// ROBOTICS AND SMART FACTORIES TERM
Performance Qualification
A validation stage that confirms equipment or a process consistently produces acceptable products under actual operating conditions.
TECHNICAL DEFINITION
Performance Qualification (PQ) is a critical validation phase demonstrating that a process or system consistently performs as intended under actual or simulated production conditions, producing products that meet all predefined quality attributes and specifications over time.
BACKGROUND
The Fourth Industrial Revolution, also known as 4IR, Industry 4.0 or the Intelligence Age, is a neologism describing rapid technological advancement in the 21st century. It follows the Third Industrial Revolution. The term was popularized in 2016 by Klaus Schwab, the World Economic Forum founder and former executive chairman, who asserts that these developments represent a significant shift in industrial capitalism.
READ MORE ON WIKIPEDIASYNONYMS & ALIASES
- Process validation
- System performance
- Production qualification
- Final validation
USAGE NOTE
PQ is the final step in equipment or process validation, ensuring consistent product quality.
DEVELOPERS
Organizations developing technology related to Performance Qualification.
Develops the Opcenter Manufacturing Execution System (MES) and MindSphere IIoT platform, which capture and analyze real-time production data, enforce process parameters, and create electronic batch records (EBRs) used as objective evidence for Performance Qualification.
Offers the FactoryTalk PharmaSuite MES, a platform specifically designed for life sciences manufacturing to manage recipes, orchestrate production, and automatically collect the critical process data required to document and prove consistent performance during PQ studies.
Provides the Syncade Manufacturing Execution System, which integrates with their DeltaV control systems to ensure that manufacturing processes run consistently within validated parameters, automatically capturing the necessary data for PQ reports in regulated industries.
Develops the AVEVA PI System, an enterprise-level data historian that collects and contextualizes vast amounts of operational data. This technology is fundamental for the long-term monitoring and analysis required to demonstrate process stability and meet PQ acceptance criteria.
Provides the Veeva Vault Quality suite, a cloud-based Quality Management System (QMS) used extensively in the life sciences industry to manage the entire validation lifecycle, including the authoring, review, execution, and approval of PQ protocols and reports in a compliant manner.
Offers Kneat Gx, a purpose-built e-validation platform that digitizes the entire validation lifecycle. It allows companies to manage and execute PQ test protocols paperlessly, capturing evidence in real-time and streamlining the review and approval process.
Develops a digital Quality Management System (QMS) that automates and connects all stages of the product lifecycle. Its validation solutions help manage the documentation, execution, and traceability of all qualification activities, including PQ, ensuring data integrity and compliance.
Provides the DELMIA Apriso Manufacturing Operations Management (MOM) application. This platform helps standardize and enforce manufacturing processes globally, providing the data-rich environment necessary to execute, monitor, and document the consistent operational performance required for successful PQ.