updated: August 12, 2024
The LIMS world uses what could be called a language of its own. For anyone exploring a new Laboratory Information Management System, this glossary of LIMS-related terms may be of assistance in your journey.
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21 CFR 11
Title 21 CFR Part 11 is part of the FDA’s Code of Federal Regulations on electronic records and electronic signatures (ERES). It establishes strict guidelines on data integrity, validation, audit trails, and paper record equivalency to ensure compliance with technological advancements for industries that adhere to GxP standards.
Here’s a high-level overview of recent changes to 21 CFR 11. For more insights, see these recent updates co-authored by Clarkston Consulting and Bill Gates.
- Data Integrity: The FDA has placed a renewed focus on data integrity, emphasizing that it must be complete, consistent, and accurate. This includes ensuring that data is attributable, legible, contemporaneous, original, and accurate (ALCOA+ principles). Companies are directed to implement risk-based strategies to manage data integrity risks based on process understanding and technology .
- Audit Trails: The FDA is intensifying its focus on requirements for secure, computer-generated, time-stamped audit trails to ensure that any changes to electronic records are recorded accurately and are retrievable for review.
- User Authentication and Access Controls: The FDA continues enforcing strict user authentication and accountability controls. Systems must be configured to ensure only authorized individuals can access and modify data.
- Validation of Electronic Systems: The updated guidance also emphasizes the need for rigorous validation of electronic systems to ensure they perform accurately and consistently. Validation involves testing the system to confirm it meets all intended requirements and functions correctly under anticipated use.
- Enforcement and Compliance: The FDA has clarified its enforcement discretion regarding certain aspects of Part 11, focusing on a risk-based approach. While earlier guidance allowed for some flexibility, the current stance emphasizes stricter adherence to data integrity and audit trail requirements to prevent data breaches and ensure reliable record-keeping).
A
Accelerator
In the context of LabVantage, an accelerator is a pre-configured, purpose-built platform designed for a specific industry or function. Accelerators reduce implementation time and are pre-designed with industry standard workflows. LabVantage offers accelerators for various industries, including Biobanking, Pharma, Diagnostics, Food & Beverage, Oil & Gas, COVID-19 testing and Quality.
AI (Artificial Intelligence)
Technology simulating human intelligence for task automation and data analysis. In LIMS, AI is used to automate workflows, perform predictive analytics, perform advanced data mining, and enhance decision-making processes.
ALCOA
Used to describe data integrity, the original ALCOA is an acronym for ‘Attributable, Legible, Contemporaneous, Original and Accurate.’ More recently, ALCOA+ was introduced, which adds the concepts of Complete, Consistent, Enduring, and Available.
Allotrope
A data format established by the Allotrope Foundation which stores laboratory data, along with contextual metadata and ancillary files.
Analyst
Primary laboratory personnel performing tests and entering results into the LIMS system.
Analytics
See data analytics
AnIML
The Analytical Information Markup Language (AnIML) is an XML-based standard for storing and sharing analytical chemistry and biological data.
Annex 11
The portion of the Rules Governing Medicinal Products in the European Union related to computerized systems.
Artificial Neural Networks (ANNs)
Computing systems inspired by biological neural networks, used in machine learning for pattern recognition and predictive analytics.
Array Management
The high-throughput screening of samples, typically using a microplate that is organized into a grid of sampling wells.
Application Server
An application server is a software framework that provides the capability to create web applications, and a server environment in which to run them.
ASTM
ASTM International is an organization which develops international standards. Over 12,000 ASTM standards operate globally in a broad range of industries.
Audit trail
An audit trail (also called an audit log) is a chronological record documenting evidence of a sequence of activities which have occurred in a given activity.
Augmented Reality (AR)
Augmented reality (AR) is an interactive experience that overlays digital information to supplement a real world environment.
AWS
Amazon Web Services (AWS) is Amazon’s on-demand cloud computing platform. It includes 165+ services, including computing, storage, networking, database, analytics, application services and more.
Axis web service
Apache Axis is an implementation of the SOAP (“Simple Object Access Protocol”) and is commonly used as a base to implement Java Web services.
