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 | | |
UniFlux | | |
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.
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