CN106202568A - Control system and standardized control method for medical laboratory quality management system file - Google Patents
Control system and standardized control method for medical laboratory quality management system file Download PDFInfo
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- 238000000034 method Methods 0.000 title claims abstract description 22
- 238000003326 Quality management system Methods 0.000 title abstract description 6
- 238000003908 quality control method Methods 0.000 claims description 27
- 238000011156 evaluation Methods 0.000 claims description 25
- 230000006870 function Effects 0.000 claims description 23
- 238000012795 verification Methods 0.000 claims description 23
- 238000012550 audit Methods 0.000 claims description 16
- 238000011425 standardization method Methods 0.000 claims description 15
- 239000000203 mixture Substances 0.000 claims description 14
- 230000008569 process Effects 0.000 claims description 12
- 230000008859 change Effects 0.000 claims description 8
- 238000012986 modification Methods 0.000 claims description 7
- 230000004048 modification Effects 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 7
- 239000006185 dispersion Substances 0.000 claims description 3
- 238000012958 reprocessing Methods 0.000 claims description 3
- 238000012552 review Methods 0.000 claims description 3
- 241000208340 Araliaceae Species 0.000 claims 1
- 235000005035 Panax pseudoginseng ssp. pseudoginseng Nutrition 0.000 claims 1
- 235000003140 Panax quinquefolius Nutrition 0.000 claims 1
- 235000008434 ginseng Nutrition 0.000 claims 1
- 238000006243 chemical reaction Methods 0.000 abstract 1
- 238000007726 management method Methods 0.000 description 9
- 239000000463 material Substances 0.000 description 4
- 238000005516 engineering process Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 238000007689 inspection Methods 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000002159 abnormal effect Effects 0.000 description 1
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Classifications
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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
Abstract
The invention discloses a control system of medical laboratory quality management system files and a standardized control method thereof, the intelligent control system comprises a system parameter setting module, a system file parameter setting module, a document file editing module, a document file approving module, a file operation reminding module, a document consulting module, a document reviewing module, a form compiling module, a record filling module and a record consulting module, and the control system and the standardized control method of the medical laboratory quality management system file can meet the quality management standard, writing and modifying files, checking and approving files, consulting and reviewing files, compiling record forms, filling and consulting records are realized by an informatization means, file version conversion and dynamic record form compiling are quickly realized by supporting simple operation, and the quality system files are comprehensively controlled simply and efficiently.
Description
Technical field
The present invention relates to Good Laboratory management standardization and the informationization technology of medical domain, be specifically related to a kind of medical science
The control system of Laboratory Quality Management System file and standardization method thereof.
Background technology
International Organization for Standardization issues ISO15189 quality control standard for 2003, and conformity assessment country of China is recognized
Can committee (CNAS) this standard of IDT in 2004 be national standard.At present, Domestic Medicine laboratory generally establishes matter
Amount management system, many laboratorys have already been through or are applying for Laboratory Accreditation, and mainly ISO15189 approves, minority is
CAP approves.ISO15189 and CAP standard is all the quality management system of documentation, sets up the top priority of quality management system
Being to set up System Documents (including charting, the most similar) with premise, document control and record control are proposed bright by standard
Really requirement, relate to file write, examine, use, evaluate, revise and manage and record fill in and the aspect such as management.System
The present situation of document control and the problem of existence are as follows.
One, Most experiments room uses the document of Quality System of papery bookbinding, and uses paper list to manage record.Make
It is primarily present problems with paper document.
1. document control cost is high: laboratory need to put into substantial amounts of people, wealth and material resources carry out the establishment of file, bookbinding and
Management.
2. document control working strength and difficulty are big: the longitudinally covered file of document control is from the whole life being created to destruction
In the cycle, laterally relating to people, machine, material, method, ring and quality events that Good Laboratory management is relevant, workload is very big and complicated,
Many job notes manually manage and have been difficult to.
3. the document control wasting of resources is big: has the mistake that many is difficult to avoid that during documentation, there is repetition simultaneously
The situation of the multiple copies of work and identical file, causes the wasting of resources.
4. document control inefficiency: write the identification information such as file identifier to be worked out and version number, hand control
File layout；Examination & approval and file publishing to repeat signature and affix one's seal；It is difficult to when using file obtain file, accessed document
Information takies more time.
