CN113177696A - Method and system for generating controlled file template of medicine quality system - Google Patents
Method and system for generating controlled file template of medicine quality system Download PDFInfo
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- CN113177696A CN113177696A CN202110381990.8A CN202110381990A CN113177696A CN 113177696 A CN113177696 A CN 113177696A CN 202110381990 A CN202110381990 A CN 202110381990A CN 113177696 A CN113177696 A CN 113177696A
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- 239000003814 drug Substances 0.000 title claims abstract description 29
- 238000000034 method Methods 0.000 title claims abstract description 27
- 229940079593 drug Drugs 0.000 claims abstract description 18
- 238000003326 Quality management system Methods 0.000 claims abstract description 12
- 230000000694 effects Effects 0.000 claims abstract description 12
- 238000012545 processing Methods 0.000 claims description 13
- 230000008569 process Effects 0.000 claims description 7
- 238000013500 data storage Methods 0.000 claims description 6
- 230000004048 modification Effects 0.000 claims description 6
- 238000012986 modification Methods 0.000 claims description 6
- 210000001747 pupil Anatomy 0.000 claims description 3
- 238000007726 management method Methods 0.000 description 7
- 230000036541 health Effects 0.000 description 4
- 238000010586 diagram Methods 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 230000008676 import Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 230000026676 system process Effects 0.000 description 1
- 238000010200 validation analysis Methods 0.000 description 1
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/06—Resources, workflows, human or project management; Enterprise or organisation planning; Enterprise or organisation modelling
- G06Q10/063—Operations research, analysis or management
- G06Q10/0639—Performance analysis of employees; Performance analysis of enterprise or organisation operations
- G06Q10/06395—Quality analysis or management
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
- G06F16/10—File systems; File servers
- G06F16/11—File system administration, e.g. details of archiving or snapshots
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F16/00—Information retrieval; Database structures therefor; File system structures therefor
- G06F16/10—File systems; File servers
- G06F16/18—File system types
- G06F16/182—Distributed file systems
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F21/30—Authentication, i.e. establishing the identity or authorisation of security principals
- G06F21/31—User authentication
- G06F21/32—User authentication using biometric data, e.g. fingerprints, iris scans or voiceprints
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F21/00—Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F21/60—Protecting data
- G06F21/62—Protecting access to data via a platform, e.g. using keys or access control rules
- G06F21/6218—Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F40/00—Handling natural language data
- G06F40/10—Text processing
- G06F40/166—Editing, e.g. inserting or deleting
- G06F40/186—Templates
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06Q—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
- G06Q10/00—Administration; Management
- G06Q10/10—Office automation; Time management
- G06Q10/103—Workflow collaboration or project management
-
- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F2221/00—Indexing scheme relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F2221/21—Indexing scheme relating to G06F21/00 and subgroups addressing additional information or applications relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
- G06F2221/2141—Access rights, e.g. capability lists, access control lists, access tables, access matrices
Abstract
The invention relates to a method and a system for generating a controlled file template of a drug quality system, which belong to the field of drug/medical apparatus/health-care product quality management and comprise the following steps: creating blank documents in a database, setting each network user group and configuring authority for the network user group; assigning template attributes to the document; modifying the document, and saving the document as a file n; examining and approving the file n according to the quality management system flow, wherein the file takes effect if the examination and approval is passed, and the file returns if the examination and approval is not passed; setting the attribute of the file n which takes effect as a controlled file so that the members of each network user group can access and call the file; when the file n is modified and stored, a copy is created of the modified content as a file n + 1; and repeatedly executing the steps of endowing the file n +1 with the template attribute and examining and approving, and calling any generated controlled file as a template according to the requirement. The invention can generate the controlled file template of the medicine quality system by simple steps and can completely control the whole life cycle of the medicine quality system.
Description
Technical Field
The invention belongs to the field of quality management of medicines/medical instruments/health care products, and particularly relates to a method and a system for generating a controlled file template of a medicine quality system.
