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LIMSey

The Ultimate LIMS Guide

does-your-lab-really-need-a-lims

Lab Information Management System (LIMS) is software designed to support a testing laboratory’s operations. Generally, this involves tracking samples and their testing through the lab and capturing the results in such a way that can be easily reported or accessed by stakeholders. Modern LIMS can also provide audit trails for tracking changes, easy access and searching of historical records, customizable dashboards, and more. However, as the needs of labs are continuously evolving, so too is the definition of LIMS as they evolve alongside.

Benefits of LIMS

A LIMS can provide benefits to many different users of a laboratory, not just those directly involved with testing. Management, production, quality control can all benefit from features that LIMS can provide. Some common benefits that LIMS provides are listed below.

  • Information can be found at the click of a button, rather than searching through paper files or forms.
  • Information is centrally stored, rather than scattered across multiple users’ computers or in boxes.
  • Years of information can be stored easily without the need for traditional archiving.
  • Automated change tracking.
  • Automated reporting.
  • Improved workflow management.
  • Improved communication between the lab and other departments.
  • Improved data quality.
  • Reduced number of testing errors.

Before Selecting a LIMS

It is important to make a few preparations before considering and selecting a LIMS for your laboratory. These steps are necessary in helping ensure that you select the right LIMS for your needs and that you are ultimately successful in implementing the LIMS.

Define your existing workflow. This is a crucial step that is often missed. A LIMS cannot be expected to properly handle your existing workflow if you do not have your workflow accurately defined. Use process maps to draw out your entire workflow from start to finish. Meet with all relevant people and departments within the workflow to confirm that it is accurate. It is important that you define the “real” workflow, and not assume that your existing procedures and documentation reflect reality. A well-captured workflow is critical when understanding if a LIMS will suit your needs.

Brainstorm potential roles for LIMS. With your workflow mapped out, you can begin to think about where the LIMS would fit into your process. Where are the biggest bottlenecks and pain points? Where would it be most effective? Where is the most time being wasted? This is the time to come up with a “wish-list” of issues you would like LIMS to solve, but keep in mind that the LIMS will not solve them all.

Ask if you need a LIMS. You now have a detailed workflow and ideas of where the LIMS could help address issues in that workflow. Are the issues substantial enough? Is it worth changing from your current system to try and address them? Remember, no LIMS will solve every problem. Is there a smaller subset of those problems that would be worth adopting a LIMS for? The answer may never be clear, but since you have defined your workflow, its issues, and potential roles for a LIMS, you are in the best position to answer it accurately.

Successfully Implementing a LIMS

Adopting and implementing a LIMS within your lab’s workflow can be a complex and time-consuming project. Many LIMS require long configurations or training and to help increase the chances of a successful implementation it is prudent to plan properly.

Assign roles for implementation. Like any project, it is wise to assign roles and ownership for different aspects of the implementation. Adapt these roles to your needs, but generally speaking, fewer roles are better. Fewer people tends to create more motivation for each individual to actually complete tasks and make decisions, rather than assuming others will handle it. A simple set of roles is detailed below.

  • Sponsor. The sponsor is usually an individual from higher management. The sponsor has the ultimate authority over the size and scope of the LIMS and its implementation. The sponsor does not usually participate in day-to-day tasks of the implementation, but does approve proposed changes to the scope, removes roadblocks, and approves deliverables.
  • Manager. The Manager has the primary role during the LIMS implementation. The Manager manages, assigns, reviews, and approves day-to-day tasks and activities. The Manager reports to the sponsor, especially when there are any proposed changes to the scope or there are roadblocks the sponsor must address.
  • Key Users. The Key Users represent the actual end users of the LIMS. This usually consists of lab personnel and departments or customers who request testing from the lab, management, and others involved in the laboratory’s workflow. It is important to note that the Key Users represent the actual end users, and are not necessarily all of the end users. Smaller teams are usually more productive than larger ones, so pick your Key Users accordingly.

Clearly define the problems LIMS should solve. The Manager should review the “wish list” of ideas generated during the brainstorm and gather feedback from the Key Users and others within the laboratory’s workflow. Example questions to garner feedback are below.

  • What are the best aspects of the current system?
  • What are the worst aspects of the current system?
  • What are the rate-limiting factors?
  • What issues can be realistically solved by a LIMS?

As the Manager gathers more feedback from different groups from within the workflow, there will likely be common answers to the questions above. These common answers, or perhaps only some of the answers, are what LIMS should solve. It is absolutely crucial to avoid scope-creep during this step. A LIMS will not solve every problem, and expecting it to do so will lead to an inevitable failure. To further illustrate the point, think about software solutions you or your organization are currently using and are happy with.

  • Are they simple or are they complex?
  • Are they focused at solving a few issues or do they try and solve many issues?

More often than not, they are simple and they are focused on solving just a few issues. Ideally, the LIMS you ultimately pick should be simple to use and focused on keeping the best aspects of your current system but also addressing the worst aspects of it.

Selecting a LIMS. There are many considerations to take into account when actually selecting a LIMS. Perhaps one of the most important considerations is selecting a LIMS focused on your industry. Pharmaceutical labs will have very different needs than mechanical and materials testing labs. A LIMS focused on your industry is much more likely to include the types of features and functions your lab needs.

There are also different configurations of LIMS installations to consider. Most configurations can be broadly separated into one of two main types, Web-based and On-Premise. Some pros and cons for each configuration are listed below.

