Validating business requirements


17-Aug-2020 22:43

filters) or springs stretch out, requiring recalibration, and hence re-certification is necessary when a specified due time lapse.

Re-qualification of machinery/equipment should also be conducted when replacement of parts, or coupling with another device, or installing a new application software and restructuring of the computer which affects especially the pre-settings, such as on BIOS, registry, disk drive partition table, dynamically-linked (shared) libraries, or an ini file etc., have been necessary.

If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment.

Otherwise, the process of IQ, OQ and PQ is the task of validation.

Instead, the asset has to be recycled for non-regulatory purposes.

Qualification of machinery/equipment is venue dependent, in particular items that are shock sensitive and require balancing or calibration, and re-qualification needs to be conducted once the objects are relocated.



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