5. file updates not in time: file modification situation is complicated, and coping style is difficult to unified, document approvals and issuing process
Time-consuming the longest, file updates the most not in time, is also one of reason of causing file to misuse.
6. file is misused situation and is often occurred: because preserving electronic document, many parts of controlled files and abrogating file simultaneously, also deposit
At the file of " transitive state ", easily cause chaotic and misuse.
7. file training and evaluation formalization: the evaluation note of browing record based on manual signature and charting
Record, it is difficult to follow the tracks of study situation and the evaluation situation of file.
8. there is abnormal activity in record management: log file is produced by hand filling form, fills in record and exists " early
Fill out, mend and fill out, revise, forge and emit signature " etc. behavior, it is difficult to guarantee the requirement of record " accurately, in time and complete ".
9. there is bio-safety hidden danger: file is often interspersed in test block and Office Area to be used or storage, and easily by work
Its risk is ignored as personnel.
Two, few part Experiment room uses self-built or commercially available software management system file.These softwares be primarily present with
Lower problem.
1. the limited requirement being unsatisfactory for quality control standard of function: the main centralized management external software that realizes is write and
" actual approval " i.e. single " the complete electronic document " of slave mode, it is impossible to be uniformly controlled Historical archiving file, be not directed to file
The functions such as learning records and file evaluation, the most do not write or the critical function such as editing files；Software is to " document of Quality System "
Understanding inadequate, fail to realize the control to log file, i.e. can not realize " working out and managing charting, fill in note comprehensively
Record and look up the records " 3 basic functions.
2. document approvals is lack of standardization: " actual approval " the most controlled file is simply carried out by they, and " registration formula is examined afterwards
Batch ".
3. use file inconvenient: after needing client software to be installed or downloads file, to use third party software to read, also
Do not support that ff and file content are searched.
4. minority software achieves Document Editing function, but exists: the pattern that a. uses similar outside Word to edit is artificial
Write " the complete electronic document " comprising various information, it is still necessary to the extra establishment file control information such as version number and identification number is also
Controlling layout, the workload of file edit is not improved relative to paper document with difficulty；Built-in file structure is not the most provided
Masterplate, file edit quality is uneven；The most not support system plate change function, causes file to turn version work huge.
5. minority software achieves log file control function, but exists: a. establishment form need to write database table, foundation
Form templat and arrange 3 complex operations of form, needs to consider form numbering and layout, updates form extremely difficult, directly repair
Change or newly-built replacement is all introduced into the new problem such as change or numbering confusion of looing up the records；B. charting item preset content form,
Fill in during record dumb；The form that need to repeatedly fill in is follow-up can revise previous message when filling in, and record is filled in lack of standardization；c.
Look up the records to browse one by one and do not support to search, the most convenient.
Visible, currently for medical laboratory, the most there is not effectively controlling the side of the specification practicality of document of Quality System
Case.
Summary of the invention
Control the deficiency existed for existing medical laboratory Quality control system documents, the present invention provides a kind of medical science real
Test control system and the standardization method thereof of room Quality control system documents, use this control system and standardization side
Method can be on the premise of meeting quality control procedure, it is achieved System Documents turns version, writes and revise file, audits and ratify literary composition
Part, consult and evaluate file, work out and manage charting, fill in and look up the records, simply and efficiently to document of Quality System
Control comprehensively.
To achieve these goals, the present invention provides the control system of a kind of medical laboratory Quality control system documents,
This control system is formed by with lower part:
(1) system parameter setting module: be used for arranging laboratory department, employee's account, employee role and role-security, builds literary composition
Part controls environment, accurately controls employee and operates dissimilar and state file；
(2) System Documents parameter setting module: be used for setting up System Documents framework, including arranging quality system information and file set
Information, sets up file and dead file in file set；
(3) document files editor module: be used for the document template using the editor of " What You See Is What You Get " to call setting
Read slave mode or do not submit to the file of application carry out content modification or from the beginning write document in masterplate blank, and associating literary composition
Shelves and system information；
(4) document files approval module: present a paper application, auditor's audit document, ratifier's approval documents for author,
Update the state of file and version number and generate document approvals information；
(5) file operation prompting module: according to file status in document approvals process, sends file operation reminder message automatically；
(6) module consulted by document: browses for packet and searches controlled file, and reading file automatically controls layout's display literary composition
The all information of part also preserves learning records, provides file content to search, prevent from divulging a secret and authorizing output function simultaneously；
(7) document evaluation module: be used for keeping track of file evaluation situation, collect and output file review record；
(8) form compiling module: for by form data and entry information preparation charting are simply provided；
(9) module filled in record: browses for packet and lookup table, automatically controls entry layout and dynamically generate form,
Hold that action-item is chosen, record is quickly filled in the drop-down selection of department, date picker, the operation such as default value and RichTextBox；
(10) module consulted in record: for checking all records of certain form in summary mode, and presses summary info inquiry spy
Determine record, then check the details recorded with original forms mode.