B
Base Computing Unit
A Base Computing Unit, or BCU, is an abstract computing unit. BCUs are general enough to be conveniently universal – representing resources across vendors, operating systems, and hosting types. It Is also elastic enough to reflect inevitable improvements in technology over time. One BCU corresponds to the following resources:
- Processor: 4 Cores
- Memory: 16 GB RAM
- Disk: 50 GB minimum
- Network: 100 Mbps NIC minimum
BCU
See Base Computing Unit.
Big Data
Large and complex data sets that traditional data-processing software cannot handle, often requiring advanced analytics to extract insights.
Biobanking
The process of collecting, storing, and managing biological samples such as fluids and tissues for research purposes. Recent advancements include automated sample tracking, enhanced data security, and compliance with new regulations for ethical and legal standards.
Bioinformatics
The application of computational tools to process and analyze biological data, often used in genomic and proteomic research for data interpretation and management.
Biorepository
A biorepository (also referred to as a ‘biobank‘) is a biological materials repository that collects, processes, stores, and distributes biospecimens to support future scientific investigation.
Blockchain
An online technology that securely stores data for sharing up-to-date data across a public or private computer network. Participant transactions are made using cryptographic ‘keys’ (public or private) and are permanently recorded in a distributed ‘ledger,’ enabling the exchange of physical or intangible items. Recent applications in LIMS include secure data sharing, audit trails, and improved transparency in laboratory processes.
Browser
Alternatively referred to as a web browser or Internet browser, a browser is a software program used to view and navigate content on the web. Examples include Microsoft Edge, Apple Safari and Google Chrome.
Business Continuity
An organization’s ability to sustain business functions during and after a natural or man-made disaster has occurred.
Business Intelligence
Business intelligence, or BI, uses software and computing/IT services to transform organizational data into actionable insights to drive business decision-making.
C
CAPA
Corrective Action and Preventative Action.
CDS
Chromatography data system.
CFR
The U.S. Code of Federal Regulations (see also: 21 CFR 11).
Change Control
The means and methods planned in advance to manage potential changes in any process or workflow, primarily to ensure product quality and safety, minimize risk, and ensure traceability.
Change Management
A discipline for leading and implementing change, whether for teams, processes, or organization-wide transitions. The primary goal is to drive success and outcomes effectively. See Also: Change Control
Cheminformatics
The use of computer and informational techniques to resolve chemical problems, aiding in drug discovery and chemical research.
Chemometrics
The science of analyzing and extracting information from chemical systems using computer science, mathematics, statistics, and other analytical disciplines.
CLIA
Clinical Laboratory Improvement Amendments (CLIA). This is a program run by the U.S. Centers for Medicare & Medicaid Services (CMS), which regulates all (non-research) human laboratory testing.
Clinical Diagnostics
Refers to the performance of FDA- (or other regulator) approved clinical diagnostic test(s) on a human tissue or other human biological sample, the results of which are provided to health care providers for use in the clinical management of individual patients.” (Law Insider)
Cloud Computing
Cloud computing is the on-demand availability of computer resources (computing power, storage, etc.), delivered via the internet.
Cluster
A computer cluster refers to connected computers working together on the same task.
CMO
Contract Manufacturing Organization.
COA
Certificate of Analysis.
Code Smell
An attribute in source code which can indicate a deeper problem, potentially leading to a security vulnerability or increasing the likelihood of failure. Depending on the programmer, the presence of duplicate code could be an example of a code smell.
Compliance Management
The process of ensuring that laboratory practices and procedures adhere to regulatory and industry standards. Compliance management involves implementing and maintaining protocols and systems to verify that laboratory operations meet regulatory requirements such as GxP and ISO standards.
Computerized System
A computerized system consists of the hardware, software, an operating system and network components, together with relevant supporting documentation.
Configure/Configuration
In LIMS terminology, ‘configuration’ refers to the reliance on built-in system tools within the LIMS to change its appearance or functionality. Configuration reduces or eliminates the need to change the core underpinnings of the platform, reducing compliance issues or problems which could arise with future updates.
Consumables
Goods used during laboratory testing that do not become part of a final product or material. For example, consumables might include reagents, standards, gloves, test tubes, slides, stoppers, and pipettes.
Continuous Delivery
A software engineering approach in which software is developed in short cycles. This ensures it can be released manually at almost any time. The incremental, continuous delivery approach is designed to reduce cost, time and risk.
