CN114610750A - User-defined data object-based correlation query method for good pharmaceutical practice - Google Patents
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本发明涉及数据查询技术领域，具体涉及一种良好制药实践的基于自定义数据对象关联查询方法。The invention relates to the technical field of data query, in particular to a method for association query based on custom data objects based on good pharmaceutical practice.
背景技术Background technique
随着社会经济及科技的发展，制药行业也在不断发展,为了更好的控制药品的质量，国家相关部门进一步加强了制药企业GMP认证管理工作。GMP是药品生产的最基本的质量管理规范，通过提高企业工作人员的素质，加强生产现场的质量控制，维护生产设备，选取诚信度较高的原料供应商等有效措施来加强制药企业GMP管理，在确保药品质量的同时提高了人们用药的安全性。With the development of social economy and science and technology, the pharmaceutical industry is also developing continuously. In order to better control the quality of drugs, relevant state departments have further strengthened the management of GMP certification of pharmaceutical enterprises. GMP is the most basic quality management standard for pharmaceutical production. By improving the quality of enterprise staff, strengthening the quality control of the production site, maintaining production equipment, selecting raw material suppliers with high integrity and other effective measures to strengthen the GMP management of pharmaceutical enterprises, While ensuring the quality of medicines, the safety of people's medicines is improved.
为了更好、更高效的对药品生产过程的质量进行管控，尤其是信息安全的管控，医药企业采用智能化的管理系统进行管理。现有技术中的管理系统，如公开号为CN110995860B的中国专利文献中公开的一种“基于受控查询区块链的GMP/GSP质量管理平台”，所述平台采用联盟链的形式搭建，所述联盟链包括多个记录存储节点和任意个受控查询节点；所述受控查询节点和存储节点通过通讯协议进行消息互通；所述记录存储节点连接所有需要向区块链上记录存储信息的用户；所述受控查询节点连接所有需要获取区块链上存储信息的用户；所有需要查询获取上链信息的参与方只能通过所述受控查询节点进行操作；参与方将所有需要上链存储的GMP/GSP文件信息，提交到联盟链，实现GMP/GSP文件信息上链。本发明提出的基于受控查询区块链的GMP/GSP质量管理平台可以保障数据不可伪造不可篡改删除，保障了数据的完整性、一致性和安全性。In order to better and more efficiently control the quality of the drug production process, especially the control of information security, pharmaceutical companies use intelligent management systems for management. The management system in the prior art, such as a "GMP/GSP quality management platform based on the controlled query block chain" disclosed in the Chinese patent document with the publication number CN110995860B, the platform is built in the form of a consortium chain, so The alliance chain includes a plurality of record storage nodes and any number of controlled query nodes; the controlled query nodes and the storage nodes communicate with each other through a communication protocol; Users; the controlled query node connects all users who need to obtain information stored on the blockchain; all participants who need to query and obtain on-chain information can only operate through the controlled query node; The stored GMP/GSP file information is submitted to the alliance chain, and the GMP/GSP file information is uploaded to the chain. The GMP/GSP quality management platform based on the controlled query block chain proposed by the invention can ensure that the data cannot be forged and cannot be tampered with and deleted, and the integrity, consistency and security of the data can be guaranteed.
然而，上述质量管理平台，虽然在一定程度上可保障数据的完整性、一致性和安全性，但是，数据对象的安全、高效查询问题也是急需解决的，而上述质量管理平台并未涉及，即上述质量管理平台并未解决数据对象的可配置化，以实现数据对象的关联查询问题。However, although the above-mentioned quality management platform can guarantee the integrity, consistency and security of data to a certain extent, the problem of safe and efficient query of data objects also needs to be solved urgently, and the above-mentioned quality management platform does not involve, namely, The above-mentioned quality management platform does not solve the problem of configurability of data objects to realize the related query of data objects.
发明内容SUMMARY OF THE INVENTION
本发明提供一种良好制药实践的基于自定义数据对象关联查询方法，以解决数据对象的可配置化，以实现数据对象的查询和关联查询。The present invention provides a custom data object association query method based on good pharmaceutical practice, so as to solve the configurability of data objects and realize the query and association query of data objects.
