Laboratory information management system

Laboratories around the world depend on a LIMS to manage data, assign rights, manage inventory, and more.

Sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), a laboratory information management system (LIMS) is a software-based laboratory and information management system that offers a set of key features that support a modern laboratory's operations. Those key features include — but are not limited to — workflow and data tracking support, flexible architecture, and smart data exchange interfaces, which fully "support its use in regulated environments." The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics.

Due to the rapid pace at which laboratories and their data management needs shift, the definition of LIMS has become somewhat controversial. As the needs of the modern laboratory vary widely from lab to lab, what is needed from a laboratory information management system also shifts. The end result is the definition of a LIMS will shift based on who you ask and what their vision of the modern lab is. Dr. Alan McLelland of the Institute of Biochemistry, Royal Infirmary, Glasgow highlighted this problem in the late 1990s by explaining how a LIMS is perceived by an analyst, a laboratory manager, an information systems manager, and an accountant, "all of them correct, but each of them limited by the users' own perceptions."

Historically the LIMS, LIS, and process development execution system (PDES) have all performed similar functions. A LIMS has generally targeted environmental, research, or commercial analysis, such as pharmaceutical or petrochemical work, whereas the term "LIS" has tended to be used to reference lab informatics systems in the forensics and clinical markets, which often required special case management tools. The distinction between a LIS and LIMS has blurred in recent times, however, as most LIMS now fully support comprehensive case-centric data. The PDES normally addresses a wider scope, including, for example, virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.

More recently, LIMS products have been expanding even farther beyond their original purpose of sample management. Assay data management, data mining, data analysis, and electronic laboratory notebook (ELN) integration are all features that have been added to many LIMS, enabling the realization of translational medicine completely within a single software solution.

History of LIMS

Up until the late 1970s, the management of laboratory samples and the associated analysis and reporting were time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities at the same time sought to develop a more commercial reporting solution in the form of special instrument-based systems.

In 1982 the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew, industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds of LIMS-related conferences. By 1988 the second-generation commercial offerings were tapping into relational databases to expand LIMS into more application-specific territory, and International LIMS Conferences were in full swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to implement better data processing and exchanges.

By 1995 the client/server tools had developed to the point of allowing processing of data anywhere on the network. Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the confines of the laboratory. From 1996 to 2002 additional functionality was included in LIMS, from wireless networking capabilities and georeferencing of samples, to the adoption of XML standards and the development of Internet purchasing.

Technology

Laboratory information management operations

Sample management

A lab worker matches blood samples to documents. With a LIMS, this sort of sample management is made more efficient.

The core function of LIMS has traditionally been 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 such as clinical or phenotypic information corresponding with the sample are also often recorded. The LIMS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column. Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may be required.

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 vendors must create LIMS that are adaptable to individual environments. LIMS users may also have regulatory concerns to comply with such as CLIA, HIPAA, GLP, and FDA specifications, affecting 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.

Instrument and application integration

Modern LIMS offer an increasing amount of integration with laboratory instruments and applications. 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 data for quality control assessment of the operation on the sample. Access to the instrument data can sometimes be regulated based on chain of custody assignments or other security features if need be.

A relatively new development in LIMS products is the ability to import and manage raw assay data results.^{[citation needed]} 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.

Electronic data exchange

The exponentially growing volume of data created in laboratories coupled with increased business demands and focus on profitability have pushed LIMS vendors to increase attention to how their LIMS handles electronic data exchanges. Attention must be paid to how an instrument's input and output data is managed, how remote sample collection data is imported and exported, and how PDAs and tablet technology integrates with the LIMS. The successful transfer of data files in Microsoft Excel and other formats, as well as the import and export of data to Oracle, SQL, and Microsoft Access databases is a pivotal aspect of a the modern LIMS. In fact, the transition "from proprietary databases to standardized database management systems such as Oracle ... and SQL" has arguably had one of the biggest impacts on how data is managed and exchanged in laboratories.

Additional functions

Aside from the key functions of sample management, instrument and application integration, and electronic data exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited to:

audit management

fully track and maintain an audit trail

barcode handling

assign one or more data points to a barcode format; read and extract information from a barcode

chain of custody

assign roles and groups that dictate access to specific data records and who is managing them

compliance

follow regulatory standards that affect the laboratory

customer relationship management

handle the demographic information and communications for associated clients

document management

process and convert data to certain formats; manage how documents are distributed and accessed

instrument calibration and maintenance

schedule important maintenance and calibration of lab instruments and keep detailed records of such activities

inventory and equipment management

measure and record inventories of vital supplies and laboratory equipment

manual and electronic data entry

provide fast and reliable interfaces for data to be entered by a human or electronic component

method management

provide one location for all laboratory process and procedure (P&P) and methodology to be housed and managed

personnel and workload management

organize work schedules, workload assignments, employee demographic information, and financial information

quality assurance and control

guage and control sample quality, data entry standards, and workflow; reports

create and schedule reports in a specific format; schedule and distribute reports to designated parties

time tracking

claculate and maintain processing and handling times on chemical reactions, workflows, and more

Client-side LIMS options

A LIMS can use many delivery technologies. Thin-client LIMS implementations — including Java-based solutions — often require no special client-side installation resulting in less IT involvement in their deployment. An exception is a web-based solution based on .NET technologies, requiring 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 and web-enabled 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.

