quality department, management personnel and implementation personnel; the stakeholder description of production operators is the user of records, and the expectation is to query the required templates through electronic records and to edit them online through electronic records; the stakeholder description of the production department is the drafting, review and issuance of production documents, and the expectation is to draft and configure templates through electronic records, review the contents of electronic records, and issue electronic records by designated roles; The stakeholder description for the quality management personnel is the review and issuance of quality management documents, and the expectation is to approve the electronic record template through electronic records; the stakeholder description for the quality department is template drafting, record approval, and template issuance, and the expectation is to draft and configure templates through electronic records, review the content of electronic records, and issue electronic records through designated roles; the stakeholder description for the implementation personnel is to provide an electronic record system, assist in the configuration of electronic record templates, and the expectation is to be able to upload templates through electronic records and then produce the format.
[0017] 6) The method for analyzing the needs of electronic records of pharmaceutical companies according to 1), wherein: The electronic record design has a built-in electronic record template object, and the electronic record template object includes a format design, which is referenced by a template main record design, a template sub-record design and a template sub-record option, wherein the format design includes a form format design, a table format design and a word format design, a template main record design: each object record represents a subheading in the format design or a name of a table, a template sub-record design: each object record represents a field in the template design, and a template sub-record option design: each object record represents an option of a field.
[0018] The implementation of the format design object of the present invention first considers the implementation of the form format design and table format design objects, provides word format design expansion capabilities, and can be expanded when electronic recording capabilities are subsequently increased.
[0019] 7) According to the method for demand analysis of electronic records for pharmaceutical companies described in 1), the electronic record design includes the following steps: Step 1: Create a template. Determine the template type based on different types of electronic record templates. You can choose between general templates and fillable templates. Step 2: Design the format in the general template, add fields and configure the layout in the format design; or add file records and configure fillable controls in the fillable template; Step 3: After designing the general template and the fillable template in step 2, the configuration layout is completed, and the general template and the fillable template corresponding to different scenarios are formed respectively; Step 4: In step 3, the general template and the fillable template are reviewed and approved. During the review and approval process, the configuration and layout of the general template and the fillable template are adjusted in real time.
[0020] 8) The method for analyzing the needs of electronic records for pharmaceutical companies according to 1), wherein the use of electronic records comprises the following steps: Step 1: Based on the electronic record design, you can select a general template or a fillable template for online editing. After selection, electronically sign on the general template or fillable template, and review and record the electronic signature process; Step 2: Complete the electronic signature to form multiple sub-processes. Export and print one sub-process according to usage requirements, and apply for archiving in another sub-process, and conduct archiving review when applying for archiving.
[0021] 9) The method for analyzing the needs of electronic records of pharmaceutical companies according to 1), wherein: It also includes filing application and filing review, which are located in the electronic signature.
[0022] Compared with the prior art, the present invention also has the following technical effects: The electronic records of the present invention can transform traditional paper-based office work into paperless office work. Online filling, standardized content, partial data can be extracted, reducing human filling errors; only authorized users can operate electronic records, access records can be effectively tracked, facilitating compliance audits and responsibility tracing; and can trace back and manage the files and records involved in product production-related activities. BRIEF DESCRIPTION OF THE DRAWINGS
[0023] Figure 1 It is a flow chart of the method for analyzing the needs of electronic records of pharmaceutical companies applied to the present invention; Figure 2 A flow chart for designing electronic records in a method for analyzing the needs of electronic records of pharmaceutical companies according to the present invention; Figure 3 This is a flow chart of the use of the method for analyzing the needs of electronic records of pharmaceutical companies according to the present invention (detailed business process diagram). DETAILED DESCRIPTION
[0024] The following is further described in detail through specific implementation methods: Now will be referred to in detail the embodiments disclosed in the present invention, although the present disclosure will be described in conjunction with the embodiments and / or examples, they are not intended to limit the present disclosure to these embodiments and / or examples. On the contrary, the present disclosure covers alternatives, modifications and equivalents. Example
[0025] See also Figure 1 As shown, the demand analysis method applied to electronic records of pharmaceutical companies in this embodiment includes: Build different types of electronic record templates based on document structure, and determine the corresponding electronic record templates based on business scenario requirements; Analyze the stakeholders of electronic records according to the target users, design and use electronic records based on the expectations of the stakeholders, and use electronic records templates to achieve directional paperless office through template configuration, template approval and authority control. Use electronic records based on electronic record design to achieve online paperless office through online editing, electronic signature and audit records. It also includes filing application and filing review, which are located in electronic signature.
