Scientific R&D digital transformation glossary

21 CFR Part 11

The U.S. Food and Drug Administration's Title 21 CFR Part 11 regulation sets the standards for the evaluation of electronic records to determine their reliability, credibility, and equivalence to paper records.

AI (Artificial Intelligence)

refers to machines, particularly computer systems, that have the ability to learn and solve problems, often outperforming human capabilities.

ALCOA and ALCOA+

A data integrity acronomy which stands for Attributable, Legible, Contemporaneous, Original, and Accurate. ALCOA+ further encompasses the additional concepts of Complete, Consistent, Enduring, and Available.

Allotrope Data Format (ADF)

File format developed by the Allotrope Foundation that stores laboratory data, along with related metadata and supporting files.

Analytics

Analytics refers to a set of computational techniques used to extract insights from raw data.

Annex 11

The regulations for computerized systems within the European Union outlined in Annex 11 of the Rules Governing Medicinal Products.

API (Application Programming Interface)

A set of protocols, routines, and tools for building software and applications. An API specifies how software components should interact, and allows for communication between different systems and applications.

API (Active Pharmaceutical Ingredient)

The main ingredient in a medicinal product responsible for its therapeutic effect.

APR (Annual Product Review)

Annual assessment in the pharmaceutical industry to review the consistency and quality of products. This includes the examination of deviations, customer complaints, and changes to products.

ATMP (Advanced Therapy Medicinal Products)

Medicines based on genes, cells, or tissues intended for human use.

Audit trail (audit log)

A chronological record of all activities that have taken place and is used to verify data integrity.

Azure

Microsoft's cloud-computing platform providing a range of technical applications and professional services, including storage, computing, database, networking, analytics, and more.

Big data

Large and complex data sets that are generated from various sources and are difficult to manage, process, and analyze using traditional data management tools and technologies.

Bioanalysis

The identification and quantitative measurement of substances, such as proteins, drugs, and metabolites, in a biological system.

BioBank and bio-repository

The collection and processing of bodily fluids and tissue samples for future analysis and research, which are stored in a bio-repository.

Biologics

Products that have been produced from living organisms or contain components of living organisms, such as vaccines, made from animals, humans, or microorganisms.

Bioprocessing

The use of complete or parts of living cells to produce desired products.

Business continuity

A plan that outlines the steps an organization needs to take to return to its normal operations in the event of a crisis or disruption.

CAPA (Corrective and Preventive Action)

A process used to identify, correct and prevent problems in a system or process.

CDMO (Contract Development and Manufacturing Organization)

A company specializing in the development and manufacturing of products, such as Lonza Biologics.

CDS (Chromatography Data System)

Software systems used to manage, analyze and store chromatography data, such as Thermo Scientific Chromeleon and Waters Empower.

CLD (Cell Line Development)

The process of selecting, optimizing, and growing a specific cell line for the production of a desired product.

CLIA (Clinical Laboratory Improvement Amendments)

A program run by the US Centers for Medicare and Medicaid Services (CMS) that regulates all non-research human laboratory testing.

Cloud

A network of online resources (computing, storage, etc.) accessible via the Internet on-demand.

Cluster

A group of interconnected computers that work together to perform a task more efficiently.

CMO (Contract Manufacturing Organization)

A company that specializes in the manufacturing of products for other companies.

COA (Certificate of Analysis)

A document that certifies the quality and composition of a product.

Configure

To set up or arrange a computer system in a specific way to perform its designated task.

Continuous Processing

A system in a manufacturing plant that is designed to run continuously, often controlled by computers.

CPV (Continued Process Verification)

A systematic review of a process to ensure that it continues to operate within established parameters.

CRAMS (Contract Research and Manufacturing Services)

Services provided by a company that specializes in both research and manufacturing.

CRO (Contract Research Organization)

A company that provides research services for other organizations.

CSM (Customer Success Manager/Management)

A person or a team responsible for ensuring customer satisfaction and success.

Customization

The act of modifying something to better suit its purpose.

Database

A structured collection of data stored in a computer and accessible to others.

Data analytics

The process of examining and analyzing data to uncover insights and make informed decisions.

Data integrity

Ensuring the accuracy and quality of data throughout its lifecycle.

Data lake

A system or repository where data is stored in its raw or original format.

Data management

The process of collecting, storing, organizing, maintaining, and using data to support decision making and other business processes.

Data science

An interdisciplinary field that combines computational, statistical, and algorithmic methods to extract knowledge from data.

Data silo

A repository of data that is not fully and easily accessible, also known as an information silo.

Data warehouse

A large, centralized store of data from multiple sources used for reporting and analysis.

Digital transformation (DT)

The implementation of digital technology within a company.

Downstream

The processes involved in the recovery and purification of a biologic product, occurring after the upstream processes.

EDC (Electronic Data Capture)

The process of capturing, storing, and managing clinical trial data electronically.

