Due to the complex processes and technologies utilized in labs, and the many different aspects of the enterprise that laboratory systems touch, success in laboratory information management system (LIMS) projects can be difficult to achieve. A Successful LIMS Implementation project, in this case, is defined as the project satisfying the following metrics:

• delivered on time and within budget
• meets or exceeds all user requirements
• provides business value
• high-level of user adoption.

LIMS projects usually demand a substantial investment of time, money and resources, with implementations costing hundreds of thousands to millions of dollars and requiring hundreds of person days to implement. Failure of a LIMS project can be a huge waste of time and resources, and a financial disaster for the organization involved. As such, it is critical to get a LIMS implementation project right the first time in order to preserve your return on investment. In this blog, we will discuss the seven most common reasons why LIMS implementations fail.

Reasons for LIMS Implementation Failures

There are many reasons why laboratory informatics projects fail. Some of the more common ones include:

Lack of Strategic Planning Prior to LIMS Selection and Implementation

Not taking the time to fully understand your needs (both now and in the future) and develop proper requirements that reflect these needs is probably the most common cause of failure in LIMS implementation projects. Many times, companies simply purchase a LIMS based on reputation and rush to implement their current requirements into the system. The danger here is that you end up with a project that is too focused on time and/or cost at the expense of value. This approach represents a missed opportunity to understand and optimize underlying workflow process that will maximize the business value of the implementation.

Conducting a thorough workflow analysis is essential to develop optimized future-state system requirements that will guide the LIMS selection and implementation and thus ensure your project will produce significant business value for your organization. In addition, the effort (and thus cost) that is required to implement and ultimately maintain the LIMS will be significantly influenced by the quality and clarity of the requirements that are generated and implemented into the system.

Another aspect of strategic planning that is important for the success of many LIMS implementation/integration projects involves the laboratory informatics architecture. Designing a practical enterprise architecture for the laboratory, along with a roadmap to deployment, is essential for any LIMS implementations that involve integration with instruments, parallel and adjacent systems. Having an overall strategic vision for the laboratory informatics ecosystem helps to ensure that the LIMS implementation maximizes business value for your organization and stays within time and budget constraints.

Personnel Resource Challenges

Staffing requirements for a LIMS project can be extremely complex. Wide-ranging knowledge about the different systems available on the market is important to ensure you select the best LIMS for your organization. Additionally, a variety of different skill sets are necessary to accomplish the strategic planning, configuration, integration and validation required to successfully execute a LIMS implementation project. Unforeseen project challenges can also require outside specialists and/or subject matter experts to move the project forward.

Another issue is that there are multiple roles that need to be staffed with internal personnel, and the time commitment required for project duties often means these people cannot continue with the full responsibilities of their day jobs. This can mean that backfilling a number of positions in the lab for the duration of the project may be necessary.

The bottom line is that you need to have a highly competent and skilled project team in place to ensure project success. Several key roles on the project team will likely need to be staffed by the LIMS vendor and/or an external consultant.

Poor Project Management/Governance

A key factor for a successful LIMS implementation is a dedicated project manager (PM) with LIMS experience who is involved in both the planning and ongoing management of the effort. Strong project controls and governance are needed to implement a LIMS successfully, and a LIMS-experienced PM will help to drive triple constraints (on time, on scope and on budget), ensure value realization and help to avoid common people-based challenges.

A formal risk management and mitigation plan should be developed in advance, which should include ongoing reviews of project phases throughout implementation that involve all inside and outside resources. A combination of project management skills, good resources (both internal and external), and methodologies are vital to a successful LIMS implementation.

Poor Communication

Clear and frequent communication between stakeholders is critical to the success of a LIMS implementation. It is vitally important to create and implement a comprehensive project communication plan as part of your LIMS project governance model. The communication plan helps convey critical information necessary to keep the project on track, and also engages all stakeholders so they feel part of the process.

The person or people facilitating communications between stakeholders plays a key role in the communication plan. Different aspects of organizations often speak “different languages” and may have trouble communicating with each other effectively (e.g., IT and lab personnel). It is important to have someone who is well-versed in all the different stakeholder domains facilitating communications in order to avoid misunderstandings.

Excessive Customization

The requirements developed in the workflow analysis conducted at the beginning of the project should be prioritized and implemented in an iterative approach with the “must haves” implemented first as described above. Failure to follow this kind of methodical approach can cause the project to get bogged down in excessive customization to satisfy lower value requirements, leading to project time delays and cost overruns. Unnecessary customization can also occur if there is not at least one person on the project team who is aware of all the configurable functionality available in the LIMS being implemented.

Customization increases the complexity of future maintenance, migration and validation efforts, and can potentially lead to system errors. The bottom line is that LIMS customization should only be done if doing so would provide your organization significant business value or a competitive advantage.

Inadequate Planning for Master Data Management/Migration

Data management/migration is almost always a bigger job than anticipated during a LIMS implementation. Many companies tend to focus on software testing and configuration and put off dealing with master data management or data migration until late in the implementation process, but this can end up causing significant project delays in addition to impacting business continuity in the lab.

For this reason, it is wise to focus on data migration early in the implementation process. Static legacy data (and sometimes dynamic data as well) must be extracted, translated (biggest effort) and loaded into a new location. The actual migration is typically accomplished through a combination of automated programmable migration tools and manual processes. Dynamic data migration should be done last to make sure the new system contains the most up-to-date data.

Conclusion

As discussed in this article, proper planning, adequate financial and personnel resources, and a proven methodology is vital to the success of LIMS implementation projects. There are in fact several other factors that are equally critical to consider in order to ensure project success.