Background
According to the industry definition, the broad medicine comprises medicines, medical instruments and health care products, the related industries of the medicines comprise research and development (GLP), clinic (GCP) and production (GMP), compared with other production industries, the industry has more strict control requirements on the file state of a quality system, and the management and control on the file life cycle are particularly required to be paid attention under the definition that the medicine quality management system is 'no record and no occurrence'. At present, after an enterprise management system such as a paper record file or OA (office automation) system is used, it is difficult to ensure that each step from receiving to filling and writing to approval to effect using an approved and approved (hereinafter, controlled) file template is under strict control after frequent version updating, the involved personnel and operation processes are many and complex, and after a certain link modifies a file by mistake and then is widely spread, not only quality accidents are easily caused, but also tracing and liability determination are difficult during investigation afterwards. Therefore, a system which is simpler and more convenient and can comprehensively control the whole life cycle of the file is required so as to meet the requirement of a quality management system.
Disclosure of Invention
The invention aims to solve the problems in the prior art, provides a method for generating a controlled file template of a medicine quality system on line, has simple whole operation flow, and can complete the complete control of each node of the whole life cycle of a file on a network.
The technical scheme is as follows:
a method of generating a drug quality system controlled file template, comprising the steps of:
step S1: creating blank documents in a database, setting each network user group and configuring authority for the network user group;
step S2: assigning template attributes to the document;
step S3: modifying the document, and saving the document as a file n;
step S4: examining and approving the file n according to the quality management system flow, taking the file into effect if the examination and approval is passed, and returning to the step S3 if the examination and approval is not passed;
step S5: setting the attribute of the file n which takes effect as a controlled file so that the members of each network user group can access and call the file;
step S6: when the file n is modified and stored, a copy is created of the modified content as a file n + 1;
step S7: giving template attributes to the file n +1, examining and approving the file n according to the flow of the quality management system, enabling the file n +1 to take effect if the examination and approval is passed, and returning to the step S6 if the examination and approval is not passed;
step S8: the steps S6 to S7 are repeatedly executed, and each time the file number generated in step S6 is continued sequentially, any one of the generated controlled files is called as a template as necessary.
Further, in step S3, the blank document is modified into a direct online editing document or a document that meets the format requirement is uploaded.
Further, in step S4, a certain network user group is given an approval authority, and a file becomes effective after any member of the user group completes the approval process or a file becomes effective after a certain number of members complete the approval process in sequence.
Further, in step S4, the approval is completed by using an electronic signature, where the electronic signature is a biometric signature, a cryptographic signature, or any combination thereof, and the biometric signature includes handwriting, a physiognomy, and a pupil.
Further, in step S4, an effective time is set for the file n during the approval, and the file n is effective only after the set time.
Further, in step S6, the operation user and the time are recorded in the database for each modification.
Further, in step S7, when the file with the next number is set to be valid, the file with the previous number is set to be invalid.
A system for generating a controlled file template of a drug quality system comprises a server and a client, wherein the server at least comprises a central processing unit, a data memory, a database and a network interface, the data memory, the database and the network interface are connected with the central processing unit, the data memory stores the step of generating the controlled file template of the drug quality system on line for the central processing unit to call, and a processing result is stored in the database; the number of the client sides is more than one, and the client sides are connected with the network interfaces of the server side through the network.
Has the advantages that:
1) the invention can generate the controlled file template of the medicine quality system by simple steps, supports various auditing modes, and is suitable for the quality management system of medicine related industries such as medicines, medical instruments, health care products and the like.
2) The invention can directly set the modified file into the template, thereby avoiding repeated labor.
3) The original file is not affected by file modification every time, the file is easy to return, and an operator leaves traces for tracing, so that the complete control of each node in the whole life cycle of the file is ensured.
Drawings
FIG. 1 is a schematic flow diagram of a method of generating a drug quality system controlled file template;
FIG. 2 is a schematic diagram of a system for generating a drug quality system controlled file template according to the present invention;
wherein 100 is a server, 110 is a central processing unit, 120 is a data storage, 130 is a database, 140 is a network interface, and 200 is a client.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be further described in detail with reference to the accompanying drawings and embodiments:
a method for generating a drug quality system controlled file template as shown in fig. 1 to 2 comprises the following steps:
step S1: creating blank documents in a database, setting each network user group and configuring authority for the network user group;
step S2: assigning template attributes to the document;
step S3: modifying the document, and saving the document as a file n;
step S4: examining and approving the file n according to the quality management system flow, taking the file into effect if the examination and approval is passed, and returning to the step S3 if the examination and approval is not passed;
step S5: setting the attribute of the file n which takes effect as a controlled file so that the members of each network user group can access and call the file;
step S6: when the file n is modified and stored, a copy is created of the modified content as a file n + 1;
step S7: giving template attributes to the file n +1, examining and approving the file n according to the flow of the quality management system, enabling the file n +1 to take effect if the examination and approval is passed, and returning to the step S6 if the examination and approval is not passed;
step S8: repeatedly executing the step S6-the step S7, sequentially continuing the file numbers generated in the step S6 every time, namely generating a file 3 after modifying the file 2, generating a file 4 after modifying by taking the file 3 as a template, and so on; any generated controlled file is called as a template as required, and the template is prevented from being generated in the blank document again.
