LIMS stands for Laboratory Information Management System, which is a software system used in laboratories to manage and organize laboratory data, automate workflows, and meet regulatory compliance. If you’re embarking on the journey of exploring a new LIMS, this LIMS glossary can be a helpful resource in navigating the related terminology.
LIMS (Laboratory Information Management System) Glossary
Accessioning
The process of registering a sample in a LIMS and assigning it a unique identification number.
Accreditation
The process by which an independent organization assesses and verifies that a laboratory meets specified standards or regulatory compliance guidelines.
Aliquot
A smaller part of a larger whole, specifically a sample extracted for chemical examination or other processing.
Analyst
An analyst is a laboratory personnel responsible for conducting scientific experiments, tests, and analyses. These individuals possess expertise in specific scientific disciplines and utilize advanced laboratory techniques and instruments to analyze samples. Once the analysis is complete, they enter results into a Laboratory Information Management System (LIMS).
Analyte
A substance that is being analyzed in a laboratory.
Audit
A systematic and independent examination of a laboratory’s compliance with standards and regulations.
Audit Trail
A chronological record that documents the creation, modification, or deletion of electronic data in a LIMS along with a date and time stamp.
Automated Data Capture
Using technology to automatically input data into a LIMS, such as barcode scanners or RFID readers.
Barcode
A unique identifier that is attached to a sample, container, or document to enable automated tracking and identification.
Batch
A group of samples that are processed together in the laboratory, often with the same test or analysis.
Biobank
A biorepository which includes a large collection of biological samples and data for research purposes.
Biobanking
The practice of gathering bodily fluids or tissue samples for research purposes to advance our knowledge of health and disease.
Bioinformatics
The use of computational methods to analyze biological data, such as DNA sequencing results.
Biorepository
A biorepository, also known as a ‘biobank,’ is a facility that collects, processes, stores, and distributes biospecimens to facilitate future scientific research endeavors.
Biospecimen
A biospecimen is a sample of biological material, like tissue, blood, or DNA, collected from living organisms for research or diagnostic purposes. These samples are vital for studying genetics, diseases, and biological processes. Proper handling and documentation are essential for their utility in scientific and clinical contexts.
Calibration
A process used to ensure that an instrument is measuring accurately by comparing its results to a standard.
21 CFR 11
21 CFR Part 11 forms an integral segment of the Code of Federal Regulations, delineating the regulatory framework set forth by the United States Food and Drug Administration (FDA) regarding electronic records and electronic signatures (ERES). Familiarly known as ‘Part 11,’ this regulatory provision sets out benchmarks for assessing the reliability, trustworthiness, and parity with traditional paper records of electronic records and signatures.
Chain of Custody
A record that provides evidence of the possession, regulation, transmission, and analysis of a sample.
Certificate of Analysis (COA)
A document that provides the results of testing performed on a sample and certifies that the results are accurate and reliable.
Client Portal
A web-based platform that enables clients to access and view their laboratory results, download reports and invoices.
CLIA
CLIA stands for the Clinical Laboratory Improvement Amendments. It is a set of regulations in the United States that establish quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. The CLIA program is overseen by the Centers for Medicare & Medicaid Services (CMS) in collaboration with the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). CLIA regulations apply to any facility or laboratory that performs testing on human specimens for the purpose of diagnosis, prevention, or treatment of disease. Compliance with CLIA is essential for maintaining the quality of laboratory testing.
Cloud-Based LIMS
A LIMS that contains all the data on a remote server, known as the cloud. A cloud-based LIMS allows labs to upload and download all their data to the cloud. It is a hybrid of thick and thin-client architectures.
Code of Federal Regulations (CFR)
A set of rules and regulations laid down by the agencies of the US federal government to govern and regulate organizations categorized into 50 titles representing broad subject areas.
Collaborative Research
A type of research where multiple organizations or individuals work together to achieve a common goal.
Compliance
The adherence to regulatory and quality standards, such as the FDA or ISO requirements.
Consumables
Lab consumables refer to essential items regularly used and depleted in laboratory operations. Examples of consumables encompass reagents, standards, gloves, test tubes, slides, stoppers, and pipettes. Regular restocking of these items is necessary to facilitate seamless laboratory activities and uphold the quality and efficiency of scientific research, testing, and analysis.
Contamination
The presence of unwanted substances or organisms in a sample or environment, which can lead to inaccurate or unreliable results.
Corrective Action
The steps taken to address and resolve issues that have been identified through auditing, inspection, or other compliance activities.
Dashboard
A visual representation of laboratory data and key metrics utilized for monitoring and evaluating laboratory performance.
Data Management
Embarking on the journey of data governance, this involves the systematic orchestration of gathering, storing, and structuring laboratory data. Data management aims to enhance the quality and utility of information, facilitating decision-making, compliance with regulations, and supporting business objectives.
Disaster Recovery
Disaster recovery is a comprehensive plan and set of procedures designed to restore and resume normal operations of a laboratory’s IT systems and data after a disruptive event. This includes natural disasters, cyber attacks, or any unforeseen incidents that may compromise data integrity or system functionality. The goal of disaster recovery is to minimize downtime, mitigate data loss, and ensure the swift recovery of critical business functions, allowing the organization to resume operations and maintain continuity in the face of unexpected disruptions.
Equipment Maintenance
The regular upkeep and repair of laboratory equipment and instruments to ensure optimal performance.
FDA
The U.S. Food and Drug Administration (FDA) is responsible for safeguarding the well-being, efficacy, and security of human and veterinary drugs, biological products, medical devices, the U.S. food supply, cosmetics, and more.
