CN110910081A - Workflow configuration implementation method and system based on laboratory information management system - Google Patents
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Abstract
The invention provides a workflow configuration realization method and a workflow configuration realization system based on a laboratory information management system, which are used for reading the existing flow information and generating a detection flow needing to be configured; determining a workflow node of each inspection process, and determining a workflow node needing to be configured; setting operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node; setting the sequence of workflow nodes according to a checking flow to form a checking workflow; configuring the authority of the workflow; judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; and if the SOP specification is not met, the workflow is failed. By utilizing the activity workflow, different inspection workflows are registered for different samples according to the general operation flow of laboratories in the pharmaceutical industry, so that the sample inspection can be realized for various samples according to the SOP of the samples, the GMP standard is met, and the code development work and the related verification work are reduced.
Description
Technical Field
The invention relates to the field of laboratory information management of pharmaceutical enterprises, in particular to a workflow configuration implementation method and system based on a laboratory information management system.
Background
The application of the laboratory information management system of the domestic pharmaceutical enterprise is at the beginning stage at present. Most of laboratories of pharmaceutical enterprises still adopt manual methods to manage the laboratories, manual inspection processes such as sample management, process recording and inspection result checking are completed through paper records, and with the increase of sample detection quantity, the expansion of laboratory detection scale and the continuous improvement of laboratory requirements, the traditional laboratory management methods cannot meet business requirements. And the promotion of the new GMP (Good Manufacturing practice) implementation and management idea and the acceleration of the internationalization steps of each enterprise make the use of the information management system of the pharmaceutical laboratory a necessary trend.
In order to make the configuration of the workflow as consistent as possible with the laboratory inspection SOP, when the laboratory information management system workflow designer is used, the laboratory inspection SOP needs to be analyzed first to form respective inspection flows of each material. According to ISPE gam 5, european GMP texts and appendices, ISPE pharmaceutical engineering guidelines and appendices, fifth edition of the Good automated manufacturing code for gam 5(Good automated manufacturing Practice 5), american cGMP: according to the requirements of laws and regulations such as 21CFR 210&211,21CFR part 11, GMP-production quality management Specification (revised 2010), Chinese GMP computerized system annex and the like, 4-5 types of verification are required to be carried out on a laboratory information management system according to software classification, risk assessment and control must be strictly carried out on software development and any change, sufficient tests are carried out, and when the software is delivered to a user, a corresponding verification document needs to be provided so as to be really used in a medicine enterprise. Under the requirement, if the pharmaceutical laboratory information management system cannot carry out user customized configuration on the inspection flows of various samples, the concurrent processing of different inspection workflows of multiple samples is realized, the software is inevitably changed and verified continuously, the cost investment of software suppliers and medicine enterprises is greatly increased, and the popularization and the application of the pharmaceutical laboratory information management system in the pharmaceutical industry are not facilitated. Therefore, the inspection workflow designer is introduced into the information management system of the pharmaceutical laboratory, which is beneficial to improving the applicability and the productization of the information management system of the pharmaceutical laboratory in the pharmaceutical industry.
At present, the inspection processes of the information management system of the pharmaceutical laboratory on various samples are still in a customized development stage, the software development cost is high, the maintenance investment is large, how to avoid the customized development of a large number of inspection processes needs to really realize the software productization of the information management system of the pharmaceutical laboratory, and the software verification cost of pharmaceutical enterprises is further reduced.
Patent document CN104115139A discloses a technique for providing access to clients for creating, configuring and executing functions of a defined workflow that manipulates source data in a defined manner, such as under the control of a configurable workflow service that is available to multiple remote clients over one or more public networks. A client's defined workflow may, for example, include a plurality of interconnected workflow components that are specified by the client and that are each configured to perform one or more types of data manipulation operations on a specified type of input data. The configurable workflow service may also execute the defined workflow one or more times and in one or more ways, such as in some cases by provisioning multiple compute nodes provided by the configurable workflow service to each implement at least one of the workflow components of the defined workflow.
