The modern laboratory produces vast amounts of data from a wide variety of sources that are too often not integrated. With the advent of high throughput technologies, both the quality and quantity of information is increasing dramatically. At the same time, R&D partnerships continue to increase, with data flowing increasingly across organizational boundaries. Taken together, these trends contribute to significant data management challenges for both small and large organizations alike. One of the most common methods for managing these challenges successful LIMS implementation (Laboratory Information Management System) as a way to automate the business processes and data capture associated with laboratory workflows.
Getting LIMS Implementation Right the first time
According to some estimates, 75% of the total operational costs associated with a LIMS comes from manpower in traditional laboratories. Hence, removing the need for manual human interaction carries the potential to significantly reduce overhead costs. This can often be achieved by integrating laboratory operations and managing samples and tests efficiently across functions. Though this is a simple statement, it is far from an easy task to accomplish. One of the first elements on the path to laboratory efficiency is to get the LIMS implementation right the first time. All too often, companies try to quickly implement a solution without fully grasping the handoffs between groups and the associated interdependencies that can make or break the final result. So how can you set your organization up for success when implementing a Laboratory Information Management System (LIMS)? Whether you are moving from a paper-based environment to an electronic laboratory solution or if you embarking upon replacement of an aging platform, the principles described here still apply.
Principle #1. Do understand the laboratory processes and key requirements.
The first step in executing any laboratory informatics system (such as, but not limited to a LIMS or ELN) is to gain a thorough understanding of the processes that comprise the laboratory operations. This is especially true for LIMS systems, because they often serve as the operational backbone of the lab. A complete understanding of laboratory business processes is essential to selecting the right LIMS vendor and to planning the implementation. Once the laboratory processes are understood, the next steps are to define and prioritize key requirements. Because they are the basis for evaluating and selecting the LIMS platform and, ultimately, determining how much customization is needed, the requirements specification process should begin as early as possible.
Principle #2. Don’t succumb to “analysis paralysis.”
Prioritizing user requirements is just as important as defining them. There is so much information available during the evaluation phase of a LIMS implementation that it is easy to get lost in specifying lower-level, detailed processes, which can lead to “analysis paralysis.” Often when you are working with a scientific end users, they want to be sure that every detail is correct. Though such details are important, it is critical to focus on the details at the right time, in the right order. A better strategy is to develop priorities based on satisfying the immediate needs of the lab (i.e., the ones that affect current processes) followed by longer-term strategic objectives. Moreover, defining user requirements is not a one-time activity, resulting in a static set of requirements for vendor selection. Instead, it should be viewed as an ongoing process that can be refined on a regular basis to reflect the changing needs of the organization.
Principle #3. Do build the business case.
Though the justification for a LIMS solution may be obvious to the laboratory R&D staff, it is still critical to build the business case with a positive ROI. The bottom line is that facts are always harder to dispute than opinions. Building a comprehensive business case will help justify the acquisition of the LIMS, and a good one will present tangible business benefits based on defined requirements and key performance metrics.
Most organizations require a business case demonstrating a positive ROI before resources and funds are committed to a project. Depending on the project, the scope and complexity of many LIMS implementations will demand a business case that addresses the concerns and needs of all of the project’s stakeholders. A business case that anticipates potential problems or objections can also be a powerful tool to sell the project in the organization. Involving key stakeholders in the development of a business case can also be a strong way to build organizational support for the new system. A compelling business case will assess current system performance against expected post-implementation performance.
Principle #4. Don’t assume that extensive customizations will be easy to sell to the organization.
Establishing key performance indicators (KPI) allows quantifiable measurement of progress during implementation and ensures a tie to real changes in performance. These metrics can also be used to evaluate LIMS software vendors and select which software modules best suit the user requirements. The issue of whether customization is necessary to satisfy a new user requirement is often raised during the implementation process. A business case with a positive ROI allows the merits of customization to be considered on the same basis as the original implementation. Investments in customization can be evaluated according to whether they fit the requirements defined in the business case, based on performance metrics that are quantifiable, rather than subjective measures.
Principle #5. Do ensure proper project management and resource commitment.
Another characteristic that distinguishes best-in-class LIMS implementations is how well the implementation is managed. A prerequisite for a successful LIMS implementation is a dedicated project manager who is involved in both the planning and ongoing management of the effort. In addition, the company must also be willing to commit sufficient resources to the project before, during, and after implementation. And it’s equally important to have the right mix of internal and external resources. Organizations often focus too much on whether the LIMS implementation resources are internal or external to the company. The trick is to augment your internal resources with the right external resources with the proper LIMS expertise. Ideally, you want to have external resources who have performed numerous LIMS implementations before, preferably with your platform of interest. Strong project controls and governance are also needed to implement a LIMS. A formal risk management and mitigation plan should be developed in advance, which should include ongoing reviews of project phases throughout implementation, with full participation of all inside and outside resources. A combination of project management skills, resources, and methodologies are vital to a successful LIMS implementation.
Principle #6. Don’t assume that you have sufficient executive and organizational commitment.
A distinguishing trait of best-in-class LIMS implementation is that they have the full support and commitment of the company’s executives. In fact, it can be argued that this characteristic is the most important one for a successful LIMS implementation; without this support, LIMS initiatives are more likely to be starved for funds and resources. LIMS initiatives often begin with the IT director or manager, but the support of the CIO, CFO, and other C-level executives is critical. These people are responsible for setting corporate business strategy and direction, so they should be making higher-level decisions about how the LIMS system will be involved in running the business. Depending on the breadth of the system, LIMS implementations can also cause changes in familiar workflows for people throughout the organization, whether they are directly involved in the implementation or not. For this reason, it is important to gain broad organizational support during all phases of an LIMS implementation. Finally, the establishment of regular project reviews with the executive team or the project steering committee will keep them informed about project progress. It will also provide a forum so that the appropriate decision makers can deal with issues that arise.
Principle #7. Do recognize the value of early planning.
In any LIMS implementation, there is no substitute for careful planning; in fact, planning should begin during the earliest project phases. Companies get excited about the benefits of implementing LIMS and tend to want to dive in without a fully developed plan. Too often, companies do not put the time in to produce a solid project plan upfront. The project plan should have time built into it for activities associated with requirements definition, key performance measures, and vendor evaluation and selection. The best plans have buffers built into the schedule to account for activities such as testing, data migration, and unforeseen events that occur in every implementation. Companies that invest in comprehensive, upfront planning often experience shorter implementation times and spend less money overall than their peers.
Principle #8. Don’t save data migration for last.
Focus on data migration early in the implementation process. Many companies tend to focus on software testing and configuration and put off dealing with data migration until late in the implementation process. An attribute of successful LIMS implementations is that data migration is put into the project plan as early as possible. A company’s data is one of its primary assets and issues with migrating data between legacy systems and a new LIMS system can have a sizeable negative impact on laboratory operations, especially when those issues occur late in the LIMS implementation process.
About the Author
|Mr. Walla is responsible for the growth and strategic direction of the Professional Services Division of Astrix Technology Group. He has over twenty years of experience in laboratory informatics including overseeing large global informatics projects. Mr. Walla has a B.S. in Chemistry from Rutgers University.|