LIMS (Laboratory Information Management System) Glossary
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.
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.
AI-Powered LIMS
An AI-powered Laboratory Information Management System (LIMS) leverages artificial intelligence to automate repetitive tasks, generate intelligent alerts, assist in data validation, and offer recommendations based on historical lab data—enhancing operational efficiency and decision support.
ALCOA
ALCOA is a foundational principle for maintaining data integrity in regulated environments. It stands for Attributable, Legible, Contemporaneous, Original, and Accurate. The extended version, ALCOA+, adds Complete, Consistent, Enduring, and Available, highlighting the importance of trustworthy and traceable data throughout its lifecycle.
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.
API Integration
API integration in LIMS is a process that enables the system to securely connect with external applications such as ERP systems, ELNs, and billing platforms using application programming interfaces (APIs), thereby facilitating bi-directional data transfer between systems.
Artificial Intelligence (AI)
A field of technology that enables machines to simulate human-like intelligence, learning from data to make decisions and complete tasks autonomously. In LIMS, AI automates routine workflows, enables predictive analysis, facilitates in-depth data exploration, and supports informed decision-making, all of which enhance laboratory efficiency and accuracy.
ASTM Standards
ASTM standards are technical guidelines developed by ASTM International that define quality, safety, and performance criteria for materials, products, systems, and services across various industries, including construction, manufacturing, healthcare and analytical testing.
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.
Batch Management
Batch management in LIMS is the capability to group multiple samples together and process them simultaneously. This enables standardized workflows for a set of samples, improved efficiency, consistent results, and higher laboratory throughput.
Biobank
A biorepository which includes a large collection of biological samples and data for research purposes.
Biobank Information Management System (BIMS)
A Biobank Information Management System (BIMS) is a specialized software solution for biobanks to streamline the tracking and management of biological samples. BIMS captures and stores detailed donor information, manages consent documentation, and tracks specimens through all stages—collection, storage, processing, and shipment. Designed to support regulatory compliance and sample management best practices, BIMS enables secure data handling, provides role-based access for authorized users, minimizes data silos, and offers customizable reporting to support biobanking operations.
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.
Bioreactors
A bioreactor is a specialized vessel designed to provide a controlled environment for cultivating organisms or cells to carry out biological reactions. Common in pharmaceutical and biotech labs, bioreactors enable large-scale production of biologics, vaccines, and enzymes under specific temperature, oxygen, and nutrient conditions.
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.
Biotechnology
Biotechnology combines biology with technology to develop products and processes that improve human life and the environment. It draws from disciplines like genetics, microbiology, and chemical engineering, with applications in healthcare, agriculture, and other industries.
Calibration
A process used to ensure that an instrument is measuring accurately by comparing its results to a standard.
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.
Certified Reference Material (CRM)
Certified Reference Material (CRM) is a standardized material with known properties used as a control in analytical testing to validate methods, calibrate instruments, and ensure measurement accuracy and traceability in mining laboratory analyses.
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.
Client Portal
A web-based platform that enables clients to access and view their laboratory results, download reports and invoices.
Clinical Diagnostics
Clinical diagnostics is the process of identifying a disease, condition, or injury by evaluating a patient’s symptoms, medical history, and findings from a physical examination. It involves performing regulatory-approved medical tests—such as those authorized by the FDA or similar bodies—on human biological samples. The results are used by healthcare providers to support accurate diagnosis and guide treatment decisions.
Clinical Laboratory Improvement Amendments (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.
Configure/Configuration
LIMS configuration refers to modifying the system using built-in settings and options, allowing users to tailor features, workflows, and data fields to fit specific needs without altering the core code. The process of configuring a LIMS involves assembling functional components to create a solution that meets users’ requirements, without altering the underlying code.
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.
Contract Research Organization (CRO)
A Contract Research Organization, or CRO, is a company that provides specialized research services to pharmaceutical, biotechnology, and other industries on a contractual basis. With expertise in particular aspects of research and development, regulatory compliance, and preclinical studies, CROs support clients in advancing research and product development.
Corrective and Preventive Action (CAPA)
CAPA refers to a structured quality management process used to identify nonconformances, determine their root causes, and implement corrective actions to prevent their recurrence. A LIMS helps manage and track CAPA with ease, enabling laboratories to showcase corrective actions taken to prevent non-conformities during audits.
