In laboratories regulated typically by GxP and ISO, compliance with government and international standards requires documented verification that your systems are installed and functioning according to their operational specifications. This OQ⁄IPV (Operational Qualification⁄Instrument Performance Verification) User-Performed Test Procedures package provides you with test procedures to re-test that your previously qualified GeneAmp™ PCR System 9700 continues to operate according to manufacturer’s specifications. The OQ⁄IPV can also play a key role in your Change Control standard operating procedure providing documented evidence that maintenance activities or system modifications were completed successfully.
Re-qualification testing should be performed to support your semi-annual CLIA Calibration or cGMP annual re-qualification requirement, after a major repair, instrument relocation, or before a previously-installed system will be used in a regulated test environment.
The package includes a bound, printed copy of test procedures. Directions for performing the test procedures can be found in the instrument user manual. The package does not include Temperature Verification Kits and Probes.
Note that we also offer OQ⁄IPV services performed on-site by a certified field service engineer.
For Research Use Only. Not for use in diagnostics procedures.
For Research Use Only. Not for use in diagnostic procedures.