December 10, 2020
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 to overcome various challenges, including data management, automation, and regulatory challenges, which may vary from one laboratory to another.
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 to efficiently manage ample amounts of data. There could be a possibility where 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.
1. 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 do you need to track, your annual LIMS budget, the staff members who would use the LIMS, 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 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.
2. 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.
3. 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. It could be a time-taking 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:
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.
4. 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 of 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.
5. 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. As it is not very uncommon that even configuration specialists miss on these flaws and hence maximum users should be trained while testing to ensure rigorous testing of the system and to gather feedback from all users.
6. 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 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, and preparing a final summary report of all test cases.
7. Roll it Out to Staff With a Go-Live Plan
Done with finalizing and validating the LIMS? Introduce it to your staff.
Go-live plan must include the following:
8. 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. However, a few important points to consider are as follows:
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.