Intelligent Glossary
Reference for pharmaceutical validation terminology.
A standard software development and system engineering model that visually maps each step of the development lifecycle to its corresponding testing phase (PQ, OQ, IQ).
A high-level document that establishes the strategy, scope, responsibilities, and timeline for all validation activities within a project or facility.
A systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle.
The document conveying the needs of the user to the system supplier/developer. It defines clearly and precisely what the user wants the system to do.
Documented verification that the equipment or systems, as installed or modified, comply with the approved design and manufacturer's recommendations.
Documented verification that the equipment or systems, as installed or modified, perform as intended throughout the anticipated operating ranges.
Documented verification that the equipment and ancillary systems, as connected together, can perform effectively and reproducibly based on the approved process method.