IQ/OQ Validation for Instrumentation

With our Installation Qualification/Operational Qualification (IQ/OQ) service, you can rest assured that your instrumentation is installed correctly and functions according to manufacturer specifications. IQ documentation is supplied in a standard (checklist) format, and it includes all items delivered and installed. OQ service uses primary standards for system validation to ensure accuracy and precision of the installed system. OQ documentation includes analysis data and statistical analysis, which satisfy government and internal laboratory requirements (e.g., FDA).

IQ/OQ is performed on-site at your facility by one of our degreed chemists, who is specially trained to validate Brinkmann^®/Metrohm^® instrumentation. To perform an IQ/OQ, a certified analytical balance must be in close proximity to the installation location. First, the installation location is determined suitable before the instrument is installed. Next, during the IQ, all connections to peripheral units and communication with them are checked. Then, during the OQ, the functionality of all operational modes and parameters is checked, including proper transfer of data to printers, computers and additional dosing devices.

The final phase of IQ/OQ is validation of the entire titration system. The manufacturer’s specified Application Bulletins are used to show that the accuracy and precision of the system meet the required specifications. This is accomplished by analyzing a primary titration standard with NIST-traceable standard titrant and performing 10 replicate determinations.

At the end of the IQ/OQ you are supplied with complete documentation, including installation checklist, operational checklist, validation data spreadsheet, pass/fail documentation and copies of the Application Bulletins used in the procedure.

IQ/OQ service is performed by our Applications Laboratory Chemists/Specialists. To schedule an appointment, call our Apps Lab at 1-800-645-3050 ext. 2421.