Continuous Integration
Continuous integration (CI) is a development practice in which code changes from multiple contributors are frequently integrated into a single software project or repository.
Corrective Action
An action to correct a deviation, undesirable situation or result in an organization’s processes or activities.
CRAMS
Contract Research and Manufacturing Services.
CRO
Contract Research Organization.
Cross-site Scripting (XSS)
A type of cyber attack in which a malicious script is injected into a trusted web application or web site.
Customize/Customization
In LIMS terminology, ‘customization’ refers to the process of LIMS modifications that require coding. A customization makes changes to the underlying LIMS software. Customization can make future updates difficult, and can lead to compliance issues.
D
Data Archiving
Moving and storing data separately from active project materials, usually directed by corporate policies for archiving and retaining data.
Data Analytics
The science of analyzing raw data in order to draw conclusions.
Data Governance
The overall management of data availability, usability, integrity, and security in an organization. Data governance involves policies, procedures, and standards to ensure data quality, compliance, and security, supporting effective data management and utilization.
Data Integrity
Data validity, accuracy, and completeness must be maintained throughout the drug development lifecycle. Data integrity encompasses practices and technologies that ensure this reliability, particularly during storage, transfer, and processing, complying with FDA, GxP, and global regulatory standards.
Data Lake
A data lake is a centralized repository that allows you to store large volumes of data. Unlike a data warehouse, data lakes consist of raw, unstructured data which has yet to be processed.
Data Lifecycle Management
The process of managing data from creation through its useful life to eventual deletion, ensuring data quality and compliance.
Data Migration
The movement of data from one storage location or platform to another. It is frequently needed when existing data must be integrated into new software or an application. Accurate data migration is crucial for upgrading LIMS and maintaining data integrity during transitions.
Data Science
A field that uses scientific methods, processes & systems to extract knowledge from structured and unstructured data.
Data Silo
A collection of information in an organization that is isolated from other parts of the organization and therefore cannot be accessed by everyone.
Data Virtualization
The process of abstracting data from various sources to create a unified, logical view without physically moving or transforming the data.
Data Warehouse
A data warehouse (DW or DWH) is a repository of data from one or more sources used for reporting and data analysis. Data warehouses are a core component of business intelligence. Unlike data lakes in which the data is unstructured, data warehouses are used to store structured and processed data.
Database
An organized collection of data stored in a computer system.
Deep Learning
A type of machine learning using algorithms modeled on human neural networks to teach machines to process and recognize patterns from large amounts of data (text, images, and sounds). “Deep” means multiple network layers are deployed to complete advanced computations on large data sets or create insights and predictions. Algorithms ‘train’ machines using examples.
Digital Signature
An electronic signature based upon cryptographic methods by which the signer’s identity can be verified.
Digital Twin
A virtual model of a physical laboratory environment used for simulation, analysis, and optimization of lab operations and workflows. Digital twins replicate lab environments digitally, enabling real-time monitoring, predictive maintenance, and enhanced decision-making through simulations and data analysis.
Digital Transformation (DT)
The process by which organizations use technology and data to build a business ecosystem in order to reduce risk, accelerate innovation, and drive growth.
Disaster Recovery
Disaster recovery, a key element of business continuity planning, refers to the process, tools and methods used to restore critical IT functions in the wake of a natural or manmade disaster.
Downstream
A process that occurs later in production; e.g., for a finished product, packaging or transportation would be downstream from laboratory testing.
DQC
Data Quality Control.
E
EBR – Electronic Batch Record
A digital version of a paper batch record is used to document a product’s manufacturing, ensuring compliance and traceability.
ECM
Enterprise Content Management.
EHR – Electronic Health Record
The portions of an Electronic Medical Record (EMR) shared outside the hospital, doctor’s office or other EMR source.
Electronic Laboratory Notebook
An electronic lab notebook (electronic laboratory notebook, or ELN) is software designed to replace paper laboratory notebooks used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. Lab notebooks are often considered to be legal documents.
Electronic signature
An electronic signature (e-signature) is an electronic symbol or mark used by a person to signify their intent to sign a document. Unlike a digital signature (which guarantees authenticity using cryptographic verification), a digital signature indicates only the intent to sign.
ELN
See Electronic Lab Notebook
EMR
Electronic Medical Records.
