Regulatory Compliance Services

Regulatory Compliance Services

Regulatory Compliance Services  -  IQ/OQ/PQ/IPV procedures

IQ-Installation Qualification
This is a document that records the parameters of an instrument install. The information in this document covers the physical install of an instrument. This does not include or cover actual performance of a system. Items like bench space, proper power, on/off, any errors, etc …. Serial numbers and models are also recorded for your records. 

OQ- Operational Qualification
This document includes a series of tests that provide information about how the instrument is working. Does it meet the manufactures specifications? This is the most common type of documentation for HPLC / FPLC systems. This is often performed before a PQ. 

PQ-Performance Qualification
This is a test that verifies performance and reproducibility of a system. This is commonly performed after an OQ has been completed. Most often performed on HPLC / FPLC type equipment. 

IPV- Instrument Performance Verification
This is a series of tests and values, recorded to verify the equipment is operating within correct parameters. This also documents whether the system meets the manufactures specifications. This is most commonly used for Spectrophotometers and Polarimeter.  

Any test equipment used by Chem AS Engineering  is calibrated by accredited organization.