Employee role that this control system sets according to laboratory and authority, accurately control employee and operate dissimilar and shape
The file of state, it is achieved editing files, file application, audit document, approval documents, accessed document, evaluation file, dead file,
Work out form, fill in record and 10 kinds of major functions of looing up the records；This control system the most directly stores and manages " entity " file,
File is by disperseing storage be mutually related system information, identification information, version information, status information, approval information and main body
Contents etc. are constituted, and are only automatically integrated by system when reading file and present " full document ", go through that " QA Supervisor arranges system
File parameters sets up System Documents framework generation structure information and identification information, the rich text of author's employing ' What You See Is What You Get '
Editing machine calls document template editor's document files of setting and generates body matter and set up association, examine role and clear a paper life
Becoming version information and approval information " 3 steps could form complete controlled file, and all employees carry out file study and evaluate literary composition
Part, generates the additional information of file, additionally, can quickly realize file by simple operations to turn version；This control system is by compiling
Tabulation lattice, filling in record and check that 3 kinds of functional realiey records of record control, establishment form only need to be simply provided form data and note
Record item information, revising and disable form does not affect and follow-up check and fill in record；This control system achieves the complete of System Documents
Face controls, and meets the requirement of quality control standard.
The built-in 5 kinds of file structure masterplates of this control system also automatically generate the version number of document.5 kinds of document template are respectively
For: quality manual masterplate, program file masterplate, item class SOP masterplate, program class SOP masterplate and external documents masterplate, utilize mould
Version can be effectively improved document quality and write efficiency；Documentation release number by this document approve number, examination & verification by number and
File application array becomes, and version number is operated by document approvals and automatically updates, and can follow the tracks of the dynamic change of file.Example: certain file
Version number be 1.3.5, then this document have 5 times submit to application, 3 examination & verifications are passed through, and approve for 1 time.
It addition, the invention still further relates to the standardization method of a kind of medical laboratory Quality control system documents, these rule
The step of generalized control method is:
(1) laboratory department, employee's account, employee role and role-security are set, build at the beginning of document control environment, completion system
Beginningization；
(2) setting includes: a. quality system information, b. fileset information, 3 aspects of file identification information in c. file set
System Documents parameter, sets up System Documents overall framework and generates system information and the identification information of file；
(3) for document files, perform step (4)-(9), for log file, perform step (10)-(12)；
(4) writing role uses editor to write or editing files body matter, and associates system information；
(5) after Document Editing completes, author presents a paper application, and file enters pending state, sends Note Auditing and reminds
Message；
(6) examination & verification role receives reminder message, it is provided that audit opinion audit document, and examination & verification is passed through, and file enters issued for approval state,
Send file approval reminder message；
(7) approval role receives reminder message, it is provided that approval suggestion approval documents, approves, and file enters slave mode, sends out
File is sent to learn reminder message；
(8) all employees receive reminder message, and reading file carries out study and and guides work, recording learning situation；
(9) during system running, file suitability is evaluated by employee, and keeps track of evaluation situation, and evaluation confirms suitable
With, then file is continuing with；
(10) authorize role that form data and entry information preparation charting are set；
(11) during system running, employee opens suitable form and fills in record, forms quality and technical notes file；
(12) carry out checking log file when quality examination and track record, check all notes of a form in the mode of making a summary
Record, searches specific record by summary info, then checks certain details recorded with forms mode.
Further, in described step (5), before application of presenting a paper, if file still imperfection, could be on the basis of former
Again revise.
