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3 Ways LIMS Traceability Promotes Quality

Feb 15, 2021 8:15:00 AM

3 Ways LIMS Traceability Promotes Quality

As the adoption of laboratory information management systems (LIMS) continues to grow, laboratories of all sizes, budgets, and specialties are faced with the question of whether they should implement one for their teams. Though it may seem tempting to find specialized use cases—and there is certainly value to be found in comparing implementations within specific laboratory settings—there are some universal needs shared by all laboratories, which a LIMS can meet and fulfill.

One core functionality of every LIMS is the traceability that it automates across all laboratory samples and testing. There are many ways in which this traceability in turn promotes quality, but in this article, three of these ways will be addressed.

Easier Audit Trails

Laboratory audits are intended to make sure that laboratories are compliant with their protocols and industry standards, that lab practices meet required guidelines, and that the results gained from this laboratory are high-quality and well-documented. The value of a LIMS in meeting compliance requirements is that every LIMS automates documentation processes and even collects extensive metadata on factors beyond the standard lifecycle; this data can be mapped to sample number, sub-samples, test numbers (for solutions), and so forth.

Because a LIMS is designed to be flexible, processes can be constructed to account for individual lab user preferences and match the guidelines the laboratory must adhere to in order to conduct its business. With a LIMS, the lifecycle of each sample can be shown in detail because everything that is done through the system is documented. Every status change associated with a sample is automatically tracked, as well as the person and location responsible for the change. This tracking eliminates an entire set of sample-related concerns about analysts forgetting to document important things or inputting inaccurate information.

Additionally each lab can define metadata to attach to the wide and varied steps of its workflow. Metadata can include such simple elements as the sample’s barcode. Every action performed and result observed is logged, time-stamped and uploaded into the LIMS. Any changes or mistaken values can be flagged and acted upon, or else referred to in any future proceedings. 

The automation inherent with a LIMS solution means that when a laboratory finally obtains a final result per the boundaries of their work, it can be treated appropriately and follows the laboratory's specific standard operating procedures and best practices. Lab members have full confidence that the sample was generated following the precise specifications by which it was supposed to be generated. All results are validated, and all samples undergo the tests outlined as part of any associated SOPs. Because these results are validated, they can help determine whether a sample is acceptable for use or if further testing or investigation is needed. All results are logged to specific samples, as are any investigations or subsequent actions taken.

This system is highly beneficial from a compliance perspective, because it supports the lab’s quality assurance process as intended. Any sample and its result generated in the system can be pulled up and traced back to understanding the process to generate it, the person who generated it, the lifecycle of the result/test/sample, as well as any and every change made along the way.

Using the sample tracking and testing features of a LIMS allows each laboratory to maintain an easy-to-access digital record that provides transparency for an audit or otherwise. All results are traceable within the LIMS, with some generated automatically (as already noted). The LIMS collects large volumes of data—far beyond what individual lab members could manually collect—and automatically validates the data and stores it. In this way, laboratories can defend that their processes are compliant in the event of an audit. Lab managers can be confident in their team to accurately and efficiently perform their jobs.

Additionally, for any laboratories using pre-validated workflows, these are already known to comply with best practices and industry requirements. The more customization is brought into the picture, the more additional validation will need to be performed on any LIMS workflows.

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Supports Use of Barcodes

Barcoding samples is exactly what it sounds like: adding a scannable code that can be read by a machine to identify laboratory samples and even track relevant information on each one, such as sample history, tests performed, and more. Barcoding is a proven way to drive down sample errors and misidentification by eliminating the human errors that come with manual labelling, tracking, and documenting information. Using barcodes on samples ensures that they are accurately identified, and avoids the manual errors that can arise during manual documentation.

Because barcodes are automatically applied, they reduce the incidence of processing errors in much the same way as a dropdown list can reduce the variations and errors inherent to manual data entry. Within a LIMS, the barcodes are automatically generated, which has major implications for the laboratory workflow and facilitates both compliance and accuracy. Every sample can have a unique identifier that is documented in such a way that it will not be misidentified at a later date. Particularly when dealing with such large numbers, having a single inaccurate digit in an identifier—whether it's in the labelling step or when pulling up the sample—could be majorly detrimental. In many labs, samples may look the same, so there are no visual cues available as a safeguard from error; the only differences between samples (and their identifiers) might be the batch number and the bar code.

Scanning barcodes to the LIMS means that laboratory members need to spend less time double-checking to make sure everything is documented correctly. This process guarantees traceability: one simple barcode scan, and any lab member can instantly know exactly what the sample is and to what tests it has been subjected. Best of all, standards, reagents, and other lab supplies can also be included in the barcode system; this can also help keep track of batches and stay on top of any potential issues that may arise down the road. The fact that a LIMS handles all of these complicated details automatically and stores them in an easy-to-access method is one reason alone to consider implementing a LIMS in any research laboratory.

Streamlined Certificate of Analysis

A certificate of analysis (COA) is a document that can be issued after certified quality testing is performed on a product and it is found to meet its specifications. An important part of every legitimate COA is complete and thorough documentation of the testing that was performed in order to produce it. In instances such as for medical or pharmaceutical products, the COA confirms that the item in question is suitable for use because everything about its production adhered to GMP standards.

To generate the results required for a COA, the sample must be generated in a validated way, and then checked against its specifications. Automating these checks can help ensure the correct sample is being tested and that it does in fact pass the standards to be deemed high quality. The automated workflow of a LIMS can actually facilitate the blocking of samples from advancing any further through lab processes unless they pass the specifications required for a COA. Using a LIMS also reduces the time spent removing possible transcription errors, since all sample parameters are automatically entered and validated. 

At the end of the day, all laboratories can benefit from facilitating consistency in an automated way. All laboratories face internal or third-party audits, where they are held accountable for their compliance and the quality of the laboratory's results and products is effectively verified. Additionally, laboratories work with samples and have to stand behind the quality of their results and products. With the ability to scan barcodes and generate the required data for COAs, LIMS automates traceability and promotes quality throughout all laboratory processes.

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Topics: QA/QC

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