The LIMS Glossary

Tuesday, February 25, 2020

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 Code of Federal Regulations. It establishes the United States Food and Drug Administration’s (FDA’s) regulations on electronic records and electronic signatures (ERES). Often referred to as ‘Part 11,’ it establishes criteria to evaluate whether electronic records & signatures are reliable, trustworthy and equivalent to paper records.

A

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 intelligence
Artificial Intelligence (AI) is generally used to describe machines (or computers) that learn, problem-solve and are capable of other “human” functions.

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.

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

Biobanking

The collection of bodily fluid or tissue samples for research use to improve our understanding of health and disease. See also: Biorepository.

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

A series of data records managed by a cluster of computers. Each of these blocks of data is secured and bound to each other using cryptographic principles.

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)

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.

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.

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.

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.

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 analytics

The science of analyzing raw data in order to draw conclusions.

Data integrity

The maintenance and assurance of the accuracy and consistency of data over its entire life-cycle.

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 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 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.

Digital signature

An electronic signature based upon cryptographic methods by which the signer’s identity can be verified.

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

ECM

Enterprise Content Management.

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

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.

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.

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.

IoT

The Internet of Things (IoT) is a collection of devices that connect to the internet or one another.

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.

L

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.

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

The use of algorithms & statistical models by computers to perform a specific task in the absence of instructions by analyzing patterns to extrapolate solutions.

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

Additional attached information associated with a test or individual result.

N

Natural Language Processing

The technology used to help computers understand natural 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. 

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

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).

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.

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).

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.

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.

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

QA

Quality Assurance.

QC

Quality Control.

QMS

See Quality Management System.

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.

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.

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).

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.

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.

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.

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 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.

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.

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