The application of LIMS is becoming more and more popular. This article completely expounds almost all the key issues in the development and application of LIMS, and shares it with you.
Basic Concepts and Development History
1.1 Basic Concepts
Simply put, a laboratory information management system (LIMS) refers to a computer software and hardware system that manages various experimental information through computer network technology. That is to say, it combines computer network technology with modern management ideas, and uses data processing technology, mass data storage technology, broadband transmission network technology, and automated instrument analysis technology to conduct comprehensive management of laboratory information management and quality control. Computer software and hardware systems to meet various objectives of laboratory management (planning, control, execution).
1.1.1 Classification
According to the function, LIMS can generally be divided into two categories:
The first type is pure data management type. The main functions of this type of LIMS software generally include: data acquisition, transmission, storage, processing, mathematical statistical analysis, automatic determination of data qualification, output and release, report management, network management and other modules. But its function is single and easy to implement.
The second type is the comprehensive laboratory management type. In addition to the functions of the first type, the following management functions are added: sample management, resource (material, equipment, spare parts, fixed asset management, etc.) management, affairs (such as workload Statistics and salary and bonus management, document and file management) management and other modules form a complete laboratory comprehensive management system and inspection work quality monitoring system. Its functions are relatively comprehensive. In addition to the strict management and control of inspection data, it can also meet the daily management requirements of the laboratory; the network structure is correspondingly more complicated, the implementation is more difficult, the investment is relatively large, and it often requires professional units and Laboratory cooperation to develop the design.
1.1.2 Research objects
The main research object is the law of information in laboratory management activities and the method of using computer and network technology to realize auxiliary management. The main research content is how to use computer and network technology to realize the whole process of information processing.
Specifically, it includes four aspects: 1. Research on information needs; 2. Research on information flow process and information volume; 3. Research on the structure of LIMS; 4. Research on main design tools.
1.1.3 Basic Features
LIMS is designed around laboratory management objectives;
Structured decision support for LIMS;
Centralized and unified management of data;
Analytical prediction and control functions;
system view
1.1.4 LIMS and management software
As an information management system, LIMS has commonalities with management software such as ERP and MIS. For example, it supports enterprises or units in rational and systematic management of operation and production through modern management models and computer management information systems, and maximizes the use of It has the functions of equipment, resources, people and technology to maximize economic benefits.
But it is also different from enterprise management software. First of all, as laboratory management software, LIMS has standards to follow. Its system scheme design must strictly follow international and national laboratory requirements. However, enterprise management software such as ERP and MIS do not have corresponding standards to implement, which makes huge differences between ERP and MIS of different users. Secondly, LIMS can not only provide a management platform for the laboratory, but also provide more help to improve the operation efficiency and academic level of the entire laboratory. Modern instruments are intelligent and highly automated, which enables laboratory personnel to manipulate instruments through LIMS, greatly improving work efficiency.
1.1.5 Development History
The development of the LIMS system can be roughly divided into the following stages: the embryonic stage (the late 1960s to the early 1970s is the embryonic stage, which is the period when the LIMS design idea was born, and the data management of the laboratory is still in the stage of manual recording.) —— Commercialization period (computer language and network technology in this era are not yet developed, the price of computers is relatively expensive, and professional technicians are required to write and maintain programs.) - The period of perfect functions - the rise of networked products.
system structure
2.1 Architecture
Taking the Web server as the center, it is realized by a three-tier architecture, namely: three functional levels of interface, business and data.
Using the three-tier architecture model to implement LIMS, the interface layer and the business layer of the system are separated from each other. Whether it is the change of the interface layer or the change of the business layer, it can be achieved without affecting each other. Therefore, Jiayu Detection Network believes that it is beneficial to the system. The maintenance and function expansion of the system enhance the flexibility of the system; the business logic is implemented in the application server, not on each client, and at the same time, the access to the data can only be done through the application server, thus enhancing the The security of the system is realized, and the "thin client" is realized; the data required by the client can be pre-processed or fully processed in the application server, and then the processing result is transmitted to the client to reduce the network traffic.
2.2 Basic operating environment
2.2.1 Software environment: ①Server operating system: Windows NT Server, UNIX, LINUX, etc.; Database: MSSQL Server, SYSBASE, ORACLE, etc. ② Workstation Windows 98, Windows 2000, Windows XP, etc.
2.2.2 Hardware environment: Servers, PCs, printers, uninterruptible power supplies and other equipment can be configured according to the scale of the unit laboratory.