EPA
The U.S. Environmental Protection Agency (EPA) is the federal agency tasked with protecting human health and the environment.
ERP
Enterprise resource planning (ERP) is the integrated management of business processes facilitated by software and technology. See also: Resource planning.
eSig
See Electronic signature.
F
FAIR
FAIR principles aim to maximize the value of research data by making it as open and usable as possible while maintaining appropriate protections and ethical considerations with the aim of improving the management and stewardship of digital assets. FAIR stands for Findable, Accessible, Interoperable, and Reusable.
- Findable: Data should be easy for both humans and computers to find. This involves assigning a unique and persistent identifier to each dataset, providing rich metadata, and indexing data in searchable resources. For example, digital object identifiers (DOIs) and metadata descriptions ensure datasets can be easily located through search engines and databases.
- Accessible: Once data is found, it must be accessible under well-defined conditions. This includes clarifying how data can be accessed, authentication, and authorization protocols if necessary. Data repositories should provide clear instructions for accessing data, including any necessary credentials or access restrictions.
- Interoperable: Data should be able to integrate with other data. This requires using standardized formats, ontologies, languages, and vocabularies that allow for the combination and exchange of data across different systems.
- Reusable: Data should be well-documented and described to allow for its replication and combination in different settings. Providing comprehensive documentation and metadata and a clear usage license, such as Creative Commons, ensures data can be reused in future research.
Fat client
See Thick client.
FDA
The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety, efficacy & security of human and veterinary drugs, biological products, and medical devices; the U.S. food supply, cosmetics and more.
FIMS
A Forensic Information Management System (FIMS) is a case-focused system that encompasses the full evidentiary life cycle. Distinct from a LIMS, a FIMS will often include property management, crime scene work, medical examiner, external user portal, and forensic intelligence.
Firewall
A firewall is a network security device that monitors incoming and outgoing network traffic and applies security rules to allow or block specific traffic.
G
GAMP
Good Automated Manufacturing Practices.
GDPR
The General Data Protection Regulation is a legal privacy framework that requires businesses to protect the personal data and privacy of European Union citizens for transactions that occur within EU member states.
Gene Editing
Techniques that allow for precise modifications to DNA, such as CRISPR-Cas9, used in genetic research and therapy.
Generative Adversarial Networks (GANs)
A framework within machine learning that combines two neural networks in competition with each other, creating new, synthetic data that appears real. A familiar example is using GANs to modify existing images or generate realistic images from text prompts. GANs are a significant framework being applied in the development of generative AI.
Generative AI
A category of artificial intelligence algorithms that create new content, data, or outcomes that resemble the original training data. These models learn patterns, structures, and features from a large amount of data and generate new, synthetic data that retains the statistical properties of the training set. Generative AI encompasses various techniques and applications, including text, image, audio, and video generation.
Genetic Sequencing
A laboratory technique used to either determine the entire genetic makeup of an organism (known as whole genome sequencing) or to pinpoint the details of a single targeted gene.
Good Laboratory Practice (GLP)
Standard quality and data integrity principles followed in non-clinical laboratory studies to yield reproducible results. GLP rules dictate processes used from planning through reporting.
Good Manufacturing Practice (GMP)
Good Manufacturing Practice (GMP or cGMP) requirements refer to a system of regulations, codes, and guidelines for quality control and production in manufacturing pharmaceuticals, medical devices, food, and other products. Rules apply to testing, facilities, staff, and many aspects of production, including testing, contract manufacturing, product distribution, product defects, and user complaints.
GxP Compliance
GxP compliance refers to an organization meeting the applicable GxP regulatory requirements.
GxP Regulated Computerized System
Computer systems which are subject to – and must comply with – GxP regulations.
GxP Regulation
Various good practice requirements under which a company operates. These may include the U.S. FD&C Act, FDA regulations, E.U. Directives, GMPs (good manufacturing practice), GLPs (good laboratory practice), and other legislation or regulations to which a company may be subject. Sometimes a “c” is included before the acronym, which stands for “current”; for example, cGMP.
H
HIPAA
The 1996 U.S. Health Insurance Portability Accountability Act was designed to protect health insurance coverage for workers when losing or changing jobs and to protect personal health data.
HL7
Health Level Seven (HL7) is a set of international standards used by various healthcare providers for the transfer of clinical & administrative data between software applications.