Electronic signature (e-signature)

A digital signature used to sign electronic documents and records. An electronic signature is a legally binding method of approving an electronic document, similar to a traditional hand-written signature on a paper document.

ELISA (Enzyme-Linked ImmunoSorbent Assay)

A widely used laboratory technique for detecting the presence of specific proteins or antibodies in a sample of fluid by using antibodies that are specifically tailored to bind to the target protein or antibody.

ELN (Electronic Laboratory Notebook)

A digital tool for recording and managing scientific research data.

EMA (European Medicines Agency)

A regulatory body responsible for the evaluation and supervision of medicinal products within the European Union.

ERP (Enterprise Resource Planning)

A business management software that integrates various functions and processes of an organization into a single system, including finance, accounting, human resources, and supply chain management

ETL (Extract, Transform, Load)

A process used to integrate data from multiple sources into a centralized database or data warehouse.

F.A.I.R. (Findable, Accessible, Interoperable, Reusable)

A set of principles for data management that ensure data quality, integrity, and usability by making it findable, accessible, interoperable, and reusable.

FDA (Food and Drug Administration)

A US regulatory body responsible for overseeing the safety and efficacy of food, drugs, and medical devices.

Firewall

A security system designed to protect a network from unauthorized access, ensuring the confidentiality and integrity of data.

GDPR (General Data Protection Regulation)

An EU law that governs the collection, storage, and use of personal data, ensuring the privacy and security of individuals’ information.

GLP (Good Laboratory Practice)

A set of quality guidelines and regulations for conducting scientific research in a laboratory setting.

GMP (Good Manufacturing Practice)

A set of quality guidelines and regulations for the manufacturing of products, ensuring the safety and efficacy of the end-product.

GraphQL

A query language and runtime for APIs (Application Programming Interfaces) which provides a potentially more efficient, powerful, and flexible alternative to traditional REST APIs.

gRPC (Google Remote Procedure Calls)

An open-source framework for building modern, high-performance, cross-platform remote procedure call (RPC) APIs.

GxP (Good Practice Quality Guidelines)

A set of quality guidelines and regulations for various industries, including pharmaceuticals, food, and medical devices, to ensure the safety and efficacy of products.

Hosting

A host is a computer connected to a network, serving as a source of information, services, and applications for users on the network.

HPLC (High-Performance Liquid Chromatography)

A scientific technique used to separate, identify, and quantify compounds in a mixture.

IaaS (Infrastructure as a Service)

The delivery of computer infrastructure, such as servers, storage, and networking, as a fully outsourced service.

JSON (JavaScript Object Notation)

A lightweight data-interchange format that is easy for humans to read and write and easy for machines to parse and generate. JSON is widely used for asynchronous communication between web applications, as well as for data storage and exchange in a variety of programming languages.

IDP (Identity Provider)

A system or service that acts as the central authority for user authentication and authorization, and enables single sign-on (SSO) by allowing a user to log in once and access multiple resources without having to log in again for each one.

Industry 4.0

The transformation of an industry through technology and automation, allowing for data exchange and improved efficiency.

Informatics

The science of collecting, evaluating, organizing, and disseminating information for storage and retrieval.

Infrastructure

The framework or network of components required to operate and manage an enterprise IT environment.

IoT (Internet of Things)

The network of physical devices, vehicles, home appliances, and other items embedded with electronics, software, sensors, and connectivity, allowing for the exchange of data.

IoT analytics

The process of analyzing data generated by IoT devices and systems to gain insights into device performance, usage patterns, and business operations

ISO 9001

An international standard that outlines the requirements for a quality management system, helping companies focus on customer needs.

ISO 27001

An international standard for information security management, providing guidelines to protect an organization's data assets.

IT Information Technology

A branch of engineering that deals with the use of computers and telecommunications to retrieve, store and transmit information.

LIMS (Laboratory Information Management System)

A software system for managing laboratory data and processes.

MES (Manufacturing Execution System)

A software solution that automates, manages and tracks production operations in real-time.

Metadata

Information that provides context or additional information about data, helping to describe, categorize, and organize it.

Microservices

An architectural style in which a large application is broken down into smaller, independent services that can be developed, deployed, and managed separately.

ML (Machine Learning)

A subfield of artificial intelligence that focuses on developing algorithms and statistical models that enable computers to improve automatically through experience.

NGS (Next-Generation Sequencing)

A high-throughput sequencing technology that enables the rapid sequencing of DNA or RNA.

Omics

A field of study that aims to quantify and analyze large sets of biological molecules, such as DNA, RNA, proteins, and metabolites, using parallel analysis techniques like sequencing and chromatography.

OpenID

An open standard and decentralized authentication protocol. It allows users to authenticate with an online service provider without having to create and remember different usernames and passwords for each provider.

OQ (Operational Qualification)

A process of verifying that a system or equipment is installed, configured, and performing according to its specifications.

PaaS (Platform as a Service)

A cloud computing model where a third-party provider delivers hardware and software tools to users over the Internet

PII (Personally Identifiable Information)

Information that can be used to identify an individual, such as name, address, social security number, etc.