Further, in described step (6), if examination & verification decision is passed through, then file enters issued for approval state, sends approval
Reminder message；If examination & verification determines not pass through, then file enters final state, sends examination & verification failed message, it is desirable to rewritable paper；
If examination & verification decision is reprocessed, then file enters state of reprocessing, and sends and reprocesses reminder message, it is desirable to amendment file.
Further, in described step (7), if approval decision is passed through, then file enters slave mode and files former being subject to
Control file (if present), sends study reminder message；If approval determines not pass through, then file enters final state, sends
Approval failed message, it is desirable to rewritable paper.
Further, in described step (9), if evaluation confirms to be suitable for, then file is continuing with；If evaluation confirms not
It is suitable for, then sends amendment reminder message, it is desirable to amendment file.
Further, during using form, modified as needed to form, then establishment form disables and/or increases entry newly；As
Need to cancel form, then establishment form arranges form for disabling.
Further, during system running, fill in record as followed the tracks of, check repeatedly the imperfect of table at forms mode
Can again fill in during record.
Further, after System Documents is set up, as needed file to turn version, then System Documents parameter is set and adds new system version
Basis and key element, editing files association redaction key element, the controlled file of generation of clearing a paper；As controlled file need to be cancelled, then arrange
System Documents parameter dead file identifies.
Use control system of the present invention and standardization method thereof to control Quality control system documents and have all
Many advantages also can obtain good result, is mainly manifested in following aspect.
1. economize on resources and document control cost: files electronicization storage and management, it is not necessary to print bookbinding consumptive material, do not use
File and file cabinet, stop a large amount of consumptive materials waste that miswork causes, can save nearly 5000 of paper every year；Without arranging
Special messenger carries out file management, and document control only needs less personnel's routine work to complete, and saves file control for laboratory every year
Make all kinds of cost accounting about 60,000 yuans.
2. reduce working strength and improve work efficiency: write file and only need to pay close attention to body matter, support that rapid file turns version
Operation, it is not necessary to artificial distribution of document and establishment control inventory, and charting can dynamically be revised, is substantially reduced document control work strong
Degree and difficulty, file turns version and is worked overtime 45 days by original 30 people and be reduced to 15 people's routine work 15 days；Document approvals flows automatically
Turning and prompting message, check that locating function supported in file and record, significantly improve work efficiency, accessed document was by original 15 minutes
Foreshorten to 1 minute.
3. improving quality inspection and patient Man Yidu: built-in document template, file learns, evaluates and revise benign cycle,
Improving document quality, file updates in time, it is achieved controls file comprehensively, decreases file mistake and misuse causes miswork,
Record is filled in specification and is guaranteed record " accurately, in time and completely ", has stopped average the most about 15 records lack of standardization of section office, permissible
Improve quality inspection and patient Man Yidu.
4. stop bio-safety hidden danger: document control does not has medium to transmit, stop bio-safety hidden danger.
5. file control system complete function is simple to operate: utilizes rational Modular function design, passes through simple operations
Realize the corresponding function of each role, integrate the function of modules, it is possible to achieve control document of Quality System comprehensively.
6. document control method specification is easy: first sets employee's authority etc. and builds at the beginning of document control environment, completion system
Beginningization, then sets System Documents parameter and sets up System Documents framework, then write file one by one and examine the controlled file of formation, read
Read file automatic recording learning situation, use the suitability evaluating file in file processes, modification and perfection file if desired, both pasted
Nearly conventional thought and real work pattern, also meet the clause requirement of administrative standard, the control to log file, also corresponds to existing
The real clause needed with standard.
7. System Documents confidentiality significantly improves: constituting the various information dispersion storage of complete file, system has not existed
Whole file is individual, only automatically integrates when checking file and presents " complete file ", and employee need to authorize access and operation file, permissible
Effectively prevent file from divulging a secret.
Accompanying drawing explanation
The block diagram of Tu1Shi medical laboratory Quality control system documents control system.
The standardization method step figure of Tu2Shi medical laboratory Quality control system documents.
Detailed description of the invention
In order to make technical problem solved by the invention, technical scheme and beneficial effect clearer, below in conjunction with
Accompanying drawing and embodiment, the present invention is further illustrated.Should be appreciated that embodiment described herein is used only for explaining this
Invention, is not intended to limit the present invention.