Web based

  • Pros
    • No installation required on each user’s computer
    • More frequent updates
    • Bugs are identified and fixed more quickly
    • Less work for IT departments
    • Do not have to maintain your own server
    • Access your data from anywhere
    • Shorter implementation times
  • Cons
    • Internet connection is required for access
    • IT departments have less control
    • Data and backups are maintained by LIMS vendor
    • May have higher total cost of ownership

On-Premise

  • Pros
    • IT maintains control of data and backups
    • Internet connection may not be required for access
    • May have lower total cost of ownership
  • Cons
    • More work for IT departments
    • Must maintain your own server
    • Updates may have to involve collaboration between IT and LIMS vendor
    • May not be able to access data from outside company network
    • May need to install software on each user’s computer
    • Longer implementation times
    • May have higher capital expenses

After weighing the different installation options, begin compiling a list of potential LIMS vendors. Many LIMS vendors can be found via internet searches, industry publications, and trade shows. Research each LIMS vendor and schedule phone calls or demonstrations with any that seem as though they could be a good fit. Many LIMS vendors offer free trial periods as well, and these are extremely helpful. Seeing the software and its capabilities in a demonstration is a great start, but actually trying it out yourself will give you and your team a much better idea of whether or not the LIMS will fit with your laboratory’s needs.

Define transition from current system to LIMS. Migrating from the current laboratory’s system to a LIMS is not usually a quick process. Between mapping your existing process, defining the role LIMS should play in your lab, and configuring the LIMS, it may be several weeks before you begin using a LIMS. Even once your lab begins using a LIMS, it is often not an instant transition. Planning how the transition will work helps ensure a successful implementation. The three basic states of the transition are below along with some notes and/or questions to answer for each.

  • State of the laboratory BEFORE the implementation.
    • This should have already been identified and defined when the existing workflow was mapped.
  • State of the laboratory DURING the implementation.
    • Run a subset of work through LIMS and gather feedback?
    • Run both the old system and the LIMS in parallel for a period of time?
    • Pick a hard cut-off date for an official switch?
  • State of the laboratory AFTER the implementation.
    • What does a successful implementation look like?
    • What will happen to the old system and its data?

Why a LIMS Can Fail

There are a number of reasons why a LIMS can fail during or after the implementation in a laboratory. The most common reasons for failure can be attributed to unclear requirements and expectations. Examples of such failures are listed below.

Unclear role for LIMS. One of the first steps even before considering a LIMS is defining exactly what it needs to do for your organization and for your lab. The importance of this step cannot be overstated. Without properly understanding the role of LIMS, none of the following questions can be answered.

  • What features do we need in a LIMS?
  • What configuration suits our organization best?
  • What questions should we ask LIMS vendors?
  • How do we define a successful LIMS implementation?

Expectations for LIMS to solve every need. Ideally, adopting a LIMS for the laboratory would address every current and future need. As the needs grow and evolve, so too would the LIMS. If this ideal scenario sounds too good to be true, it’s because it is. No single software can handle every possible need, and expecting a LIMS to do so is a common reason for failed implementations. List and prioritize the top needs of the lab and the organization. Which needs should be handled by LIMS? Which needs are not as critical? Which needs would be better handled by other solutions? Just as a master craftsman uses multiple tools to finish a job, the laboratory will likely rely on multiple tools as well.

Not involving necessary stakeholders. When adopting a solution like a LIMS for your organization it will modify the workflow of multiple people. Since the laboratory is the most directly affected, lab personnel are usually very involved and vocal during a LIMS implementation. The same is not always true of other affected departments or individuals. Forgetting about these other stakeholders can cause issues during and after an implementation. What if they had valid objections about key decisions? What if they had better ideas for the implementation? Keeping such stakeholders involved early on and throughout the process can vastly help the chances of a successful and efficient implementation.

Involving too many people. It can be tempting to get as many people and departments involved in a LIMS implementation as possible. While it is important to get ideas and initial feedback from many people at the beginning stages, when it comes to decision making and agreements, fewer individuals and fewer groups will usually work better. The more people involved, the more objections and disagreements have to be resolved. Including more people than necessary in the decision making process than necessary will slow the implementation down at best, and can completely derail it at worst.

After the LIMS Implmentation

After a successful implementation there are a few best practices you can follow to help keep your organization’s LIMS effective and organized.

Create internal LIMS procedure. While the LIMS vendor usually provides documentation and training resources for the LIMS, it is important to create and maintain your own procedures that are specific to how your organization actually uses it. The LIMS vendor’s documentation will often be the best resource for details on how to use the software, but your internal procedures will document the role of LIMS and how it should be used for your specific workflow.

Designate internal LIMS “expert” and a backup. The LIMS vendor should always be willing to help answer questions and provide support, but it is helpful to also have an internal resource to help with LIMS questions. This internal resource is more familiar with your organization’s process and is the best first point of contact for LIMS questions. It is also common for them to act as the liaison between your organization and the LIMS vendor. This can provide more consistent communication between the vendor and your organization, but it also helps the internal resource become more familiar with the LIMS. The internal resource should also continuously train a backup in case they leave the

Periodic review. Schedule regular reviews of your internal LIMS procedures and also verify they are being followed properly within your LIMS. If they are not followed properly, does there need to be training to enforce the procedures? On the other hand, do the procedures need to be changed to reflect how the LIMS is actually being used? While the internal procedures are important, do not hesitate to change them if better ways of using your LIMS are discovered during the reviews.

Final Thoughts

Implementing a LIMS for your organization can be very beneficial to not only the laboratory, but to many other departments and areas that depend on the laboratory and its data. However, it is important to remember that implementing a LIMS can be a time consuming process that requires a great deal of planning and thought to be successful. Even after the implementation, work is not complete because continuously reviewing your process and how your organization is using the LIMS is critical to maintaining its effectiveness. While implementing a LIMS comes with many challenges, when done correctly, it can be an extremely valuable tool to your organization.

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