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LIMS (Laboratory Information Management System) is a system that enables the digital management of processes in quality control laboratories, from sample acceptance to the approval of analysis results. This system, also referred to as LBYS in Turkey, helps track raw material, semi-finished product, process sample, and finished product analyses through a single central system.
The primary task of quality control laboratories is to verify whether products and materials meet specified quality criteria. This process requires the management of sample information, analysis methods, specifications, equipment, user operations, results, and approval records. LIMS links this data within a single digital structure, making quality control processes more traceable, standardized, and controlled.
How to Manage Quality Control Laboratory Processes with LIMS?
1. Samples are registered in the system.
The quality control process begins with the acceptance of the sample into the laboratory. Information such as sample code, product name, batch or lot number, sample type, quantity, acceptance date, and source can be recorded on the LIMS system.
Raw material, semi-finished product, or finished product samples can be managed with different workflows. This allows laboratory personnel to more easily track which sample is at which stage.
2. Necessary analyses are assigned to the samples.
After sample acceptance, the required tests are defined in the system. Chemical, physical, microbiological, or different analysis groups can be associated with the sample record.
For each test, the analytical method, unit of measurement, specification value, and responsible laboratory unit can be defined. This structure clearly indicates which tests are expected on which sample.
3. Specifications and Acceptance Criteria are Managed
In quality control laboratories, analysis results alone are not sufficient. It is necessary to evaluate whether the result meets the specifications defined for the product or raw material in question.
LIMS allows you to define lower limits, upper limits, target values, or different acceptance criteria. When the result is entered into the system, it can be automatically compared with these values, and the compliance status can be shown to the user.
4. Analysis Tasks are Assigned to Users
Laboratory managers can assign tests to specific analysts or units. The system allows users to view which users are responsible for which samples and tests.
This structure helps to distribute the workload more evenly. Pending, ongoing, and delayed tests can be tracked more easily, allowing for more efficient use of laboratory capacity.
5. Equipment and Method Information is Associated with the Analysis
The reliability of quality control results is directly related to the analysis method and equipment used. LIMS can record which test was performed using which method and equipment.
The device's identity, analysis date, and, if necessary, calibration or maintenance status can be correlated with the relevant result. This information is important for reviewing past analyses and investigating potential device-related problems.
How are Quality Control Results and Release Processes Managed?
6. Analysis Results are Recorded Digitally.
Once the test is complete, the results can be directly entered into the relevant sample and analysis record on LIMS. The result value, unit of measurement, analysis date, analyst information, and descriptions can be stored in the system.
In systems with integrated equipment, measurement results can be transferred directly from laboratory equipment to the system. This approach helps reduce the risk of errors in result transfer by minimizing manual data entry.
7. Undesirable Results Are Brought Under Control
If the analysis results fall outside the specified specifications, the system can alert the user. The result may be referred for further review, re-analysis, or quality assessment.
With QMS integration, nonconforming results can be transferred to the quality management system. Thus, nonconformity, root cause analysis, or CAPA processes can be managed in conjunction with the laboratory results.
8. Results undergo a review and approval process.
In quality control laboratories, it may not be sufficient for the results to be entered simply by the analyst. The results may need to be checked and approved by an authorized user.
On LIMS, different roles can be defined for analyst, reviewer, and approver. This separates the result generation and approval processes, supporting a division of labor.
9. Product or Batch Quality Status is Determined
Once all necessary analyses are completed, the quality status of the product or batch to which the sample belongs can be determined. Based on the results, the product can be evaluated in different statuses such as suitable, pending, blocked, or rejected.
When using ERP, WMS, or EBR integration, this quality status can be shared with other systems. This helps prevent the use of products without quality approval in production or shipment.
10. Quality Control Results are Reported and Archived.
Completed analyses can be reported on a sample or batch basis. Analysis results, specification values, methods used, user information, and approval records can be shown on a single report.
Past quality control records can be searched by product, batch, date, sample code, or analysis type. This speeds up access to past results and creates an organized database that can be used for trend analysis.
What is the use of LIMS in a Quality Control Laboratory?
LIMS manages quality control processes such as sample acceptance, test assignment, analysis results, specification checks, user approval, and reporting on a centralized system. This reduces data fragmentation across different Excel files, paper records, and independent applications.
Can raw material quality control be performed using LIMS?
Yes. Samples taken from raw materials arriving at the warehouse can be recorded in the LIMS and the necessary tests can be assigned. Once the results are complete, the raw material's suitability status can be determined and this information can be shared with the WMS or ERP system.
How to Perform Finished Product Control with LIMS?
A sample of the finished product is associated with the relevant production batch, and the necessary analyses are performed. Quality approval can be given when all results meet the specifications. Thanks to EBR integration, production records and laboratory results can be evaluated for the same batch.
Can LIMS shorten quality control time?
Features such as sample tracking, automated test assignment, instrument integration, specification checking, and electronic approval can reduce manual operations. This structure can help in faster evaluation and reporting of laboratory results.
Can OOS results be tracked with LIMS?
Out-of-specification results can be marked on the system and subjected to further evaluation. A re-analysis, review, or nonconformity process can be initiated according to the institution's quality procedures. If QMS integration is available, the relevant quality records can be directly linked.
How does LIMS support data integrity in a Quality Control Laboratory?
User authorization, audit trails, electronic approval, mandatory data fields, and a centralized record structure help maintain better control over laboratory data. It is possible to trace retrospectively who generated, checked, and approved the results.
Can trend analysis be done with LIMS?
Past analysis results can be compared by product, batch, parameter, or time range. This makes it easier to identify changes in a particular quality parameter over time or recurring out-of-limit results.
Which systems can LIMS integrate with?
LIMS can integrate with systems such as ERP, WMS, EBR, and QMS. Product and batch information can be retrieved from ERP or EBR, material and stock records can be used from WMS, and non-conforming laboratory results can be linked to QMS processes.
What are the benefits of managing a Quality Control Laboratory with LIMS?
Using LIMS strengthens sample and analysis traceability, reduces manual data entry, standardizes specification checks, accelerates result approval processes, and facilitates access to historical quality records. It also makes laboratory workload and performance more visible.
Conclusion
With LIMS, the quality control laboratory enables the digital management of all processes, from sample acceptance and analysis assignment to specification checks, result approval, and reporting. This structure helps to maintain laboratory data in a more standardized, traceable, and centralized manner.
Especially in manufacturing plants where raw material, semi-finished, and finished product controls are intensive, LIMS/LBYS enables the quality control laboratory to work more integrated with production, warehouse, and quality systems. Thus, laboratory results are not merely a report, but become a direct part of product and batch decisions.
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