As it is shown in figure 1, the present invention provides the control system of a kind of medical laboratory Quality control system documents, this control system
System is formed by with lower part:
(1) system parameter setting module: be used for arranging laboratory department, employee's account, employee role and role-security, builds literary composition
Part controls environment, accurately controls employee and operates dissimilar and state file；
(2) System Documents parameter setting module: be used for setting up System Documents framework, including arrange quality system (title, version,
Key element) information and file set (title, department, examination & approval role) information, in file set, set up file (title and built-in is set
Structure masterplate, automatically generates reference number of a document) and dead file；
(3) document files editor module: be used for the document template using the editor of " What You See Is What You Get " to call setting
Read slave mode or do not submit to the file of application carry out content modification or from the beginning write document in masterplate blank, and associating literary composition
Shelves and system information；
(4) document files approval module: present a paper application, auditor's audit document, ratifier's approval documents for author,
Update the state of file and version number and generate document approvals information；
(5) file operation prompting module: according to file status in document approvals process, sends file operation reminder message automatically；
(6) module consulted by document: browse and search controlled file (authorized employees includes historical archive) for packet, reads
File automatically controls layout's display all information of file and preserves learning records, provides file content to search, prevent simultaneously
Divulge a secret and authorize output function；
(7) document evaluation module: be used for keeping track of file evaluation situation, collect and output file review record；
(8) form compiling module: for by form data and entry information preparation (increase, revise, disable) are simply provided
Charting；
(9) module filled in record: browses for packet and lookup table, automatically controls entry layout and dynamically generate form,
Hold that action-item is chosen, record is quickly filled in the drop-down selection of department, date picker, the operation such as default value and RichTextBox；
(10) module consulted in record: for checking all records of certain form in summary mode, and presses summary info inquiry spy
Determine record, then check the details recorded with original forms mode.
Employee role that this control system sets according to laboratory and authority, accurately control employee and operate dissimilar and shape
The file of state, it is achieved comprehensive control of System Documents, meets the requirement of quality control standard.File comprises document files and record
File 2 type, document files have write, pending, reprocess, audit termination, issued for approval, approval termination, slave mode and
8 kinds of states of historical archive, it is possible to achieve editor's (write, reprocess, slave mode) file, file (write, reprocess) are applied for, audited
(pending) file, approval (issued for approval) file, consult (slave mode, historical archive) file, evaluation (slave mode) file,
Disable 7 kinds of functions of (slave mode) file, additionally, accessed document automatically saves learning records, by arranging System Documents parameter
Deng 3 operations, can quickly realize file and turn version；Charting has and enables and disable 2 kinds of states, it is possible to achieve establishment is (new
Build, revise, disable) form, fill in (enabling) charting and check (enable and disable) 3 kinds of functions of charting,
Establishment form only need to be simply provided form data and entry information, and revising and disable form does not affect and follow-up check and fill in note
Record.
This control system the most directly stores and manages file " entity ", and file is stored in disparate databases table also by dispersion
The system that is mutually related information, identification information, version information, status information, approval information and body matter are constituted, and are only reading
Time automatically integrated by system and to present " full document ".Go through and " System Documents parameter is set and sets up System Documents framework generation body
To be information with identification information, editor's document files generate body matter setting up associate, experiences approval process generation version information
And approval information " 3 steps, complete controlled file could be formed.
This control system sets up the overall framework of System Documents by arranging System Documents parameter, comprises following operation step
Rapid:System title, version and key element are set；Add file set (such as quality manual), title, applicable department need to be specified, examine
Criticize role；Setting up file in file set, need to specify title and built-in file structure masterplate, system automatically generates file and compiles
Number etc. file identification information；As needed file to turn version, the new system version of interpolation and key element are set；As controlled literary composition need to be cancelled
Part, file identification in dead file collection.
This control system uses the editor of " What You See Is What You Get " to realize documents editing function, and editing machine calls and sets
Fixed document template reads slave mode or does not submits to the file of application carry out content modification or from the beginning write in masterplate blank space
Content, generates document body content, and content supports the many forms such as word, bulleted list, picture, multimedia and adnexa.
The built-in 5 kinds of file structure masterplates of this control system, are respectively as follows: quality manual masterplate, program file masterplate, item class
SOP masterplate, program class SOP masterplate, external documents masterplate, can be effectively improved document quality and write efficiency.