Hosting
Providing a location for computer resources – for example, LIMS servers – either physically or virtually. AWS is a cloud hosting provider, which means that LIMS servers might be located within AWS datacenters.
HPLC
High-Performance Liquid Chromatography.
HTML
Hypertext Markup Language (HTML) is the standard language used to design and display documents in a web browser.
I
IaaS
See Infrastructure as a Service.
IEC
International Electrotechnical Commission.
IEEE
Institute of Electrical and Electronics Engineers, a professional association known for publishing technical standards, etc.
In Process
Any object (e.g. sample, test or master data) produced or used while a batch of material is actively being manufactured.
Industry x.0
An Accenture business approach that uses advanced technologies to reinvent products and services from design & engineering to manufacturing & support.
Informatics
Informatics is a branch of information engineering. It involves the practice of information processing and the engineering of information systems.
Infrastructure
The computing framework in which the LIMS system operates. IT infrastructure would include physical or virtualized servers, networks, firewalls, storage and more.
Infrastructure as a Service
Infrastructure as a service (IaaS) is an instant computing infrastructure delivered over the internet which can scale up or down with demand. With IaaS, customers typically pay only for what they use – avoiding the expense and complexity of buying and managing physical servers and other infrastructure.
Interoperability
The seamless exchange of data between computer systems, software, or applications that enables connection and communication without human intervention. Successful integration between lab systems and other corporate software and devices is crucial.
IoT (Internet of Things)
A network of interconnected devices used for real-time data collection and monitoring. In laboratories, IoT enables automated equipment monitoring, data collection, and predictive maintenance.
ISO Standards
“The norms and requirements established by the International Organization for Standardization (ISO), an independent, non-governmental international organization with a membership of 165 national standards bodies.” Companies that meet ISO standards follow its specifications, guidelines, and characteristics to ensure consistency in producing goods and services, including materials and processes used in their production.
Types of standards include:
- Quality Management: Standards such as ISO 9001 define seven quality management systems for products and services: customer focus, leadership, engaging people, taking a process approach, performance improvement, evidence-based decision-making, and relationship management.
- Environmental Management: ISO 14001 outlines an environmental management system companies can use to measure their current environmental impact, then set, meet, and monitor progress against goals for carbon footprint, waste reduction, resource usage, and other performance factors.
- Information Security: ISO/IEC 27001 details steps for creating, maintaining, and improving an information security management system to ensure long-term data security.
IQ
An Installation Qualification (IQ) is documented verification that a LIMS is installed according to written and pre-approved specifications.
IRB
Internal Review Board (or Institutional Review Board).
ISBER
ISBER (the International Society for Biological and Environmental Repositories) is a global biobanking organization.
ISO
International Organization for Standardization. ISO standards may apply to multiple industries or applications (such as ISO 9001 – quality system management). Others are sector-specific (e.g., ISO 29001 for the petroleum industry).
J
Java
A modern, class-based and object-oriented general-purpose programming language.
K
Knowledge Graph
A network of real-world entities and their interrelationships, enabling enhanced data integration, discovery, and inference capabilities.
L
Lab Automation
The application of technology to improve laboratory processes, data quality, and accuracy. Lab automation includes robotic systems, automated instruments, and software that streamlines repetitive tasks, reduces human error, and enhances productivity.
Lab Manager
Supervisor of a testing laboratory.
Laboratory Informatics
Laboratory informatics is the application of information technology through a platform of instruments, software, and data management tools in the lab environment. Lab informatics systems capture, process, store and otherwise manage scientific data.
Laboratory Information System (LIS)
A system designed specifically for clinical laboratories to manage patient data, test results, and laboratory workflows, ensuring seamless integration with healthcare systems.
Laboratory Workflow
The sequence of processes through which a laboratory sample moves from receipt to reporting, including all intermediate steps.
Language Model
Machine learning that is designed to complete a sentence or phrase by supplying the most likely next word, called ‘probability distribution.’ Language models can produce coherent and contextually relevant text based on input data.
LES
Laboratory Execution System.
LIMS
Laboratory Information Management System.
Load Balancer
A device that distributes network or application traffic across several servers – for example, LIMS servers configured to operate in a cluster – in order to increase capacity and reliability while decreasing the burden on other servers.
