Laboratory information management system

laboratory information management system ( LIMS ), sometimes Referred to as a laboratory information system ( LIS ) or laboratory management system ( LMS ) is a software-based laboratory and information management system with features That support has modern laboratory’s operations. Key features include but are limited to- workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully support its use in regulated environments.

The definition of a LIMS is somewhat controversial: LIMSs are dynamic because the laboratory’s requirements are rapidly evolving and different labs often have different needs. Therefore, a working definition of a LIMS ultimately depends on the interpretation by the individuals or groups involved. [1]

Historically the LIMS, LIS, and process development execution system (PDES) have all performed similar functions. The term “LIMS” has a tendency to refer to informatics systems targeted for environmental, research, or commercial analysis such as pharmaceutical or petrochemical work. “DSL” has tended to Refer to laboratory informatics systems in the forensics and clinical markets, qui Often required special tools case management. “PDES” has been applied to a wider scope, including, for example, virtual manufacturing techniques, while not necessarily integrating with laboratory equipment .

In recent times LIMS functionality has spread even farther beyond its original purpose of sample management. assay data management, data mining , data analysis, and electronic laboratory notebook (ELN) integration-have-been added to many LIMS Enabling the realization of translational medicine completely Call Within a single software solution. Additionally, the distinction between LIMS and LIS has blurred, as many LIMS now also fully support comprehensive case-centric clinical data.

History

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 error s. 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-based systems. [2]

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 Center in Pittsburgh began planting the seeds through 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 client / server architecture , And laboratories to implement better data processing and exchanges. [2]

By 1995 the client / server tools had developed to the point of allowing the processing of any data on the network. Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the confines of the laboratory. LIMS, from wireless networking capabilities and georeferencing of samples, to the adoption of XML standards and the development of Internet purchasing. [2]

As of 2012, some LIMS is defined. Additions include clinical functionality, electronic laboratory notebook (ELN) functionality, as well as a service (SaaS) distribution model.

Technology

Operations

The LIMS is an evolving concept, with new features and functionality being added often. LIMS will also likely change. Despite these changes, a LIMS tends to have a base of functionality that defines it. That functionality can Roughly be divided into five laboratory processing phases, with Numerous software functions falling under each: [3] (1) the receipt and log in of a sample and Its associated customer data, (2) the assignment, scheduling, and tracking (3) the inspection and approval of the sample, and (3) the processing and quality control of the sample,

There are several pieces of core functionality associated with these laboratory processing phases that tend to appear in most LIMS:

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 the sample will be registered in the LIMS. Some LIMS will allow the customer to place an “order” for a sample directly to the LIMS at which the sample is generated in an unreceived state. This paper presents the results of the analysis of the results of the study. The process may involve accessioning the sample and producing barcodes to affix to the sample container. Various other parameters such as clinical or phenotypic information. The LIMS then tracks the chain of custody as well as sample location. Renting a house for rent in Rothesay, Row, 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 extensively implemented configurations for each other. LIMS vendors can not 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 issues to comply with such 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 the 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 for the Laboratory. A LIMS may create a “fed” or “fed” into the instrument. The LIMS can then be used to analyze the results. Access to the instrument data can be regulated on a chain of custody assignments or other security features if need be.

Modern LIMS products now also allow for the import and management of raw assay data results. [4] Modern targeted assays such as qPCR and deep sequencing can produce tens of thousands of data per sample. Moreover, in the case of drug and diagnosis development as many as 12 or more assays may be run for each sample. In order to be able to perform this task, it is necessary to have a high level of performance. Some LIMS products address this by simply attaching assay data as BLOBs to samples, purpose this limits the utility of which 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 . It is also possible to use the LIMS methodology to determine the quality of the data. The successful transfer of data in a spreadsheet and other formats is a pivotal aspect of the modern LIMS. In fact, the transition “from proprietary databases to standardized database management systems, such as MySQL” has arguably had an impact on the data management and exchanged in laboratories. In addition to mobile and database electronic data exchange,

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 are dictate
compliance
Follow regulatory standards that affect the laboratory
Customer relationship management
Handle the demographic information and communications
Document management
Process and convert data to certain formats; Manage how documents are distributed and accessed
Instrument calibration and maintenance
Schedule of maintenance and calibration of lab instruments
Inventory and equipment management
Measure and record inventories of vital supplies and laboratory equipment
Manual and electronic data entry
A component of a human component
Method management
(1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) The operation and procedure of the operation and procedure
Personnel and workload management
Organize work schedules, workload assignments, employee demographic information, training, and financial information
Quality assurance and control
Gauge and control sample quality, data entry standards, and workflow
carryforwards
Create and schedule reports in a specific format; Schedule and distribute reports to designated parties
Time tracking
Calculate and maintain processing and handling times on chemical reactions, workflows, and more
traceability
Show audit trail and / or chain of custody of a sample
workflows
Track a sample, a batch of samples, or a “lot” of batches through its lifecycle

Client-side options

A LIMS has used many architectures and distribution models over the years. As technology has changed, how a LIMS is installed, managed, and used has also changed with it. The following represented architectures which have been used at one point or another.

