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The "4Q's" model as defined below is now
well accepted as an approach for equipment qualification within regulated laboratories. nlg analytical offer services that fit into each "Q" in the model.
Design Qualification (DQ)
Defines the instrument specifications & details the conscious decisions
in the selection of the supplier
Installation Qualification (IQ)
Establishes that the instrument is received as designed and specified, that it is properly installed in an environment
suitable for the operation of the instrument
Operational Qualification (OQ)
Checks to confirm key aspects of the performance in the absence of effects which may be introduced by the method
Performance Qualification (PQ)
The process of demonstrating that an instrument performs according to a specification appropriate for routine use
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nlg analytical can help you reach and
correctly document the decision of which chromatography
instrument supplier and equipment that best meets your needs
nlg analytical will fully document the
installation of your chromatography instruments and verify that
they are correctly installed in a suitable environment
Using v:kit, our unique chromatography
instrument qualification system, nlg analytical offer a
comprehensive operational qualification for all your HPLC and GC
equipment - independent of make or model
Using either your samples and column or a
universal kit supplied by nlg analytical we will qualify the
performance of your HPLC and GC systems
The modular nature the nlg analytical operational qualification tests enable just a module or functionality to be qualified after a repair
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- Test conditions (set-points) and pass/fail criteria are customer definable
- Standard operating procedures (SOP) maintained by nlg
analytical under a strict change control regime
- Tests performed by engineers with documented training
histories
- All reference materials and calibrated tools have a known valid relationship to a national or
international standard
- Efficient test design minimises the amount of equipment downtime
- Audit-ready reports designed to meet the requirements of
regulatory agencies
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