Good Laboratory Practices (GLP)
A set of guidelines and standards for laboratory operations, such as sample handling and data management.
GDPR
GDPR stands for “General Data Protection Regulation”. It is a European Union (EU) regulation that came into effect on May 25th, 2018, and is designed to protect the privacy of personal data of the EU citizens.
HIPAA
Acronym for Health Insurance Portability and Accountability Act. Enacted by the US Congress in 1996, it provides security and data privacy to safeguard personal health information. It is a group of rules and regulations for contending fraudulence and abuse in healthcare and insurance.
Instrument
A device or machine used to perform measurements or analysis in a laboratory.
Instrument Integration
The process of connecting laboratory instruments or equipment to a LIMS to enable the automated transfer of data and results.
ISBER
ISBER, which stands for the International Society for Biological and Environmental Repositories, is a global biobanking organization.
ISO 15189
ISO 15189 is an international standard that specifies requirements for the competence and quality of medical laboratories. Developed by the International Organization for Standardization (ISO), it outlines criteria for the implementation of a quality management system tailored to the specific needs of medical laboratories. ISO 15189 covers aspects such as personnel competence, equipment, quality control, and pre-analytical, analytical, and post-analytical processes. Compliance with ISO 15189 ensures that medical laboratories consistently provide accurate, reliable, and efficient diagnostic results, contributing to patient safety and confidence in healthcare services.
Laboratory
A space furnished with the necessary tools and resources to conduct scientific investigations, studies, or research, or to produce drugs or substances.
Laboratory Automation
Laboratory automation refers to the application of technology and automated systems to streamline and enhance various processes and tasks within a laboratory setting.
Laboratory Informatics
Laboratory informatics refers to the utilization of information technology through a platform of instruments, software, and data management tools within the laboratory environment. Lab informatics systems capture, process, store, and manage scientific data, facilitating efficient research and data handling.
Laboratory Inventory Management
Laboratory inventory management involves efficiently monitoring and controlling the stock of reagents, supplies, and equipment within a laboratory. It aims to ensure adequate supplies for experiments, prevent waste, reduce costs, and maintain an organized and well-functioning laboratory environment.
Laboratory Proficiency Testing
Proficiency testing in laboratories is an external evaluation aimed at assessing the quality and accuracy of lab testing results. This process involves analyzing unknown specimens from an external source, serving as a crucial external quality control measure. It goes beyond internal assessments, offering a valuable comparison and objective evaluation of various aspects, including lab staff competencies, specimen handling, equipment functionality, and the accuracy of results reporting.
Laboratory Specimen Management
It entails systematic handling of storage, retrieval, and eco-friendly disposal procedures for laboratory samples.
Laboratory Technician
A person who performs laboratory analysis.
Laboratory Workflow
A series of tasks or steps that are performed in a specific order to complete a laboratory process.
Method
A procedure or protocol used to perform a laboratory analysis.
Method Validation
The process of verifying that a laboratory method is accurate, precise, and reliable for its intended use.
NELAC
NELAC stands for the National Environmental Laboratory Accreditation Conference. It is a non-profit organization that develops standards and provides accreditation for environmental laboratories in the United States. NELAC aims to promote uniformity and consistency in laboratory testing procedures, ensuring the reliability and credibility of environmental data. Laboratories accredited by NELAC comply with established quality assurance and quality control measures, contributing to the overall integrity of environmental testing and analysis.
Patient Portal
A patient portal is an internet-based healthcare application that enables patients to engage and exchange information with their healthcare providers, such as physicians and diagnostic laboratories. Furthermore, it enables patients to receive test reports and invoices from labs as soon as they are released.
Platform as a Service
This pertains to a group of cloud computing services that provides a platform for clients to create, execute, and oversee applications without the intricacy of constructing and upholding the typical infrastructure.
Protected Health Information (PHI)
The particulars that a healthcare practitioner gathers to recognize a person and decide on suitable treatment. This could include demographic information, medical backgrounds, examination and lab outcomes, mental wellness status, insurance details, and other relevant information.
Quality Assurance
Quality assurance comprises a series of pre-established and organized tasks that are necessary to uphold an essential level of quality throughout the various operations performed in a laboratory. The functions include quality control charts and reports, instrument maintenance, certificates of analysis (CoA), etc
Quality Control
A set of procedures used to ensure that laboratory results are accurate and precise.
Result
The output or data generated by an analysis performed on a sample.
Report Template
A predefined format used to generate reports from LIMS data, including standardized fields and data.
Sample
A portion of material or substance that is being analyzed in a laboratory
Sample Tracking Software
Software utilized for monitoring the location, status, and handling of laboratory samples and specimens.
Software as a Service
A software distribution approach, also known as “software-as-a-service,” in which a software application is hosted on the internet and accessed by customers through a lightweight client, typically via a web browser. Using SaaS is generally viewed as an inexpensive approach to enjoy the advantages of a commercial license, without the accompanying intricacy of information technology infrastructure and substantial upfront expenses.
SOP (Standard Operating Procedure)
A document that outlines the steps required to process a sample, perform a laboratory analysis or maintain records, documents, and instruments.
Test
An analysis or measurement performed on a sample.
Tetrahydrocannabinol (THC)
THC is a psychoactive component in cannabis, which interacts with the brain and central nervous system, causing changes in perception, mood, and cognition, and is known for its recreational and therapeutic properties.
User Roles
Varied levels of access and permissions assigned to LIMS users based on their job functions and responsibilities.
Validation
A process used to verify that a laboratory method or instrument is performing accurately and reliably. To learn more, click “What is LIMS Validation.”
Workflow
A series of tasks or steps that are performed in a specific order to complete a laboratory process.