In step S3, the blank document is modified into a direct online edited document or a document that meets the format requirement, such as various OFFICE files that are already available to each user.
In step S4, an approval authority is given to a network user group, and a file is set to be effective after any user in the user group completes an approval process or a file is effective after a certain number of users complete the approval process in sequence, which is suitable for different needs of users in linear management and users in functional management.
In step S4, the approval is completed using an electronic signature, the electronic signature being a biometric signature, a cryptographic signature, or any combination thereof, the biometric signature including handwriting, a physiognomy, and a pupil.
In step S4, an effective time is set for the file n during the approval, and the file n is effective only after the set time.
In step S6, the operation user and time are recorded in the database for each modification and storage, so as to make the trace and traceability required by the quality system.
In step S7, when the file with the next number is set to be valid, the file with the previous number is set to be invalid, so as to ensure the reliability of the file.
A system for generating a drug quality system controlled file template comprises a server 100 and a client 200, wherein the server 100 at least comprises a central processing unit 110, a data storage 120, a database 130 and a network interface 140, wherein the data storage 120 is connected with the central processing unit 110, the data storage 120 stores the steps of the method for generating the drug quality system controlled file template on line for the central processing unit to call, and the processing result is stored in the database 130; the client 200 is more than one and is connected with the network interface 140 of the server through the network.
Example 1: a quality system controlled file template system is set up at a server, blank documents are set up in a database, and each network user group is set up and configured with authority; assigning template attributes to the document; recording corresponding content in the document, and saving the content as a file 1; the member of the network user group examines and approves the file 1 according to the quality management system process, and verifies the face data, the electronic signature and the password of the member of the user group during examination and approval; the attribute of the file 1 is set to be controlled after approval and validation, and members of each network user group of the client can access and call through the network; when any user modifies the file 1 and then stores the modified content as a file 2 in the database, and records the operation user and time; and then the file 2 is endowed with template attributes and approved, the file 1 fails when the file 2 is validated after approval, the file 1-the file n is respectively produced after multiple modifications, and members of a network user group can call any controlled file as a template according to needs without creating the controlled file from blank files again, so that the method is suitable for file management of a quality management system of medicine related industries such as medicines, medical instruments, health products and the like.
Example 2: the user can combine the system of the invention with various internal office management systems of the user, directly import the originally existing file of the user into the database, or upload the existing file (such as word file or wps file) after creating a blank file, and the rest steps are the same as the embodiment 1.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and scope of the present invention are intended to be covered thereby.
Claims (8)
1. A method of generating a drug quality system controlled file template, characterized by: the method comprises the following steps:
step S1: creating blank documents in a database, setting each network user group and configuring authority for the network user group;
step S2: assigning template attributes to the document;
step S3: modifying the document, and saving the document as a file n;
step S4: examining and approving the file n according to the quality management system flow, taking the file into effect if the examination and approval is passed, and returning to the step S3 if the examination and approval is not passed;
step S5: setting the attribute of the file n which takes effect as a controlled file so that the members of each network user group can access and call the file;
step S6: when the file n is modified and stored, a copy is created of the modified content as a file n + 1;
step S7: giving template attributes to the file n +1, examining and approving the file n according to the flow of the quality management system, enabling the file n +1 to take effect if the examination and approval is passed, and returning to the step S6 if the examination and approval is not passed;
step S8: the steps S6 to S7 are repeatedly executed, and each time the file number generated in step S6 is continued sequentially, any one of the generated controlled files is called as a template as necessary.
2. The method of claim 1, wherein: in step S3, the blank document is modified into a direct online edited document or a document that meets the format requirement is uploaded.