This control system document approval process specification, is made up of file application, audit document, 3 steps of approval documents, should
Flow process automatically updates file status and version number, generates document approvals information, is a step of preparation of document, is also to be formed to be subject to
Control file and complete file must be by approach.The file that examination & approval are not passed through terminates automatically, and the file approved becomes controlled literary composition
Part, former controlled file is automatically abrogated filing, controlled file and archive file auto-associating, can be followed the tracks of the dynamic change of identical file
Change.Additionally, system has file operation prompting function, document approvals process can be accelerated, shorten documentation time.
This control system fileversion number is approved number, examination & verification by number and file application by this document of like-identified
Array become, fileset version number by this document collection All Files approve number, examination & verification by number and file application array
Become.Example: the version number of certain file is 1.3.5, then this document has 5 submission applications, and 3 examination & verifications are passed through, and approve for 1 time.Version
This number is operated by document approvals and to automatically update, and each file Jun You version number going through approval process (does not submits the file of application to
Version number is 0.0.0), fileversion number can follow the tracks of the dynamic change of file, and fileset version number can react its overall feelings
Condition.
This control system accessed document is the most convenient, and file obtains the most at any time, can browse listed files by packet
Or locating function is quickly found out required controlled file (authorized employees includes historical archive), provides during reading file and search merit
Energy quick obtaining information needed, additionally, authorized employees can use with output file off-line, moreover it is possible to link checks that corresponding history is deposited
Files.
This control system support quickly realizes file and turns the function of version, and it operates and flow process is:By arranging system literary composition
Part parameter increases system version and key element newly；Update associating of document and system information by documents editing operation, and carry out must
The content modification wanted；Controlled file is regenerated by document approvals flow process.
This control system controls charting file with achieving " easy, flexible, specification ", it may be assumed that a. is by being simply provided
Form data and entry information 2 operation realize establishment form, and during use, system automatically controls entry layout and dynamically generates
Form, revising and disable form does not affect and follow-up check and fill in record；B. fill in record support action-item choose, department drop-down
The fast operatings such as selection, date picker, default value and RichTextBox, RichTextBox content allow word, picture, multimedia and
The many forms supports such as adnexa are filled in flexibly, and repeatedly form is follow-up when filling in record, it is impossible to revise previous entry letter
Breath also can follow the tracks of which entry when who fill in；When c. checking record, summary mode checks that support is looked into by summary info
Inquiry is quickly found out required record.
It addition, the invention still further relates to the standardization method of a kind of medical laboratory Quality control system documents, such as Fig. 2
Shown in, the step of this standardization method is:
(1) laboratory department, employee's account, employee role and role-security are set, build at the beginning of document control environment, completion system
Beginningization；
(2) setting includes a. quality system (title, version, key element) information, and b. file set (title, department, examination & approval role) is believed
Breath, the System Documents parameter of 3 aspects of file identification (title) information in c. file set, set up System Documents overall framework also
Generate system information and the identification information of file；
(3) for document files, perform step (4)-(9), for log file, perform step (10)-(12)；
(4) writing role uses editor to write or editing files body matter, and associates system information；
(5) after Document Editing completes, author presents a paper application, and file enters pending state, sends Note Auditing and reminds
Message；
(6) examination & verification role receives reminder message, it is provided that audit opinion audit document, and examination & verification is passed through, and file enters issued for approval state,
Send file approval reminder message；
(7) approval role receives reminder message, it is provided that approval suggestion approval documents, approves, and file enters slave mode, sends out
File is sent to learn reminder message；
(8) all employees receive reminder message, and reading file carries out study and and guides work, recording learning situation；
(9) during system running, file suitability is evaluated by employee, and keeps track of evaluation situation, and evaluation confirms suitable
With, then file is continuing with；
(10) authorize role that form data and entry information preparation charting are set；
(11) during system running, employee opens suitable form and fills in record, forms quality and technical notes file；
(12) carry out checking log file when quality examination and track record, check all notes of a form in the mode of making a summary
Record, searches specific record by summary info, then checks certain details recorded with forms mode.
Further, in described step (5), before application of presenting a paper, if file still imperfection, could be on the basis of former
Again revise.
Further, in described step (6), if examination & verification decision is passed through, then file enters issued for approval state, sends approval
Reminder message；If examination & verification determines not pass through, then file enters final state, sends examination & verification failed message, it is desirable to rewritable paper；
If examination & verification decision is reprocessed, then file enters state of reprocessing, and sends and reprocesses reminder message, it is desirable to amendment file.