Patent document CN102567825A discloses a method and apparatus for workflow flow configuration, the method comprising the steps of: outputting data objects, wherein the data objects comprise a receipt object and an approval object which are associated with a process variable; and configuring subsequent nodes of the workflow according to the data object. In the whole workflow process configuration, the flow variables which are defined in a complicated way are not used any more, and the subsequent nodes are configured by the field attributes of the document objects associated with the flow variables, so that the workflow process configuration method is easy to understand, reduces the probability of configuration errors and reduces the workload of the workflow configuration.
Disclosure of Invention
Aiming at the defects in the prior art, the invention aims to provide a workflow configuration implementation method and a workflow configuration implementation system of a laboratory information management system.
The workflow configuration implementation method based on the laboratory information management system provided by the invention comprises the following steps of: reading the existing process information to generate a checking process needing configuration; and determining workflow nodes: determining a workflow node of each inspection process, and determining a workflow node needing to be configured; and (3) permission confirmation step: setting operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node; arranging workflow nodes: setting the sequence of workflow nodes according to a checking flow to form a checking workflow; and (3) setting the authority: configuring the authority of the workflow; and a workflow validation step: judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; if the SOP standard is not met, the workflow is failed; a workflow display step: displaying the validated workflow on a viewing panel, and displaying inspection information of the sample; and an effective workflow saving step: the validated workflow is saved in xml format.
Preferably, the workflow configuration implementation method based on the laboratory information management system further includes a step of SOP specification analysis; and (3) SOP specification analysis step: and analyzing the SOP specification, and performing function matching on the inspection process in the SOP specification and the workflow node.
Preferably, the workflow configuration implementation method based on the laboratory information management system further comprises a workflow selection step; and a workflow selection step: in registering a sample operation, a desired workflow is selected for the sample, and after the registering of the sample operation is completed, the sample can be examined in accordance with the selected workflow.
Preferably, the verification information includes current verification stage, handler information.
Preferably, the workflow nodes needing configuration are configured in a flow designer.
Preferably, the workflow nodes mainly include a start point of the inspection flow, an end point of the inspection flow, and an intermediate inspection node of the inspection flow.
Preferably, the storage information of the workflow node mainly includes a node executor, a node name, a node return flag, and a node termination flag.
Preferably, the validated workflow saved in xml format is enabled to generate a workflow version number.
According to the present invention, a computer-readable storage medium is provided, in which a computer program is stored, which, when being executed by a processor, carries out the steps of the above-mentioned method.
The workflow configuration implementation system based on the laboratory information management system comprises the following modules: reading the existing process information to generate a checking process needing configuration; determining a workflow node module: determining a workflow node of each inspection process, and determining a workflow node needing to be configured; and a permission confirming module: setting operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node; the workflow node arranging module: setting the sequence of workflow nodes according to a checking flow to form a checking workflow; and a permission setting module: configuring the authority of the workflow; an effective workflow module: judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; if the SOP standard is not met, the workflow is failed; a workflow display module: displaying the validated workflow on a viewing panel, and displaying inspection information of the sample; an effective workflow saving module: the validated workflow is saved in xml format.
Compared with the prior art, the invention has the following beneficial effects:
1. the invention realizes the configuration processing of the inspection flow, avoids a large amount of customized development of the inspection flow and reduces the software verification cost of pharmaceutical enterprises;
2. the method supports pharmaceutical enterprise laboratory personnel to further optimize the inspection process by combining with the SOP procedure of the laboratory, meets the requirement of compliance and provides effective support for the subsequent optimization inspection process;
3. the invention supports the laboratory departments of pharmaceutical enterprises to carry out the control of the whole inspection process, provides an automatic workflow configuration realization method of different inspection processes of multiple samples, is used as an effective control means of the laboratory sample detection process control, and obviously improves the compliance control level and the working efficiency of the laboratory diversified product detection process.
