GB/T 40343-2021Intelligent laboratory—Information management system—Functional requirements (English PDF)
智能实验室 信息管理系统 功能要求
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Issued by
SAMR; SAC
Level / Type
National · Recommended
Issue date
August 20, 2021
Implementation date
March 1, 2022
Scope
GB/T 40343-2021 is the English-translated version of 智能实验室 信息管理系统 功能要求.
GB/T 40343-2021 sets out what the information management system of an intelligent laboratory has to do.
It defines a function model and the core functions for test process management, from task registration and assignment through data acquisition, processing and review to report generation, and for the management of personnel, instruments and equipment, reagents, consumables and reference materials, samples, methods, and facilities and environment.
It also describes extended functions such as document and quality record management, quality control, customer interaction, risk management, predictive maintenance and energy efficiency management, together with communication requirements and system management of users, access control, security and settings.
It applies to intelligent laboratories in any field, and other laboratory information systems can use it as a reference. The standard was issued on 20 August 2021 and has applied since 1 March 2022.
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Document preview — GB/T 40343-2021
National Standard of the People's Republic of China
- ICS
- 35.240.50
- Classification
- N 60
Issued by: State Administration for Market Regulation; Standardization Administration of the PRC
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Abbreviations
- 5 General
- 6 Function model
- 7 Core functional requirements
- 7.1 Test process management
- 7.1.1 Task registration
- 7.1.2 Assignment of tasks
- 7.1.3 Data Acquisition
- 7.1.4 Data Processing
- 7.1.5 Data review
- 7.1.6 Report generation
- 7.2 Resource Management
- 7.2.1 Personnel Management
- 7.2.2 Device Management
- 7.2.2.1 Overview
- 7.2.2.2 Instrument and equipment management
- 7.2.2.3 Management of reagents/consumables/standard materials/standard samples
- 7.2.3 Sample management
- 7.2.4 Method management
- 7.2.5 Facilities and environmental management
- 8 Extended functions
- 8.1 Intelligent system document management
- 8.2 Quality control management
- 8.3 Intelligent Quality Record Management
- 8.4 Customer Interaction Management
- 8.5 Risk Management
- 8.6 Forecast of Operational Trends
- 8.7 Smart Resource Allocation
- 8.8 Energy efficiency management
- 8.9 Predictive maintenance
- 8.10 Other intelligent applications
- 9 Communication function requirements
- 10 System management function requirements
- 10.1 User Management
- 10.2 Access control
- 10.3 System Security
- 10.4 System Settings
- 10.5 Other management functions
Foreword
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" Drafting.
1 Scope
This document specifies the function model, core function requirements, communication function requirements and system management functions of the intelligent laboratory information management system Requirements, introduced the extended functions of the intelligent laboratory information management system.
This document is applicable to the information management system of intelligent laboratories in different fields, and other information systems used in laboratories can be used as a reference.
This document can also be used as a guide for laboratory information transformation and intelligent laboratory construction.
2 Normative references
The contents of the following documents constitute the indispensable clauses of this document through normative references in the text. Among them, dated quotations Only the version corresponding to that date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document.
GB/T 27025 General requirements for the competence of testing and calibration laboratories
GB/T 39555-2020 Intelligent laboratory instrument equipment climate environment test equipment data interface
GB/T 39556-2020 Communication requirements for intelligent laboratory equipment
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Intelligent laboratory
A laboratory that applies information and communication technology to intelligently manage laboratory activities through information management systems and other systems.
Note: Intelligentization refers to the ability of things to actively meet the various needs of people with the support of technologies such as the network, big data, Internet of Things, and artificial intelligence. Attributes.
3.2 Laboratory activity
A general term for the testing, calibration and sampling related to subsequent testing or calibration in the laboratory.
Note: Testing and calibration are sometimes called tests.
3.3 Laboratory information management system
A computer system that manages laboratory activity data through acquisition, analysis, reporting, storage and other means.
Note: In this document, data is used to represent all structured and unstructured data and information in the laboratory, not just test data.
3.4 Workflow
The process of work from start to completion is composed of information such as process logic and route rules.
4 Abbreviations
The following abbreviations apply to this document.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 27025General requirements for the competence of testing and calibration laboratories
- GB/T 39555-2020Intelligent laboratory—Instruments and equipment—Data interface of climatic and environmental testing equipment
- GB/T 39556-2020Intelligent laboratory—Instruments and equipment—Communication requirements
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Related Standards
GB/T 27025-2019 — General requirements for the competence of testing and calibration laboratories
GB/T 39555-2020 — Intelligent laboratory—Instruments and equipment—Data interface of climatic and environmental testing equipment
GB/T 39556-2020 — Intelligent laboratory—Instruments and equipment—Communication requirements
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GB/T 40343-2021
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