CN101714132A - Method for automatically generating batch release abstracts in vaccine production - Google Patents
Method for automatically generating batch release abstracts in vaccine production Download PDFInfo
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- CN101714132A CN101714132A CN200910230223A CN200910230223A CN101714132A CN 101714132 A CN101714132 A CN 101714132A CN 200910230223 A CN200910230223 A CN 200910230223A CN 200910230223 A CN200910230223 A CN 200910230223A CN 101714132 A CN101714132 A CN 101714132A
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 28
- 229960005486 vaccine Drugs 0.000 title claims abstract description 25
- 238000000034 method Methods 0.000 title claims abstract description 14
- 238000013499 data model Methods 0.000 claims description 6
- 238000010923 batch production Methods 0.000 claims description 3
- 238000012423 maintenance Methods 0.000 claims description 3
- 238000007726 management method Methods 0.000 claims description 3
- 229940079593 drug Drugs 0.000 abstract description 4
- 239000003814 drug Substances 0.000 abstract description 4
- 238000013480 data collection Methods 0.000 abstract 1
- 230000002708 enhancing effect Effects 0.000 abstract 1
- 208000037805 labour Diseases 0.000 abstract 1
- 239000000047 product Substances 0.000 description 15
- 238000003556 assay Methods 0.000 description 2
- 230000005856 abnormality Effects 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000013479 data entry Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 231100000572 poisoning Toxicity 0.000 description 1
- 230000000607 poisoning effect Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
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- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Abstract
The invention provides a method for automatically generating batch release abstracts in vaccine production, which is used for vaccine enterprises in which drug production off-site supervision systems are implemented, automatically generates the batch release abstract documents in an enterprise-required format to replace the original manual editing mode, and comprises the following contents: 1) a data module; 2) a definition of batch release abstract document format; 3) a definition of corresponding relationship between data project contents and system data contents; and 4) a production batch release abstract document. The design method in the invention can automatically generate the electronic documents of the vaccine batch release abstracts which are required to report to the country by data collection in the vaccine production process and flexible customizing on the batch release abstract format, and has the advantages of improving efficiency greatly, saving labors and enhancing accuracy compared with the original manual filling mode.
Description
Technical field
The present invention relates to a kind of production of vaccine approval and sign and send out the method that summary generates automatically, specifically a kind of.The present invention relates in production of vaccine, a kind of word document format that can freely define, and generate the instrument that summary (making and the calibrating record) content is sent out in approval and sign automatically according to form, major technique relates to the word document content and replaces.
Background technology
In pharmaceutical production, the vaccine formulation is owing to be biological products, and the process abnormality complexity is in case the influence that goes wrong also is maximum.After general pharmaceutical production is finished, as long as by the check of this enterprise sale of just can letting pass, but vaccine product is except this enterprise upchecks, the more important thing is that every batch of vaccine product all wants sample presentation to test for the national drug biological products assay institute, after having only the national drug biological products assay institute to upcheck, the sale of could letting pass of this batch products.
Vaccine enterprise gives vaccine product that calibrating inspected by ready samples except that sample, also has the approval and sign of a this batch products to send out summary (making and the calibrating record), content record the production and the check data of critical process of process of producing product, supply State Bureau to examine.It all is the Word file of set form generally that summary is sent out in approval and sign, carries out the edit typing by the related personnel of enterprise according to practical condition.But have part vaccine enterprise to implement non-at-scene quality monitoring system now, the information that summary needs is sent out in approval and sign, has most ofly also carried out typing in non-at-scene supervisory systems.
By exchanging with enterprise, we consider whether can generate automatically and make and the calibrating record by extract data from supervisory systems, avoid enterprise to repeat logging data, improve enterprise work efficient.
Realize that thinking is such, at first send out the summary form according to approval and sign, compile the word file by enterprise, the part that need obtain from supervisory systems is defined as special character, form the word template, next define the corresponding relation of data in these special characters and the system.Behind batch vaccine product data entry system, system generates a new approval and sign automatically according to the word template and sends out Summary file, according to corresponding relation, obtains data and replace special character from system, summary record is sent out in the approval and sign that forms batch vaccine finished product, has substituted edit.
Summary of the invention
The purpose of this invention is to provide a kind of production of vaccine approval and sign and send out the method that summary generates automatically.