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Other features, objects and advantages of the invention will become more apparent upon reading of the detailed description of non-limiting embodiments with reference to the following drawings:
FIG. 1 is a schematic process flow diagram of the method of the present invention.
Detailed Description
The present invention will be described in detail with reference to specific examples. The following examples will assist those skilled in the art in further understanding the invention, but are not intended to limit the invention in any way. It should be noted that it would be obvious to those skilled in the art that various changes and modifications can be made without departing from the spirit of the invention. All falling within the scope of the present invention.
The invention provides a workflow configuration implementation method based on a laboratory information management system, which comprises the following steps: confirming and checking flow steps: reading the information of the existing process, generating a testing process to be configured, analyzing and summarizing the sample testing process of the laboratory of the pharmaceutical enterprise, and determining how many different testing processes are available from the sample to be tested in the existing laboratory; and determining workflow nodes: determining a workflow node of each inspection flow, determining the workflow nodes to be configured, and confirming the workflow operation nodes of each inspection flow so as to determine all the workflow operation nodes to be configured by the laboratory flow designer; and (3) permission confirmation step: setting the operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node, and the inspection work is completely controlled by the set authority when reaching a specific certain node; arranging workflow nodes: setting the sequence of workflow nodes according to the inspection flow to form an inspection workflow, and setting the sequence of each workflow operation node according to the different inspection flows obtained by sorting to form corresponding different inspection workflows; and (3) setting the authority: configuring the authority of the workflow, and giving the authority to each designed workflow according to different authorities; and a workflow validation step: judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; if the SOP standard is not met, the workflow is failed; a workflow display step: displaying the validated workflow on a viewing panel, and displaying inspection information of the sample; and an effective workflow saving step: the validated workflow is saved in xml format.
Specifically, the workflow configuration implementation method based on the laboratory information management system further comprises an SOP specification analysis step; and (3) SOP specification analysis step: and analyzing the SOP specification, and performing function matching on the inspection process in the SOP specification and the workflow node.
Specifically, the workflow configuration implementation method based on the laboratory information management system further comprises a workflow selection step; and a workflow selection step: in registering a sample operation, a desired workflow is selected for the sample, and after the registering of the sample operation is completed, the sample can be examined in accordance with the selected workflow.
Specifically, the inspection information includes information of a current inspection stage and a handler.
Specifically, the workflow nodes needing to be configured are configured in a flow designer.
Specifically, the workflow nodes mainly include a start point of the inspection flow, an end point of the inspection flow, and an intermediate inspection node of the inspection flow.
Specifically, the storage information of the workflow node mainly includes a node executor, a node name, a node return flag, and a node termination flag.
Specifically, the workflow saved in the xml format is enabled to generate a workflow version number. And under the condition that the workflow configuration is completed and meets the SOP specification of a laboratory, the configured workflow is validated, and the corresponding version control, audit trail and electronic signature requirements of the pharmaceutical industry are realized.
According to the present invention, a computer-readable storage medium is provided, in which a computer program is stored, which, when being executed by a processor, carries out the steps of the above-mentioned method.
The invention provides a workflow configuration implementation system based on a laboratory information management system, which comprises the following modules: a confirmation and inspection flow module: reading the existing process information to generate a checking process needing configuration; determining a workflow node module: determining a workflow node of each inspection process, and determining a workflow node needing to be configured; and a permission confirming module: setting operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node; the workflow node arranging module: setting the sequence of workflow nodes according to a checking flow to form a checking workflow; and a permission setting module: configuring the authority of the workflow; an effective workflow module: judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; if the SOP standard is not met, the workflow is failed; a workflow display module: displaying the validated workflow on a viewing panel, and displaying inspection information of the sample; an effective workflow saving module: the validated workflow is saved in xml format.
The workflow configuration implementation system based on the laboratory information management system can be implemented through the step flow of the workflow configuration implementation method based on the laboratory information management system. The skilled person can understand the workflow configuration implementation method based on the laboratory information management system as a preferred example of the workflow configuration implementation system based on the laboratory information management system.
