|
Overview
The Qualification procedures use a combination of test functions and analytical methods to evaluate and verify the instrument or system is operating within acceptable limits. A qualification is renewed annually or at earlier intervals depending on the customer specific requirements.
Types of Qualification
IQ - Instrument Qualifica
OQ - Operational Qualification
PQ – Performance Qualification
Standards & Equipment
All standards utilised are traceable to nationally recognised standards. Test equipment used is certified at the time the qualification takes place.
Qualification Requirements
Whether your instrument or system has been recently installed or undergone repair or maintenance, an Operational Qualification of the instrument or system should be undertaken.
Similarly if the instrument has been relocated or replaced a re-qualification of the module and/or system should also be undertaken to ensure compliance.
Annual Re-Qualification
It is best practice to combine a routine maintenance package with a qualification visit providing you with the utmost reliability and conformity.
Data Capture
Raw data will be collected through the existing Chromatography Datasystem or alternatively with our own mobile resources.
Certification
Sci-Tek will issue a complete suite of certification detailing result analysis of each test performed.
Out of Specification
In the event that an instrument or module fails qualification, our Engineers will determine the root cause and present a non-conformance document detailing the corrective action. More often than not, a component has failed and requires replacing. Once fitted, the failed test can repeated.
|