[0026] Different types of electronic record templates are constructed based on the analysis of the two requirements. First, the corresponding electronic record templates are determined through business scenario requirements (such as: use of vacuum drying ovens, laboratory inspections, preparation and calibration, QC instrument maintenance and repair, and preparation of test solutions, etc.), and different types of electronic record templates are divided into corresponding business scenario requirements through document structures (such as: ledgers, checklists, preparation record sheets, text fields, merged cells, complex tables (for example: stability test sample inspection structure registration ledgers), one-to-many (for example: sample distribution records), chapter categories, and scoring categories, etc.), so as to achieve wide adaptation to the needs of pharmaceutical companies and ensure product quality, safety and compliance.
[0027] The authority control of the electronic record template can control that only authorized users can operate the electronic record, and the access record can be effectively tracked, which is convenient for compliance audit and responsibility tracing. For example: for the audit inspection of pharmaceutical companies, the electronic record of the present invention can effectively realize audit tracking, and at the same time, combined with electronic signatures to realize real-name confirmation, for example: after the authorized user modifies the electronic record, it is necessary to realize real-name identification through electronic signatures (face recognition, handwritten signatures, etc.) to confirm that the electronic record modification is modified by the authorized user.
[0028] Secondly, the electronic record design and use in the electronic record template are set based on the expectations of the relevant stakeholders of the electronic records. For example, the relevant stakeholders of the electronic records are the production department, and the expectations of the production department are: 1. Draft and configure templates through electronic records; 2. Review the content of electronic records; 3. Designate roles to issue electronic records; 4. Audit and track records; 5. Print, download, and preview the content of electronic records; 6. Archive electronic records by time or content; 7. Perform report analysis through electronic records.
[0029] Therefore, according to the expectations of the production department, the template configuration, template approval and authority control in the electronic record design are set to achieve targeted paperless office. The electronic record is used based on the electronic record design to realize online paperless office with online editing, electronic signature and audit records. The paper ledger records are managed and reviewed in an electronic record system required by regulations. Data collection, storage, processing and sharing are realized in a digital and automated manner, thereby saving time and cost, improving data accuracy and increasing the production qualification rate of pharmaceutical companies. Data monitoring and data analysis are realized through electronic record design and use. Pharmaceutical companies can discover problems in a timely manner and make adjustments to achieve continuous improvement and optimization of the production process.
[0030] More specifically, in the expectations of stakeholders related to electronic records, there is a demand priority matrix, where core business components are assigned a value of 3, important auxiliary parts of the core business that cannot run smoothly without it are assigned a value of 2, and marginal businesses that can run smoothly even without this expectation are assigned a value of 1.
[0031] A demand priority matrix is set in the expectations of the stakeholders related to electronic records, and the characteristics of the stakeholders related to electronic records and the way of using electronic records are set through the demand priority matrix, so as to achieve one-to-one precise satisfaction of the needs of the stakeholders related to electronic records. For example, the stakeholders related to electronic records are production operators, and the production operators have a value of 3 for the core business component. Therefore, the characteristics of the stakeholders related to electronic records are online editing, signing, and applying for electronic records. Typical representatives, the main users of computer systems; can be trained and used, and it is impossible to confirm whether their projects are equipped with computers and pads, depending on different situations. Therefore, the present invention can realize the precise design of electronic records according to the different demand priority matrices expected by the stakeholders related to electronic records to meet different needs.
[0032] Secondly, the expectations of the demand priority matrix include query, online editing, electronic signature, retrieving data, application template, drafting template, configuration template, reviewing electronic records, issuance template, audit trail, print download preview, archiving, reporting, review template, and uploading documents; Among them, query, online editing, electronic signature, drafting template, configuration template, review of electronic records, issuance template, audit tracking and review template are value 3 in the demand priority matrix, application template, print download preview and archiving are value 2 in the demand priority matrix, and retrieval of data, report and upload of documents are value 1 in the demand priority matrix.
[0033] The expectations of stakeholders related to electronic records in electronic record design are further refined, and each electronic record design is prioritized. During the design process, the electronic record templates required by stakeholders related to electronic records can be designed according to the different priority levels in the demand priority matrix, which is more precise and reduces human filling errors.
