Useful Tips | The Imperative for Modernization in Laboratory Information Systems: 25 Typical Modules of LIMS Systems

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LIMS (Laboratory Information Management System) is a system for managing laboratory information. By comprehensively handling elements such as sample testing processes, analysis data and reports, laboratory resources, and customer information, it establishes a quality management system that conforms to standardized laboratory management practices, thereby enabling informational management of laboratories. It is an information platform for laboratories to improve analytical capabilities, standardize sample testing procedures, and reduce experimental costs, thereby providing excellent services to customers. This article introduces some of the basic functions of a LIMS system. 1. Test request: The test request is the first step in the business management process within LIMS. Typically, test requests are submitted directly by clients via LIMS, or they are filled out by the laboratory’s relevant service departments to assist or on behalf of the clients. The LIMS should record information related to the clients requesting the tests (internal or external clients), information regarding the samples to be tested, testing requirements, and any special requirements. The customer submitting the testing request must be an authorized customer in the LIMS. The system can also record the information filled in, the person who filled it in, the time of filling, etc. It should also support the output and printing of paper application forms. Advanced LIMS can provide various ways to enter request forms, such as importing information, filling out test requests via the Internet, and assigning testing tasks directly from other business information systems. 2. Contract review and sample receipt: After receiving the customer’s testing request and samples, the relevant laboratory staff conduct a contract review in the LIMS to check whether there are any discrepancies between the samples submitted for testing and those specified in the request. 3. Assignment of testing tasks: The LIMS should be able to automatically assign testing tasks to individual testers or testing teams by identifying the departments responsible for the tests and their authorization to conduct them. For special users, inspection tasks can also be assigned manually. 4. Entry of test results: The entry of test results refers to the process of inputting the test results into LIMS in various ways after the sample testing is completed. The data entry stage for test results is an important part of the LIMS. Advanced LIMS provide many useful functions to assist laboratory technicians in conducting tests and entering results, as well as to enable better quality control. 5. Automatic calculation: By integrating the testing methods into the LIMS, testers can simply enter the test results from the instruments to obtain the final results. 6. Instrument data acquisition is carried out automatically; the result data output by the instruments, test spectra, and other relevant information, along with the original records, are directly imported into the LIMS. This reduces the workload of testers and minimizes the risk of errors. 7. Various result formats: The LIMS allows for the storage of a large number of non-data-related result files, such as photos, images, and experimental spectra. 8. Result correction using quality control samples. Many LIMS systems have introduced the concept of a test batch, wherein multiple samples are tested together using the same instrument and the same testing method. An example is a content determination experiment conducted using an ICP with an automatic sample injector. Inspectors can add quality control samples to each batch, and use the test results of these quality control samples to adjust the results of that batch. If the test results of the quality control samples fall outside the specified range, it is determined that the results of the entire batch are invalid; in such cases, the instrument needs to be recalibrated and the tests need to be repeated. 9. By checking the inspection methods, SOPLIMS can be associated with and test the corresponding operating instructions, instrument manuals, and test method documents. During the testing process, inspectors can easily access the currently valid versions of these relevant technical documents. 10. Testing the workflow: If certain tests conducted in the laboratory require multiple people and multiple steps to complete. If a test involves multiple steps such as sample preparation, weighing, digestion, volume adjustment, and actual experimentation, these steps may be carried out by different personnel. In such cases, a LIMS can be used to define the testing workflow, allowing for detailed recording of information such as the time taken for each step and the name of the person who performed it. 11. Data modification tracking: A comprehensive LIMS should have the capability to track data modifications. For the test data that has been entered or modified, the system should record who performed the entry or modification as well as the time when the operation took place, so as to enable tracing. 12. Data and report review: Data and report reviewers use the LIMS to examine test data and test reports. A good LIMS should have the capability to automatically generate reports. In addition to being able to view and review the test result data, data and report reviewers should also be able to access relevant quality information during the testing process, such as information about the instruments used in the experiments, reference standards, and test personnel. The review of data and test result reports must be verified using security measures such as electronic signatures to ensure that the operators are properly authorized. 