本发明提供技术方案如下：The present invention provides technical solutions as follows:
一种良好制药实践的基于自定义数据对象关联查询方法，包括以下内容：A custom data object-based association query method based on good pharmaceutical practice, including the following:
根据对象的对象模型生成对象的唯一标志；Generate the unique identifier of the object according to the object model of the object;
根据对象属性信息和关联信息，针对引用、被引用对象构建对象关系网；According to the object attribute information and related information, build an object relationship network for the referenced and referenced objects;
构造对象的动态查询构造器。Dynamic query builder for constructing objects.
本发明的有益效果如下：The beneficial effects of the present invention are as follows:
构建基础的对象模型后，会产生一个对象的唯一标志，该标志代表着该对象，对象模型中包含的信息包括对象属性信息和关联信息，因此，可以根据对象属性信息和关联信息，针对引用、被引用对象构建对象关系网，然后通过构造对象的动态查询构造器，以实现在对象关系网中进行对象的查询和关联查询等查询操作。After building the basic object model, a unique mark of an object will be generated, which represents the object. The information contained in the object model includes object attribute information and association information. The referenced object builds an object relational network, and then through the dynamic query builder of the constructed object, query operations such as object query and association query are implemented in the object relational network.
本发明一种良好制药实践的基于自定义数据对象关联查询方法，应用于符合GMP规范的可配置化系统中，以在配置数据对象模型后，实现对象的查询和关联查询等操作，属于可配置业务领域。The present invention is a custom data object association query method based on good pharmaceutical practice, which is applied to a configurable system that complies with GMP specifications, so that after configuring a data object model, operations such as object query and associated query can be realized, which belongs to configurable business area.
进一步地，所述的对象模型，是根据企业不同的业务性质配置的。Further, the object model is configured according to different business properties of the enterprise.
有益效果：本发明方案所述企业不同的业务有两层含义，一种是指一个企业内部有不同的业务，另外一种是指不同的企业之间也有不同的业务，这样根据企业不同的业务性质来配置对象模型，配置出的对象模型不仅仅用于一个企业的系统服务，而且同样适用于其他企业的系统服务，解决了在不同的医药制造企业在质量事件、质量文档的不同的业务性质的管理问题。Beneficial effect: The different businesses of the enterprises described in the solution of the present invention have two meanings, one means that there are different businesses within an enterprise, and the other means that different businesses also have different businesses, so that according to the different businesses of the enterprises The configured object model is not only used for the system service of one enterprise, but also applicable to the system service of other enterprises, which solves the different business nature of quality events and quality documents in different pharmaceutical manufacturing enterprises management issues.
进一步地，所述唯一标志，用于获取对象的相关信息。Further, the unique flag is used to obtain relevant information of the object.
有益效果：所述唯一标志代表着该对象，相当于赋予对象一种识别标签，便于查询对象模型的相关信息，如可以通过该唯一标志获取对象的相关信息。Beneficial effects: the unique mark represents the object, which is equivalent to giving the object an identification label, which is convenient for querying the relevant information of the object model. For example, the relevant information of the object can be obtained through the unique mark.
进一步地，所述对象属性信息，是通过对象的唯一标志，获取到的对象属性信息。Further, the object attribute information is the object attribute information obtained through the unique identifier of the object.
有益效果：对象属性信息是对象信息的一种，因此可通过对象的唯一标志，获取对象属性信息，从而用于构建引用、被引用对象关系网。Beneficial effects: The object attribute information is a kind of object information, so the object attribute information can be obtained through the unique mark of the object, so as to be used for constructing a reference and referenced object relationship network.
进一步地，所述的动态查询构造器，通过构造一个统一的对象查询抽象层实现。Further, the dynamic query builder is realized by constructing a unified object query abstraction layer.
有益效果：对象模型构建后，对象的属性信息和关联信息是一个零散的成网状的信息池里面（即引用、被引用对象之间的对象关系网），本系统通过构造一个统一的对象查询抽象层，来达到传统的类似于数据库查询SQL的效果。Beneficial effect: After the object model is constructed, the attribute information and related information of the object are in a scattered meshed information pool (that is, the object relationship network between the referenced and referenced objects). The system constructs a unified object query Abstraction layer to achieve the traditional effect similar to database query SQL.
进一步地，所述的动态查询构造器，用于对象的查询，以及在不同的对象模型之间进行关联查询。Further, the dynamic query builder is used for querying objects and performing associated queries between different object models.