The following represent the four most-used LIMS architectures, and their associated strengths and weaknesses:

Thick-client

A thick-client LIMS is a more traditional client/server architecture, with some of the system residing on the computer or workstation of the user (the client) and the rest on the server. The LIMS software is installed on the client computer, which does all of the data processing. Later it passes information to the server, which has the primary purpose of data storage. Most changes, upgrades, and other modifications will happen on the client side. This was one of the first architectures implemented into a LIMS, having the advantage of providing higher processing speeds (because processing is done on the client and not the server) and slightly more security (as access to the server data is limited only to those with client software). Additionally, thick-client systems have the added advantage of providing more interactivity and customization, though often at a greater learning curve. The disadvantages of client-side LIMS include the need for more robust client computers and more time-consuming upgrades, as well as a lack of base functionality through a web browser. The thick-client LIMS can become web-enabled through an add-on component.

Thin-client

A thin-client LIMS is a more modern architecture which offers full application functionality accessed through a device's web browser. The actual LIMS software resides on a server (host) which feeds and processes information without saving it to the user's hard disk. Any necessary changes, upgrades, and other modifications are handled by the entity hosting the server-side LIMS software, meaning all end-users see all changes made. To this end, a true thin-client LIMS will leave no "footprint" on the client's computer, and only the integrity of the web browser need be maintained by the user. The advantages of this system include significantly lower cost of ownership and fewer network and client-side maintenance expenses. However, this architecture has the disadvantage of requiring real-time server access, a need for increased network throughput, and slightly less functionality. A sort of hybrid architecture that incorporates the features of thin-client browser usage with a thick client exists in the form of a web-based LIMS.

Some LIMS vendors are beginning to rent hosted, thin-client solutions as "software as a service" (SaaS). These solutions tend to be less configurable than on premise solutions and are therefore considered for less demanding implementations such as laboratories with few users and limited sample processing volumes.

Another implementation of the thin client architecture that's offered is the maintenance, warranty, and support (MSW) agreement. Pricing levels are typically based on a percentage of the license fee, with a standard level of service for 10 concurrent users being approximately 10 hours of supports and additional customer service at $200 per hour. Though some may choose to opt out of an MSW after the first year, it's often more economical to continue the plan in order to receive updates to the LIMS, giving it a longer life span in the laboratory.

Web-enabled

A web-enables LIMS architecture is essentially a thick-client architecture with an added web browser component. In this setup, the client-side software has additional functionality that allows users to interface with the software through their device's browser. This functionality is typically limited only to certain functions of the web client. The primary advantage of a web-enabled LIMS is the end-user can access data both on the client side and the server side of the configuration. As in a thick-client architecture, updates in the software must be propagated to every client machine. However, the added disadvantages of requiring always-on access to the host server and the need for cross-platform functionality mean that additional overhead costs may arise.

Web-based

Arguably one of the most confusing architectures, web-based LIMS architecture is a hybrid of the thick- and thin-client architectures. While much of the client-side work is done through a web browser, the LIMS also requires the additional support of Microsoft's .NET Framework technology installed on the client device. The end result is a process that is apparent to the end-user through the Microrosoft-compatible web browser, but perhaps not so apparent as it runs thick-client-like processing in the background. In this case, web-based architecture has the advantage of providing more functionality through a more friendly web interface. The disadvantages of this setup are more sunk costs in system administration and support for Internet Explorer and .NET technologies, and reduced functionality on PDAs and tablets.

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 is minimized.

Standards covered by LIMS

A LIMS covers standards such as:

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

LIMS vendors

See the LIMS vendor page for a list of LIMS vendors past and present.

See also

• Laboratory informatics

Further reading

Gibbon, G.A. (1996). "A brief history of LIMS" (PDF). Laboratory Automation and Information Management 32 (1): 1–5. http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TH3-3VJRS4M-1&_user=10&_coverDate=05%2F31%2F1996&_rdoc=2&_fmt=high&_orig=browse&_origin=browse&_zone=rslt_list_item&_srch=doc-info(%23toc%235271%231996%23999679998%2349189%23FLP%23display%23Volume)&_cdi=5271&_sort=d&_docanchor=&_ct=30&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=f1570c2b4a71b1ea7fa0477673837b49&searchtype=a. 

Wood, Simon (2007). "Comprehensive Laboratory Informatics: A Multilayer Approach", pp. 1.