// ROBOTICS AND SMART FACTORIES TERM
Process Validation
Documented evidence that a process consistently produces a product that meets its predetermined specifications and quality attributes.
TECHNICAL DEFINITION
Process Validation is the documented program providing a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes, typically involving Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
BACKGROUND
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
READ MORE ON WIKIPEDIASYNONYMS & ALIASES
- Process qualification
- Validation study
- System validation
USAGE NOTE
Process validation is mandatory in regulated industries to ensure product safety and efficacy.
DEVELOPERS
Organizations developing technology related to Process Validation.
Develops a comprehensive suite of industrial software (e.g., MES, PLM, TIA Portal) and automation hardware that enable digital twins, simulation, and data-driven process control, crucial for modern process validation and continuous improvement in Industry 5.0.
A global leader in industrial automation and information solutions. Their offerings, including FactoryTalk software suite, provide capabilities for manufacturing execution, quality management, and performance analytics, directly supporting process validation through real-time data and control.
Offers enterprise resource planning (ERP) software with robust modules for manufacturing, quality management (SAP QM), and supply chain. These systems provide the backbone for collecting, managing, and analyzing data essential for process validation, compliance, and traceability in connected manufacturing environments.
Specializes in Validation Lifecycle Management (VLM) software, offering a cloud-based platform for managing and automating all validation activities across the enterprise. Their solutions are critical for ensuring compliance and efficiency in highly regulated industries.
Provides quality management system (QMS) and manufacturing execution system (MES) software solutions specifically designed for regulated industries. Their platform helps companies streamline compliance, control documentation, and manage all aspects of process validation, audit, and quality processes.
A cloud-based software provider for the global life sciences industry. Their Veeva QualityOne suite includes solutions for quality content and process management, enabling pharmaceutical and biotech companies to manage and execute complex process validation requirements in a highly regulated environment.
Provides automation solutions and services, including process control systems, measurement devices, and analytical technologies. Their advanced automation helps maintain processes within validated parameters, optimize performance, and ensure consistent product quality.
Offers industrial software, including MES (Proficy Manufacturing Suite) and an industrial IoT platform (Predix). These technologies enable real-time data collection, analytics, and operational intelligence, supporting continuous process monitoring and validation in advanced manufacturing.