The workflow configuration implementation method utilizes activity to carry out basic design of the workflow, and meanwhile, various workflow nodes required by design workflow of laboratories in the pharmaceutical industry are assisted by authority control, so that the inspection requirements of multiple inspection processes of different samples in the laboratories are met. The method relates to the realization of a detection service workflow designer of an information management system of a pharmaceutical enterprise laboratory, and solves the problem that the laboratory in the pharmaceutical industry has multiple detection flows and a single detection flow is not suitable due to the limitation of the requirements of different samples on different SOPs. According to the general operation flow of the pharmacy industry laboratory, corresponding operation nodes are designed, and different inspection workflows are registered for different samples by arranging the flow of each node through activity workflows, so that the pharmacy enterprise laboratory can inspect the samples according to the SOP of the pharmacy enterprise laboratory, the GMP standard is met, and code development work and related verification work are reduced. Through laboratory SOP flow node analysis that gathers, form all kinds of workflow operation nodes in the workflow designer, assist with corresponding authority control, realize the user configuration ization of inspection workflow, no matter reach the optimum from the efficiency of inspection or compliance requirement, the effectual laboratory door of help pharmaceutical enterprise examines the whole flow management and control.
The method is based on the flow chart visualization editor and has the characteristic that the inspection path is executed according to the flow sequence by a mode of dragging configuration of the operation node. Meanwhile, when the method is implemented, a series of management such as workflow transfer according to the authority, workflow suspension, workflow continuous execution and the like can be better performed by combining the authority management.
The following describes embodiments of the overall invention in detail:
1. the information management system of the pharmaceutical laboratory needs to comprise a workflow configuration function, is formed based on Activity transformation, and comprises a starting point, an end point of a process, a plurality of intermediate node components such as inspection processes and the like. Various node types and node attributes are added based on Activity, and the node attributes comprise whether the node can be returned or not, whether the node can be terminated or not, whether the termination needs to be audited or not and the like; the binding function of the sub-processes is added, a corresponding sub-workflow can be added to a certain node, and the sub-workflow runs independently relative to the main workflow; the execution time of the flow node can be limited, and a corresponding notification mode (such as e-mail, short message and the like) can be selected and configured after time out; and a history record storage function set corresponding to the process node is added, and all history record versions can be traced back as required.
2. Placing nodes: a set of processes must contain a start and a stop and at least one check process node, all placed in the operator panel by means of dragging.
3. Analyzing the existing SOP for laboratory inspection, functionally corresponding each inspection procedure related to SOP for laboratory inspection with the inspection flow node in the workflow designer, and completing function matching
4. Connecting the nodes: clicking on a node drags out a connecting line with direction to connect to the next node, which indicates the execution direction of the workflow and the next work. According to this way, referring to the previous step, the corresponding inspection flow nodes are connected according to the SOP.
5. Node setting: and right clicking a certain node, and setting an executor of the node, the name of the node, whether the node can be returned or not and whether the node can be terminated or not in a popup dialog box.
6. The designed inspection workflow is checked with the laboratory inspection SOP, and the consistency of the design workflow and the laboratory inspection SOP is confirmed, so that the laboratory information management system can be ensured to inspect in the information system according to the flow design completely according to the specification of the laboratory SOP when detecting the sample.
7. And (4) a preservation process: after all the nodes are set, and after the nodes are confirmed to be correct, information in the workflow is saved into an xml format by clicking a saving button for reading, analyzing and executing a program, and a corresponding version number is formed.
8. When the national relevant inspection standard and the process adjustment occur, a new inspection workflow can be redesigned according to the process, or the existing workflow is readjusted, and the readjusted workflow carries out edition upgrading operation on the original edition and is assisted with an audit trail function. To meet the process change requirements.
9. The user can select the required workflow for the sample during registration, and after the registration is completed, the sample can be checked according to the set workflow.
