The increasing importance of LIMS

LIMS stands for Laboratory Information Management System. It is asoftware program that is used in a number of different industries. LIMS is used in the pharmaceutical, chemical, oil and gas industries, biotechnology, food technology and also in the field of analytics. The system is used anywhere where samples are processed and the data related to them needs to be stored. To put it a little more simply, LIMS is a management system for samples.

I would like to use an example to illustrate why using an LIMS is often a necessity. Let’s imagine that we run a laboratory that specialises in analysing water samples. This laboratory receives orders from customers from different regions and industries. Our task is to test different water samples for their quality.

The workflow for a sample

The process for our water analysis laboratory starts with the customer submitting their order. The customer has informed the laboratory that it needs a water sample analysed. As part of the order, the customer also sends information on the size of the sample, the number of tests that have to be carried out, as well as other relevant information that both the laboratory and the customer need. This is the first set of data that the laboratory has to collect.

The next step starts as soon as the sample arrives. The laboratory can already start performing its tests. It is crucial that the correct order data is assigned to the sample. If several tests need to be performed, they can run in parallel. This allows the laboratory to analyse the sample quicker. Once all of the tests have been completed, all of the data can be amalgamated. Then, a report is prepared, which presents the results of all the analyses. Next, the laboratory can issue an invoice if it had not already done so at the start of the process. The customer receives both the report and the invoice by post, e-mail or fax, depending on how he or she has requested it. This completes the process in our example.

This example is heavily simplified because every process contains deviations that have to be taken into account. In addition, every process step in a laboratory is complex, as various details have to be collected and processed, such as the data pertaining to the sample, equipment, results or performing the analyses. The sample data is the most important data as it represents the continuity of the process. This data must always be traceable. On top of that, the tests must be defined accordingly and the customer’s quality requirements must be met.

There are various reasons as to why a customer trusts a particular laboratory even before they place an order:

• The service must be affordable for the customer.
• The laboratory is certified, which means that it has proven that the company’s workflows meet certain guidelines.
• Since laboratories operate in a highly regulated environment and have to comply with certain regulations, there are constant checks in place to ensure that a certain quality of services or products is guaranteed.

In other words, companies must not only be cost-effective, fast and efficient, but also offer quality. Many laboratories that have to process a high throughput of samples want and need to remain competitive. That’s why it is essential that their processes are constantly optimised and automated. What’s more, the guidelines and requirements that must be met in a regulated environment are becoming increasingly complex. The amount of information that needs to be processed and stored is also growing exponentially.

An LIMS is one of the solutions that enable laboratories to organise their processes efficiently and clearly. This enables companies to meet requirements more easily and makes it easier to manage data.

What are the regulations?

In the pharmaceutical, biotechnology and food industries, the regulations are much stricter. The following regulations play a particularly important role here:

• EMA (European Medicines Agency)
• CHMP (Committee for Medical Products for Human Use)
• COMP (Committee for Orphan Medical Products)
• PRAC (Pharmacovigilance Risk Assessment Committee)
• FDA (US Food and Drug Administration)
• BfArM (German Federal Institute for Drugs and Medical Products (Bundesinstitut für Arzneimittel und Medizinprodukte))
• AkdÄ (Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft))

When setting up a laboratory information management system, the requirements for the underlying process must be taken into account. That’s why the laboratory must be aware of the current requirements and guidelines. Examples of these requirements or guidelines can be found in the following documents: FDA 21 CFR Part 11 and GAMP 5.

These documents are important for the computer system validation (CSV). This is a documented validation process that consistently and reproducibly proves that a computerised system executes its processes as required by it.

Since a LIMS requires an IT infrastructure, a CSV will probably also have to be carried out. To find out which requirements and guidelines need to be met, it is best to work with the relevant authorities from the outset and refer to the most recent documents.

Which LIMS providers are out there?

If a company needs an LIMS, it has two options, both of which have different advantages and disadvantages.

1. The company can program its own LIMS system. The advantage of this is that the company will end up with a tailor-made product. The disadvantage is that developing the software can become a very complex process.

2. The company chooses an LIMS provider and buys the software licences. In doing so, the company can rely on the support of the LIMS provider. Most LIMS providers offer configurable systems that can map most of the required functionalities.

Whether a company develops its own laboratory information management system or which LIMS provider offers the best solution (if the company has decided against developing their own) depends on a number of factors.

The following questions can help in the selection of an LIMS:

• What exactly does the company need?
• How large is thecompany’s budget?
• What should the cooperation with an LIMS provider look like?
• When should the LIMS be ready to use?
• To what extent are processes optimised with LIMS?
• Is the company more competitive with LIMS?

There are a large number of LIMS providers these days. The best known and most successful are:

• LabVantage – LIMS LabVantage
• Labware – LIMS LabWare
• Core Informatics (ThermoFisher) – LIMS CoreLIMS
• Abbott Informatics – LIMS STARLIMS
• Eppendorf – LIMS eLABNExt
• Labworks – LIMS LABWORKS
• AgileBio – LIMS LabCollector
• Agilent – LIMS iLab Operations Software, SLIMS

And what about systems that are similar to LIMS?

LIMS is just one of many software programs that a laboratory can use. Since a range of different and complex processes take place in a laboratory, there are also different solutions to optimise each process. Some of them are:

• ELN (Electronic Lab Notebook): The Electronic Lab Notebook is used to document research results or changing workflows. LIMS and ELN have similar functionalities and are often confused. LIMS is sample-oriented and, in contrast to ELN, is used in structured workflows.
• SMDS (Scientific Data Management System): This software serves as a database for scientific data and as a platform for exchanging data.
• LES (Laboratory Execution System): Similar to the LIMS, an LES is used in various workflows. The difference is that an LES maps the workflows of the lab staff. This means that the LES supports the work of lab assistants with the aim of ensuring that work instructions are followed in the correct order.
• LIS (Laboratory Information System): An LIS is very similar to an LIMS. The difference is that an LIS is more likely to be used where patient data is needed. An LIS is therefore person-oriented, whereas a LIMS is sample-oriented.

Conclusion

Companies must constantly optimise and automate their processes to remain competitive. LIMS is a software solution that works very well when samples are processed and the workflows are structured. That’s why LIMS are very commonplace in laboratories in the pharmaceutical, biotechnology and food industries. Plus, LIMS simplifies processes and the management of data. As a result, LIMS users can meet the requirements of regulators more easily. Digitalisation, which entails using new technologies, will continue to drive the use of LIMS forward.

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