Laboratory Information Management Systems (LIMS) continue to present manufacturers with a challenge in determining return on investment. Measurements such as Return on Investment (ROI) may not be appropriate, as they do not provide a measurable indication of continuing value. As a result, manufacturers are turning to Total Cost of Ownership (TCO) to assess the return on their LIMS investment. The direct and indirect costs incurred throughout the lifecycle, as well as the purpose the LIMS serves, must all be considered. So how much does it actually cost to own a LIMS?

Analysis

LIMS automate laboratory processes, administrative functions, and translate lab data into information for use throughout the company. The most frequent users are laboratories involved in R&D, QA and/or QC.

The direct costs are the hardware, licensing fees, installation, implementation, training, support services and software updates.

Indirect costs are in-house resources related to maintenance, system downtime, additional training, and customization.

Off-The-Shelf (OTS) Or Do-It-Yourself (DIY)?

Typical QA/QC labs process between 3,000 and 300,000 samples annually. For R&D labs, the number maybe far higher.

Commercial LIMS are traditionally a derivative of in-house solutions developed by labs to simplify their reporting and data acquisition practices. The volumes of data associated with complex testing protocols found in drug R&D, QA, OC and the stringent reporting requirements of regulatory agencies are challenging the homegrown systems. As LIMS become more complex, the resources required to implement and maintain them must be considered. As a result, implementation of commercial off-the-shelf solutions is outpacing that of homegrown systems. FACTORYTALK believes commercial solutions free in-house IT departments to focus on integrating systems throughout the enterprise into an overall architecture to achieve productivity gains.

Cost Justification of LIMS

The primary justification for purchasing a LIMS is to manage lab data. Other justifications include improving regulatory compliance, reducing sample turn-around time, improving report writing, and sample tracking capability.

It is FACTORYTALK's position that enterprises must transform laboratory data into company knowledge to improve efficiency and increase productivity.

Hardware, Software, and Services

A LIMS purchase generally consists of software and services although the scope of the project may also require the LIMS supplier to include hardware such as servers, workstations, or PCs. Software usually accounts for approximately one-half of the total purchase price while services are approximately one-third. These percentages are usually consistent regardless of the original purchase price of the LIMS, which can be anywhere between US$100,000 and 300,000. FACTORYTALK expects a slight shift in these percentages in the future in favor of software as configurable of out-of the- box not requiring extensive customization.

Maintaining the LIMS

The costs associated with maintaining a LIMS may not be readily transparent. In addition to annual maintenance fees paid to the supplier, database support, in-house IT support, hardware support, and additional training or upgrades may be required. Customization, system management, and template administration are in general the activities incurring the greatest additional costs (measured as percentage of the initial purchase price). Responsibility for maintaining the LIMS can get an issue as LIMS crosses lab and IT boundaries. IT personnel may not understand the mechanics of the lab and conversely, lab personnel may not be proficient data base administrators. But primarily it is the IT departments shouldering responsibility for maintaining the LIMS, with secondary responsibility falling to the abs. Hybrid models where hardware falls under the domain of IT and software under the lab are another common way.

Meeting Objectives

It is impossible to determine if a LIMS implementation has met expectations without performing a post-implementation audit.

Our surprising finding is that nearly 50 percent of implementations do not perform such an audit. To measure the success of a LIMS implementation, users must have a clear understanding of the objectives and develop audit criteria based on those objectives. For example, if the objective is to maximize lab throughput, a few easily quantifiable metrics include system downtime, ability to enter data via on-line instruments, number of data entry errors, and number of samples processed. LIMS provide the tools to monitor, track, and communicate data and quality control information to improve workflow processes as well as the ability to process more samples in a given period.

Our Recommendations

■ To accurately assess the effectiveness of a LIMS, we recommend a post-implementation audit based on previously defined criteria be performed.
■ Manufacturers should apply similar software acquisition processes to LIMS as they do with other purchases. Sound acquisition methodologies are the basis for any successful project and enable known and tested solutions to be implemented without headache.

Free Consultation

While LIMS maybe new to some people and customers may have questions, we will provide satisfying, understandable answers.

Simply contact Factorytalk and "Call for a Coffee" for a free consultation.

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Factorytalk Pte Ltd
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