Customize/Customization
LIMS customization refers to modifications made to the system’s core software code, allowing for unique functionalities or specialized features not available in the standard setup. This process requires coding, either by altering the existing codebase or by creating new code.
Dashboard
A visual representation of laboratory data and key metrics utilized for monitoring and evaluating laboratory performance.
Data Integrity
Data integrity refers to the accuracy, reliability, and consistency of data throughout its lifecycle, including during collection, storage, transfer, and analysis. It involves implementing practices and systems to maintain data quality and ensure compliance with regulatory standards like FDA and GxP guidelines. This is essential for laboratories to ensure that data remains trustworthy and valid, supporting regulatory requirements and high-quality outcomes.
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.
Data Migration
Data migration is the process of transferring data from one system, storage location, or platform to another, commonly required when implementing new software or upgrading legacy systems. LIMS data migration involves moving laboratory data from an existing system or legacy platform to a new LIMS, often due to needs like system upgrades, vendor changes, compliance requirements, or operational expansion. A precise and carefully managed data migration is essential to preserve data integrity, support advanced features, and ensure seamless laboratory operations and collaboration.
Deoxyribonucleic Acid (DNA)
DNA is the hereditary material found in nearly all living organisms. Composed of four nucleotide bases—adenine (A), thymine (T), cytosine (C), and guanine (G)—it forms a double-helix structure where A pairs with T, and C pairs with G. DNA carries genetic instructions essential for development, functioning, and reproduction.
Digital Signature
A digital signature is a cryptographically generated electronic signature that verifies the identity of the signer and preserves the integrity of digital documents.
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.
Donor Consent Management
Donor consent management is the process of recording, tracking, and enforcing the legal and ethical permissions provided by sample donors, ensuring that specimens and associated protected health information (PHI) are used only in accordance with agreed terms.
Electronic Health Record (EHR)
An Electronic Health Record (EHR) is a digital compilation of a patient’s health information stored in a software system. Information stored includes their medical history, diagnoses, medications, test results, allergies, immunizations, and treatment plans. EHRs are accessible to authorized healthcare providers involved in a patient’s care, enabling coordinated and informed decision-making. This system enhances patient care by facilitating efficient information sharing across different medical settings and providers.
Electronic Signature
An electronic signature in LIMS is a secure digital authentication method used to review, approve, and sign electronic records, similar to paper records. This ensures accountability and compliance with 21 CFR Part 11 regulations.
Environmental Protection Agency (EPA)
The EPA is the federal agency in the United States responsible for protecting human health and the environment through regulations, monitoring, and enforcement of environmental policies.
Equipment Maintenance
The regular upkeep and repair of laboratory equipment and instruments to ensure optimal performance.
Food and Drug Administration (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.
Gene
A gene is a specific segment of DNA that contains instructions to produce a protein or RNA molecule. Inherited from parents, genes influence traits such as appearance, health, and biological functions by encoding information vital to cellular activity.
General Data Protection Regulation (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.
Genomics
Genomics is a branch of molecular biology that studies the complete set of DNA (genome) within an organism. It focuses on understanding gene structure, function, variation, mapping, and genome editing to uncover insights into health, disease, and evolution.
Good Laboratory Practices (GLP)
A set of guidelines and standards for laboratory operations, such as sample handling and data management.
GxP Compliance
GxP encompasses a set of quality and regulatory guidelines—such as Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)—that ensure product quality, safety, and data integrity. GxP compliance means meeting these standards across all applicable processes.
Health Insurance Portability and Accountability Act (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.
International Organization for Standardization (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.
International Society for Biological and Environmental Repositories (ISBER)
ISBER, which stands for the International Society for Biological and Environmental Repositories, is a global biobanking organization.
Internet of Things (IoT)
The Internet of Things refers to a network of connected devices that communicate and share data in real time. In laboratories, IoT enables automated monitoring of equipment, environmental conditions, and predictive maintenance.
Lab Automation
Lab automation uses technologies such as robotics, smart instruments, and specialized software, such as laboratory information management systems (LIMS), to perform routine laboratory tasks. It increases efficiency, minimizes human error, and enhances reproducibility and data accuracy.
