Laboratory information management system

A Laboratory Information Management System or Laboratory Integration Management Solution (LIMS) is a software system used in laboratories for the integraton of all laboratory softwares, instruments, and the management of samples, laboratory users, standards and other laboratory functions such as QA/QC Quality Assurance and Quality Control, sample planning, invoicing, plate management, and workflow automation.

A Laboratory Information Management System and a Process Development Execution System (PDES) perform similar functions. A LIMS will generally target environmental, research or commercial analysis, such as pharmaceutical or petrochemical work, whereas a LIS tends to cover the clinical market (hospitals and other clinical labs). A PDES normally addresses a wider scope: including, for example, virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.

LIMS implementations may also support information gathering, decision making, calculation, review and release into the workplace and away from the office. More recently, LIMS products are starting to expand into Electronic Laboratory Notebooks (ELN), assay data management, data mining and data analysis. This broader set of capabilities enables the realization of translational medicine completely within a single software solution. The recent availability of systems that offer full and comprehensive LIMS functionality combined with the functionality of Electronic Laboratory Notebooks, in a single solution platform, represents the potential for transformative change in a company's operations.

Technology

Laboratory information management

Sample management

The core function of LIMS is the management of samples. This typically is initiated when a sample is received in the laboratory at which point the sample will be registered in the LIMS. This registration process may involve accessioning the sample and producing barcodes to affix to the sample container. Various other parameters will usually be recorded such as clinical or phenotypic information corresponding with the sample. The LIMS will then track chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location such as a shelf/rack/box/row/column. Other event tracking may be required such as freeze\thaw cycles that a sample undergoes in the laboratory.

Modern LIMS have implemented extensive configurability as each laboratory's needs for tracking additional data points can vary widely. LIMS vendors cannot typically make assumptions about what these data tracking needs are and therefore need to be adaptable to each environment. LIMS users may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP and FDA specifications and this can affect certain aspects of sample management in a LIMS solution. One key to compliance with many of these standards is audit logging of all changes to LIMS data, and in some cases a full electronic signature system is required for rigorous tracking of field level changes to LIMS data.

LIMS roles

One may configure a LIMS whereby users are assigned roles or groups. Typically the role of a user will dictate their access to specific data records in the LIMS. Each user account is protected by security mechanisms such as a user id and a password. Users may have customized interfaces based on their role in the organization. For example, a laboratory manager might have full access to all of a LIMS functions and data, whereas technicians might have access only to data and functionality needed for their individual work-tasks.

Instrument data management

Most LIMS offer some capability for integration with instruments. A LIMS may create control files that are "fed" into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The LIMS may then import instrument results files to extract QC or results data for assessment of the operation on the sample(s). Data owners may access the resulting stored information at any time.

A relatively new development in LIMS products is the ability to import and manage raw assay data results. Modern targeted assays such as qPCR and deep sequencing can produce tens of thousands of data points per sample. Furthermore, in the case of drug and diagnostic development as many as 12 or more assays may be run for each sample. In order to track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance. Some LIMS products address this by simply attaching assay data as BLOBs to samples, but this limits the utility of that data in data mining and downstream analysis.

Web-based technology

A LIMS can use many delivery technologies. Web-based LIMS implementations, as well as Java based solutions, often require no special client-side installation resulting in less IT involvement in their deployment. An exception is web based solutions that are based on .NET technologies and require a special plug-in on the client and may be limited to Microsoft only browsers. This can lead to issues in instances where there is a high penetration of Apple and Linux usage by lab technicians or researchers. Another concern regarding web based deployment is possible exploitation by hackers where highly sensitive laboratory and research data may be compromised. Even with modern security methods in place, deploying a LIMS solution "outside the firewall" of an organization opens the LIMS to potential intrusion.

Some vendors are beginning to offer hosted LIMS solutions (SaaS) on a rental basis. These solutions tend to be less configurable than on premise solutions and are therefore considered for less demanding implementation such as laboratories with few users and limited sample processing volumes.

LIMS configurability

LIMS implementations are notorious for often being lengthy and costly. This is due in part to the diversity of requirements within each lab, but also to the inflexible nature of LIMS products for adapting to these widely varying requirements. Newer LIMS solutions are beginning to emerge that take advantage of modern techniques in software design that are inherently more configurable and adaptable, particularly at the data layer, than prior solutions. This means not only that implementations are much faster, but also that the costs are lower and the risk of obsolescence are minimized.

Standards covered by LIMS

A LIMS covers standards such as:

• 21 CFR Part 11 from the Food and Drug Administration (United States)
• ISO/IEC 17025
• ISO 15189
• Good laboratory practice

Notable LIMS providers

• Autoscribe Ltd
• Analytik Jena
• LABVANTAGE Solutions
• LabWare
• Pardus Ltd.
• The Weaver Group Inc.
• Thermo Scientific LIMS
• Waters Corp.

See also

• Laboratory informatics
• Further information can be acquired at LIMS.com

Further reading

• Gibbon, Gerst A Brief History of LIMS. Laboratory Automation and Information Management 1996, 32(1), 1-5