The objective of the invention is to realize in the following manner, to implementing the vaccine enterprise of the non-at-scene supervisory systems of pharmaceutical production, according to system's data with existing, generate automatically enterprise require form approval and sign send out the summary record document, substitute original edit pattern, comprise following content:
1) data model; 2) the Summary file formal definition is sent out in approval and sign; 3) data items content and system data content corresponding relation definition; 4) Summary file is sent out in the production approval and sign; Below foregoing is described respectively:
1) data model
Summary word template definition is sent out in approval and sign: comprising:
Template is numbered the template Unified coding to definition, is convenient to maintenance management;
Template name: the template name of giving definition;
Template file: by calling word, carry out template definition, preserve into the word file;
The template data project definition:
Template numbering: affiliated template
Data item name: to the data item name that needs in the template to replace; Comprise producing and use the cell lot number;
Data items is represented character: the special character of data items in the representation template comprises producing and represents with cell lot number Yong $xbph$;
2) the Summary file formal definition is sent out in approval and sign, be that summary word template definition is sent out in approval and sign, call the newly-built file of local word by defining tool, sending out the summary form according to approval and sign edits file, need to show the place of concrete production data, be defined as special character, preserve after definition is finished;
3) data items content and system data content corresponding relation definition
With the special character that defines in the last step template, the corresponding relation of selective system data item comprises using to produce in the $xbph$ representative system and uses the cell lot number, and the result is saved in the tables of data;
4) Summary file is sent out in the production approval and sign
After certain batch of vaccine product data are entered into non-at-scene supervisory systems, to send out summary template and data item corresponding relation according to approval and sign defined above and just can form final approval and sign and sent out Summary file, performing step is:
(1) in batch production data from system, obtains the concrete data item occurrence that all need.As to produce with cell lot number value be XB090801-01
(2) from corresponding relation, find the special character of data item correspondence successively.As produce with cell lot number Shi $xbph$
(3), set up a new word file by duplicating template file;
(4) to newly-built word file, call word control method by js, find corresponding special character position successively, as $xbph$, replace to corresponding reality value XB090801-01 then;
(5) rename and preserve word file after the replacement, Summary file is sent out in the approval and sign that generates automatically exactly;
(6) if the system data typing is complete, general edit again.If individual data is incomplete, the file related content that generates can be sky automatically, can slightly make an amendment and adjust.
Beneficial effect of the present invention is as follows
1) the vaccine product production cycle long, related data is many, it is cumbersome that Summary file is sent out in original edit approval and sign, the special hilllock of basic need special messenger.Change into after non-at-scene supervisory systems extraction data, form approval and sign automatically and send out Summary file, can cancel approval and sign substantially and send out summary editor post.Improve efficient to enterprise, saved cost.
2) original edit approval and sign is sent out Summary file and is occurred mistake easily, and all is etc. after batch products production is finished, just to begin editor, and there is the space of altered data in enterprise.
Automatically forming approval and sign by system, to send out Summary file stronger than edit accuracy, and data from non-at-scene supervisory systems, non-at-scene supervisory systems data all will report Bureau of Drugs Supervision, restricted to data typing promptness, the user must logging data in wanting seeking time, and some data directly gathers by industrial control equipment, so the data validity is than higher.
If enterprise distorts the approval and sign of automatic formation and sends out summary, will cause with non-at-scene supervisory systems data inconsistently, in case the poisoning incident takes place, can become the fraud evidence.This risk generally can not emitted by enterprise, sends out summary and can also guarantee the reported data authenticity so generate approval and sign automatically.
Embodiment
To implementing the vaccine enterprise of the non-at-scene supervisory systems of pharmaceutical production, according to system's data with existing, automatically manufacturing enterprise require form approval and sign send out the summary record document, substitute original edit pattern.Comprise following content:
1) data model
2) the Summary file formal definition is sent out in approval and sign
3) data items content and system data content corresponding relation definition;
4) Summary file is sent out in the production approval and sign
Below foregoing is described respectively:
1) data model
Summary word template definition is sent out in approval and sign: comprising:
Template is numbered the template Unified coding to definition, is convenient to maintenance management;
Template name: give the template name of definition, because approval and sign fat file form basic fixed, template of General Definition gets final product.
Template file: by calling word, carry out template definition, preserve into the word file.
The template data project definition:
Template numbering: affiliated template
Data item name: to the data item name that needs in the template to replace.As: produce and use the cell lot number
Data items is represented character: the special character of data items in the representation template, as: produce and represent with cell lot number Yong $xbph$.
2) the Summary file formal definition is sent out in approval and sign
Be that summary word template definition is sent out in approval and sign, call the newly-built file of local word, send out the summary form according to approval and sign file is edited, need to show the place of concrete production data, be defined as special character, preserve after definition is finished by defining tool.
3) data items content and system data content corresponding relation definition
With the special character that defines in the last step template, the corresponding relation of selective system data item.Use the cell lot number as producing in the $xbph$ representative system, and the result is saved in the tables of data.