M
Machine Learning (ML)
A subset of AI, also known as predictive analytics, that enables machines to learn and perform tasks based on data and past experiences. Statistical algorithms are used to train machines to identify patterns in data and create new information or make predictions or decisions without human intervention.
Managed Services
Managed Services refers to full lifecycle application management services for a LIMS solution in which an organization turns over the administration and optimization of their LIMS.
Master Data
Software templates – typically stored as electronic records in a laboratory informatics system – that define the testing required to fulfill a laboratory’s needs. Master Data determines how lab informatics software systems process and analyze samples and results.
Master Data Definition Packet
A collection of documents, reports, or signatures needed to track the creation of a product’s Master Data.
Metadata
Data that describes other data, providing context, structure, and meaning, essential for the functioning of a semantic layer.
Metaverse
Currently refers to the concept of an immersive shared virtual world which people access via the internet to socialize, play and work. In its current meaning, it is often associated with technologies such as VR and AR, and cryptocurrencies.
Mixed Reality (MR)
Mixed reality (MR) is the merging of realand virtual worlds to produce new environments and visualizations, where physical and digital objects co-exist and interact in real time. Mixed reality is a hybrid of augmented reality and virtual reality.
Molecular Biology
The field of science which studies the chemical structures and processes of the basic units of life, largely focused on nucleic acids (e.g., DNA and RNA) and protein, and how they interact and behave within cells.
N
Natural Language Generation (NLG)
A subfield of AI, NLG software allows computer systems to ‘converse’ with humans using natural language in text or spoken form. Chatbots are a common example. NLG technology also has many business uses, such as for reporting, call center or survey analysis, and smart assistants. In healthcare, NLG is used for data analysis.
Natural Language Processing (NLP)
A branch of AI that focuses on the interaction between computers and humans by enabling systems to understand and process human language.
Negative Testing
Testing a requirement to ensure it handles invalid or unexpected use, or reports errors appropriately.
Network Computing
Computers or nodes that work together over a network. It can refer to Cloud computing, Distributed computing or Virtual Network computing.
Next Generation Sequencing (NGS)
A parallel DNA sequencing technique (also known as high-throughput sequencing) which allows faster and less expensive DNA and RNA sequencing than the previous conventional method (Sanger sequencing).
Node
Any system or device connected to a network.
Normalize/Normalization/Normalized Data
Although the term is used broadly in statistics, in the LIMS world it typically refers to the extent to which a database design conforms to precisely defined “normal forms”, which reduce data redundancy and improve referential integrity. Most LIMS databases use third normal form (3NF).
O
Omics
The broad term used to collectively refer to the various disciplines of biology such as genomics, proteomics, metabolomics and transcriptomics which target the characterization of the structure, function and interrelatedness of biological molecules.
On-premises (also on-prem)
Software installed and run on computers located on the premises of the organization that uses it (as opposed to in the cloud or at a third-party host).
Ontology
A structured framework for organizing information, representing knowledge as a set of concepts and their relationships, used to model data in a semantic layer.
OOS
Out of Specification.
OQ
An Operational Qualification (OQ) is documented verification that a LIMS operates according to written and pre-approved specifications throughout specified operating ranges.
OWASP
The Open Web Application Security Project (OWASP) is an online community providing information relevant to web app security. The organization is best known for the OWASP Top 10, which summarizes the top cybersecurity threats.
P
PaaS
See Platform as a Service
Part 11
See 21 CFR 11.
Performance Qualification
Documented testing and verification that a system performs processes according to its approved specifications, within the scope of the business process and operating environment. For a LIMS system – particularly those in heavily regulated environments – the PQ demonstrates fitness for intended use. Sometimes this test is referred to as a System Acceptance Test (SAT) or User Acceptance Test (UAT).
Personalized Medicine and Precision Medicine
According to the National Cancer Institute, personalized medicine (also referred to as precision medicine) integrates “information about a person’s genes, proteins, and environment to prevent, diagnose, and treat disease.”
Pharmacodynamics
See Pharmacokinetics.
Pharmacokinetics
The branch of pharmacology which examines how a body or organism affects an administered substance. The counterpart of pharmacokinetics is pharmacodynamics, which studies the effect of a substance on a body or organism.
