A good LIMS solution can automate a laboratory’s workflows and simplify data management processes. This helps laboratories stay ISO 17025 compliant and pass audits.

The ability to standardize naming conventions can also help to avoid confusion and errors. This can be a significant boost for lab productivity.

LIMS software also supports chain of custody (CoC) procedures with easy sample tracking. It can also include document control to manage important documents required for ISO compliance like quality manuals, policies and procedures.

Compliance

As samples enter the laboratory, LIMS systems capture and store all of their associated metadata – such as sample ID, source, collection date, test order information and results, derived sample data, and time-based study metrics. This data is centralized and easily retrievable, eliminating the need for disparate storage systems and ensuring consistent and structured data entry practices to reduce errors. LIMS also facilitates instrument integration by connecting laboratory instruments directly to the system. Instruments can be configured to record data automatically, reducing manual transfer times and removing the risk of transcription errors. Additionally, LIMS can be programmed to track calibration and maintenance schedules preventing laboratories from using uncalibrated or out-of-date equipment.

To meet ISO 17025 requirements, laboratories must keep records of all activities. LIMS can support this process by ensuring that all requests are reviewed prior to being processed (including those from customers via customer portals), tracking the status of each request, and logging who reviews and approves each request. Additionally, LIMS can track the details of all consumables received and stored within the laboratory, including a full inventory of recipes for materials created in-house (including their lot numbers) and the expiration dates of all components used in tests.

Finally, a LIMS can help maintain compliance with staff competency requirements by ensuring that analysts are only allowed to perform methods for which they are trained/certified and alerting them when their training is approaching expiration. This helps prevent non-compliant behaviors that can be difficult to document in a paper system.

Automation

The ability to automate a laboratory’s processes and workflow reduces human error in lab operations. By integrating directly with instruments a LIMS ensures data is accurate, valid and consistent from sample to sample. This eliminates errors caused by manual calculations, such as concentration conversions, and helps to produce more precise results. By reducing data inconsistencies and improving consistency, a LIMS also helps to make adhering to standards more manageable for labs.

Additionally, by capturing all procedures and protocols in one place, a LIMS helps to ensure that all staff are following the same documented procedures. This can help to further mitigate the impact of internal departmental audits or regulatory inspections that can result in failure to meet compliance requirements.

Lastly, a modern LIMS can also automate a number of manual tasks to further enhance data accuracy and improve overall laboratory efficiency. For example, a LIMS can be programmed to calculate all concentration conversions for scientists automatically, eliminating the need to manually perform these calculations. A LIMS can also be used to track all reagents and consumables, allowing for automated inventory updates based on real-time usage. This saves time by reducing paperwork and reporting, facilitating better collaboration between team members and increasing visibility of the entire lab operation. This increased efficiency enables laboratories to complete more tests and analyses in a shorter amount of time, which can be critical during a pandemic or natural disaster situation.

Documentation

One of the most common issues raised by auditors during inspection is missing or incomplete documentation for laboratory systems. This is often due to the sheer number of tasks that need to be documented and recorded by laboratory staff, but can also be a result of the initial implementation of LIMS or its lack of flexibility when it comes to workflows and business processes.

A LIMS allows centralized management of documents required for ISO 17025 compliance, including quality manuals, policies, and procedures. This helps reduce the risk of errors and makes it easier for personnel to access the data they need when needed.

LIMS is also critical to the traceability of samples throughout the testing process. It can track sample identification, chain of custody details, and other information, ensuring that all aspects of an analysis are logged and documented. This helps auditors assess whether laboratories are following the appropriate processes and ensuring that samples are not lost or misplaced.

When it comes to the operation of laboratory equipment, a LIMS can help with compliance by tracking calibration schedules, recording maintenance details, and allowing laboratories to take equipment offline when necessary. It can also track analyst training and certification, ensuring that only qualified personnel are using the correct methods and ensuring that results are valid. It can even flag that a test has been entered incorrectly or is outside of the rules, so that the analyst is prompted to review and correct it before it is submitted for reporting.

Collaboration

As LIMS automates tasks and centralizes information, it can help laboratories improve efficiencies and demonstrate compliance with ISO standards. This is especially important during external regulatory inspections where a robust LIMS system can help streamline audit processes, highlight adherence to best practices, and showcase laboratory excellence.

For example, a laboratory may need to track sample details including unique identification codes, date and time of analysis, storage parameters (including temperature records), as well as the results and analysis procedures. A LIMS can help by providing a single point of data entry, as well as automatic notifications when specific tasks require attention such as method validation or the expiration of an analyst’s certification.

In addition, some LIMS can help meet ISO 17025 requirements that cover process definitions and enforcement, such as the review of customer requests to ensure they are feasible and covered by existing contracts. This can be automated by a LIMS and enforced through preventing a request from being processed until it has been reviewed.

For larger laboratories, LIMS can be used to integrate laboratory systems such as Enterprise Resource Planning (ERP) software and Electronic Lab Notebooks (ELN). It also allows researchers to work collaboratively, whether they are in the same facility or separated by the globe. However, it is important to consider how a laboratory plans on collaborating before choosing a LIMS solution. Look for a vendor with a good track record of supporting multi-lab research and who can provide expert advice on how to get the most out of their LIMS for collaboration purposes.