Thick-client

A thick client LIMS is a more traditional client / server architecture, with Reviews some of the system Residing on the computer or workstation of the user ( the customer ) 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 in a LIMS, having the advantage of providing higher processing speeds. Additionally, thick-client systems have also provided more interactivity and customization, though often at a greater learning curve. The disadvantages of customer-side LIMS include the need for more robust customer computers and more time-consuming upgrades, as well as a lack of basic functionality through a web browser . The thick-client LIMS can become web-enabled through an add-on component. [5]

LIMS, [5] this is based on the misconception that “users with the client application installed on their PC can access server side information”. This secrecy-of-design reliance is known as security through obscurity and ignores an adversary’s ability to mimic client-server interaction through, for example, reverse engineering , network traffic interception , or simply purchasing a thick-client license. Such a view is in contradiction of the “Open Design” principle of the National Institute of Standards and Technology ‘s Guide to General Server Security qui states That ”

Thin-client

A thin-client LIMS is a more modern architecture that offers full functionality. The actual LIMS software 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 will be maintained by the user. The advantages of this system include the cost of ownership and fewer networks and customer-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 lot of hybrid architecture that incorporates the features of thin-client browser with a thick client installation 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-premises solutions and are therefore considered for less demanding implementations.

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

Web-enabled

A web-enabled 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 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

A web-based LIMS architecture is a hybrid of the thick-and-thin client architectures. While the LIMS may also require the support of desktop software installed on the client device. The end result is a process that is apparent to the end-user through a web browser. 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 reduced functionality on mobile platforms.

The disadvantage of a thick client is in the installation and update phases of the applications. Users who want the security, high speed and functionality of a client can use Microsoft ClickOnce Technology. Citation needed ] This is a Windows-based smart client. The software does not need to be installed on each user’s workstation one by one. ClickOnce applications can be self-updating; They can check for newer versions as they become available and automatically replace any files.

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 most LIMS products for adapting to these widely varying requirements. Newer LIMS solutions are the beginning of emerging technologies that are inherently more configurable and adaptable. This is not only the case, but also the cost of obsolescence is minimized.

Distinction between a LIMS and a LIS

Until recently, the LIMS and Laboratory Information System (LIS) have exhibited a few key differences, making them noticeably separate entities.

A LIMS has-been traditionally designed to carry and process data related to batches of samples from biology labs, water treatment facilities , drug trials , and other entities That handle complex batches of data. A LIS has been written for a patient in a clinical setting.

A LIMS may have to satisfy good manufacturing practice (GMP) and meet the requirements of the regulatory bodies and research scientists in many different industries. A LIS, however, must satisfy the reporting and auditing needs of health service agencies eg the hospital accreditation agency, HIPAA in the US, or other clinical medical practitioners.

A LIMS is the most competitive in group-centric settings (dealing with “batches” and “samples”) which often deal with mostly anonymous research-specific laboratory data, “And” specimens “) and clinical labs. An LIS is regulated as a medical device by the FDA, and the companies that produce the software are therefore liable for defects. Due to this, an LIS can not be customized by the client.

Standards

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 and Good Automated Manufacturing Practice (GAMP).

See also

  • Data management
  • List of LIMS software packages
  • Scientific management
  • Title 21 CFR Part 11
  • Virtual research environment

References

  1. Jump up^ Cramer, Kevin (28 November 2016). “What is a LIMS?” . Sapiosciences.com . Retrieved 28 November 2016 .
  2. ^ Jump up to:a b c Gibbon, GA (1996). “A brief history of LIMS” (PDF) . Laboratory Automation and Information Management . 32 (1): 1-5. Doi : 10.1016 / 1381-141X (95) 00024-K . Retrieved 7 November 2012 .
  3. Jump up^ DO Skobelev; TM Zaytseva; AD Kozlov; VL Perepelitsa; AS Makarova (2011). “Laboratory information management systems in the work of the analytic laboratory” (PDF) . Measurement Techniques . 53 (10): 1182-1189. Doi : 10.1007 / s11018-011-9638-7 . Retrieved 7 November 2012 .
  4. Jump up^ Khan, Masood N .; Findlay, John W. (2009). “11.6 Integration: Tying It All Together”. Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena . John Wiley & Sons. p. 324. ISBN  0470041382 . Retrieved 7 November 2012 .
  5. ^ Jump up to:a b O’Leary, Keith M. “Selecting the Right LIMS: Critiquing technological strengths and limitations” . Scientific Computing . Retrieved 7 November2012 .
  6. Jump up^ “Guide to General Server Security” (PDF) . National Institute of Standards and Technology. July 2008 . Retrieved 2 October 2011 .

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