Platform as a Service
Platform as a Service (PaaS) is a type of cloud computing service which allows customers to develop, run, and manage applications without the need to build or maintain typical necessary infrastructure.
PMBOK
Project Management Body of Knowledge, as implemented by the Project Management Institute (PMI).
PMI
Project Management Institute.
Portal
A webpage or landing page that provides an entry point (typically via login) to information, tools or other pages. A LIMS Portal allows non-LIMS users to submit requests and track key metrics, or obtain additional information.
Positive Testing
Testing to ensure a requirement has been met. For example, if a requirement is to add a button, the positive test would be to verify that the button appears: if, however, a requirement is to remove a button, the positive test would be to verify that the button does not appear.
PQ
See Performance Qualification.
Predictive Analytics
The use of data and data analysis to identify the likelihood of a future outcome, based on historical data.
Predictive Maintenance
Techniques to predict when equipment maintenance should be performed based on data analysis, preventing unexpected failures and extending equipment life.
Pre-validation
Producing evidence of previous system validation; for example, IQ, OQ and PQ. A pre-validated LIMS can shorten deployment time considerably by providing evidence of previous validation that does not need to be repeated.
Preventative Action
An action to ensure that a deviation or undesirable situation in a company’s processes or activities does not recur or reduces the risk of recurrence.
Process Owner
The person responsible for the business process or processes being managed. In the context of a LIMS, the Process Owner ensures the system is operating according to SOPs. This position may sometimes be referred to as the LIMS Administrator.
Product Specification
Collected documentation which defines the testing and specification limits for a single product.
Professional Services
In the context of a LIMS, Professional Services refers to additional support from a LIMS service provider to ease and accelerate the implementation process, thus reducing total cost of ownership and risk.
Q
QMS
See Quality Management System.
Quality Assurance (QA)
Systematic processes to ensure laboratory services meet specified standards, including regular audits, inspections, and quality control measures.
Quality Control (QC)
Processes to ensure that laboratory outputs meet predefined quality criteria, involving regular testing and inspection.
Quality Management System
The Quality Management System (QMS) is a collection of business processes used to achieve quality policies and objectives through procedures, responsibilities, documented information, performance metrics, and continuous improvement. Certain LIMS functions are likely used as part of a larger QMS; for example, the enforcement of certification before an analyst can execute a certain test or use a type of instrument.
Quality Risk Management
Quality Risk Management (QRM) refers to the processes used to assess and control risks to the quality of a drug, device, diagnostic or other medical medical product.
R
R&D
Research & Development.
Reagent Lot
A unique identifier for a substance or solution used in the laboratory to conduct testing on samples.
Regulatory Compliance
Adherence to laws, regulations, guidelines, and specifications relevant to laboratory operations, ensuring that all processes meet required standards for safety, accuracy, and efficiency.
Reinforcement Learning
A form of machine learning that equips software to ‘learn’ from its own processing feedback to achieve a goal. Actions taken by the software are either reinforced or ignored as they ‘self-discover’ the ideal processing path leading to the desired outcome.
Relational Database Service
A Relational Database Service (RDS) allows organizations to set up, operate, and scale a relational database (a collection of data items with pre-defined relationships between them) in the cloud. In other words, an RDS is SaaS for database software.
Resource planning
The scheduling, allocation and utilization of resources (e.g., team members, equipment, facilities, etc.) in order to maximize the efficiency of their use.
REST (or RESTful)
REST (Representational State Transfer) or RESTful APIs take advantage of existing protocols – typically HTTP – to avoid the need for developers to install additional software or libraries.
Recovery Point Objective
The acceptable age of files when recovered from backup or storage after a disaster. For example, when operating a LIMS system having daily backups of servers, the RPO would be 24-hours.
Recovery Time Objective
The acceptable duration of time during which a system is unavailable after a disaster happens. For example, a LIMS system might need to be returned to service within 8 hours after the disaster.
RDS
See Relational Database Service.
RPO
See Recovery Point Objective.
RTO
See Recovery Time Objective.
S
SaaS
See Software as a Service.
Safety Data Sheet
Safety Data Sheets (SDS) include information such as the properties of each chemical; the physical, health, and environmental health hazards; protective measures; and safety precautions for handling, storing, and transporting the chemical.
Sample
A representative portion of a material, substance or product that is sent to the laboratory for the purpose of testing or recording of observations.
