Glossary

A comprehensive list of terms and definitions IDBS uses

21 CFR 11

Title 21 CFR Part 11 is one of the regulations set forth by the FDA. It establishes criteria to evaluate whether electronic records are reliable, trustworthy and equivalent to paper records.

ActivityBase

ActivityBase is IDBS’ data management platform designed for high-throughput screening. It is the established industry software platform for screening data management, with feature-rich data analysis tools, built-in object/compound registration tools and the industry-standard database.

AI

Artificial Intelligence (AI) refers to machines, especially computer systems, with learning capabilities and problem solving skills, mimicking and often overperforming what humans can do.

ALCOA and ALCOA+

The ALCOA acronym has been used to describe data integrity. It stands for ‘Attributable, Legible, Contemporaneous, Original and Accurate’. More recently, ALCOA+ was introduced with the concepts of Complete, Consistent, Enduring and Available.

Allotrope Data Format (ADF)

A file format established by the Allotrope foundation that stores laboratory data, along with contextual metadata and ancillary files

Analytics

Set of computational methods aiming to identify insights within raw data

Annex 11

In the European Union computerized systems regulation are defined in the annex 11 of Rules Governing Medicinal Products

API

Application Programming Interface OR Active Pharmaceutical Ingredient

APR

Annual Product Review is to review the consistency and quality of the products in the pharmaceutical industry on an annual basis. This includes checking for deviations, market complaints and change controls.

ATMP

Advanced Therapy Medicinal Products are medicines based on genes, cells or tissues. These are for human use.

Audit trail

An audit trail is the chronological record of all activities that have occurred. It is used to certify data integrity.

AWS

Amazon Web Services ( AWS ) is Amazon’s on-demand cloud-computing platform providing a set of technical applications and professional services (storage, computing, database, networking, analytics and more).

Bioanalysis

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

BioBank and Bio-repository

A BioBank refers to the bodily fluids and tissue samples collected and processed for the purpose of future analysis and research and stored in a Bio-repository.

Biologics

A product that has been produced from a living organism or contains components of a living organism, such as an animal, human or microorganism. E.g. vaccine.

Bioprocessing

A procedure that uses complete or parts of living cells to produce desired items.

Business continuity

A plan outlining the steps an organization needs to take in a particular situation to ensure a return to the status quo.

CAPA

Corrective Action and Preventative Action

CDMO

Contract Development and Manufacturing Organization e.g. Lonza Biologics

CDS

Chromatography Data System, for example, Thermo Scientific Chromeleon and Waters Empower.

CLD

Cell Line Development includes choosing, optimizing and growing a desired cell line to create a desired product.

CLIA

Clinical Laboratory Improvement Amendments (CLIA) is a program run by the U.S. Centers for Medicare and Medicaid Services (CMS), which regulates all (non-research) human laboratory testing

Cloud

The cloud refers to online computer resources (computing, storage and more) delivered on-demand via Internet.

Cluster

A set of connected computers combining resources to perform a same task faster

CMO

Contract Manufacturing Organization

COA

Certificate of Analysis

Configure

Order or arrange a computer system so that it can be used in a particular way for its designated task

Continuous processing

The systems in a manufacturing plant that have been designed to run continuously. They are often controlled by computers.

CPV

Continuous (or Continued) Process Validation

CRAMS

Contract Research and Manufacturing Services

CRO

Contract Research Organization

CSM

Customer Success Manager/Management

Customization

Changing something to suit its purpose

Database

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

Data integrity

Maintaining data accuracy and quality throughout its lifecycle

Data lake

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

Data science

Interdisciplinary scientific field (computational, statistical, algorithmic etc.) focused on extracting knowledge from data

Data silo

Also know as an information silo, a data silo is data that is not fully and easily accessible.

Data warehouse

A large store of data used for reporting and analysis

Digital transformation (DT)

The adoption of digital technology in a company

Downstream

Downstream processes are the recovery and purification of a biologic product.