3. The method of claim 1, wherein: in step S4, an approval right is given to a network user group, and a file is set to be effective after any user in the user group completes an approval process or a file is effective after a certain number of users complete the approval process in sequence.
4. The method of claim 1, wherein: in step S4, the approval is completed by using an electronic signature, where the electronic signature is a biometric signature, a cryptographic signature, or any combination thereof, and the biometric signature includes handwriting, a physiognomy, and a pupil.
5. The method of claim 1, wherein: in step S4, an effective time is set for the file n during the approval, and the file n is effective only after the set time.
6. The method of claim 5, wherein: in step S6, the operation user and the time are recorded in the database for each modification and storage.
7. The method of claim 5, wherein: in step S7, when the file with the next number is set to be valid, the file with the previous number is set to be invalid.
8. A system for generating a drug quality system controlled file template, comprising: the method comprises a server (100) and a client (200), wherein the server (100) at least comprises a central processing unit (110), a data storage (120) connected with the central processing unit (110), a database (130) and a network interface (140), the data storage (120) stores the steps of the method for generating the drug quality system controlled file template on line according to any one of claims 1 to 7 for the central processing unit to call, and the processing result is stored in the database (130); the number of the client sides (200) is more than one, and the client sides are connected with the network interface (140) of the server side through a network.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110381990.8A CN113177696A (en) | 2021-04-09 | 2021-04-09 | Method and system for generating controlled file template of medicine quality system |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110381990.8A CN113177696A (en) | 2021-04-09 | 2021-04-09 | Method and system for generating controlled file template of medicine quality system |
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| CN113177696A true CN113177696A (en) | 2021-07-27 |
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| CN202110381990.8A Pending CN113177696A (en) | 2021-04-09 | 2021-04-09 | Method and system for generating controlled file template of medicine quality system |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114201950A (en) * | 2021-12-21 | 2022-03-18 | 辉图建筑工程科技(上海)有限公司 | Engineering documentation, text receiving and transmitting system based on intelligent cloud platform |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002259895A (en) * | 2001-03-02 | 2002-09-13 | Higashi Nippon System Kensetsu Kk | Document management system, method and program |
| US20070192671A1 (en) * | 2006-02-13 | 2007-08-16 | Rufener Jerry | Document management systems |
| US20070220068A1 (en) * | 2006-02-15 | 2007-09-20 | Bruce Thompson | Electronic document and business process control |
| CN106202568A (en) * | 2016-08-05 | 2016-12-07 | 欧阳能良 | Control system and standardized control method for medical laboratory quality management system file |
| CN107122381A (en) * | 2017-02-15 | 2017-09-01 | 北京小度信息科技有限公司 | Document generating method and device and data analysing method and device |
| CN111695131A (en) * | 2020-06-23 | 2020-09-22 | 上海用正医药科技有限公司 | Document management method and system for clinical trial |
-
2021
- 2021-04-09 CN CN202110381990.8A patent/CN113177696A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002259895A (en) * | 2001-03-02 | 2002-09-13 | Higashi Nippon System Kensetsu Kk | Document management system, method and program |
| US20070192671A1 (en) * | 2006-02-13 | 2007-08-16 | Rufener Jerry | Document management systems |
| US20070220068A1 (en) * | 2006-02-15 | 2007-09-20 | Bruce Thompson | Electronic document and business process control |
| CN106202568A (en) * | 2016-08-05 | 2016-12-07 | 欧阳能良 | Control system and standardized control method for medical laboratory quality management system file |
| CN107122381A (en) * | 2017-02-15 | 2017-09-01 | 北京小度信息科技有限公司 | Document generating method and device and data analysing method and device |
| CN111695131A (en) * | 2020-06-23 | 2020-09-22 | 上海用正医药科技有限公司 | Document management method and system for clinical trial |
Non-Patent Citations (1)
| Title |
|---|
| 刁奇志;左永艳;曾强;莫展;汪开华;: "医学实验室ISO15189质量管理体系文件的建立及文档的规范管理", 中国医药导报, no. 32, 15 November 2016 (2016-11-15), pages 180 - 182 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114201950A (en) * | 2021-12-21 | 2022-03-18 | 辉图建筑工程科技(上海)有限公司 | Engineering documentation, text receiving and transmitting system based on intelligent cloud platform |
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