Laboratory Information Management System (LIMS)

At the laboratory level you can think of a LIMS or Laboratory Information Management System as a software solution that supports and enhances a modern laboratory’s operations. The functions and uses of a LIMS have evolved over the years from simple sample management to a lab enterprise resource planning and execution tool that manages multiple aspects of laboratory operation, including critical resources such as instruments, reagents and standards, documents, customers, suppliers, and personnel, and functions such as QC, method execution ELN, sample receiving and shipping, lot release, decision support, CAPA and much more.

Early in LIMS history the cost, upwards of $300K, and resources required to implement a LIMS limited use to the larger enterprise. That has steadily changed with expanded functional/benefit value and reduced prices. For example, most BlazeLIMS systems today cost between $40K and $80K depending on size and functions. Nevertheless even that more attractive cost will often fail to gain budgetary priority unless motivated by the necessity of regulatory compliance and/or an expanding laboratory workload. In today’s investment climate, cost saving alone will often not carry the day, even when a one year payoff is projected.

Consider expanding your vision for LIMS to be a central component for an enterpise digital transformation.

A comprehensive LIMS solution like BlazeLIMS automates tedious labor intensive tasks to reduce costs, errors and rework, and improve reproducibility, throughput, and turnaround. BlazeLIMS implements, tracks, manages and supports laboratory operations, workflow, resources, performance, costs and much more. Within the lab, these benefits of BlazeLIMS are highly valuable in themselves. To illustrate, a few of the many examples with high value are:

• Create a sample record for product testing in seconds, by selecting a pre-defined template which populates required testing, assigns a unique identifier, and creates barcode label(s).
• Display a backlog for any operational step from receipt to analysis to approval, and any support activity such as instrument calibration, reagent ordering, user training, etc.
• On data entry of a result, apply multiple checks to validate the result and run associated equations.
• Produce and deliver a COA report with one button.
• Produce a daily email quality summary with one button.
• Produce a report of all analysis that used a purchased that may have quality problems.

Depending upon the specific laboratory, LIMS projects which broadly implement this level of automation will save 20% to 40% on labor, as well as reduce errors and rework, and improve turnaround. For BlazeLIMS the costs will typically range from $40K to $80K, depending upon the laboratory size. However attractive this might be to laboratory management, it is important to recognize early in a project that these tangible benefits may not alone carry the day in justifying that level of investment unless a lab is facing significant capacity bottlenecks or regulatory requirements. A more compelling case emerges when you integrate systems and optimize enterprise performance.

A comprehensive LIMS solution builds on automating tasks and integrating systems to optimize performance, not only of the laboratory functions but more importantly of the entire enterprise. This involves delivering usable analytics and providing useful tools to drive improvement rigorously, and is a key ingredient in transitioning task oriented personnel into knowledge based workers and contributors, elevating the entire enterprise.  To illustrate, a few of the many examples with high value are:

• Provide a real-time product quality dashboard of control charts, lot release status, etc. for the PLC or DCS system operators.
• Provide a flexible ad-hoc query tool to domain experts to extract and analyze data according to demands.
• Automatically send a comprehensive quality report by email to quality assurance personnel.
• Provide an integrated CAPA facility to capture and organize follow up for a managed quality program.
• Provide a dashboard KPI’s for decision support and continuous improvement.
• Detect early quality trends by running automatic Westgard or Western Electric control charts and delivering rule violation notifications to production managers.

What are the characteristics of a comprehensive COTS LIMS and why is this critical? A comprehensive COTS LIMS provides features that are both broad and deep. By broad we mean an integrated coverage of all the lab resources that contribute to the operation, starting with sample and container management, but also extending to instruments, methods, reagents and standards, storage facilities, personnel, documents, specs, customers, suppliers, and more. In addition, these features cover the sweep of the automate, integrate and optimize goals. For example:

• Track and manage the life cycle and usability of reagents and standards through purchase, make, quarantine, release, reserve, use and disposal so that expiration or low inventory do not impact throughput, turnaround and quality.
• Track and maintain instrument status and enforce suitability for usage in prep or lab standards.
• Provide user records controlling qualifications for lab tasks.
• Track and maintain records for products, specs, customers, projects, patients, sites, labs, materials, lots, etc. and tie them to samples, materials, etc.
• Provide work requests to track and manage multiple sample submissions.

By deep we mean that this coverage extends vertically into detailed functions and data for each of these areas. To illustrate, a few of the many examples are:

• Provide barcode labeling for positive and error free identification of samples, sample containers, instruments including lab ware, reagents and standards, personnel, batches, and more.
• Provide a symbolic calculation processor with the ability to access operand values across the entire domain of impact, including not only result values, but also instrument calibration values, batch, prep, standards, and more, in effect turning the LIMS tables into a giant spreadsheet.
• Provide specification management and application for combinations of product, customer, sampling point, season, patient demographics, experiment, etc. that handle the details of precision, text override, units conversion, text override, etc.
• Provide notifications for a wide range of special events.

This broad and deep coverage is available as COTS (Commercial Off The Shelf) configurable features, not driving up cost by requiring customized programming or scripting. These characteristics are critical for a cost effective solution with a long term life that will not hem you in as lab requirements evolve over time.