2.3 Network structure of the system
The laboratory and all its internal instruments are distributed in various buildings within a unit. The topological structure of the network generally adopts the star Ethernet type, and the network is formed by the Ethernet card at the rate of 100Mbps. With the current technological development level, the unit can fully realize the connection bandwidth of more than 100M. Therefore, all kinds of equipment in the laboratory can be connected to the network equipment at all levels through network cables, and then connected to the server. Between the network equipment and the laboratory equipment, it is also necessary to arrange the relevant analytical instrument data interfaces.
Design and Development Principles
3.1 Overall System Concept
3.2 System Adaptability
3.3 Joint development
3.4 System design and working procedures
3.5 Take advantage of computer functions
3.6 Top-down
Function introduction
4.1 Basic Features of LIMS
Technologically advanced, efficient, practical and safe;
The data management function is perfect, and the problem of data loss and change will not occur in the process of data collection, processing and publishing;
Friendly interface, easy to operate, using Web database technology and unified browser interface;
High degree of automation, simple network structure design;
Modular design, easy to expand functions;
Comply with the standard requirements of ISO/IEC Guide 25 and meet the characteristics of laboratory management;
Flexible product design and short customization cycle.
4.2 Introduction to the functions of LIMS
4.2.1 Standard library management system
Mainly to complete the functions of entering, updating, modifying and reviewing relevant standards. A complete set of standard library is the fundamental guarantee for the smooth operation of the entire business. The content of the standard library should include standard code, standard name, standard category, project code, project name, project standard value, project standard unit, inspection method, inspection For necessary fields such as departments, in order to ensure the accuracy of the standard, the standard library should be reviewed by senior experts before it can be officially used.
4.2.2 Sample Management System
The system is the most frequently operated module in the laboratory. It provides support for sample analysis and evaluation, including sample analysis, sample registration, sample management, sample testing, review system, result output, QA/QC, etc.
4.2.3 Dispute Handling System
When users question the analysis results, disputes can be handled through the dispute module. The LIMS should fully document the relevant information about the sample analysis and be traceable. Users only need to submit dispute requests in writing, telephone, fax, e-mail, online publishing, etc., and the personnel in charge of dispute handling will respond to user needs in a timely manner.
4.2.4 Information query system
Information query: including analysis progress and comprehensive information query. Users can query related information according to the authorization level. In order to quickly find the required information from the system and avoid redundant information, users can perform specific, customized searches. All query results can be sorted, classified and counted. Information query can quickly reflect the historical data of each step from the original data to the processed data, and can also query the personnel situation, project progress, customers, standard data, various laboratory document regulations, various reports, and various technical materials, etc. Wait.
Information statistics: flexible and convenient various statistical chart information modules that reflect the requirements of different users. It can also provide seamless connection with various special statistical software as required.
4.2.5 Laboratory Affairs Management System
The laboratory affairs management system includes laboratory chores, internal announcements, personnel whereabouts, plans, work arrangements, document processing, public information, personnel management and funding management. Mainly engaged in daily affairs processing, provide summary laboratory personnel, equipment, projects and experimental data, complete various daily report preparation and realize online information collection, sorting, retrieval and data statistics.
4.2.6 Testing and charging management system
The function of charging the samples under inspection: after the sample acceptance is completed, a payment document will be formed (except for those that have been processed in arrears), and the staff of the Finance Section will charge according to the unique number generated when the sample is accepted. Financial charges should include the application (sampled) unit, payment method (cash, check, wire transfer), discount, payable, actual payment and other fields. n Financial management functions include accounting (general ledger module, accounts receivable module, accounts payable module, cash management module, fixed asset accounting module, multi-currency module, payroll module, cost module) and financial management (financial planning, financial analysis) , financial decision-making) and other modules; the system automatically completes voucher accounting, automatically generates reports according to the defined report formats and formulas, and ensures the accuracy and consistency of data, reduces manual labor, and greatly improves work efficiency and work quality. .
4.2.7 Scientific research management and data query system
Including scientific research project establishment, process monitoring (document), stage test (report), scientific research file management and project conclusion and so on. The system will be integrated with the internal document information database of the unit to facilitate the information query of scientific researchers and improve the level and quality of scientific research.
4.2.8 Resource management system
Resource management includes human resources, material resources, standard material management, other material management and management modules of intangible assets such as intellectual property.
4.2.9 Customer Relationship Management System
Due to the gradual strengthening of consumers' consumer awareness, customers have changed from passive acceptance in the past to actively seeking their own needs. Therefore, it will be a competitive trend among enterprises to focus on satisfying customer needs with individual differences. In the era of customer orientation, only positive personalized service can improve consumer loyalty and capture the hearts of customers. Customer relationship management focuses on how to understand and influence customer behavior through continuous communication, increase new customers and retain old customers by analyzing the information that is effective for customers and can be used for reference, and provide customized customer service according to the individual needs of customers. Tailor-made services to increase customer satisfaction and improve customer profit contribution.
