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LIMS (Laboratory Information Management System) is a system that enables the digital planning, execution, monitoring, and reporting of test and analysis processes carried out in laboratories. Also known as LBYS in Turkey, this system helps manage laboratory operations from sample acceptance to result approval through a single centralized system.
Test and analysis management is not simply about entering the results into the system. Determining which test will be applied to which sample, which method will be used, who is responsible for the analysis, which equipment is used, which limits the results are compared against, and who approves the final report are also part of the process. LIMS makes laboratory processes more controlled and traceable by linking all these steps together.
How to Begin Managing Test and Analysis Processes with LIMS?
1. Sample Acceptance and Testing Request is Created.
The testing and analysis process begins with the acceptance of the sample into the laboratory. The sample is registered in the system, and basic information such as sample type, product name, batch number, customer or source information, acceptance date, and purpose of analysis is defined.
The tests to be performed can also be determined during sample acceptance. Thus, the necessary analyses for each sample are defined in the system from the outset.
2. Tests and Analyses are Assigned to the Sample
One or more tests can be assigned to each sample on LIMS. Physical, chemical, microbiological, or different analysis groups can be associated with the sample record.
For each test, the analysis name, method, unit of measurement, reference range, and, if necessary, instrument information can be defined. This structure allows laboratory personnel to clearly see which procedures need to be performed on which sample.
3. Analysis Methods are Standardized
The reliability of test results depends on the accuracy and up-to-dateness of the analytical method used. Validated analytical methods can be defined on LIMS, and each test can be associated with these methods.
Method name, method code, revision information, unit of measurement, and reference values can be stored in the system. This reduces the risk of users using different or outdated analysis methods.
4. Tests are assigned to the Analyst or Laboratory Unit.
Analysis tasks can be assigned to specific users or laboratory departments. The system can show which analyst is responsible for which tests and which analyses are pending.
This structure helps to distribute the workload more evenly. Laboratory managers can more easily track pending, ongoing, and delayed analyses.
5. Device and Equipment Information is Associated with Tests
Information about the device or equipment used during the test can be linked to the analysis record. Which test was performed on which device, the device's usage time, and, if necessary, the device's status can all be tracked on the system.
This approach allows test results to be correlated not only with the sample and analyst, but also with the equipment used. This information is particularly valuable in laboratories where instrument performance or calibration history is critical.
How are test results, control, and reporting processes managed?
6. Analysis Results are Recorded Digitally.
Once the test is complete, the results can be directly entered into the relevant test record on LIMS. The result value, unit of measurement, analysis date, analyst information, and necessary descriptions can be stored in the system.
This allows the analysis result to be directly linked to the digital sample record without being written in another file or paper form.
7. Automatic data transfer can be performed between devices.
With appropriate device integrations, analysis results can be transferred directly from laboratory equipment to the LIMS system. This reduces the need to manually re-enter measurement values.
This approach both shortens data entry time and helps reduce risks such as entering incorrect numbers, decimal errors, or transferring results to the wrong sample.
8. Results are compared with reference values.
LIMS can compare analysis results against predefined specifications or reference values. The system can indicate whether the result is within the specified limits.
An alert can be generated for out-of-limit results, or the result can be referred for further evaluation. This structure helps in the faster identification of inappropriate results.
9. The Results Control and Approval Process is Managed.
Saving the analysis result does not complete the process. The result may need to be reviewed and, if necessary, approved by an authorized user. Separate roles can be defined within LIMS for analyst, reviewing user, and approving user.
This structure supports division of labor. The system allows tracking who entered the result, who checked it, and the date it was approved.
10. Test Results are Reported and Archived
Once all tests are completed, the analysis results for the sample can be converted into a report. Sample information, test names, results, reference values, method information, and approval records can all be presented in a single report.
Once a report is generated, the records can be archived. Past analyses can be accessed by sample code, product, batch, date, or test name. This structure makes it easier to review past laboratory data.
What is Test Management with LIMS?
Test management with LIMS involves defining the analyses to be applied to the sample within the system, assigning them to analysts, recording, monitoring, and reporting the results. Thus, the test lifecycle can be monitored through a single system.
Can LIMS shorten analysis times?
LIMS can reduce manual workload through automated test assignments, device integrations, digital results entry, and electronic approval mechanisms. This structure can help analyses progress faster and results be reported in a shorter time.
Is it possible to assign multiple tests to the same sample using LIMS?
Yes. Physical, chemical, microbiological, or different test groups can be assigned to a single sample. Each test is tracked with separate results, method, and user information, while all can be viewed under the same sample record.
How to Manage Out-of-Limit Analysis Results?
LIMS can compare the result against defined specifications and flag values that fall outside the limits. If necessary, the result can be referred for further control, re-analysis, or quality assessment. If QMS integration is available, the relevant nonconformity or CAPA process can be initiated.
What does LIMS and device integration provide?
Thanks to device integration, analysis results can be transferred directly from the device to the LIMS. This reduces manual data entry, speeds up result transfer, and helps reduce data entry errors.
Can test results be tracked retrospectively with LIMS?
Yes. Past records can be searched based on sample code, batch number, analysis date, user, test name, or product information. Along with the results, the analysis method, approval information, and, if necessary, device registration can also be reviewed.
How does LIMS support data integrity in testing processes?
User authorization, audit trails, electronic approval, mandatory data fields, and a centralized record structure help to maintain better control over analytical data. This allows for retrospective tracking of who generated a result and when.
Which systems can LIMS integrate with?
LIMS can integrate with systems such as ERP, QMS, EBR, and WMS. Production batch information can be retrieved from ERP or EBR, sample source or material information can be used from WMS, and non-conforming results can be linked to QMS processes.
What are the benefits of using LIMS for testing and analysis processes for a business?
Using a LIMS helps to manage analysis workloads more efficiently, track results faster, reduce manual data entry, speed up reporting processes, and make laboratory data more traceable.
Conclusion
LIMS enables the digital management of all testing and analysis processes, including sample acceptance, test assignment, method selection, equipment usage, results recording, control, approval, and reporting. This structure makes laboratory workflows more standardized and traceable.
LIMS/LBYS provides a crucial digital infrastructure, especially in laboratories with high sample volumes, those using different types of analyses, or those requiring rapid and reliable reporting of test results. Managing test and analysis data within a centralized system supports laboratory efficiency and data integrity.
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