“Getting” a LIMS or ELN is a much more complicated and lengthy journey than many organizations expect. For many labs, just defining requirements and refining a vendor short list can be a months-long endeavor, but there is much farther to travel after selecting your preferred LIMS or ELN product. Many clients envision an efficient, automated lab that runs on a shiny new LIMS or ELN, but we often see expensive software systems fail to live up to these expectations. LIMS or ELN licenses alone can cost hundreds of thousands of dollars, and at that price, how could they not perform as promised?! This blog post examines the LIMS and ELN Implementation Planning part of the journey and highlights some common problems to avoid as you traverse the road to your laboratory informatics destination.
LIMS and ELN applications are not “plug and play” and require thoughtful planning and set-up to realize process efficiencies and cost savings. Realizing efficiencies means you have to make your processes efficient before you configure your LIMS or ELN to automate them.
Many CSols clients realize value before implementation by following our process improvement recommendations. These changes can be as simple as relocating the sample drop-off area or re-formatting a report.
Pre-LIMS or –ELN process improvements are not always that straight-forward, however.
Automating an improved process is a better strategy than applying LIMS or ELN to clunky processes. For example, users will get more value out of an optimized LIMS form than they will if you just automate a paper form that doesn’t work well.
Process improvements require some planning on the part of your team to optimize the process, perform dry runs, and manage the change. These are one-time upfront costs that will pay dividends over the life of your LIMS or ELN.
The LIMS and ELN planning process can be daunting, especially if you have to make many process improvements before you can begin your implementation. The best way to avoid feeling overwhelmed is to have a plan and stick with it. Before you can develop a detailed project plan, you should have a laboratory informatics roadmap to guide you through the LIMS or ELN selection and implementation process. Your lab informatics roadmap should define high-level timelines for process improvement initiatives and any parallel projects that support the future LIMS or ELN, like updating your wireless network.
Once you have agreement on your roadmap, continue to stay on track with a tightly defined scope. It is tempting to get distracted with a new system’s bells and whistles, but remain focused on what your team has designated as high-value. Yes, LIMS can automatically decrement the exact amount of mobile phase the HPLC pulls from the bottle, but that is a costly configuration if all you need to know is how many bottles of mobile phase you have left.
One of the items your roadmap should account for is validation—and even if you are not in a regulated environment, you should plan some time into your implementation and deployment for user testing. CSols often joins projects in late phases because clients did not plan adequate time for validation and testing. LIMS and ELN clients often underestimate how much time it takes to create test scripts, execute testing, and generate validation documentation.
At the very beginning of your project, work with your quality and validation teams to make sure your LIMS or ELN project is aligned with your enterprise-wide and local validation programs. The amount of time validation will take depends on many factors. The regulatory environment, how much of the OOTB configuration changed, and the intricacy of instrument integrations can all impact the complexity of the validation and how much time it will require.
If your organization does not have an overarching validation program, institute a validation program during the planning stages. Waiting until everything else is finished to start thinking about validation will take more time and cost more money. Keep validation needs front-of-mind during the planning stages of your project to avoid delays and costly overruns.
Consider the business reasons for why your lab exists and make sure that you address non-lab stakeholders during your LIMS or ELN planning process. The following groups of stakeholders should be included when gathering requirements, vetting functionality, and performing user testing.
Make sure you understand the needs of all the people who need samples tested so your new system will accommodate all types of incoming work. There are countless possible scenarios for accommodating lab work requestors and automating the work request process; the best way to determine what meets your needs and how those processes could be automated is a thorough understanding of your work requestors and a laboratory informatics needs assessment.
Common data consumers are:
There are different business drivers for different types of samples and your LIMS will perform best if it is set up to accommodate those differences and publish data to the right people at the right time.
Remember that LIMS and ELN are enterprise-level systems and—even if other groups undervalue the lab—your laboratory generates value for the business. Without fail, there is a group who needs to understand that value to do their job.
CSols process analyses leverage our proprietary SIPOC-driven methodology to ensure we capture the needs of such tangential groups during our LIMS and ELN needs assessments.
For many of our larger clients, IT drives LIMS or ELN projects. Smaller clients, however, tend to drive lab informatics projects out of QC or laboratory operations. A LIMS or ELN is ultimately a laboratory tool, but such systems need a support team that includes IT SMEs to advise on infrastructure and policies.
A LIMS or ELN can facilitate better communication with easy-to-access information, self-service data searches, and integration with other systems, but these benefits only come with closely managed change and stakeholder involvement.
LIMS or ELN can automate an infinite number of processes based on this logic, but only if it is clearly defined and configured into the application. If you want the system to approve passing results automatically, be prepared to define the logic for a passing result and failing result.
Many of our larger clients release a governance plan with a new LIMS or ELN deployment to support consensus building and process or system changes. This document does not have to be large or complex, but it should define change management standards, layout minimum steps new configuration implementation should follow, and set standards for your company’s universal dictionary for system keywords and database columns.
Reaching your goal of an efficient, automated laboratory requires more planning and preparation than one person can reasonably do well. Project management general wisdom suggests that PMs will default to their “day jobs” if they are more accustomed to those tasks than performing IT project management. Even if your LIMS or ELN project has a dedicated project manager, there are too many vital roles on the project team for one person to fill without sacrificing laboratory work or project timelines.
All vendors will expect you to have a project team in place for a successful implementation. A minimally staffed project team commonly includes
Even the most knowledgeable, organized lab manager can’t do all those things alone!
Do you have concerns about planning for your LIMS or ELN? Comment below to share your concerns or success stories!
Or contact us today to find out how CSols can help you avoid common lab informatics mistakes.