4.2.10 System Management System System
The management module manages system users, including user setting and editing, data query users, department setting and editing, and department management, etc. It also manages resource configuration and log management. n System management includes system initialization, setting user rights, system settings, log management, forum management and data maintenance. Data maintenance is the largest part of the system maintenance workload. Because the system generates a large amount of data every day, the effective storage and backup of these data are very important.
4.2.11 Internal Forum and Bulletin Board
Thematic forums can be set up according to business types. Each forum is in charge of such business leaders of the laboratory. The content involves the development trends of such businesses, technical exchanges of employees, discussions of professional issues, etc.; the bulletin board is mainly for laboratories. The current research priorities, arrangement of work activities, main difficulties, scientific research plans, etc. are announced, so that employees can keep abreast of the work dynamics of the laboratory, which is conducive to mobilizing employees' work initiative.
4.2.12 Help System
There is an independent running help system, online help following specific modules, and more intelligent help information (the system automatically gives corresponding help information according to the position of the mouse), providing comprehensive help information.
The role of LIMS in laboratory quality management
5.1 Sample Management
In quality management, sample registration, analysis and inspection, data review and final analysis report constitute the sample management process. According to different organizational structures, different responsibilities of members of each organization, and different sample types, LIMS organizes this process into a sample management process that can run in the most standardized and efficient way through user configuration, and analyzes the entire process during operation. And its various links are precisely controlled, so as to improve the efficiency of sample management. Quality management personnel can quickly obtain the information of all samples through LIMS, and can respond and take measures at the first time when quality problems occur. In addition, LIMS can also be connected with systems such as business office systems, allowing leaders and relevant departments to share inspection information and make timely adjustments to problems that arise.
5.2 Data Management
LIMS can manage these data in a unified manner, and all data input, storage, processing and distribution are carried out in one database, which avoids data loss and multiple replications. The centralized management of data also provides the quickest and most convenient means for quick query and report formation, and strengthens product quality control through relevant statistical means and trend graphs, which has incomparable advantages over paper storage. Jiayu Detection Network believes that the security mechanism of LIMS ensures that only authorized personnel can input, read, process and distribute data, and prevent the phenomenon of illegal copying and modification of data. For normal data correction, the system will also require input changes. reason, and automatically record the name and time of the person who changed it.
5.3 Instrument Management
LIMS can be connected to analytical instruments (such as liquid chromatographs, gas chromatographs, balances, etc.), and through the automatic collection of instrumental analysis data, manual input errors can be reduced, data transmission speed can be accelerated, and a lot of analyst time can be saved. n While collecting and analyzing data, LIMS can also collect relevant environmental data, making the data analysis more comprehensive and reliable. nLIMS can also perform instrument maintenance, allowing the creation of regular calibration schedules for instruments, tracking and recording calibrations. nLIMS can also count the utilization rate of the instrument to maximize the utilization of the instrument. The development of the network makes it possible for LIMS to remotely control analytical instruments, so that laboratory personnel can use automated instruments to the maximum extent and dynamically track and monitor the entire process of sample analysis at any time.
5.4 Report Management
LIMS has powerful reporting capabilities. LIMS comes with a module dedicated to report design, allowing users to design reports that meet their own requirements. The types of reports can be conventional inspection reports, analysis reports, quality reports, management reports, etc. These reports can not only simply reflect the internal data of the system, but also process the data, such as quality trend report, quality fluctuation graph, etc. LIMS can be set to automatically print reports at a certain link in the process, or publish reports in the form of emails and web pages, to reflect the quality situation in a timely and accurate manner. The above reports also have certain permission settings, and only authorized personnel can read and print them, thus ensuring data security.
5.5 Security Management
LIMS adopts advanced network technology and can use multi-level, logical processing, and data storage layered separation technology to ensure data integrity and prevent virus damage and human modification. nBy assigning permissions to users, only certain specified data are allowed to be observed and manipulated. Each operation in LIMS should be able to specify the operation authority. If the user is not given certain authority, the corresponding operation cannot be performed during his work. The test results of the laboratory must be reviewed by the person in charge of the competent department before being sent. A reasonable review mechanism is also what an excellent LIMS system should have.
5.6 Resource management
LIMS can manage personnel, reference substances, reagents, etc., and can make statistics on workload and calculate costs.
electronic signature
6.1 Concept
FDA definition: An electronic record is any collection of text, graphics, materials, sounds, images, or other information in digital form that is generated, modified, maintained, archived, extracted, and distributed by a computer system, while an electronic signature is Any computer-edited symbol or string of symbols used, recognized or authorized by a person to have the legal equivalent of a handwritten signature. Electronic records and electronic signatures are applicable to all industries related to human health.
