A LIMS (Laboratory Information Management System) primarily helps laboratories to manage samples and data. It also standardizes laboratory operations by streamlining workflows, enforcing staff to follow standard operating procedures (SOPs), managing tests, and reporting test results as required. Apart from this, it also helps laboratories overcome various challenges, including data management, automation, and regulatory challenges, which may vary from one laboratory to another.
Why Should You Implement a LIMS?
With the advancement in technology, modern laboratories now generate a large amount and a wide variety of data. Implementing a LIMS can help these laboratories efficiently manage ample amounts of data. There could be a possibility that laboratories would like to stick to their current system, such as spreadsheets, to manage data due to the complexities involved in the implementation process. However, by following well-planned, comprehensive steps, a LIMS implementation could be easily successful. Along with improving the operational efficiency of a laboratory, a LIMS could also reduce the man-hours spent in managing the data and, therefore, have a positive return on investment.
What are the Steps Involved in Deploying a LIMS?
1. Understand Your Goals
In any LIMS implementation, defining the goals for the new system is essential as it provides a clear understanding of the system’s purpose and what you can expect from it. It also helps understand the criteria for measuring its success. Common laboratory objectives include enhanced adherence to regulations, stronger data security, faster turnaround of results, stronger quality control checks and quality assurance, workflow automation to reduce manual intervention, more effective and personalized reporting, and more. It’s also important to explore innovative uses like integrated calibration scheduling and staff competency management. It’s advisable to create a User Requirements document outlining essential and nice-to-have functionality, besides potential benefits as an outcome of LIMS implementation.
2. Create a LIMS Implementation Plan
A laboratory undertaking a LIMS implementation project must devise a thorough LIMS implementation plan, without which the implementation may not deliver the expected results within the available budget and timeframe. A comprehensive LIMS implementation plan should provide a clear outline of various aspects, including estimated timelines, essential performance metrics, available LIMS vendor choices, and more.
The plan should also consider data migration from the existing system to the new system. Data migration should not be put off until late in the implementation process. Data, especially mission-critical experimental data, is a valuable asset, and it is crucial to carefully plan and execute its migration from the legacy system to the new system.
3. Evaluate and Select the Right LIMS for Your Laboratory
Selecting the right LIMS for your laboratory can be a daunting and time-consuming task. You may have confusion during the evaluation phase to zero in on the perfect LIMS for your laboratory. Before you commence the evaluation, you must shortlist potential LIMS systems that appear promising. Many systems you come across may or may not have the potential to meet all of your needs. Taking a reasonable time in determining the best system that suits your laboratory needs is acceptable. A wrong decision can be detrimental to your laboratory’s health.
While evaluating a LIMS for your laboratory, you must know what functions the LIMS must perform, which metrics you need to track, your annual LIMS budget, the staff members who would use the LIMS, and the expected number of users. Similarly, you need to make sure that the LIMS vendor provides a demo/trial of the system, price quotes for LIMS implementation, licensing, instrument and software integration, technical support, product upgrades, legacy data migration, and product configuration. To minimize the total cost of ownership, it is best to choose a vendor who offers some or most of the services complimentary.
The LIMS vendor must have knowledgeable and efficient support staff who are capable enough to configure the product per your laboratory workflows, data management, and reporting requirements. Additionally, they must be available to troubleshoot issues.
4. Get Signed Contracts
After selecting a LIMS for your laboratory and before placing the order, you must ensure that the legal and scientific content within the contract is properly reviewed by an expert. The licensing cost is usually calculated on a per-user basis and billed annually. Sometimes, you may need custom features to meet the specific requirements of your laboratory. The customization of your LIMS may involve a one-time development and implementation cost, which should be clearly defined in the contract. To avoid the customization cost, it is best to select a configurable LIMS that can easily mirror your current and future laboratory workflows without the need for custom development.
5. Determine Your Laboratory Requirements in Detail
Once the contracts are signed, your laboratory needs to specify all the requirements for your LIMS. At this stage, you will need to have a detailed understanding of your laboratory’s workflows to configure your LIMS because these workflows will eventually translate into LIMS workflows. It could be a time-consuming process as your laboratory should consider a few important factors at every single step of every workflow performed using the LIMS. Some of the factors to consider are as follows:
Understanding your laboratory’s activities and workflows.