有益效果：通过动态查询构造器，以实现对象的查询，以及在不同的对象模型之间进行关联查询，以解决在管理系统中，在不同的业务对象模型之间有需要关联查询的业务需要。Beneficial effects: the dynamic query builder is used to realize the query of objects, and to perform associated query among different object models, so as to solve the business needs of associated query among different business object models in the management system.
进一步地，所述的动态查询构造器，还用于聚合、分组等查询语法来查询对象结果集。Further, the dynamic query builder is also used for query syntax such as aggregation and grouping to query the object result set.
有益效果：通过动态查询构造器，进一步来实现数据对象的聚合、分组等查询。Beneficial effect: query such as aggregation and grouping of data objects can be further realized through the dynamic query constructor.
进一步地，所述的动态查询构造器，通过构造对象的自定义动态查询语言实现。Further, the dynamic query builder is implemented through a custom dynamic query language for constructing objects.
有益效果：通过构造对象的自定义动态查询语言来实现动态查询构造器，该对象语言可以像传统的SQL语句一样使用查询，关联、聚合、分组等查询语法来查询对象结果集。Beneficial effects: the dynamic query builder is implemented by constructing a custom dynamic query language for objects, which can query object result sets using query syntaxes such as query, association, aggregation, grouping, etc., just like traditional SQL statements.
附图说明Description of drawings
图1为本发明一种良好制药实践的基于自定义数据对象关联查询方法实施例一的流程图。FIG. 1 is a flow chart of Embodiment 1 of a method for an association query based on a custom data object according to a good pharmaceutical practice of the present invention.
具体实施方式Detailed ways
下面通过具体实施方式进一步详细说明：The following is further described in detail by specific embodiments:
实施例一Example 1
如附图1所示，本实施例公开了一种良好制药实践的基于自定义数据对象关联查询方法，包括以下内容：As shown in FIG. 1 , the present embodiment discloses a custom data object-based associated query method based on good pharmaceutical practice, including the following content:
根据对象的对象模型生成对象的唯一标志。本发明所述的对象模型，是作为基础的业务对象的载体，是对业务的基础抽象和属性定义，应用于符合GMP规范的可配置化系统中，分为质量事件、质量文档、质量培训、通用类型等基础对象模型，每种对象模型代表着一种业务。Generates a unique identifier for an object based on the object's object model. The object model described in the present invention is the carrier of the basic business object, and is the basic abstraction and attribute definition of the business. Basic object models such as generic types, each object model represents a business.
对象模型：基于制药行业，内置了四种基础的对象模型，事件对象模型，文档对象模型，培训对象模型，通用对象模型。在这四种基础的对象模型基础上，我们可以衍生出不同的对象模型，例如在事件对象模型基础上，可以衍生出质量事件对象模型，偏差对象模型，CAPA对象模型，变更事件模型。对象模型是用户可以自定义的方式产生，构建用户模型时可以构建对象的基础信息和对象模型与对象模型之间的关联关系，一旦对象模型构建完成后就会生成该对象的唯一标志，该标志代表着该对象模型及产生的对象模型数据的实例数据类型。Object Model: Based on the pharmaceutical industry, there are four built-in basic object models, event object model, document object model, training object model, and general object model. On the basis of these four basic object models, we can derive different object models. For example, on the basis of the event object model, we can derive the quality event object model, the deviation object model, the CAPA object model, and the change event model. The object model is generated in a user-defined way. When building the user model, the basic information of the object and the relationship between the object model and the object model can be constructed. Once the object model is constructed, the unique symbol of the object will be generated. An instance data type representing the object model and the resulting object model data.
本实施例中，所述的对象模型，是根据企业不同的业务性质配置的，所述企业不同的业务有两层含义，一种是指一个企业内部有不同的业务，另外一种是指不同的企业之间也有不同的业务，这样根据企业不同的业务性质来配置对象模型，配置出的对象模型不仅仅用于一个企业的系统服务，而且同样适用于其他企业的系统服务，解决了在不同的医药制造企业在质量事件、质量文档的不同的业务性质的管理问题。In this embodiment, the object model is configured according to different business properties of the enterprise, and the different businesses of the enterprise have two meanings, one means that there are different businesses within an enterprise, and the other means different businesses There are also different businesses between different enterprises, so the object model is configured according to the different business nature of the enterprise. The configured object model is not only used for the system services of one enterprise, but also applicable to the system services of other enterprises, which solves the problem of different The pharmaceutical manufacturing enterprises have different business nature management issues in quality events, quality documentation.
