Glossary

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.

Big Data is a collection of data from many sources – characterized by the “5Vs”:
Volume – the amount of data from multiple sources
Variety – the different types of data e.g. structured, unstructured, semi-structured etc.
Veracity – the quality, credibility, integrity and accuracy of the data i.e. the degree to which it can be trusted
Velocity – the speed at which the data is generated, distributed and collected
Value – the benefit of the data to the organization

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.

Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available and Traceable.

The ALCOA acronym has been used to describe data integrity, which is an essential part of the pharmaceutical quality system described in Eudralex GMP guidance and FDA guidance.

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.

Automation describes the use of technology, programs, robotics or processes to achieve outcomes with minimal human input i.e. to operate automatically.

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.

Bioprocessing in the pharmaceutical industry is the use of living cells, microorganisms, or their components (e.g., enzymes, bacteria, yeast) to manufacture, develop, and purify high-value therapeutic products like vaccines, antibodies, and proteins. It involves controlled, large-scale cultivation to produce drugs. Learn more about how IDBS software can help solve key bioprocessing challenges like fragmented data across siloed systems and limited real-time insights to scalability issues, compliance burdens and poor cross-team collaboration.

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).

Contract development and manufacturing organizations (CDMOs) are companies that provide drug development and manufacturing services in the pharmaceutical industry on a contract basis. Learn about how IDBS GxP-compliant software solutions in Development and Manufacturing can help CDMOs improve quality, productivity, audit-readiness and on-time delivery.

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.

Contract manufacturing organizations (CMOs) are companies that provide drug manufacturing services in the pharmaceutical industry on a contract basis. Learn about how IDBS GxP-compliant software solutions can help CMOs improve quality, productivity and on-time delivery.

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. Learn how IDBS can empower CROs with bioanalytical informatics solutions.

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.

The data backbone is the underlying infrastructure that provides support for the storage, management and retrieval of contextualized, organized and structured data that can be used to drive insights via analytics.

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.

A subset of the data warehouse serving a particular part of the organization or business area.

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.

Digital Employee Experience

A measure of how well people work with digital tools at their workplace, that enables them to be engaged, proficient and productive.

The implementation of digital systems to process data, automate business processes with improved data visibility and reporting. It includes the changing of processes to reflect business requirements within a digital paradigm.

Digitization in pharma is the adoption of a software computer program which aims to automate different aspects of the pharmaceutical industry.

A virtual representation of an actual tangible product, process or system that is the counterpart for practical purposes e.g. simulation, testing, monitoring etc.

Downstream processing (DSP) in the pharmaceutical industry refers to the crucial, post-fermentation, or post-cultivation stages involving the recovery, purification, and concentration of biosynthetic products (like antibodies, vaccines, and proteins). It separates, isolates, and purifies active pharmaceutical ingredients (APIs) from raw materials to meet strict quality and regulatory standards.

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

Electronic notebooks are used in a laboratory to help scientists and lab technicians document and record any details of experiments that are made.  An Electronic Laboratory Notebook (ELN) in the pharmaceutical and adjacent industries is a secure, software-based system that replaces traditional paper notebooks for recording, managing, and storing experimental data, protocols, and notes. It facilitates regulatory compliance (e.g., FDA 21 CFR Part 11), enhances data integrity, improves searchability, and enables collaboration across research and development teams.

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 E-WorkBook is the original IDBS lab informatics platform for scientific research, discovery and development. E-WorkBook has a long history of use in top pharma companies but also in many large companies in adjacent sectors. E-WorkBook has been helping our customers become more efficient and effective since 2006. 

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.

A Golden Batch in the pharmaceutical industry is an idealized, historical production run that represents the perfect, most efficient, and highest-quality outcome for a product. Learn how IDBS PIMS helps to enhance process optimization for both process monitoring and golden batch comparisons. The PIMS Batch module also manages batch data verification settings which can be pre-configured to flag out of range values. Provides approval workflows and dashboards to monitor data entry and batch release status.

