Equipment Qualification

Equipment Qualification

PACT Webinar January 29, 2009

Equipment Qualification

{ What is I t? { When is it Done? { What is I nvolved? { Sum m ary

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Qualification

{ Perform ed t o " Est ablish confidence t hat process equipm ent & ancillary system s are capable of consistently operating within established lim its & t oler an ces"

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Validation

{ The purpose of validat ion is " to ensure that user needs and intended uses can be fulfilled on a consistent basis"

{ I t is " confirm ation by exam ination and provision of obj ective evidence that specified requirem ents for a particular device or activity have been m et"

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Validation Helpful Information

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