PIMS (Process Information Management System)

A software solution that integrates product, process, and patient data across the biopharmaceutical lifecycle and supply chain, providing insights to optimize processes and ensure product quality.

Professional services

Services requiring specialized training, offered by vendors to assist customers with adoption and implementation.

Protocol

Step-by-step instructions for performing a specific experimental workflow in a consistent and reliable manner.

QA (Quality Assurance)

A systematic approach to ensuring that a product, service, or process meets specified quality standards.

QC (Quality Control)

A set of procedures and processes aimed at ensuring that a product, service, or process meets specified quality standards.

QMS (Quality Management System)

A collection of processes, policies, and procedures aimed at ensuring that a product or service meets customer requirements and industry standards.

qPCR (quantitative Polymerase Chain Reaction)

A laboratory technique used to measure the amount of a specific DNA or RNA molecule in a sample. It is based on the polymerase chain reaction (PCR) method, which amplifies a target DNA sequence, and uses fluorescence-based detection to quantify the amount of amplified DNA.

Quantum computing

A field of computer science that seeks to build computers that can perform certain computational tasks faster and more efficiently than classical computers.

R&D (Research and Development)

The process of creating new products, technologies, or processes through systematic investigation and experimentation.

Regulatory compliance

Adhering to legal and regulatory requirements, such as FDA regulations and GDPR, in the development, manufacture, and distribution of products.

REST (Representational State Transfer)

A software architectural style that defines a set of constraints and properties for creating web services. A REST API (Application Programming Interface) is a web-based API that uses the REST architecture to provide a standard method for accessing web resources.

ROI (Return On Investment)

A measure of the return or profit generated from an investment relative to its cost.

RPC (Remote Procedure Calls)

A protocol that allows a computer program to cause a subroutine or procedure to execute on another computer.

SaaS (Software as a Service)

A delivery model for software applications where the provider hosts the software and makes it available to customers over the Internet.

SAML (Security Assertion Markup Language)

A standard for exchanging authentication and authorization data between parties, particularly between an identity provider (IdP) and a service provider (SP).

SCIM (System for Cross-domain Identity Management)

A standard protocol for automating the exchange of user identity information between organizations and applications. It allows for the creation, update, and retrieval of user identities and their associated attributes, such as name, email address, and group membership.

SciOps

An approach to R&D based on the DevOps software development methodology that emphasizes collaboration, communication, data integration, and workflow automation.

SDMS (Scientific Data Management System)

A software solution that manages, stores, and analyzes scientific data.

SDS (Safety Data Sheet)

A document that provides information on the properties and handling of hazardous materials.

SLA (Service Level Agreement)

A contract between a service provider and a customer that defines the level of service expected from the service provider. The SLA outlines the responsibilities of both parties and sets expectations for the quality and availability of the services provided.

SME (Subject Matter Expert)

An individual with specialized knowledge in a particular field, or a small to medium-sized business organization.

SOC 2 Type 1, SOC 2 Type 2, SOC 3

A set of information security standards that service organizations must adhere to, covering security, availability, and confidentiality of customer data.

SOP (Standard Operating Procedure)

A detailed, written instructions for performing a specific task or process in a consistent and reliable manner.

SSO (Single Sing-On)

A user authentication process that allows a user to access multiple applications with a single set of login credentials (username and password). The goal of SSO is to simplify the login process for users and reduce the number of times a user has to log in to different systems.

TickITplus

An upgraded version of the ISO 9001 certification for IT quality.

TLS (Transport Layer Security)

A widely used protocol for securing communication over the internet. It provides privacy and data integrity between two communicating applications. TLS is the successor to the Secure Sockets Layer (SSL) protocol and is used to encrypt the communication between web browsers and web servers, email clients and servers, and other applications that transmit sensitive data over the internet.

Validation

The process of ensuring that a product, service, or system meets specified requirements.

Vendor

A company or individual that provides goods or services to another company.

Vendor management

The process of selecting, monitoring, and evaluating vendors to ensure that they are providing the best value and service to the organization.

Upstream processing

The first stage of the bioprocessing manufacturing process where cells are selected, optimized and grown in bioreactors before being harvested.

VPC (Virtual Private Cloud) and VNet (Virtual Network

A secure, encrypted connection between a device or network and the internet. It allows users to access the internet as if they were connected to a private network, thereby maintaining privacy and security while transmitting sensitive information over the internet.

VPN

A secure, encrypted connection between a device or network and the internet. It allows users to access the internet as if they were connected to a private network, thereby maintaining privacy and security while transmitting sensitive information over the internet.

Western blot

A laboratory technique used to detect and analyze specific proteins in a sample.

Workflow

A manual or automated sequence of steps or processes involved in moving a piece of work from the start to completion

XML (Extensible Markup Language)

A markup language that is used for encoding documents in a format that is both human-readable and machine-readable.