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) 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) 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.
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.
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.
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.
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).
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).
Continuous manufacturing (CM) is an end-to-end manufacturing process that enables products to be made without interruptions or pauses. In existence since the 18th century, continuous manufacturing is the norm for certain industries, such as oil, automotive, and food processing.
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 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.
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) 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.
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.
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.
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.
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.
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.
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.
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.
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, 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) 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.
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 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.
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) 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) 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.
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.
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.