本实施例中，所述唯一标志，用于获取对象的相关信息。当构建基础的对象模型后，会产生一个唯一的对象标志，该标志代表着该对象，可以通过该标志获取对象的相关信息。本实施例中，所述对象属性信息，是通过对象的唯一标志，获取到的对象属性信息。In this embodiment, the unique flag is used to obtain the relevant information of the object. When the basic object model is constructed, a unique object flag will be generated, which represents the object, and the related information of the object can be obtained through the flag. In this embodiment, the object attribute information is the object attribute information obtained through the unique identifier of the object.
本实施例中所述的方法，还包括根据对象属性信息和关联信息，针对引用、被引用对象构建对象关系网。The method described in this embodiment further includes constructing an object relationship network for the referenced and referenced objects according to the object attribute information and associated information.
在本实施方法中，对象与对象之间是可以建立关联关系的，不是孤立存在的，例如对象A引用了对象B，对象B也可以引用对象A，对象B也可以引用对象C，这样就会形成 A-B-C,B-C,B-A几种对象关系，最终对象都会汇集为一个对象的关系链条关系。在构建对象关系网时，需要在构建对象时创建对象之间的引用关系，本实例参与了引用关系、被引用关系、父子关系、兄弟关系等几种对象关系，通过这几种对象关系来描述对象与对象之间的关系。In this implementation method, an association relationship can be established between objects and objects, and they do not exist in isolation. For example, if object A references object B, object B can also refer to object A, and object B can also refer to object C. Several object relationships of A-B-C, B-C, and B-A are formed, and eventually the objects will be aggregated into a relationship chain relationship of one object. When building an object relationship network, it is necessary to create a reference relationship between objects when building an object. This example participates in several object relationships such as reference relationship, referenced relationship, parent-child relationship, and sibling relationship, which are described by these object relationships. object-to-object relationship.
本实施例中所述的方法，还包括构造对象的动态查询构造器。所述的动态查询构造器，通过构造一个统一的对象查询抽象层实现。所述的动态查询构造器，用于对象的查询，以及在不同的对象模型之间进行关联查询。所述的动态查询构造器，还用于聚合、分组等查询语法来查询对象结果集。所述的动态查询构造器，通过构造对象的自定义动态查询语言实现。The method described in this embodiment further includes a dynamic query constructor for constructing objects. The dynamic query constructor is realized by constructing a unified object query abstraction layer. The dynamic query builder is used for querying objects and performing related queries between different object models. The dynamic query builder is also used for query syntax such as aggregation and grouping to query the object result set. The dynamic query builder is implemented through a custom dynamic query language for constructing objects.
对象模型构建后，对象属性信息和关联信息是一个零散的成网状的信息池里面，本系统通过构造一个统一的对象查询抽象层，通过对象语言，来达到传统的类似于数据库查询SQL的效果，该对象语言可以像传统的SQL语句一样使用查询，关联、聚合、分组等查询语法来查询对象结果集。After the object model is constructed, the object attribute information and related information are scattered in a networked information pool. The system constructs a unified object query abstraction layer and uses the object language to achieve the traditional effect similar to database query SQL. , the object language can use query syntax such as query, association, aggregation, grouping, etc. to query object result sets like traditional SQL statements.
统一的对象查询抽象层：在对象关系网建立后，我们会针对对象的关系网建立一个隔离的逻辑抽象对象查询解析引擎，类似的语法为From 对象 Where 对象.XXXX=XXXX这种类似传统的SQL的形式来查询对象数据，通过该语法后，对象查询解析引擎会解析为具体的查询到数据库去查询数据并解析对象与对象之间的数据，从而达到不用关系数据的存储结构，只需关系对应的对象就可以达到查询的目的。Unified object query abstraction layer: After the object relationship network is established, we will build an isolated logical abstraction object query and analysis engine for the object relationship network. The similar syntax is From object Where object. XXXX=XXXX, which is similar to traditional SQL After passing this grammar, the object query and analysis engine will parse the specific query to the database to query the data and parse the data between the objects, so as to achieve a storage structure without relational data, only the relational correspondence The object can achieve the purpose of the query.
