GxP Compliance Tools for Octet Systems

The IQ/OQ kit provides comprehensive documentation to verify the Octet instrument, accessories and computer system are supplied and installed per Sartorius's guidelines by certified personnel. It also provides documented verification that the Octet instrument operates as intended at the user site by inspecting the critical components. These tests verify that the various key operational parameters, such as the optical system, plate temperature, system alignment, lamp performance, and shaker speed meet stipulated specifications.

PQ kits provide rapid and convenient methods to verify the performance of your Octet^® R8 and RH16 systems. PQ can be performed using one or two tightly controlled assays, depending on the instrument’s intended use. The PQ-Kinetics and quantitation assays verify accuracy and precision of the assays are within specifications for a well- characterized model system pair.

For researchers working in GLP or GMP laboratories, the Octet Software Validation Package provides the most comprehensive documentation and tools available to validate the Octet^® GxP Server Monitor and Octet^® CFR Software features and functions. It trims validation time to just three days using a fully -integrated manual that mirrors the validation process in a regulated laboratory and provides sample data sets to authenticate analysis within Octet^® software to traditional programs including Microsoft^® Excel^®, and GraphPad Prism.

This service enables the Octet system users to sample multiple lots of a biosensor during assay qualification and validation and reserve a well-characterized lot for purchase. The service is available for the following biosensor types: Octet^® ProA , Octet^® SA, Octet^® SAX, Octet^® NTA, and Octet^® AMC. Customers can order up to five different biosensor lots, up to 20 trays from each lot for evaluation, and reserve up to 40 additional trays for future purchase.