STEMvision IQ/OQ/IPV Service Visit

STEMCELL Technologies offers a combined qualification service visit for the STEMvision™ Automated Colony-Forming Unit (CFU) Assay Reader, an instrument used for automated, standardized, algorithm-based imaging and counting in human and mouse hematopoietic CFU assays. The IQ/OQ/IPV package brings together Installation Qualification (IQ), Operational Qualification (OQ), and Instrument Performance Verification (IPV) in a single visit.

The IQ procedures verify that the instrument is delivered and installed according to the manufacturer's specifications. STEMCELL recommends that IQ be performed at the time of instrument installation, after the instrument is moved to a new location, or when additional components and functionality are added to the instrument. The OQ and IPV services offer confirmation of the accuracy and precision of the instrument, confirming that it is operating and performing as intended. They provide a comprehensive verification of the instrument to established specifications and help identify issues with the system arising from normal wear and improper use or maintenance.

The qualification services provide audit-quality information on instrument performance for customer records and for presentation to a regulatory body. STEMCELL recommends that OQ and IPV services be performed after an IQ service or major repair, in accordance with the customer's regulatory requirements, or as dictated by the IQ/OQ/IPV Protocol for the specific instrument.