GxP (“Good x Practice”) is a collection of quality guidelines and regulations in the pharmaceutical industry designed to ensure products are safe, effective, and high-quality. The “x” acts as a placeholder for various operational fields, including manufacturing (GMP), laboratory studies (GLP), and clinical trials (GCP). Learn about the GxP software solutions offered by IDBS.

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.

(Experimental work) performed on a computer or using a simulation software.

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. Read about IDBS certifications here.

International standards on how to manage information security intended to protect an organization’s data assets. Read about IDBS certifications here.

The Knowledge Base serves as a centralized repository of information, providing detailed explanations and resources on various topics within the BioPharma industry.

Laboratory data management is the system of collating, managing, and analyzing laboratory samples.

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.

Large Language Model

A large language model is an AI tool that recognizes and generates text in general/day-to-day language. They are trained on huge data sets.

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. In the pharmaceutical industry DMPK (Drug Metabolism and Pharmacokinetics) studies are essential to evaluate how a drug moves through, is broken down by, and is removed from the body across four main activities referred to as ADME (Absorption, Distribution, Metabolism, Excretion). They are required to identify safe, effective drug candidates, predict human pharmacokinetics, assess potential drug-drug interactions, and meet strict regulatory requirements for IND/NDA filings. Learn about how IDBS Polar software can help streamline DMPK studies and boost data integrity and study reproducibility.

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 Polar is an enterprise lab informatics software platform with ELN, LES and LIMS capabilities for GxP and non-GxP implementations. Its unified platform helps scientists streamline their workflows, contextualize experiment, product and process data and deliver AI-ready data for insights that accelerate innovation.

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.

Professional Services is a term used to describe a vendor or software partner’s services provided to help a customer implement software systems. Learn about the benefits of using IDBS Professional Services to implement IDBS software.

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. Explore the IDBS ROI calculator to estimate the benefits IDBS software solutions can bring to scientific teams.

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 is the previous name of IDBS PIMS software.  IDBS acquired Skyland Analytics and Skyland PIMS in 2021 and rebranded Skyland PIMS to IDBS PIMS. IDBS PIMS (Process Information Management System) is 21 CFR Part-11 compliant, cloud-native software that creates a contextualized data backbone of critical manufacturing process and quality data across products and batches to address critical requirements for all BioPharma manufacturing (small and large molecules and new modalities). PIMS customers report transformation of their Process Monitoring, Investigations, and Tech Transfer through automated data management and insights.

Subject Matter Expert OR Small to Medium Enterprise

SOC 2 Type 2 and SOC 3 are, in the context of the pharmaceutical industry, crucial security and data privacy frameworks validating that service providers (e.g., cloud labs, data processors) manage sensitive research and patient information safely. SOC 2 Type 2 provides a detailed, 3-12 month audit of control effectiveness, while SOC 3 is a simplified, public summary of these findings for marketing trust. Read about IDBS certifications here.

Technology transfer or tech transfer in the pharmaceutical industry is the structured, documented, and validated process of transferring knowledge, manufacturing methods, and analytical techniques from development (R&D) to commercial production sites. It ensures that drug products, whether small molecules or biologics, are produced with consistent safety, quality, and efficacy across different locations.

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

TickITplus is an IT quality management certification scheme tailored to the needs of the modern technology industry, including software development and IT services within highly regulated sectors like pharmaceuticals. It serves as an extension to ISO 9001, providing a specialized framework (the Base Process Library) to manage IT processes, enhance process capability, and improve security, often aligning with GxP (Good Practice) requirements. In the context of the pharmaceutical industry, TickITplus is used to ensure that software and computerized systems—ranging from R&D tools to manufacturing execution systems—are developed, implemented, and maintained with appropriate quality controls.  Learn about IDBS certifications here.

In bioprocessing, upstream processing or upstream development 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.