Calibration and IQOQ After Software Upgrades or Updates
Calibration
Based on our software verification and validation testing during product development, we believe that software upgrades have no effect on the values of transducer calibration and data collected by the testing system. If your internal standards or compliance to other regulatory bodies (including those outside of ISO or ASTM) require you to recalibrate your testing instrument after a software change, we recommend a more comprehensive validation.
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IQOQ
IQOQ validation is required for compliance with certain regulatory standards. If your system is governed by an IQOQ validation, you will need to evaluate whether any revalidation is necessary after a software update or upgrade. This evaluation will likely include an analysis of what items have changed in the software, and a risk assessment of how those changes affect your internal testing. If it is determined that a redo of the Instron IQOQ is required, please contact your local Service team.
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