Laboratory
A space furnished with the necessary tools and resources to conduct scientific investigations, studies, or research, or to produce drugs or substances.
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.
Library Preparation
Library preparation in genomics refers to the set of laboratory processes that convert extracted DNA or RNA into a sequencing-ready format by fragmenting nucleic acids, adding adapters, and indexing samples before sequencing.
Machine Learning (ML)
Machine Learning is a subset of AI that enables systems to learn from data patterns and improve performance over time without being explicitly programmed. In labs, ML algorithms can identify trends, forecast outcomes, and assist in quality control.
Mechanical Testing
Mechanical testing in the materials industry refers to the evaluation of a material’s response to applied forces, such as tension, compression, bending, and shear, to determine properties like strength, elasticity, ductility, and toughness.
Metallurgical Testing
Metallurgical testing refers to a suite of laboratory tests used in the mining industry to evaluate the physical and chemical behavior of minerals and ores during processing. Metallurgical testing methods include assays, flotation tests, leach studies, and other performance evaluations.
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.
National Environmental Laboratory Accreditation Conference (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.
Natural Language Processing (NLP)
NLP is an AI technology that allows computers to understand, interpret, and respond to human language. In labs, NLP can be used to extract data from unstructured reports, automate documentation, and enhance search functions within LIMS.
Next Generation Sequencing (NGS)
NGS is a high-throughput DNA sequencing technology that allows simultaneous analysis of multiple genetic sequences. It offers faster and more cost-effective genetic insights than traditional methods like Sanger sequencing.
Non-Destructive Testing (NDT)
Non-destructive testing (NDT) refers to a wide array of techniques that are used to evaluate the quality and structural integrity of materials or their components without causing damage or altering their usability. Common NDT techniques include ultrasonic, radiographic, or dye-penetrant methods.
Ore Grade Analysis
Ore grade analysis in mining refers to laboratory testing that determines the concentration of valuable metals or minerals (such as gold, copper, iron, zinc) in an ore sample, which is critical for valuation, processing decisions, and product quality control.
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 (PaaS)
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.
Predictive Analytics
Predictive analytics uses statistical models, machine learning, and data mining to predict future outcomes based on historical data. Lab managers use it to anticipate equipment maintenance needs, patient trends, or testing demand surges.
Pre-validation
Pre-validation refers to documented evidence from prior system validations—such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Leveraging a pre-validated system, like a LIMS, can significantly reduce deployment time.
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 (QA)
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 (QC)
A set of procedures used to ensure that laboratory results are accurate and precise.
Reference Genome
A reference genome is a digital representation of an organism’s complete genetic sequence used as a standard against which sequencing data is aligned and compared in genomic analyses.
Regulatory Compliance
Regulatory compliance involves adhering to applicable laws and guidelines set by regulatory agencies to ensure laboratory practices are safe, ethical, and legally compliant.
Report Template
A predefined format used to generate reports from LIMS data, including standardized fields and data.
Result
The output or data generated by an analysis performed on a sample.
Sample
A portion of material or substance that is being analyzed in a laboratory.
Sample Lifecycle Management
Sample lifecycle management in LIMS refers to end-to-end tracking and control of a sample from receipt and accessioning through testing, storage, reporting, and final disposal.
Sample Management
Sample management is the process of tracking and handling laboratory samples throughout their lifecycle—from collection and storage to testing and disposal—ensuring accuracy, traceability, and regulatory compliance.
Sample Tracking Software
Software utilized for monitoring the location, status, and handling of laboratory samples and specimens.
Software as a Service (SaaS)
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.
Standard Operating Procedure (SOP)
A document that outlines the steps required to process a sample, perform a laboratory analysis or maintain records, documents, and instruments.
Storage Tracking
Storage tracking in a biobanking LIMS is the systematic recording and visualization of sample locations within a biobank’s storage infrastructure (freezers, racks, boxes), enabling rapid retrieval and optimal utilization of the storage space.
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.
Workflow Automation
Workflow automation in LIMS is the process of configuring pre-defined sample processing workflows to manage sample routing, processing, testing, and reporting for each sample type to prevent deviations from standard operating procedures (SOPs), enabling labs to generate high-quality results.