· Author: Third Wave Analytics

How to Efficiently Navigate the LIMS Implementation Process

Is your lab still using Excel spreadsheets to gather information about your testing process, environment, and results? Or, is your current Laboratory Information Management System (LIMS) outdated, inflexible, or missing crucial features that a new system could provide for your end users?

If so, it’s time to implement a better LIMS (an informatics solution) to meet your business needs, laboratory operations goals, and workflow. The right LIMS solution can improve operational efficiency and save your lab time and money. A modern LIMS will make the workday more manageable for your lab team, from sample tracking to protocol management, workflow execution, quality control, and data management. A new LIMS can also give you a clear understanding and insight into areas for improvement in your lab operations.

Here’s a tried-and-tested project plan for evaluating, configuring, and completing a successful LIMS implementation.

1) Evaluate and select the optimal LIMS software for your lab

To narrow down options that will work well for your lab team, first, answer the following:

  • Which team members will use the system? Identify your power, every day, and occasional users within your lab. Each stakeholder will have unique user requirements and inputs for their role in your laboratory processes.
  • What is your LIMS budget and expected return on investment?
  • Which metrics will you use to track progress toward your lab goals? How will you report on metrics?
  • Who will maintain the lab system? 
  • How will you define and configure the LIMS features for your lab?
  • Who will lead your LIMS implementation project?
  • Which devices and computers will use the LIMS? 

Once those questions are answered, begin to evaluate solutions. Aim for a comprehensive solution that addresses all or most lab management workflows for modern laboratories. It should also be configurable to adjust to your unique requirements – and scalable so it can grow with your lab. The LIMS solution should also offer innovative new features that expand your lab capabilities. Avoid point solutions that can’t handle your lab workflow or LIMS systems with extra features that don’t add value. 

Take the time to find the system that truly fits your lab. It’s reasonable to allow a month to evaluate options and decide what will work best for your team.

Ask each LIMS vendor to provide you with the following during the evaluation:

  • A demo and trial of the LIMS, with a clear overview of key features and capabilities.
  • References and case studies from customers who use the LIMS to improve their lab operations and results. 
  • Details about any data migration processes performed during implementation and specific data security measures to protect laboratory data.
  • An introduction to the professional support team that will configure specific LIMS features for your lab, and an overview of their LIMS implementation project management plan. 
  • An overview of LIMS sandbox options so features can be configured separately from your active LIMS environment. 
  • A list of purchase options that include implementation costs and annual licensing. 
  • A complete view of technical information and release notes for the LIMS before it’s configured for your lab. Consider fully verified solutions to ensure the software is designed and developed for your requirements. 
  • Details about the software verification services configuring the LIMS for your lab environment and goals. 

2) Finalize licensing and LIMS implementation plans

After you select a LIMS, work with your vendor to finalize the licensing and configuration plan, with associated annual costs. Ask for these to be finalized in a signed contract for your lab. 

Before signing the contract, review and amend it as needed. Take extra care to review legal and scientific contract details. Ultimately, the LIMS vendor functions as a key business partner, and the contract is the binding business agreement that puts the partnership in motion. 

The contract essentials include: 

  • Specific license information. Licenses are generally offered on a per-user basis, billed annually. 
  • Complete implementation costs. Your lab team will likely want the LIMS configured with features and functions that fit your lab goals, operations, workflow, and existing systems. LIMS implementation usually entails a one-time development and implementation cost. Request that the costs, configuration deliverables, and timeline details be included in your contract. 

3) Work through all requirements before launching your LIMS

After the contract signing, set up a series of meetings with your LIMS vendor. During these, your lab can discuss the LIMS configuration so it works optimally for your team. Several core LIMS features might not require configuration and will work for your team ‘out of the box.’ Now is the time to solidify your testing workflow and determine if some features must be tailored to your lab.

Use the following questions to discover and verify your lab workflow for each lab process you’d like to upgrade:

  • What are your lab’s physical actions at this step?
  • If applicable, how should samples/controls be tracked in the LIMS at this step? For instance, will you require unique sample barcodes?
  • What type of data will the LIMS provide to help each lab team member complete their work? For example, will you require auto-calculation of mastermix volumes?
  • What kinds of information will the LIMS capture? Will you require DNA concentration, sample volume, or the lot number of reagents used during testing?

Gathering requirements takes time, but a thorough assessment will result in an optimal LIMS workflow. Work through each step with your lab team to build the framework and make revisions as needed. 