13. Sample management: Sample management is a very important part of LIMS. A LIMS should dynamically record the entire process of a sample, from its arrival at the laboratory to the completion of testing, and until the sample is retrieved by the user or disposed of by the laboratory. When a sample enters the laboratory, the user can record in the system the time of arrival, the current status of the sample, and whether there are any deviations from the described or specified conditions. LIMS should use methods such as barcodes to label samples, ensuring the uniqueness of these labels in order to facilitate the transfer and retrieval of samples throughout the testing process. LIMS should provide information on sample storage locations and conditions. If possible, based on characteristics such as the nature and material of the samples, a storage location that meets the storage conditions should be automatically assigned. The receipt and return of experimental samples must be recorded in the LIMS, and these operations can be carried out by scanning barcodes. For samples that need to be disposed of after the sample retention date, the system should record information such as the method of disposal and the disposal date. 14. Subcontracting Management: When a laboratory needs to outsource testing tasks due to unforeseen or ongoing reasons, the LIMS must provide effective control and management over such tasks. Firstly, unless the client specifies a particular subcontractor, the testing institution or laboratory assigned for laboratory subcontracting must be one that has been evaluated and approved by this laboratory. It is necessary to maintain information about subcontracted laboratories in the LIMS, including their testing capabilities, quality system status, relevant qualification certificates, contact information, etc. If necessary, the LIMS can also store electronic versions of documents such as subcontract agreements and subcontractor audit records. When subcontracting samples, LIMS should be able to generate a subcontracting request form. When outputting information, it must adhere to the principle of protecting customer information. The LIMS should provide a tracking function for sub-sent samples, including the date of submission; if the samples are sent by mail, tracking can be done using the tracking number. After the laboratory performing the testing tasks issues a test report, it can enter the subcontracted results into the LIMS. If necessary, it can also store a scanned copy or electronic version of the report issued by the laboratory conducting the tests in the system. 15. Personnel Management: The personnel management in a LIMS is not as comprehensive as that in human resources systems. Although it includes some basic information about employees, its focus should be more on managing their testing capabilities, training, and authorization. A LIMS should be able to maintain relevant information such as personnel’s technical profiles, educational background, qualifications, and current job descriptions. The training process for personnel is a dynamic one; it encompasses training planning, implementation, and evaluation. The laboratory can select training programs suitable for current and upcoming testing tasks through LIMS, and evaluate and revise these programs based on actual conditions. The laboratory can notify the trainees through LIMS and distribute electronic training materials and textbooks via the system. Participants in the training can also provide feedback on the training through LIMS to improve its relevance and effectiveness. LIMS should also provide additional functions such as records of training assessments and archiving of training materials. A LIMS should maintain records of user authorizations and use these to control processes; for example, authorized signatories who have not been authorized by the system are not allowed to issue test reports. A tester cannot conduct an experiment without authorization for a particular testing method and instrument. 16. Management of Instruments and Measuring Devices: The management of instruments and testing devices in LIMS differs from the management systems used for fixed assets, as we are accustomed to seeing. It is divided into static data management and dynamic management. The static management of instruments includes the management of basic information on instruments and equipment, the management of instrument accessories, and the maintenance of instrument technical parameters. The dynamic management of instruments includes periodic verification of instruments, daily maintenance, calibration of instruments, testing of instruments, value traceability plans, and management of instrument status. Through the dynamic management of measuring instruments, laboratory testers and managers can stay informed about the status of the instruments at all times, ensuring the accuracy and validity of the test results. 17. Management of Reagents, Reference Materials, and Suppliers: The procurement process for reagents and reference materials is usually not managed within the LIMS. However, the suppliers that provide these reagents and reference materials need to be managed. It is necessary to maintain in the LIMS information on the laboratory-approved qualified suppliers, such as their addresses, contact details, and catalogs of the reagents and reference materials they supply. For each batch of reagents purchased, its supplier should be recorded to enable tracing. The LIMS should also manage the storage and inventory of reagents. For reagents and reference materials that have a significant impact on the test results, the LIMS should enter, or record via barcode scanning, information such as the batch number of the reagents used for each test. 18. Method management: The LIMS should implement strict version control for experimental methods. By managing the version updates of these methods within the LIMS, it is ensured that the testing methods used in the laboratory are consistent and up-to-date. 19. Management of facilities and environmental conditions: With the continuous development of science and technology, an increasing number of laboratories are using thermo-hygrometers capable of data collection and analysis, as well as measuring instruments for detecting electromagnetic interference, radiation, and vibration levels in the test environment. By combining the LIMS with these instruments for real-time monitoring of the laboratory environment, it is possible to monitor and analyze the environmental conditions in the laboratory more effectively. The environmental conditions can be linked to the instruments and testing tasks, and thresholds for these conditions can be set; when these thresholds are exceeded, the LIMS can send alerts and warnings to the test personnel. Ensure the accuracy and validity of test results. 