The process of tracking samples in a LIMS, for example, through unique sample barcodes.
What data the LIMS should provide to help you easily manage your laboratory and make informed decisions.
Details about the information or data a LIMS should capture, for example, test results from analytical instruments.
As it is rarely possible for a laboratory to readily explain all these mentioned factors, you must consider the minimal viable product (MVP) approach during this step to make the implementation phases more specific and less time-consuming. In this approach, you only include the functions which are indispensable at the initial stage. Anything not essential can be included in later phases rather than investing time and resources in it at the initial stage. This way, each phase is defined in detail, and such specific phase implementations are always known to be very effective.
6. Configure the LIMS Per Your Laboratory Workflows
At this step, you need to provide specific details about the requirements of your laboratory to your LIMS vendor. This is important for the LIMS experts to configure the system per your laboratory workflows. More specific details would lead to faster and more accurate LIMS software configuration. Some of the details include sample management requirements, the workflows for processing each sample type, detailed information about the instruments and software to be integrated with the LIMS, reporting, invoicing, and regulatory requirements. A LIMS has the potential to redefine your laboratory efficiency. Hence, it is very important to ensure that the LIMS functionality meets the present and future needs of your laboratory.
7. Perform Robust Testing
Followed by previous steps, it is necessary to fully test the system. At this stage, it is known as user acceptance testing. There might be potential bugs in a LIMS that a user might run into. It is not very uncommon for even configuration specialists to miss out on some flaws. Hence, rigorous testing should be performed in conditions that closely mimic real-lab scenarios.
8. User Training
Adopt the “Train the Trainer” approach in which key users trained by the LIMS vendor train the wider laboratory personnel. This enables staff to receive training from experts who are well-versed in their standard operating procedures and laboratory terminology.
9. LIMS Software Verification
This formal LIMS validation takes your testing process done in the previous steps to the next level. However, this step is considered optional. This verification is usually done by configuration specialists as they are better aware of the system. However, the verification can be performed by laboratory users or third-party entities as well. The verification steps involve the following:
Creating a pre-specified LIMS software verification plan.
Preparing a list of LIMS-specific requirements.
Executing a test case to ensure the LIMS system fulfills all laboratory requirements.
Preparing a final summary report of all test cases.
10. Roll it Out to Staff With a Go-Live Plan
Done with finalizing and validating the LIMS? Introduce it to your staff.
The go-live plan must include the following:
Time and date of LIMS deployment
Who will deploy the LIMS software
When it can be used by laboratory users for managing actual laboratory data
If staff can access existing systems during the deployment process
If data-backup is taken and migrated before LIMS deployment to prevent any data loss
If the current data is impacted or altered by the deployment of the new LIMS software
11. Update Your LIMS
This step is optional as it completely depends on how important it is for your laboratory to update the LIMS with new functionalities. It is essential to consistently assess and upgrade your LIMS as workflows, operational procedures, or the overall business environment evolves. The LIMS should be flexible to seamlessly adapt to these transformations. A few important points to consider are as follows:
Envision the new features you may need a few months down the line
Which features could be grouped in a single deployment
Inform your LIMS vendor about the new feature requirements ahead of time so that they can include them in the development sprint
Check if your LIMS vendor charges for developing the new custom features and finalize the charges if any
Test the new features in a sandbox environment once they are ready
Determine the time to deploy the new version of LIMS with the new features
Some SaaS LIMS vendors develop and provide new features free of charge as long as your subscription is valid. It is best to choose such vendors to reduce expenses.
Although LIMS implementation is a time-consuming and expensive process, it is suggested that doing it for your laboratory will always yield fruitful results. A LIMS helps laboratories to manage their data, address regulatory compliance, and meet business needs. Hence, it is worth spending the time and resources on implementing a LIMS that works well for your laboratory. You will surely end up saving time and money if you implement a LIMS in your laboratory using the steps outlined above.