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
DQ services
nlg analytical can help you reach and
correctly document the decision of which chromatography
instrument supplier and equipment that best meets your needs
IQ services
nlg analytical will fully document the
installation of your chromatography instruments and verify that
they are correctly installed in a suitable environment
OQ services
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
PQ services
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
Qualification after repair
The modular nature the nlg analytical operational qualification tests enable just a module or functionality to be qualified after a repair
nlg analytical are experts in HPLC and GC
qualification
Key qualification features
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
NLG
Analytical Contact: NLG Analytical Ltd, 16 John Bradshaw Court, Alexandria Way, Congleton Business Park, Congleton, Cheshire, CW12 1LB, UK
Tel: +44(0)1260 274-266
Fax: +44(0)1260 273-319 e-mail: info@nlg-analytical.co.uk
