LIMS 101: All Your Questions Answered

Laboratories around the world have evolved over the years to deliver on the demands of industry watchdogs, technicians, staff, customers, and other stakeholders in the value chain. The rise of a Laboratory Information Management System (LIMS)—the lifeblood of a modern lab—has been one of the most fundamental phenomena in this evolution. Not surprisingly, LIMS is a tool of interest for all laboratories irrespective of the industry. So, if you find yourself asking the question, ‘how does a LIMS work?’, or even ‘what is a LIMS?’, we’ve got you covered. In this blog, we break down what a LIMS is, its functions, and other nuances for you.

What does LIMS stand for?

The acronym LIMS stands for Laboratory Information Management System (LIMS).

What is the meaning of a LIMS?

A LIMS is a software solution that addresses the data management, automation, and regulatory needs of laboratories. In addition to effectively managing laboratory samples and associated data, a LIMS helps automate workflows and integrate instruments.

What are the benefits of a LIMS?

There are several advantages of a LIMS, some of which are:

• Automated Workflows: Automated workflows obviate the need to record data manually, thus reducing human errors and increasing efficiency. Automated workflows include interfaces with laboratory instruments, reporting systems of regulatory agencies, and in-house systems such as Enterprise Resource Planning (ERP) software and supplier systems.
  
• Sample Management: A LIMS helps manage samples effectively. A user can assign storage locations to samples that accurately reflect the sample storage hierarchy.
  
• A flexible user interface: LIMS user interface can be customized or configured to match each laboratory’s particular needs and processes.
  
• Data Privacy and Protection: Enhanced privacy and data protection are achieved through role-based access to data.
  
• Ease of Reporting: A LIMS allows authorized users to easily produce different kinds of reports such as reports about tests carried out, the total number of samples, patients, or inventory items.
  
• Regulatory Compliance: A LIMS helps meet compliance with regulations such as HIPAA, 21 CFR Part 11, ISO/IEC 17025:2017, ISO 15189, EU GDPR, ISO 20387, CLIA, GxP, and more.
  
• SOP Enforcement: A LIMS enforces staff to follow predefined Standard Operating Procedures (SOPs), thus ensuring repeatable and reproducible results.

Now that we know the key advantages of a LIMS system broadly, let’s understand who uses a LIMS and how it works.

Who uses a LIMS?

A LIMS is used by laboratory technicians, staff, and managers from, but not limited to them. Industries such as clinical research and diagnostics, biobanking, food and beverage, cannabis, oil and gas, agriculture, environment monitoring, water testing, material testing, forensics, chemical, veterinary, mortuary, manufacturing and the likes. To find out more, please visit our blog on the same topic. 

What is the purpose of a LIMS?

The earliest LIMS were used for managing laboratory samples and their associated data, test analyses, and reporting. While the use case of sample management remains at the heart of a modern LIMS, the role of a LIMS has grown significantly to include data integrity considerations throughout the life cycle of samples. Modern LIMS provide functionality such as audit trail, electronic signatures, and Chain-of-Custody (CoC). Any change in samples can be recorded along with the reason for the change and the editor of the change. Electronic signatures help authenticate laboratory activities. Moreover, a sample CoC helps track in whose custody a sample is present. These functionalities equip LIMS with the capability to meet regulatory mandates. 

Apart from superior sample tracking, a modern LIMS constitutes several enhancements over the traditional LIMS including inventory management, quality management, test management, personnel management, standardization of procedures, centralization of data, advanced search tool, data analysis, and more.

Inventory management prevents the unavailability of supplies such as reagents, and alerts lab managers when supplies fall below a threshold quantity to help with reordering of supplies. The test management module tracks samples falling outside specifications and helps chart a trend analysis plot for quality assurance.

Another notable feature of a modern LIMS is storage management. Maintaining a record of the physical location of samples can be a nightmare for technicians in a biobank, which houses thousands of samples for research purposes, each with a different freezing or storage requirement. A LIMS can store all the descriptive information about storage conditions and location information for each sample. 

A modern LIMS also helps in personnel management by keeping a record of the formal courses, training and certifications lab personnel have attained, thus ensuring only the most competent personnel handle designated equipment and analytical tests. Lastly, modern LIMS support easy generation of a variety of reports including reports of sample CoC, sample summary, inventory, test results, audit trail, QC data, invoices, freezer space, instrument calibration, and more.

How does a LIMS system work?

