Instron has been conducting Installation Qualification (IQ) and Operational Qualification (OQ) validation services since the FDA current good manufacturing practice (CGMP) requirements regulation (21 CFR 820) was issued.

This Instron service provides assistance to the customer in developing the (IQOQ) portions of their "Validation Plan" as they relate to the Instron testing system's suitability and capability to produce valid results.

An Instron Service Engineer will conduct the IQ and OQ during the installation of the testing system. He will ensure that the installation adheres to Instron's specifications and provide you all the necessary supporting documentation. Once installed the service engineer will perform operational testing of the system to provide you with the objective evidence necessary to confirm that the system is producing valid results. As part of the OQ the service engineer will calibrate the load weighing system and provide traceability to the National Institute of Standards and Technology (NIST).

Upon completion of the IQ and OQ the service engineer will provide the customer with: 1) Completed Installation Qualification Checklist 2) Completed Operational Qualification Checklist with the following attached: (a) Calibration Certificate for load cell(s) (b) Calibration Certificate for extensometers(s)(if applicable) (c) Calibration Certificate for speed (d) Calibration Certificate for displacement (e) Completed Software Functionality Checklist (f) Results from each calculation verified 3) Completion Certificate

Call 1-800-564-8378 (3450) for a quote and to schedule your IQOQ services.