A laboratory revolves around a multitude of functions performed by the Quality Control (QC) team involving analysts, chemists, QC managers, and QA team. The functions are administering or performing sample analysis or testing using various tools like analytical instruments, logbooks, worksheets as per the specifications. These functions or tasks are to be performed as per set standard processes to ensure quality, consistency, accuracy, and traceability of the sample testing processes.
In order to achieve a desired predetermined output, it is important to have a streamlined process. There will be multiple stages in this process with checks and balances to show the correctness of the data with no skipping of the stages set in the process and with metrics to measure the performance of the process and individuals as well.
Such a process can be done manually or in excel but an automated system with checks and balances is the best suitable for such an important process like sample analysis. This system is popularly known as LIMS. When a LIMS is implemented in a QC lab it streamlines the entire process as it takes over the human control and ensures all samples are tested and released as per approved process configured in the system.
Sample analysis in QC lab has multiple steps like sample login, allocation, testing, recording of test results, review and approval of analysis. These analyze required complex calculations and the use of analytical instruments. Let’s see how we can effectively use LIMS to stream the line process.
In LIMS, a sample login is done, and AR number is generated by the system, which is associated with the sample till its release, this significantly improves the tracking of the sample by its status by a simple search.
Sample allocation can be done by the qualified analysts on the method or on the instrument. If the analyst is not qualified the system will not allow the allocation. Such method helps the QC manager to know the sample load and do a better allocation. The formulae used in the tests are stored in the LIMS as masters and the analysts can use them as per the specification. The entire specification is entered as master and analyst can use the master as a worksheet to record results. The printed logbooks and worksheets are replaced with this controlled worksheet which helps to record results as per the process.
The analysis of the sample is done using different types of analytical instruments and LIMS will interface with them, fetch results and enter them automatically into the worksheet. This eliminates data errors and result recording will be as per the standard process. The calibration process of the analytical instruments is maintained by LIMS which ensures only calibrated instruments are used for analysis.
At every process, there has to be review and approval as checks and balances of the process. LIMS ensures this by not allowing the next step without predefined review and approval matrix at each step. The chain of custody of each sample is provided as an audit trail with date and time stamps to trace any mistake or anomaly.
Implementing a LIMS improves the overall operational efficiency of a laboratory. A LIMS saves time otherwise spent on manual data logging and maintenance, thus offering an efficient data management solution. This leads to a decrease in human-error and a more accurate information system to support various decisions. It also comes with an audit trail, that automatically reduces the time taken for manual auditing. Additionally, a LIMS is most useful when dealing with voluminous data that requires batch analysis and repetitive daily operations. It also covers various compliance standards, helping laboratories maintain their regulatory, safety and privacy standards. CaliberLIMS is one such product that provides all the above-listed benefits to the customer.
Laboratory Information Management System (LIMS) is evidently a necessity for laboratories to manage their daily operations with greater efficiency. Pharma companies strive to ensure compliance, increase productivity, and align thoroughly with standard processes. Digitalization of…