The definition given by the "China Electronic Signature Law": Electronic signature refers to the data contained in the data message in electronic form and attached to identify the signer's identity and indicate that the signer recognizes the content. In layman's terms, an electronic signature is an electronic signature of an electronic document through cryptographic technology, not a digital image of a written signature. It is similar to a handwritten signature or seal, and it can also be said to be an electronic seal. A reliable electronic signature has the same legal effect as a handwritten signature or stamp.
Data message refers to information generated, sent, received or stored by electronic, optical, magnetic or similar means. The data message should be able to tangibly express the content, and the data message for inquiry can be retrieved at any time, and it is regarded as a written form that meets the requirements of laws and regulations.
6.2 Function
identity authentication; confidentiality; integrity; non-repudiation
6.3 Mode
At present, there are three main modes of electronic signatures used in the United States: smart card type; password type; biometric type.
6.4 Electronic Signature and Encryption Technology
The electronic authentication technology based on digital certificate can successfully solve the security problems such as user identification, data security, data integrity and historical behavior non-repudiation. Electronic authentication adopts PKI (Public Key Infrastructure) technology, which provides security guarantee for users to send and receive e-mails, visit Web sites, and transfer documents online.
The use of digital certificate-based user identity authentication technology to digitally sign document data in daily management work can ensure the integrity of document data information, confirm the true source of document data, and prevent denial or other people pretending to forge and tamper with data; The data encryption technology of digital certificate encrypts confidential documents transmitted on the network, which can prevent the leakage of commercial secrets or other sensitive information.
The realization of electronic signature technology requires the use of asymmetric encryption (RSA algorithm) and message digest (HASH algorithm). Asymmetric encryption (RSA algorithm) means that the user has two keys, one is the public key and the other is the private key. The public key is public and can be used by anyone, and the private key is kept secret and can only be used by the user himself. The user can encrypt the information with the private key and send it to the other party. The other party can use the user's public key to decrypt the ciphertext. key decryption. The public and private keys are mutually decrypted, and absolutely no third party can intervene. Jiayu Detection Network believes that the message digest uses the HASH algorithm to calculate any information to be transmitted to generate a 128-bit message digest, and information with different contents will generate different message digests, so the message digest becomes The "fingerprint" of electronic information.
The software of electronic signature should do: realize electronic seal, document encryption, signer's identity verification and other functions, which plays an important role in solving the problems of signer's identity confirmation, document content integrity and signature non-repudiation. ;The software should also support multiple signatures by multiple people, and each signature can be generated anywhere in the document, completely controlled by the signer; the software avoids the use of macro technology; the digital certificate used for electronic signatures can be stored in smart cards and USB electronic tokens such as hardware devices.
Applications and future of LIMS
7.1 Application of LIMS in laboratories of various industries
The use of LIMS technology in the laboratory will bring greater benefits to laboratory management and work quality control, which is an inevitable development trend of the laboratory.
The transformation and improvement of various testing laboratories are inseparable from LIMS. It plays an important role in improving efficiency, reducing costs and improving product quality.
At present, LIMS has been widely used in chemical industry, medical treatment, medicine, environmental protection, scientific research, teaching, food, wine, tobacco, import and export inspection and quarantine, metallurgy, mining, machinery manufacturing, measurement and other industrial laboratories.
7.2 The future of LIMS
LIMS applications are developing very rapidly. From the perspective of laboratory management, the system should be continuously updated and improved as the needs of the laboratory change. In the future, the LIMS of the laboratory should be highly specialized, intelligent, systematic, automated, and have a large spatial span. and multidisciplinary.
The development and application of LIMS must keep up with the forefront of technology and meet the requirements of the digital age. Beijing Tianjian Tongtai Technology Co., Ltd. has more than ten years of deep accumulation of IT service practice, specializing in providing test, inspection and testing business information products and solutions, knowledge information bus products and solutions; the company has comprehensive services including Shenying® test business Management Platform System, Condor® Test Data Management System (TDM), Condor® Laboratory Information Management System (LIMS), and Zhihui™ Intelligent Knowledge Management System.
Condor®LIMS is a mature software system that can be quickly adjusted to customer needs. Condor laboratory information management system meets all the requirements of ISO/IEC: 17025 system, and conducts reasonable and effective scientific management of laboratory resources, samples, analysis tasks, experimental results, quality control, etc. Condor® LIMS can ensure the integrity, legality and traceability of your laboratory data; greatly reduce the labor cost of laboratory management, so that complex process management can be carried out in an orderly manner. The company has become the most important IT service partner in many fields such as aerospace, automobile manufacturing, weapon industry, marine and marine, energy and environmental protection, and communication electronics.
(From: Laboratory Manager)