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AI Manufacturing

AI manufacturing harnesses the power of artificial intelligence (AI) to automate complex processes, complete tasks, and develop products. There are various benefits to leveraging AI manufacturing, including less downtime, reduced costs, and greater operational efficiencies.

Artificial Intelligence (AI)

Artificial intelligence (AI) is computer-simulated intelligence. AI aims to replicate human intelligence and in some cases, surpass it. Artificial intelligence is powered by machines and includes natural language processing, speech recognition, machine learning, and vision.

Augmented Reality (AR)

Augmented reality (AR) integrates digital information with a user’s physical environment. AR layers text, videos, photos, and holographs onto a user’s real-world view. As such, it brings the physical and digital worlds together — without the user losing sight of their actual reality.

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Batch Manufacturing

Batch manufacturing is a step-by-step batch production method that allows companies to complete multiple unit operations at once, either in parallel or sequentially. This method captures all the needed equipment, materials, resources, and data that goes into making a product.

Batch Record (BR)

A batch record (BR) is the documented execution detail of the manufacturing process of a regulated product, including authors, steps, materials, and equipment. Batch records are required for the manufacture of drugs and medical devices in life science manufacturing.

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Clinical Manufacturing

In drug production, clinical manufacturing is the process of manufacturing drugs to support clinical studies on human subjects. These studies answer questions about the safety and efficacy of drugs and procedures, to determine if they should be commercialized and manufactured at scale.

Cloud SaaS

Cloud SaaS is a solution that is hosted entirely online, in the public cloud. The program and any associated data are accessible from anywhere, so long as there’s an internet connection. Cloud software solutions are subscription based, and tiered depending on user needs.

Cloud Software

Cloud software, also known as cloud SaaS or cloud software as a service, is a solution hosted online in the public cloud. These programs are accessible from any device with an internet connection, including phones, tablets, computers, and even TVs depending on the nature of the software.

Cloud-Based MES

A cloud-based MES is a software as a service (SaaS) solution that uses cloud technology to optimize manufacturing execution systems. Cloud-based MES system over the internet in a hosted cloud, and provide users with access to real-time data (available on demand).

Commercial Manufacturing

As its name suggests, commercial manufacturing is a stage of drug production whereby approved therapies are commercialized — meaning they’re manufactured at scale, marketed to consumers and healthcare organizations, and sold according to Good Manufacturing Practices (GMP).

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Digital Manufacturing (DM)

Digital manufacturing (DM) uses interactive computer-based technology to streamline manufacturing processes. It connects systems across every production stage, consolidating all processes into one main computer database to create a “digital thread” of events for heightened visibility.

Digital Transformation

Digital transformation is the process of leveraging digital technologies to streamline operations, increase efficiencies, and improve systems and processes. Examples of digital transformation include mobile banking apps, chatbots, and 3D printing for manufacturing.

Digital Work Instructions

Digital work instructions are electronic versions of work instructions, and may include rich visual images, videos, diagrams, and augmented and/or mixed reality experiences for real-time guidance. Their purpose is to provide a step-by-step framework to successfully complete tasks.

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Electronic Batch Record (EBR)

Electronic batch records (EBRs) are digital tools that track and monitor batch production throughout the manufacturing process. Unlike manually curated paper-based records, EBRs automatically capture data and verify processes in real time, helping organizations save time and money.

Enterprise Resource Planning (ERP)

Enterprise resource planning (ERP) is a software solution spread across multiple business functional units and subunits such as warehouse, procurement, human resources, program management, risk assessment, supply chain operations, manufacturing processes, and compliance.

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Good Manufacturing Practice (GMP)

Good manufacturing practice (GMP) is a system that ensures products are manufactured according to specific quality standards. These standards are designed to guarantee product purity and reduce the likelihood of unsafe products entering the market.

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Hybrid Cloud

The hybrid cloud combines privately stored data with the public cloud. Information is shared between these environments and applications are run in parallel for an organization. This approach enables companies to get the best of both worlds in both visibility and flexibility.

Hybrid Infrastructure

Hybrid infrastructure is defined as an infrastructure made of on-premise data centers, private clouds, and/or public clouds. It uses hybrid IT infrastructure or cloud infrastructure services to manage, maintain, and monitor the entire IT infrastructure within an organization.

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Internet of Things

The internet of things (IoT) is a system of interconnected systems including sensors, machines, and digital and computing devices that allow for an instantaneous exchange of information. IoT examples include smartphones, smart appliances, security systems, and more.