Upon entry of a sample, a LIMS captures all the data associated with the sample such as the sample ID, collection date, source, concentration, and volume. A barcode assigned to each sample can be scanned during storage and usage to track samples at any time in the sample lifecycle. As the sample moves through the laboratory, information such as who has interacted with the sample also gets captured. Hence, an audit trail is maintained. Functionalities such as audit trail and chain-of-custody are integral to ensuring data integrity.

A modern LIMS standardizes and digitizes operating procedures. Thus, irrespective of who processes a sample or runs a test, lab managers can rest assured of a reproducible result. Test assignments can also be managed with the help of a LIMS. Pertinent protocols can be assigned as soon as a sample enters a laboratory and upon completion of tests, test results can be sent for approval and can be disseminated appropriately.

A modern LIMS also allows users to track where a sample is, throughout the sample lifecycle, from a vial’s whereabouts down to the location of the freezer and the room a sample is in. Lab managers know where a sample is at all times.

Modern LIMS connect with laboratory equipment, thus ensuring seamless workflows and data transfer. They can export sample data directly to other applications for processing or downstream analysis, or import sample details for storage.

Since a LIMS records the entire journey of a sample, it holds all the information required for reports, audits, and quality controls. A cloud-based modern LIMS has all this data in the cloud, and hence users can easily access it from anywhere and everywhere. Given that the data is stored on the cloud, it is updated in real-time, as the data is accessed and processed. All the stakeholders, therefore, have access to the latest information being logged from across the data centers.

Why should you use a LIMS in your medical laboratory?

A modern lab houses thousands of samples and associated metadata. Manual methods are not up to the task of handling, tracking, and analyzing such large numbers of samples and data. Spreadsheets, a tool used by many labs for managing patient data till recently, require extensive manual data entry and also create room for errors. Furthermore, manual data management methods may compromise sensitive patient data, leading to hefty penalties running into thousands of dollars. Data can be lost accidentally if records get deleted. A LIMS can store a large amount of data, automate workflows, and also standardize operations. What’s more, it is equipped with appropriate data security controls, and in a cloud-based LIMS, there are no chances of data loss.

A LIMS radically improves the efficiency of a lab by enabling workflow automation which reduces human error, centralizing access and storage of data, supporting compliance with regulations, tracking reagents, monitoring instruments, and integrating with instruments.

Why should you invest in a LIMS?

Investing in the right tools can create huge efficiencies for any organization in both the short and the long term. A LIMS streamlines processes, automates workflows, and is built for ready regulatory compliance. Laboratories that use homegrown systems or spreadsheets risk data quality and slip-ups in data management.

Modern LIMS systems are also configurable, which means they can meet the unique needs of each laboratory. A configurable LIMS is adaptable and can upgrade through its lifecycle which makes it an excellent investment because once invested, a configurable LIMS only requires upgrades, not an overhaul.

How does LIMS benefit your lab’s productivity?

A LIMS records the journey of a sample from its entry into a lab, its storage, testing, reporting, archiving, to disposal, which is not possible impeccably with home-grown systems. With data integrity measures in place and maintenance of chain-of-custody across workflows, it ensures the right result for every patient, physician, and client every time. In addition to exceptional sample management and tracking, a LIMS digitizes operating procedures, reducing the time spent on manual processes. The capabilities of a LIMS make labs ever-ready for regulatory inspections, which means lab managers do not have to struggle to prepare reports at the time of inspection.

How much does a LIMS cost?

A LIMS solution is not a one-size-fits-all solution. The needs of each lab are different, and so are the LIMS features that address those needs. There are two components associated with LIMS software price: software and services, and both vary depending on certain considerations, including the features a lab needs, the systems to be integrated, the number of users, and the level of configuration and customization required. Labs should choose a LIMS vendor that offers services, such as instrument integration, product upgrades, product configuration, training, and technical support at a reasonable cost so as to optimize the total cost of ownership (TCO). Typically, cloud-based LIMS products reduce the TCO. 

Conclusion

Modern LIMS have come a long way from the first LIMS implemented whose only function was to manage samples. Today, a LIMS not only performs exceptional sample tracking but also offers a host of other features and functionalities that make them an indispensable part of a modern lab. This blog delineates these features by answering fundamental questions about a LIMS. Some of these features are: maintaining an audit trail and a chain-of-custody, automating workflows, integrating with instruments and software systems, meeting regulatory compliance and quality standards, and ease of reporting. With these features and functionalities, a LIMS has not only cemented its place in the modern lab but has also emerged as a key differentiator between leading labs that have adopted LIMS and those still on the fence about it. Home-grown systems do not hold a candle to LIMS and labs that haven’t embraced LIMS yet, must do it soon or cease to exist sooner than later.