A comprehensive list of terms and definitions IDBS uses
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 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.
Artificial Intelligence (AI) refers to machines, especially computer systems, with learning capabilities and problem solving skills, mimicking and often overperforming what humans can do.
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.
A file format established by the Allotrope foundation that stores laboratory data, along with contextual metadata and ancillary files
Set of computational methods aiming to identify insights within raw data
In the European Union computerized systems regulation are defined in the annex 11 of Rules Governing Medicinal Products
Application Programming Interface OR Active Pharmaceutical Ingredient
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.
Advanced Therapy Medicinal Products are medicines based on genes, cells or tissues. These are for human use.
An audit trail is the chronological record of all activities that have occurred. It is used to certify data integrity.
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).
The identification and quantitative measurement of substances such as proteins, drugs, metabolites, in a biological system
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.
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.
A procedure that uses complete or parts of living cells to produce desired items.
A plan outlining the steps an organization needs to take in a particular situation to ensure a return to the status quo.
Corrective Action and Preventative Action
Contract Development and Manufacturing Organization e.g. Lonza Biologics
Chromatography Data System, for example, Thermo Scientific Chromeleon and Waters Empower.
Cell Line Development includes choosing, optimizing and growing a desired cell line to create a desired product.
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
The cloud refers to online computer resources (computing, storage and more) delivered on-demand via Internet.
A set of connected computers combining resources to perform a same task faster
Contract Manufacturing Organization
Certificate of Analysis
Order or arrange a computer system so that it can be used in a particular way for its designated task
The systems in a manufacturing plant that have been designed to run continuously. They are often controlled by computers.
Continued Process Verification
Contract Research and Manufacturing Services
Contract Research Organization
Customer Success Manager/Management
Changing something to suit its purpose
A structured set of data stored in a computer and accessible to others
Maintaining data accuracy and quality throughout its lifecycle
A system or repository where data is stored in its original or raw format
Interdisciplinary scientific field (computational, statistical, algorithmic etc.) focused on extracting knowledge from data
Also know as an information silo, a data silo is data that is not fully and easily accessible.
A large store of data used for reporting and analysis
The adoption of digital technology in a company
Downstream processes are the recovery and purification of a biologic product.
European Medicines Agency
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.
Findable, Accessible, Interoperable, Reusable – a set of data management principles that ensure their quality, integrity, and usability
Food and Drug Administration – a regulatory body in the US.
A network security system designed to protect it from unauthorized access
General Data Protection Regulation – an EU law on data protection
Good Laboratory Practice
Good Manufacturing Practice
Good Practice quality guidelines and regulations
A computer connected to a computer network. The host can work as a source of information, services and applications to users on the network.
High-Performance Liquid Chromatography
Infrastructure as a Service
A concept where technology is changing the way Industry produces goods through automation and data exchange.
The science of the collection, evaluation, organization and dissemination of information for storage and retrieval.
The framework or network of components needed to operate and manage enterprise IT environments
Internet of Things
The international standard that specifies requirements for a quality management system. This helps companies focus on what their customers need.
International standards on how to manage information security intended to protect an organization’s data assets
Laboratory Execution System
Manufacturing Execution System
A set of data that describes, gives more information, or provides context about one or more aspects of that data
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.)
The study of the absorption, distribution, metabolism and excretion of drugs in a living organism
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.
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.
Services that require specific training. These are provided by a vendor to help a customer adoption and implementation.
Quality Management System
Research and Development
Return On Investment
A specimen of a whole entity small enough to be easily managed and avoid damage to the whole
Scientific Data Management System
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.
Subject Matter Expert OR Small to Medium Enterprise
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.
Standard Operating Procedure
An upgrade of the ISO9001 certification for IT quality
In bioprocessing, upstream processing is the first stage of the manufacturing process, where cells are selected, optimized and grown in bioreactors before being harvested.
Checking or proving the validity or accuracy of something to comply with relevant standards and regulations
Virtual Private Network
A sequence of steps or processes involved in moving a piece of work from the start to completion