[0034] In addition, in this embodiment, the target users include the person filling out the ledger records, the approver, and the file administrator. The person filling out the ledger records is responsible for filling out and submitting the ledger records in the system; the approver is responsible for reviewing and approving the ledger record templates and specific ledger records; and the file administrator is responsible for designing and configuring electronic spreadsheets, managing ledger templates, and maintaining the system.
[0035] By refining the target users and conducting classification analysis on the stakeholders related to electronic records, it is possible to classify the stakeholders related to electronic records and design the electronic record templates; at the same time, through the cooperation of the target users and the stakeholders related to electronic records, it is possible to track the data through electronic signatures and filling, and to trace the data in the electronic records, so that the stakeholders related to the electronic records can correct the erroneous records in time.
[0036] In this embodiment, the electronic record-related stakeholders are analyzed according to the target user, including: Stakeholder names, stakeholder descriptions and expectations, where the stakeholder names include production operators, production department quality management personnel, quality department, management personnel and implementation personnel; the stakeholder description of production operators is the user of records, and the expectation is to query the required templates through electronic records and to edit them online through electronic records; the stakeholder description of the production department is the drafting, review and issuance of production documents, and the expectation is to draft and configure templates through electronic records, review the contents of electronic records, and issue electronic records by designated roles; The stakeholder description for the quality management personnel is the review and issuance of quality management documents, and the expectation is to approve the electronic record template through electronic records; the stakeholder description for the quality department is template drafting, record approval, and template issuance, and the expectation is to draft and configure templates through electronic records, review the content of electronic records, and issue electronic records through designated roles; the stakeholder description for the implementation personnel is to provide an electronic record system, assist in the configuration of electronic record templates, and the expectation is to be able to upload templates through electronic records and then produce the format. Example
[0037] See also Figure 2 As shown, based on Example 1, the electronic record design of this embodiment has a built-in electronic record template object, and the electronic record template object includes a format design, and the format design refers to the template main record design, the template sub-record design and the template sub-record option, wherein the format design includes a form format design, a table format design and a word format design, the template main record design: each object record represents a subheading in the format design or the name of a table, the template sub-record design: each object record represents a field in the template design, and the template sub-record option design: each object record represents an option for a field.
[0038] The implementation of the format design object of the present invention first considers the implementation of the form format design and table format design objects, provides word format design expansion capabilities, and can be expanded when electronic recording capabilities are subsequently increased. Example
[0039] See also Figure 3 As shown, based on Example 1, the electronic record design in this embodiment includes the following steps: Step 1: Create a template. Determine the template type based on different types of electronic record templates. You can choose between general templates and fillable templates. Step 2: Design the format in the general template, add fields and configure the layout in the format design; or add file records and configure fillable controls in the fillable template; Step 3: After designing the general template and the fillable template in step 2, the configuration layout is completed, and the general template and the fillable template corresponding to different scenarios are formed respectively; Step 4: In step 3, the general template and the fillable template are reviewed and approved. During the review and approval process, the configuration and layout of the general template and the fillable template are adjusted in real time.
[0040] In addition, the use of electronic records in this embodiment includes the following steps: Step 1: Based on the electronic record design, you can select a general template or a fillable template for online editing. After selection, electronically sign on the general template or fillable template, and review and record the electronic signature process; Step 2: Complete the electronic signature to form multiple sub-processes. Export and print one sub-process according to usage requirements, and apply for archiving in another sub-process, and conduct archiving review when applying for archiving.
[0041] Electronic records can transform traditional paper-based office work into paperless office work. Online filling, standardized content, and partial data extraction can reduce errors in manual filling; only authorized users can operate electronic records, and access records can be effectively tracked, facilitating compliance audits and accountability tracing; and can provide traceability management between documents and records involved in product production-related activities.
[0042] The above are only embodiments of the present invention, and the common knowledge such as the known specific technical solutions and / or characteristics in the solution are not described in detail here. 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 scope of protection 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. A demand analysis method for electronic records of pharmaceutical companies, characterized in that: include: Build different types of electronic record templates based on document structure, and determine the corresponding electronic record templates based on business scenario requirements; Analyze the relevant stakeholders of electronic records according to the target users, design and use electronic records based on the expectations of the relevant stakeholders of electronic records. The electronic record design realizes targeted paperless office through template configuration, template approval and permission control. The use of electronic records realizes online paperless office through online editing, electronic signature and audit records based on the electronic record design.