实施例二Embodiment 2
在本实施例中，一种良好制药实践的基于自定义数据对象关联查询方法包括在接收到查询关键词后，对查询关键词进行判断，判断待查询内容是否是保密等级高的内容，若是，则对查询权限进行判断，若查询者不具备查询保密等级高的内容的权限，则对待查询内容不进行显示或者返回不具备权限提示，或者基于查寻者的临时权限申请，赋予查寻者初级临时权限后，对待查询内容进行初级显示，所述初级显示是指仅显示查询对象信息；本查询方法在查寻者进一步提供保障信息之后，可赋予查寻者二级临时权限，赋予查寻者二级临时权限后，对待查询内容进行二级显示，所述二级显示是指同时显示查询对象信息和各个数据对象之间的关联信息。In this embodiment, a good pharmaceutical practice-based custom data object association query method includes, after receiving the query keyword, judging the query keyword, and judging whether the content to be queried is content with a high level of confidentiality, and if so, The query permission is judged. If the queryer does not have the permission to query the content with a high confidentiality level, the query content will not be displayed or a prompt without permission will be returned, or based on the temporary permission application of the queryer, the primary temporary permission will be granted to the queryer. After that, perform a primary display of the content to be queried, and the primary display refers to displaying only the information of the query object; after the searcher further provides security information, the query method can grant the searcher a second-level temporary authority, and after the searcher is given the second-level temporary authority , and perform secondary display of the content to be queried, where the secondary display refers to simultaneously displaying the query object information and the association information between each data object.
以此，相当于对保密等级高的内容的查询，设置了一道道的查询关卡，保障了数据查询的安全性，防止数据泄露。In this way, it is equivalent to querying content with a high level of confidentiality, and setting up query checkpoints to ensure the security of data query and prevent data leakage.
若判断待查询内容不是保密等级高的内容，则直接根据查寻者权限，来进行内容的显示，具体是：若查寻者具备初级查询权限，则对待查询内容进行初级显示，所述初级显示是指仅显示查询对象信息，若查寻者具备二级查询权限，则对待查询内容进行二级显示，所述二级显示是指同时显示查询对象信息和各个数据对象之间的关联信息。If it is determined that the content to be queried is not content with a high level of confidentiality, the content will be displayed directly according to the authority of the searcher. Specifically, if the searcher has primary query authority, the content to be queried will be displayed at a primary level. The primary display refers to the primary display. Only the query object information is displayed. If the searcher has the secondary query authority, the content to be queried will be displayed in a secondary level. The secondary display refers to simultaneously displaying the query object information and the association information between each data object.
通过设置查询权限，而不是所有查寻者都同时具备数据对象信息和关联信息的查询，以此保障与查询数据相关的其他数据对象的安全性。By setting the query authority, not all searchers have the query of data object information and related information at the same time, so as to ensure the security of other data objects related to the query data.
以上所述的仅是本发明的实施例，所属领域普通技术人员知晓申请日或者优先权日之前发明所属技术领域所有的普通技术知识，能够获知该领域中所有的现有技术，并且具有应用该日期之前常规实验手段的能力，所属领域普通技术人员可以在本申请给出的启示下，结合自身能力完善并实施本方案，一些典型的公知结构或者公知方法不应当成为所属领域普通技术人员实施本申请的障碍。The above are only the embodiments of the present invention. Those of ordinary skill in the art know all the common technical knowledge in the technical field to which the invention belongs before the filing date or the priority date, can know all the prior art in this field, and have the ability to apply the invention. The ability of conventional experimental means before the date, those of ordinary skill in the art can improve and implement this scheme in combination with their own abilities under the inspiration given in this application. Barriers to application.
应当指出，对于本领域的技术人员来说，在不脱离本发明结构的前提下，还可以作出若干变形和改进，这些也应该视为本发明的保护范围，这些都不会影响本发明实施的效果和专利的实用性。本申请要求的保护范围应当以其权利要求的内容为准，说明书中的具体实施方式等记载可以用于解释权利要求的内容。It should be pointed out that for those skilled in the art, some modifications and improvements can be made without departing from the structure of the present invention. These should also be regarded as the protection scope of the present invention, and these will not affect the implementation of the present invention. Effectiveness and utility of patents. The scope of protection claimed in this application shall be based on the content of the claims, and the descriptions of the specific implementation manners in the description can be used to interpret the content of the claims.
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