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Laboratory Execution System (LES)

A laboratory execution system (LES) is a digital data-capture solution that supports laboratory operations by optimizing workflows. Similar to MES software, LES systems help pharma companies remain compliant with regulatory requirements and drive efficiency into laboratory activities.

Laboratory Information Management System (LIMS)

A laboratory information management system, also known as LIMS, is a software solution that supports modern lab operations by automating manual processes such as data capture, tracking, and maintenance. As a result, life science professionals gain access to data in real time.

Laboratory Quality Management System (LQMS)

A laboratory quality management system (LQMS) is a solution that supports the control and improvement of laboratory processes to safeguard quality and product reliability. LQMS achieves this by conducting ongoing evaluations to maintain regulatory requirements.

Lights-Out Manufacturing

Sometimes called “dark factories,” lights-out manufacturing is a fully automated process that produces products with little to no human intervention. In this production model, robots take care of day-to-day operations with appropriate monitoring in place to alert humans as needed.

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Manufacturing Execution System (MES)

A manufacturing execution system (MES) digitally tracks and documents the manufacturing process from raw materials to finished products. Its primary functions include improving productivity, efficiency, reliability, and data visibility to reduce batch release times.

Master Batch Record (MBR)

A master batch record (MBR) provides specific instructions for how to manufacture a regulated product, such as a therapy or medical device. As the name suggests, it is the “master” recipe to be referenced when creating a specific product batch instance.

MES in Pharma

An MES in pharma is a digital solution that tracks and documents the batch manufacturing process. These solutions are designed to lower costs, increase productivity, accelerate batch release, provide traceability, reduce training time, and maintain regulatory compliance.

MES Software

MES software, also known as a manufacturing execution system (MES), digitally tracks and monitors manufacturing processes from start to finish. Various industries rely on MES solutions to optimize production, including automotive, food and beverage, and electronics.

Mixed Reality (MR)

Mixed reality (MR) blends physical and digital worlds together, enabling users to simultaneously interact with both real-world and virtual environments and objects. Industries that use MR technology include education, entertainment, defense, healthcare, and pharma.

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On-Premise Software

On-premise software lives onsite and requires dedicated hardware, installation, and IT support before it can be utilized. Unlike SaaS solutions which bake support into the cost, on-premise software users typically incur additional costs for maintenance and support.

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Pharma 4.0

Pharma 4.0, adapted from Industry 4.0, refers to the convergence of people, systems, and data within one singular network. This term was originally coined by the International Society for Pharmaceutical Engineers, and it represents a new era of digital transformation.

Preclinical Development

Preclinical development aims to determine safe dosages and processes for medical treatments, drugs, or pharmaceutical procedures. Preclinical development is a four-part process that happens after preclinical animal studies are complete, and before human trials start.

Private Cloud

The private cloud is a digital environment that is dedicated to one customer. Private cloud storage is highly secure, which is why many organizations that need to adhere to strict regulations opt to leverage the private cloud over the public cloud.

Public Cloud

The public cloud is a cloud-computing IT environment, hosted by a third-party, where software solutions and applications are available to organizations and individuals on the public internet. The costs of public cloud storage range from free to subscription or usage based.

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Quality Assurance (QA)

Quality assurance (QA) is a validation process put in place to objectively evaluate a product or process against applicable standards, procedures, and expected results. The goal of QA is to ensure products and services meet stringent quality standards for safety and efficacy.

Quality by Design (QbD)

Quality by Design (QbD) is an approach to manufacturing that bakes a “quality first” mindset into the planning, development, and manufacturing processes. Its top objective is to ensure that drugs maintain their purity and efficacy from the beginning.

Quality Control (QC)

Quality control (QC) is a division of a pharmaceutical company that is legally responsible for ensuring that their company complies with regulatory requirements. QC teams ensure that products will work as intended by confirming that they are safe, effective, and error-free.

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Software as a Service (SaaS)

Software as a service (SaaS) is a method of delivering software applications over the internet, often subscription-based. Instead of purchasing servers and installing software on-premise, people can use SaaS to access the systems they need via any device with an internet connection.

Standard Operating Procedure (SOP)

A standard operating procedure (SOP) is a set of written instructions that detail how to perform a routine activity. To consistently achieve a desired outcome while maintaining integrity and quality, it is crucial for these instructions to be followed exactly as prescribed.

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Virtual Reality (VR)

Virtual reality (VR) is a full immersion into a simulated 3D environment. In this setting, users can interact with a completely virtual world through headsets, glasses, or other devices. Though commonly associated with gaming, VR carries a purpose far beyond entertainment alone.

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