Further, in described step (7), if approval decision is passed through, then file enters slave mode and files former being subject to
Control file (if present), sends study reminder message；If approval determines not pass through, then file enters final state, sends
Approval failed message, it is desirable to rewritable paper.
Further, in described step (9), if evaluation confirms to be suitable for, then file is continuing with；If evaluation confirms not
It is suitable for, then sends amendment reminder message, it is desirable to amendment file.
Further, during using form, modified as needed to form, then establishment form disables and/or increases entry newly；As
Need to cancel form, then establishment form arranges form for disabling.
Further, during system running, fill in record as followed the tracks of, check repeatedly the imperfect of table at forms mode
Can again fill in during record.
Further, after System Documents is set up, as needed file to turn version, then System Documents parameter is set and adds new system version
Basis and key element, editing files association redaction key element, the controlled file of generation of clearing a paper；As controlled file need to be cancelled, then arrange
System Documents parameter dead file identifies.
In sum, the control system of medical laboratory's Quality control system documents of the present invention and standardization side thereof
Method can realize writing and revising file, audit and ratify literary composition with information-based means on the premise of meeting quality control standard
Part, consult and evaluate file, establishment charting, fill in and look up the records, support simple operations quickly realize file turn version and
Dynamic manning quotas charting, simply and efficiently controls document of Quality System comprehensively.
The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all spirit in the present invention and
Any amendment made within principle, equal replacement and improvement etc., all should fall within the scope and spirit of the invention.
Claims (10)
1. the control system of medical laboratory's Quality control system documents, it is characterised in that this control system is by with bottom
It is grouped into:
(1) system parameter setting module: be used for arranging laboratory department, employee's account, employee role and role-security, builds literary composition
Part controls environment, accurately controls employee and operates dissimilar and state file；
(2) System Documents parameter setting module: be used for setting up System Documents framework, including arranging quality system information and file set
Information, sets up file and dead file in file set；
(3) document files editor module: be used for the document template using the editor of " What You See Is What You Get " to call setting
Read slave mode or do not submit to the file of application carry out content modification or from the beginning write document in masterplate blank, and associating literary composition
Shelves and system information；
(4) document files approval module: present a paper application, auditor's audit document, ratifier's approval documents for author,
Update the state of file and version number and generate document approvals information；
(5) file operation prompting module: according to file status in document approvals process, sends file operation reminder message automatically；
(6) module consulted by document: browses for packet and searches controlled file, and reading file automatically controls layout's display literary composition
The all information of part also preserves learning records, provides file content to search, prevent from divulging a secret and authorizing output function simultaneously；
(7) document evaluation module: be used for keeping track of file evaluation situation, collect and output file review record；
(8) form compiling module: for by form data and entry information preparation charting are simply provided；
(9) module filled in record: browses for packet and lookup table, automatically controls entry layout and dynamically generate form,
Hold that action-item is chosen, record is quickly filled in the drop-down selection of department, date picker, the operation such as default value and RichTextBox；
(10) module consulted in record: for checking all records of certain form in summary mode, and presses summary info inquiry spy
Determine record, then check the details recorded with original forms mode；
Employee role that this control system sets according to laboratory and authority, accurately control employee and operate dissimilar and state
File, it is achieved editing files, file application, audit document, approval documents, accessed document, evaluation file, dead file, establishment
Form, fill in record and 10 kinds of major functions of looing up the records；This control system the most directly stores and manages " entity " file, file
Stored by dispersion and be mutually related system information, identification information, version information, status information, approval information and body matter
Deng constituting, only automatically integrated by system when reading file and present " full document ", go through that " QA Supervisor arranges System Documents
Parameter sets up System Documents framework generation structure information and identification information, the RichText Edition of author's employing ' What You See Is What You Get '
Device calls document template editor's document files of setting and generates body matter and set up association, examine role and clear a paper generation version
This information and approval information " 3 steps could form complete controlled file, and all employees carry out file study and evaluate file,
Generate the additional information of file；This control system is by working out form, filling in record and check 3 kinds of functional realiey record controls of record
System, establishment form only need to be simply provided form data and entry information, and revising and disable form does not affect and follow-up check and fill out
Write record.
