When is re-qualification neccessary after ICS and firmware changes? - WKB52539

Article number: 52539

ENVIRONMENT

Upgrading to a newer version ICS – major repair of the system (or module) requiring IQ or verify files on the software and OQ and PQ on the system (or module) the ICS controls.
Upgrading to a newer version of firmware (without ICS reload) – "usually" a minor repair unless specified by Release Notes requiring system suitability on the system (or module).
Reloading current version of ICS – minor repair of the system or module requiring IQ or verify files of the software and the customer’s system suitability testing.
Reloading current version of firmware – minor repair of the system or module requiring the customer’s system suitability testing.
Re-qualification is covered under a plan with qualification option if the instrument is “broken” and the fix is to perform any of the above options.
Re-qualification is billable if the upgrade is not mandatory and done outside the yearly re-qualification timing for a plan with qualification option or if the upgrade is done to fix a system not on plan.

id52539, UNIFQLIC