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Terminology | Defined Meaning |
Validation Plan (VP) | This document supports the VMP, but provides the detailed validation requirements for a specific piece of equipment. |
User Requirement Specification (URS) | This document describes what the equipment is intended to do and all essential requirements such as production rates, operating ranges, etc. The owner usually develops this document. This document links to the PQ document which tests for each of the requirements. |
Functional Requirement Specifications (FRS) | This document describes the detailed functionality of the equipment. The supplier usually develops this document. This document is linked to the OQ document which tests for each function. |
Design Specifications (DS) | These documents describe the equipment in sufficient detail to enable it to be built. These documents are linked to the IQ document that tests for all design requirements. |
Design Qualification (DQ) or Design Reviews | Planned and systematic review of specifications, design, and development throughout the life cycle. Design reviews evaluate deliverables against standards and requirements, identity problems, and propose required corrective actions. |
Installation Qualification (IQ) | Documented verification that all key aspects of the hardware and software installation adhere to appropriate codes and approved design intentions and that the recommendations of the manufacturer have been suitably considered. |
Operational Qualification (OQ) | Documented verification that the equipment-related system or subsystem performs as specified throughout representative or anticipated operating ranges. |
Factory acceptance test (FAT) | Documented verification that the equipment-related system or subsystem performs as specified throughout representative or anticipated operating ranges at manufacturer factory before shipment to end user's workshop. |
Site acceptance test (SAT) | Documented verification that the equipment-related system or subsystem performs as specified throughout representative or anticipated operating ranges at site in end user's workshop. |
Performance Qualification (PQ) | Documented verification that the process and / or the total process-related system performs as intended throughout all anticipated operating ranges while operating in itsspecified operating environment. |
Commissioning | A well planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the End User that results in a safe and functional environment that meets established design requirements and expectations. |