IQ/OQ documentation

Installation and Operational Qualification (IQ/OQ) of production and analysis equipment are part of the formal qualification required by cGMP.

Our IQ/OQ documentation packages are developed according to FDA requirements and consist of professionally developed templates that facilitate equipment qualification.

Each IQ/OQ document for a column- or membrane based purification system is adapted to the design and strategy for the specific system making it unique to that system. Fast Trak Validation™ can also assist you in making modifications to the documents.

IQ/OQ documentation is available on request for the following products:

Systems	Columns	Other
ÄKTAexplorer™	BPG™	Packing Station
ÄKTApurifier™	Chromaflow™	Slurry Tank
ÄKTAFPLC™	FineLINE™
ÄKTAprime™	STREAMLINE™
ÄKTAbasic™	BPSS
ÄKTApilot™	BioProcess LPLC, MPLC
ÄKTAcrossflow™	BioProcess HPLC
ÄKTAprocess™
BioProcess™, LPLC, MPLC, HPLC
UniFlux
Membrane benchtop
OligoProcess™
ÄKTA OligoPilot™
OligoPilot™ 400
OligoProcess PPSM
Control Cab ETTAN™ LC

The IQ/OQ documentation is supplied in a binder ready for immediate use. An electronic version in Microsoft™ Word format is also supplied and can be completed electronically. The documents are easy to fill in, with assistance of help texts, pictures and drawings.

Examples of IQ/OQ documents as Acrobat™ (PDF) files can be obtained from GE Healthcare sales representatives.