| IQ/OQ Validation for Instruments and Software |
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Be confident that your instrumentation and/or software
is installed correctly, functions according to manufacturer specifications-and,
in the case of software, communicates properly with peripheral equipment.
Specially trained chemists perform all testing at your facility, and fully
documented results help satisfy all government/GLP requirements.
For Instrumentation
IQ documentation is supplied as a standard checklist of all items delivered
and installed. The process begins by selecting a suitable location for
the installation, followed by checking the connectivity of and communication
with peripheral units. OQ checks all parameters and functionality, including
proper transfer of data to printers, computers and additional dosing devices
(where applicable). Complete documentation includes installation and operational
checklists, a validation data spreadsheet, pass/fail verification and
copies of the specific application bulletin(s) used in the procedure.
For software
The entire process begins with one of our degreed chemists installing
the actual software on your instrument, on site at your facility. The
IQ portion documents the complete hardware/operating system and instrumentation
controlled by the software; it also includes a check of the application's
basic connectivity to and communication with the instrument(s) it controls.
The OQ portion tests configuration menus, method development, instrument
control and data transfer, as well as user administration and security
settings, audit trails and data integrity/security. Complete documentation
includes installation and operational checklists.
To schedule an appointment, call our Applications Laboratory
at 1-800-727-6768.
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