10. A workbench: the edited workflow can be checked in a matched workflow checking panel, the current stage of the inspection process of the sample can be known in detail, and information such as who is a processing person can be processed.
Those skilled in the art will appreciate that, in addition to implementing the systems, apparatus, and various modules thereof provided by the present invention in purely computer readable program code, the same procedures can be implemented entirely by logically programming method steps such that the systems, apparatus, and various modules thereof are provided in the form of logic gates, switches, application specific integrated circuits, programmable logic controllers, embedded microcontrollers and the like. Therefore, the system, the device and the modules thereof provided by the present invention can be considered as a hardware component, and the modules included in the system, the device and the modules thereof for implementing various programs can also be considered as structures in the hardware component; modules for performing various functions may also be considered to be both software programs for performing the methods and structures within hardware components.
The foregoing description of specific embodiments of the present invention has been presented. It is to be understood that the present invention is not limited to the specific embodiments described above, and that various changes or modifications may be made by one skilled in the art within the scope of the appended claims without departing from the spirit of the invention. The embodiments and features of the embodiments of the present application may be combined with each other arbitrarily without conflict.
Claims (10)
1. A workflow configuration implementation method based on a laboratory information management system is characterized by comprising the following steps:
confirming and checking flow steps: reading the existing process information to generate a checking process needing configuration;
and determining workflow nodes: determining a workflow node of each inspection process, and determining a workflow node needing to be configured;
and (3) permission confirmation step: setting operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node;
arranging workflow nodes: setting the sequence of workflow nodes according to a checking flow to form a checking workflow;
and (3) setting the authority: configuring the authority of the workflow;
and a workflow validation step: judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; if the SOP standard is not met, the workflow is failed;
a workflow display step: displaying the validated workflow on a viewing panel, and displaying inspection information of the sample;
and an effective workflow saving step: the validated workflow is saved in xml format.
2. The method for implementing workflow configuration based on laboratory information management system according to claim 1, further comprising a step of SOP specification parsing;
and (3) SOP specification analysis step: and analyzing the SOP specification, and performing function matching on the inspection process in the SOP specification and the workflow node.
3. The method for implementing workflow configuration based on laboratory information management system according to claim 1, further comprising a workflow selection step;
and a workflow selection step: in registering a sample operation, a desired workflow is selected for the sample, and after the registering of the sample operation is completed, the sample can be examined in accordance with the selected workflow.
4. The method of claim 1, wherein the inspection information comprises current inspection stage, handler information.
5. The method as claimed in claim 1, wherein the workflow nodes to be configured are configured in a flow designer.
6. The method as claimed in claim 1, wherein the workflow nodes mainly include a start point of the inspection process, an end point of the inspection process, and an intermediate inspection node of the inspection process.
7. The method as claimed in claim 1, wherein the stored information of the workflow nodes mainly includes node executors, node names, flags indicating whether the nodes are returned or not, and flags indicating whether the nodes are terminated or not.
8. The method as claimed in claim 1, wherein the workflow saved in xml format is enabled to generate workflow version number.
9. A workflow configuration implementation system based on a laboratory information management system is characterized by comprising the following modules:
a confirmation and inspection flow module: reading the existing process information to generate a checking process needing configuration;
determining a workflow node module: determining a workflow node of each inspection process, and determining a workflow node needing to be configured;
and a permission confirming module: setting operation authority of each workflow node, wherein the operation authority can control the operation of the workflow node;
the workflow node arranging module: setting the sequence of workflow nodes according to a checking flow to form a checking workflow;
and a permission setting module: configuring the authority of the workflow;
an effective workflow module: judging whether the workflow meets the SOP specification or not, and if so, taking the workflow into effect; if the SOP standard is not met, the workflow is failed;
a workflow display module: displaying the validated workflow on a viewing panel, and displaying inspection information of the sample;
an effective workflow saving module: the validated workflow is saved in xml format.
10. A computer-readable storage medium, in which a computer program is stored which, when being executed by a processor, carries out the steps of the method according to any one of claims 1 to 8.
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