4) Summary file is sent out in the production approval and sign
After certain batch of vaccine product data are entered into non-at-scene supervisory systems, to send out summary template and data item corresponding relation according to approval and sign defined above and just can form final approval and sign and sent out Summary file, performing step is:
1. in batch production data from system, obtain the concrete data item occurrence that all need.As to produce with cell lot number value be XB090801-01
2. from corresponding relation, find the special character of data item correspondence successively.As produce with cell lot number Shi $xbph$
3. by duplicating template file, set up a new word file.
4. to newly-built word file, call word control method, find corresponding special character position successively,, replace to corresponding reality value XB090801-01 then as $xbph$ by js.
5. rename and preserve the word file after the replacement, Summary file is sent out in the approval and sign that generates automatically exactly.
6. if the system data typing is complete, general edit again.If individual data is incomplete, the file related content that generates can be sky automatically, can slightly make an amendment and adjust.
Claims (1)
1. the method that summary generates is automatically sent out in a production of vaccine approval and sign, it is characterized in that implementing the vaccine enterprise of the non-at-scene supervisory systems of pharmaceutical production, according to system's data with existing, automatically generate enterprise require form approval and sign send out the summary record document, substitute original edit pattern, comprise following content:
1) data model; 2) the Summary file formal definition is sent out in approval and sign; 3) data items content and system data content corresponding relation definition; 4) Summary file is sent out in the production approval and sign; Wherein:
1) data model comprises following content:
Summary word template definition is sent out in approval and sign: comprising:
Template is numbered the template Unified coding to definition, is convenient to maintenance management;
Template name: the template name of giving definition;
Template file: by calling word, carry out template definition, preserve into the word file;
The template data project definition:
Template numbering: affiliated template
Data item name: to the data item name that needs in the template to replace; Comprise producing and use the cell lot number;
Data items is represented character: the special character of data items in the representation template comprises producing and represents with cell lot number Yong $xbph$;
2) the Summary file formal definition is sent out in approval and sign, be that summary word template definition is sent out in approval and sign, call the newly-built file of local word by defining tool, sending out the summary form according to approval and sign edits file, need to show the place of concrete production data, be defined as special character, preserve after definition is finished;
3) data items content and system data content corresponding relation definition
With the special character that defines in the last step template, the corresponding relation of selective system data item comprises using to produce in the $xbph$ representative system and uses the cell lot number, and the result is saved in the tables of data;
4) Summary file is sent out in the production approval and sign
After certain batch of vaccine product data are entered into non-at-scene supervisory systems, to send out summary template and data item corresponding relation according to approval and sign defined above and just can form final approval and sign and sent out Summary file, performing step is:
(1) in batch production data from system, obtains the concrete data item occurrence that all need.As to produce with cell lot number value be XB090801-01
(2) from corresponding relation, find the special character of data item correspondence successively.As produce with cell lot number Shi $xbph$
(3), set up a new word file by duplicating template file;
(4) to newly-built word file, call word control method by js, find corresponding special character position successively, as $xbph$, replace to corresponding reality value XB090801-01 then;
(5) rename and preserve word file after the replacement, Summary file is sent out in the approval and sign that generates automatically exactly;
(6) if the system data typing is complete, general edit again.If individual data is incomplete, the file related content that generates can be sky automatically, can slightly make an amendment and adjust.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910230223A CN101714132A (en) | 2009-11-13 | 2009-11-13 | Method for automatically generating batch release abstracts in vaccine production |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910230223A CN101714132A (en) | 2009-11-13 | 2009-11-13 | Method for automatically generating batch release abstracts in vaccine production |
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| Publication Number | Publication Date |
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| CN101714132A true CN101714132A (en) | 2010-05-26 |
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| CN200910230223A Pending CN101714132A (en) | 2009-11-13 | 2009-11-13 | Method for automatically generating batch release abstracts in vaccine production |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106940693A (en) * | 2017-02-28 | 2017-07-11 | 广东智源信息技术有限公司 | Laboratory original record single structure processing method |
| CN113468861A (en) * | 2020-06-12 | 2021-10-01 | 拜耳股份有限公司 | Method and device for automatically generating abstract document |
-
2009
- 2009-11-13 CN CN200910230223A patent/CN101714132A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106940693A (en) * | 2017-02-28 | 2017-07-11 | 广东智源信息技术有限公司 | Laboratory original record single structure processing method |
| CN106940693B (en) * | 2017-02-28 | 2020-09-01 | 广东智源信息技术有限公司 | Single structure processing method for laboratory original record |
| CN113468861A (en) * | 2020-06-12 | 2021-10-01 | 拜耳股份有限公司 | Method and device for automatically generating abstract document |
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Open date: 20100526 |