20. Document management: LIMS should also manage the laboratory’s technical documents, quality documents, inspection standards, calibration specifications, and other relevant documents, thereby enabling the management and monitoring of the entire process of document drafting, issuance, modification, and review. Establishing file directories and classifications allows for control over the access levels to files. Files can be freely searched; that is, searches can be conducted by specifying any query conditions or through fuzzy searching. The retrieved files can also be printed. Files can be added and deleted; deleted (replaced) files are marked, along with notes explaining the reason for deletion. It can record the distribution status of files. When a file is approaching its expiration date or has passed it, the system automatically alerts the file administrator to take appropriate action. 21. Laboratory Quality Control: Laboratory quality control refers to the control measures taken to keep the errors in analytical test results within acceptable limits. Traditionally, we carry out laboratory quality control through in-lab quality control and inter-lab comparisons. In the laboratory, quality control generally includes blank tests, verification of calibration curves, calibration of instruments and equipment, analysis of replicate samples, spike recovery tests, and the use of quality control charts. Inter-laboratory comparisons include evaluating the analysis results of various laboratories using standard samples, conducting collaborative experiments to verify analytical methods, and using coded samples for assessment. It is an important measure for detecting and eliminating systematic errors existing between laboratories. Laboratory quality can be controlled through LIMS. The role of LIMS in quality control is reflected in two aspects: firstly, the planned, purposeful, and targeted handling of test samples, as well as comparative tests and evaluations within the laboratory and between different laboratories. Another aspect relates to the handling of quality control samples in routine testing tasks, as well as calibration curves for testing instruments, trend charts of test results, and control charts. 22. Management of laboratory quality activities: The daily quality activities in a laboratory can be managed through LIMS. Such as management review, internal audit, corrective actions, preventive actions, control of nonconformity detection, etc. These quality activities can be dynamically managed through a LIMS, or process management can be carried out via other office automation systems, or paper-based methods can be used for handling them. However, as mentioned earlier in this article, the essence of LIMS is actually the embodiment of laboratory management concepts. Therefore, the measures for continuous improvement and the adjustments to management processes that arise from quality activities in the laboratory are reflected in LIMS, thereby enabling its continuous improvement to serve the management system. 23. Serving customers: Serving customers through LIMS is accomplished at two levels. The first level involves using information-based management to more effectively protect the privacy of customer information. Secondly, it is to provide better services to customers through LIMS and its related functions, such as establishing platforms for customer feedback and complaints, allowing direct download of test reports via the Internet, enabling verification of the authenticity of reports online, providing real-time updates on the progress of tests, sending alerts via text message or email once the reports are ready, and granting customers the ability to submit test requests directly through the Internet. 24. Result report management: A very important function of LIMS is the automatic generation of test result reports. Currently, many laboratories utilize this feature of LIMS first and foremost. It is usually implemented by using third-party reporting tools or custom-developed reporting tools to create report templates in a specific format, and by automatically obtaining the test result data as well as the information required by the client to explain the test or calibration results and the methods used, in order to organize and generate reports automatically. No human intervention is required during the report generation process. The report template should be formulated in accordance with the laboratory’s requirements and the Requirements for the Accreditation of Testing and Calibration Laboratories, to ensure that the necessary information is provided. All information in the reports must be extracted from the system database. In other words, any customer information, testing and method details, instrument information, and experimental result data included in the report must be exactly consistent with the information stored in the LIMS database, and it must be possible to trace this information back within the system. If the LIMS provides a function for electronic transmission of results, and result reports are sent via the Web, automatic email delivery, or electronic fax platforms, the system must ensure the integrity and confidentiality of those result reports during transmission. Eliminate risks during transmission and protect customer information. 25. Data statistics and querying: The greatest advantage of an information system is its capabilities for data statistics, querying, and analysis. With the implementation of LIMS, laboratory managers no longer need to rely on experience-based judgment; instead, they can make management decisions and improve both the management system and quality system based on a large amount of scientific and accurate statistical data. It can be seen that the statistical and query functions of a LIMS are very important features. A good LIMS should have open, powerful, and freely customizable query and statistical functions. - End -