Glossary

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. IDBS software is FDA 21 CFR and EudraLex V4 Annex 11 compliant.

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 regulations are defined in the annex 11 of Rules Governing Medicinal Products.

Application Programming Interface OR Active Pharmaceutical Ingredient. An application programming interface is a way for two or more computer programs to communicate with each other.

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.

Annual Product Quality Review is a dossier that contains information about each batch of every product produced in a year.

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 failure of a batch to be delivered because it failed to meet its product specifications, manufacturing of such a batch was discontinued before the release testing stage, or a deviation from the manufacturing process results in rejection of the batch.

Batch manufacturing or batch production is a method in manufacturing where the products are made as specified groups or amounts, within a time frame.

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

Bioanalytical software is designed to capture, store, analyze and report on biological data and workflows generated from laboratory experiments.

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. a 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 or CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their recurrence (for Corrective Action) or prevent from occurrence (for Preventive Action).

A Contract Development and Manufacturing Organization, such as Lonza Biologics, handles not only the outsourced manufacturing of drug substances but also all of the innovation and development work that occurs before manufacturing one.

Chromatography Data System, for example, Thermo Scientific Chromeleon and Waters Empower, is a typical laboratory informatics solution that facilitates chromatography-based analysis.

Cell therapy is a therapy in which viable cells are injected, grafted or implanted into a patient in order to effectuate a medicinal effect.

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 the Internet.

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

A Contract Manufacturing Organization is a third-party manufacturer of components or products for a company.

A Certificate of Analysis is a formal laboratory-prepared document that entails the results of one or more laboratory analyses, signed – manually or electronically – by an authorized representative of the entity conducting the analyses.

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.

Contract manufacturing is when one company enters into an agreement with another to produce components or products over a specific timeframe.

Critical Process Parameter. CPP is a process parameter whose variability has an impact on CQA and therefore should be monitored or controlled to ensure the process produces the desired quality.

Continued Process Verification is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits.

Critical Quality Attribute is a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, distribution to ensure the desired product quality.

Contract Research and Manufacturing Services is a process under which the parent company of the product does not actually manufacture the product themselves.

A Contract Research Organization is a company that provides support to the pharmaceutical, biotechnology and medical device industries in the form of research services outsourced on a contract basis.

Customer Success Manager/Management. Customer success management is the process of enhancing customers’ satisfaction while using a product or service.

Changing something to suit its purpose.

A digital data backbone is a carefully designed distributed communication layer that provides the infrastructure needed to support short- and long-term scalability.

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.

Data traceability follows the lifecycle of data to track all access and changes to the data.

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.

Electronic Batch Records are digital tools that track and monitor batch production throughout the manufacturing process.

An Electronic Laboratory Notebook is a computer program that records data and information in a systematic way and essentially replaces a pen and paper system. Electronic notebooks are used in a laboratory to help scientists and lab technicians document and record any details of experiments that are made.

The European Medicines Agency is an agency of the European Union in charge of the evaluation and supervision of pharmaceutical products.

Enterprise Resource Planning is a type of software system that helps organizations automate and manage core business processes for optimal performance.

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.

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services.

A network security system designed to protect it from unauthorized access.

General Data Protection Regulation. GDPR is a regulation in EU law on data protection and privacy in the EU and the European Economic Area.

Gene therapy is a medical field that focuses on the genetic modification of cells to produce a therapeutic effect or the treatment of disease by repairing or reconstructing defective genetic material.

Good Laboratory Practice. GLP is a quality system of management controls for research labs and organizations to ensure the uniformity, consistency, reproducibility, quality, integrity and reliability of products in development for human or animal health.

Good Manufacturing Practice. GMP describes the minimum standard that a medicines manufacturer must meet in their production processes.

The time-based profile of the measurement values that were recorded for a particular batch that met product quality targets.

Good Practice quality guidelines and regulations.

A data historian or historian is a type of database that’s designed to collect and store time-series data from various sources around a process plant.

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-Throughput Process Development shortens development time, while increasing the amount of information available for quality and design (QbD).

High-Performance Liquid Chromatography is a technique in analytical chemistry used to separate, identify and quantify each component in a mixture.

Infrastructure as a Service is a cloud computing service model by means of which computing resources are supplied by a cloud services provider.

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.

The Internet of Things is a system of interrelated computing devices, mechanical and digital machines, objects, animals or people that are provided with unique identifiers and the ability to transfer data over a network without requiring human interaction.

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 Sample Management is a way to correctly select, collect, record, track and store human, animal or plant samples in a laboratory.

A Laboratory Execution System is one of the most complete digital applications for execution guidance of QA/QC operations.

A Laboratory Information Management System is a software-based solution with features that support a modern laboratory’s operations.

An ultimate guide explaining what a LIMS is, including benefits and limitations.

A Manufacturing Execution System (MES) is a software system used in manufacturing plants to optimize production processes. They enable manufacturing managers to make instant, real-time decisions based around production, quality and maintenance, by having access to instant data and real-time feedback on the status of manufacturing operations.

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

Machine Learning is the use and development of computer systems that are able to learn and adapt without following explicit instructions, by using algorithms and statistical models.

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

Personalized medicine or precision medicine is a type of medical care in which treatment is customized for an individual patient.

Operational Qualification is a collection of test cases used to verify the proper functioning of a system.

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.

Performance Qualification addresses that the software application, in real-time conditions, consistently produces products that meet all predetermined requirements.

Process monitoring is the manipulation of sensor measurements like force, vision and temperature, in determining the state of the process.

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

Quality Assurance is the maintenance of a desired level of quality in a service or product, especially by means of attention to every stage of the process of delivery or production.

Quality Control is a system of maintaining standards in manufacturing products by testing a sample of the output against the specification.

A Quality Management System is a formalized system that documents processes, procedures and responsibilities for achieving quality objectives.

Research and Development is the set of innovative activities undertaken by corporations or governments in developing new services or products and improving existing ones.

Return on Investment is a ratio between net income and investment. A high ROI means the investment’s gains compare positively to its cost.

Software as a service is a software licensing and delivery model in which software is licensed on a subscription basis and is centrally hosted.

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

A Scientific Data Management System is software that acts as a document management system. It can be used to capture, catalog and archive raw data generated by laboratory instruments.

Skyland 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.

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.

Technology transfer or tech transfer is the movement of data, designs, inventions, materials, software, technical knowledge or trade secrets from one organization to another.

A Standard Operating Procedure is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations.

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 VPN is a service that protects your internet connection and privacy online.

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