Sample Management
The process of tracking and managing samples through their lifecycle, including collection, storage, analysis, and disposal, ensuring compliance and data accuracy.
Sanger Sequencing
The traditional Sanger method, the foundation for genome sequencing, is a low throughput genetic sequencing technique. The Sanger process is slow, handles only short single fragments at a time, and – due to its multiple reaction sequences – can be cost prohibitive for many organizations.
SDMS
A Scientific Data Management System (SDMS) is software that serves as a document management system for structured and unstructured data captured from various lab resources (e.g., HPLC, mass spec, ELN).
Semantic Layer
An abstraction layer that sits between data storage and user interfaces, providing a unified, business-friendly view of data to ensure consistency and improve data accessibility.
Signature
A mark or sign made by an individual on an instrument or document to indicate knowledge, approval,
acceptance, or obligation. See also: Electronic signature and Digital signature.
Silo
See Data Silo.
SME
See Subject Matter Expert.
SOAP web service
SOAP, originally known as the Simple Object Access Protocol, is an XML-based protocol for accessing web services over HTTP.
Software as a Service
Software as a service (SaaS) is a software distribution model in which a third-party provider hosts the applications, making them available to customers over the Internet.
SOP
Standard Operating Procedure.
SPC
Statistical Process Control.
SQC
Statistical Quality Control.
SQL
Structured Query Language (SQL) is the primary interface used to communicate with Relational Databases.
SQL injection
A type of cyber attack in which malicious SQL code is inserted into an application’s software via a security vulnerability. SQL injections typically target websites, but can also be used to attack any SQL database.
Stability Analytics
Statistical analysis, charting, and reporting used in routine product-lot stability studies and shelf-life prediction.
Subject Matter Expert
Subject Matter Experts (SMEs) are individuals with specific expertise in a particular area or field.
System Owner
The System Owner is the person with responsibility for a system, including its support, maintenance and data security. In the context of a LIMS, this is sometimes the IT department. The responsibilities of the System Owner may be delegated, for example, to the Process Owner, particularly in smaller organizations.
T
Thick client
In the context of software, thick client LIMS implement their own features locally and require a full installation on the local computer. While they may connect to a server, thick clients are mostly functional even when disconnected. LIMS software written in Java Swing, C++, and .NET having a local installation may be thick clients.
Thin client
In the context of software, thin clients LIMS are primarily designed to communicate with a server and have few features that fully function when disconnected; they require a small installation on the local computer. LIMS software written in Java Swing, C++, and .NET having a local installation may be thin clients.
Transformer Models
A powerful neural network model capable of understanding relationships in a data series, including distant data elements. The model is widely used in natural language processing tasks, including generating text and translating text and spoken language, and is considered a significant driver of advances in AI.
U
Upstream
A process that occurred earlier in production; e.g., for a finished product, laboratory testing would be upstream from packaging or transportation.
V
Validation
Validation is the activity of establishing documented evidence through execution that a delivered LIMS system successfully fulfills the business’s user requirements, and does so within the intended operating environment. A Performance Qualification is an example of a validation activity
Verification
Verification is the activity of establishing documented evidence through observation and inspection that a LIMS system was designed, developed, and implemented according to original specifications, policies, and procedures. A code review is an example of a verification activity.
Virtual Reality (VR)
Virtual Reality (VR) is the term used to describe a three-dimensional, computer-generated environment that can be explored and interacted with, typically using goggles known as ‘VR headsets’ which fully immerse you in a realistic virtual environment.
VPN
A virtual private network (VPN) extends a private network across a public network, and enables users to send and receive data across shared or public networks as if they were directly connected to a private network.
W
Web portal
See Portal.
Web service
A service offered by one electronic device to another electronic device, communicating with each other via the World Wide Web. Web services are one of the primary methods by which LIMS systems are interfaced to other systems within the business.
Workflow
A sequence of tasks, steps, processes or other activities designed to perform a function.
X
XML
Extensible Markup Language (XML) is a markup language that defines a set of rules for encoding documents in a format that is both human-readable and machine-readable.
XSS
See Cross-site scripting.
Z
Zero footprint
In the context of software, zero footprint LIMS does not require any installation on the local computer since all functionality is delivered from the server. LIMS software that uses only a web browser is zero footprint.