2. The method for demand analysis of electronic records of pharmaceutical companies according to claim 1, characterized in that: The expectations of the electronic record-related stakeholders have a demand priority matrix, where the core business component has a value of 3, the important auxiliary parts of the core business, which cannot run smoothly without it, have a value of 2, and the marginal business can run smoothly even without this expectation, has a value of 1.
3. The method for analyzing the needs of electronic records of pharmaceutical companies according to claim 2, characterized in that: The expectations of the requirements priority matrix include query, online editing, electronic signature, data retrieval, application template, drafting template, configuration template, review electronic records, issuance template, audit trail, print download preview, archiving, reporting, review template and upload document; Among them, the query, online editing, electronic signature, drafting template, configuration template, review of electronic records, issuance template, audit tracking and review template are value 3 in the demand priority matrix, the application template, print download preview and archiving are value 2 in the demand priority matrix, and the retrieval of data, report and upload of documents are value 1 in the demand priority matrix.
4. The method for analyzing demand for electronic records of pharmaceutical companies according to claim 1, characterized in that: The target users include the person filling out the ledger records, the approver and the file administrator. The person filling out the ledger records is responsible for filling out and submitting the ledger records in the system; the approver is responsible for reviewing and approving the ledger record templates and specific ledger records; the file administrator is responsible for designing and configuring electronic spreadsheets, managing ledger templates and maintaining the system.
5. The method for analyzing demand for electronic records of pharmaceutical companies according to claim 1, characterized in that: The analysis of stakeholders related to electronic records based on target users includes: Stakeholder names, stakeholder descriptions and expectations, where the stakeholder names include production operators, production department quality management personnel, quality department, management personnel and implementation personnel; the stakeholder description of production operators is the user of records, and the expectation is to query the required templates through electronic records and to edit them online through electronic records; the stakeholder description of the production department is the drafting, review and issuance of production documents, and the expectation is to draft and configure templates through electronic records, review the contents of electronic records, and issue electronic records by designated roles; The stakeholder description for the quality management personnel is the review and issuance of quality management documents, and the expectation is to approve the electronic record template through electronic records; the stakeholder description for the quality department is template drafting, record approval, and template issuance, and the expectation is to draft and configure templates through electronic records, review the content of electronic records, and issue electronic records through designated roles; the stakeholder description for the implementation personnel is to provide an electronic record system, assist in the configuration of electronic record templates, and the expectation is to be able to upload templates through electronic records and then produce the format.
6. The method for analyzing demand for electronic records of pharmaceutical companies according to claim 1, characterized in that: The electronic record design has a built-in electronic record template object, and the electronic record template object includes a format design, which is referenced by a template main record design, a template sub-record design and a template sub-record option, wherein the format design includes a form format design, a table format design and a word format design, a template main record design: each object record represents a subheading in the format design or a name of a table, a template sub-record design: each object record represents a field in the template design, and a template sub-record option design: each object record represents an option of a field.
7. The method for analyzing demand for electronic records of pharmaceutical companies according to claim 1, characterized in that: The electronic record design comprises the following steps: Step 1: Create a template. Determine the template type based on different types of electronic record templates. You can choose between general templates and fillable templates. Step 2: Design the format in the general template, add fields and configure the layout in the format design; or add file records and configure fillable controls in the fillable template; Step 3: After designing the general template and the fillable template in step 2, the configuration layout is completed, and the general template and the fillable template corresponding to different scenarios are formed respectively; Step 4: In step 3, the general template and the fillable template are reviewed and approved. During the review and approval process, the configuration and layout of the general template and the fillable template are adjusted in real time.
8. The method for analyzing demand for electronic records of pharmaceutical companies according to claim 1, characterized in that: The electronic records used include the following steps: Step 1: Based on the electronic record design, you can select a general template or a fillable template for online editing. After selection, electronically sign on the general template or fillable template, and review and record the electronic signature process; Step 2: Complete the electronic signature to form multiple sub-processes. Export and print one sub-process according to usage requirements, and apply for archiving in another sub-process, and conduct archiving review when applying for archiving.
9. The method for analyzing demand for electronic records of pharmaceutical companies according to claim 1, characterized in that: It also includes filing application and filing review, which are located in the electronic signature.