The control system of a kind of medical laboratory the most according to claim 1 Quality control system documents, it is characterised in that:
The built-in 5 kinds of file structure masterplates of described control system also automatically generate documentation release number, and 5 kinds of described document template are respectively
For: quality manual masterplate, program file masterplate, item class SOP masterplate, program class SOP masterplate and external documents masterplate；Document version
This number is counted by approving of this document, audits to be become with file application array by number, and version number is operated by document approvals automatically
Update, the dynamic change of file can be followed the tracks of.
3. the standardization method of medical laboratory's Quality control system documents, it is characterised in that: this standardization
The step of method is:
(1) laboratory department, employee's account, employee role and role-security are set, build at the beginning of document control environment, completion system
Beginningization；
(2) setting includes: a. quality system information, b. fileset information, 3 aspects of file identification information in c. file set
System Documents parameter, sets up System Documents overall framework and generates system information and the identification information of file；
(3) for document files, perform step (4)-(9), for log file, perform step (10)-(12)；
(4) writing role uses editor to write or editing files body matter, and associates system information；
(5) after Document Editing completes, author presents a paper application, and file enters pending state, sends Note Auditing and reminds
Message；
(6) examination & verification role receives reminder message, it is provided that audit opinion audit document, and examination & verification is passed through, and file enters issued for approval state,
Send file approval reminder message；
(7) approval role receives reminder message, it is provided that approval suggestion approval documents, approves, and file enters slave mode, sends out
File is sent to learn reminder message；
(8) all employees receive reminder message, and reading file carries out study and and guides work, recording learning situation；
(9) during system running, file suitability is evaluated by employee, and keeps track of evaluation situation, and evaluation confirms suitable
With, then file is continuing with；
(10) authorize role that form data and entry information preparation charting are set；
(11) during system running, employee opens suitable form and fills in record, forms quality and technical notes file；
(12) carry out checking log file when quality examination and track record, check all notes of a form in the mode of making a summary
Record, searches specific record by summary info, then checks certain details recorded with forms mode.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levy and be: in described step (5), before application of presenting a paper, if file still imperfection, again can revise on the basis of former.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levying and be: in described step (6), if examination & verification decision is passed through, then file enters issued for approval state, sends approval reminder message；
If examination & verification determines not pass through, then file enters final state, sends examination & verification failed message, it is desirable to rewritable paper；If examination & verification
Decision is reprocessed, then file enters state of reprocessing, and sends and reprocesses reminder message, it is desirable to amendment file.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levying and be: in described step (7), if approval decision is passed through, then file enters slave mode and files former controlled file, sends
Study reminder message；If approval determines not pass through, then file enters final state, sends approval failed message, it is desirable to rewrite
File.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levying and be: in described step (9), if evaluation confirms to be suitable for, then file is continuing with；If evaluation confirms inapplicable, then send out
Send amendment reminder message, it is desirable to amendment file.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levying and be: during using form, modified as needed to form, then establishment form disables and/or increases entry newly；As table need to be cancelled
Lattice, then establishment form arranges form for disabling.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levy and be: during system running, fill in record as followed the tracks of, can be again when forms mode checks repeatedly the imperfect record of table
Secondary fill in.
The standardization method of a kind of medical laboratory the most according to claim 3 Quality control system documents, it is special
Levy and be: after System Documents is set up, as needed file to turn version, then System Documents parameter is set and adds new system version and key element,
Editing files association redaction key element, the controlled file of generation of clearing a paper；As cancelled controlled file, then System Documents ginseng is set
Number dead file mark.
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| CN111045984A (en) * | 2019-11-27 | 2020-04-21 | 云南电网有限责任公司电力科学研究院 | Power grid laboratory file management system and method |
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| CN113177696A (en) * | 2021-04-09 | 2021-07-27 | 上海辛格迪健康科技有限公司 | Method and system for generating controlled file template of medicine quality system |
| CN113204524A (en) * | 2021-05-28 | 2021-08-03 | 中航机载系统共性技术有限公司 | System file collaborative editing system and method |
| WO2023020549A1 (en) * | 2021-08-18 | 2023-02-23 | 北京字跳网络技术有限公司 | Information processing method and apparatus, terminal, and storage medium |
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Application publication date: 20161207 |