ELN

Electronic Laboratory Notebook

EMA

European Medicines Agency

E-WorkBook

IDBS’ data management platform designed for all R&D industries. E-WorkBook is the world’s best-in-class informatics platform for scientific research and discovery. Its flexibility can meet the demands of your industry and those of various business units in your organization today, and can rapidly adapt and scale to meet whatever requirements you may have tomorrow.

F.A.I.R.

Findable, Accessible, Interoperable, Reusable – a set of data management principles that ensure their quality, integrity, and usability

FDA

Food and Drug Administration – a regulatory body in the US.

Firewall

A network security system designed to protect it from unauthorized access

GDPR

General Data Protection Regulation – an EU law on data protection

GLP

Good Laboratory Practice

GMP

Good Manufacturing Practice

GxP

Good Practice quality guidelines and regulations

Hosting

A computer connected to a computer network. The host can work as a source of information, services and applications to users on the network.

HPLC

High-Performance Liquid Chromatography

HTPD

High-Throughput Process Development – IDBS’ Polar enables customers to harvest the true power of HTPD through high-throughput data management.

IaaS

Infrastructure as a Service

Industry x.0

A concept where technology is changing the way Industry produces goods through automation and data exchange.

Informatics

The science of the collection, evaluation, organization and dissemination of information for storage and retrieval.

Infrastructure

The framework or network of components needed to operate and manage enterprise IT environments

IoT

Internet of Things

ISO 9001

The international standard that specifies requirements for a quality management system. This helps companies focus on what their customers need.

ISO 27001

International standards on how to manage information security intended to protect an organization’s data assets

LES

Laboratory Execution System

LIMS

Laboratory Information Management System

MES

Manufacturing Execution System

Metadata

A set of data that describes, gives more information, or provides context about one or more aspects of that data

ML

Machine Learning

Omics

Studies that aim to quantify pools of bio-molecules characterized by the use of multi-parallel analysis such as recent sequencing and chromatography techniques (e.g.: genomics, transcriptomics, proteomics, metabolomics, epigenetics, lipidomics etc.)

OQ

Operational Qualification

Pharmacokinetics

The study of the absorption, distribution, metabolism and excretion of drugs in a living organism

PIMS

Process Information management System – PIMS software seamlessly combines product, process, and patient data across the biopharma lifecycle and supply chain, providing insights that accelerate process understanding and ensure product quality.

Polar

IDBS’ data management platform designed specifically for biopharma. Polar is the world’s first BioPharma Lifecycle Management (BPLM) platform. It enables customers to efficiently execute processes while curating the data needed to accelerate time to market. It does this by tackling the biggest challenges in process design, optimization, scale-up and technology transfer.

PQ

Performance Qualification

Professional Services

Services that require specific training. These are provided by a vendor to help a customer adoption and implementation.

QA

Quality Assurance

QC

Quality Control

QMS

Quality Management System

R&D

Research and Development

ROI

Return On Investment

SaaS

Software as a Service

Sample

A specimen of a whole entity small enough to be easily managed and avoid damage to the whole

SDMS

Scientific Data Management System

Skyland PIMS

Skyland Analytics is best known for its Skyland PIMS® software which seamlessly combines product, process, and patient data across the biopharma lifecycle and supply chain, providing insights that accelerate process understanding and ensure product quality.

SME

Subject Matter Expert OR Small to Medium Enterprise

SOC and SOC 2 type 2, SOC 3

SOC 2 requires service organizations to establish and follow strict information security policies, procedures and controls encompassing the security, availability, and confidentiality of customer data.

SOP

Standard Operating Procedure

TickITplus

An upgrade of the ISO9001 certification for IT quality

Upstream processing

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

Validation

Checking or proving the validity or accuracy of something to comply with relevant standards and regulations

VPN

Virtual Private Network

Workflow

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