IQ/OQ Services
At B&W Tek, we support you with full cGMP documentation packages and periodic re-qualification of our instruments in order to help you maintain your strict customer quality assurance standards as well as all mandatory regulations. The Installation Qualification (IQ) / Operation Qualification (OQ) test procedures for our 21 CFR Part 11 compliant software packages describe and document the necessary tests to be performed in order to demonstrate the successful hardware installation, confirm that the hardware has been installed according to vendor and customer guidelines, and establish confidence that the instrument will conform to the application requirements for which it was designed.
In addition to providing you with comprehensive IQ/OQ documentation, we also provide services for onsite implementation by one of our own customer support engineers or by a fully trained and certified local partner. All implementation procedures are performed in accordance with cGMP requirements, ensuring compliance with your quality assurance system, and will include demonstrations of your instrument’s components and features.