You can also consider using the ‘minimum viable product’ (MVP) approach as you gather requirements. With this approach, only critical functions are initially considered, configured, and implemented. Later, ‘nice-to-have’ functions are added in subsequent implementations. Tackling new functions in defined phases can provide more control and give your lab team time to learn about the LIMS. 

4) Configure your LIMS functions and prepare for launch

Beyond the “out-of-the-box” features the LIMS vendor offers, you may require additional LIMS configuration or custom software development.

The configuration process is almost always iterative. Typically, your vendor’s configuration specialists will tailor the LIMS to your specifications and then present the configured and custom features to your lab team to get detailed feedback. From there, requirements can be refined. Repeating steps three and four several times is expected to create the optimal lab system. 

One word of caution: If you’re following the MVP implementation approach, avoid focusing on ‘nice-to-have’ features at this stage. Instead, focus only on ‘must have’ features and tackle less critical functions later. This gives your lab team more time to learn about the system and provide feedback if any features need adjustments.

5) Ask your lab team to test the LIMS

Once your LIMS is set up and ready to launch, could you show your lab team how to use it and ask them to test all features (user acceptance testing) vigorously? The lab team may find functions or workflows that need further configuration or changes to work perfectly.

While your lab team completes the testing process, your LIMS vendor will likely have their configuration specialists finalize user training, complete with live tutorials and system documentation.

Train as many lab team members as possible to use and test the LIMS. More testers will result in a more reliable and secure solution that improves each workflow in the lab.

6) Consider LIMS verification

If your lab has specific regulatory or compliance requirements, you may need formal LIMS verification. 

Developer/user, testing and system verification is completed during steps four and five above. Formal verification usually has four stages: 

  1. Preparation for the pre-specified software verification plan.
  2. Documentation of specific system requirements.
  3. Thorough testing to ensure the system meets each functional requirement for various lab users. 
  4. Document all test cases and scenarios in a final summary report. 

The technical team configuring your LIMS is best suited to complete the verification process because they have detailed information about any modified functions. Their knowledge of the system speeds up testing time and reduces verification costs.

Your LIMS is one part of your overall lab workflow. If your lab needs to validate the entire lab process for regulatory compliance fully, consider a broader software verification across the entire workflow. This allows you to demonstrate that all software used in lab testing (including your LIMS) is appropriately integrated.

Validation and verification often involve following representative samples (positive, negative, inconclusive, and invalid) through the complete workflow. Review the entire sample testing process to ensure expected results in each scenario. 

7) Deploy your LIMS

After verifying the LIMS, your lab team can begin using it. A detailed go-live plan can help the team get acquainted with the system and see the benefits. The plan ideally includes the following: 

  • The date and time for your LIMS launch
  • A timeline that designates when users can begin using the LIMS
  • Details about the personnel assigned to LIMS deployment
  • Notification regarding any unavailable systems during deployment
  • Instructions that note if test scripts must be run to ensure deployment was successful in the production environment
  • Documentation that shows where and when data was backed up before deployment 
  • (Optional) documentation that ensures existing lab data was not impacted by LIMS deployment

8) Update the LIMS as needed (repeat steps 3-7)

Once your LIMS is in place, you can evaluate which features to add or change as your lab evolves by repeating steps three through seven above. 

As you consider new features, review the following questions: 

  • Which specific features do you want to add next? Which features does your lab team request most? 
  • Which features could be bundled in a single deployment?
  • When will you develop and deploy the new features?
  • Who will manage the development? Do you have resources designated for further LIMS development?
  • Do the new features require licensing?

LIMS implementation timelines

LIMS implementation involves focused attention from your lab team across several months. Although the timeframe to implement a LIMS is based on the complexity of your lab workflows and requirements, there are three general project types with corresponding timeframes:

  • Project Organize. In this scenario, the main objective is migration from Excel to LIMS. This entails implementing core features (Samples, Boxes, etc.), usually without automation. Project timeline: One to two months.
  • Project Optimize. This involves a more complex LIMS implementation with advanced features such as lab inventory management, instrument management, and protocol execution. Project timeline: Three to five months.
  • Project Transform. This ultimate lab upgrade incorporates complex LIMS protocols, automation, and instrument integration. The project has two phases; the first introduces core functionality (two to three months), while the second introduces complex protocols and integrations, which can take up to six additional months. Project timeline: 6-9 months.

Choosing and implementing a LIMS is detailed, yet it makes your lab workflows organized, efficient, and effective.

You can remove any guesswork to selecting a LIMS by following the process above. To learn more about improving your lab workflow and management, don’t hesitate to contact our experts today for a free trial of the Lockbox LIMS System.