IQ (Installation Qualification)

Definition of the term („What is an Installation Qualification?“)

The in­stal­la­ti­on qua­li­fi­ca­ti­on (IQ) do­cu­ments the im­ple­men­ta­ti­on of the re­qui­re­ments pre­vious­ly spe­ci­fied (e.g. in the de­sign qua­li­fi­ca­ti­on) as part of the set­up and in­stal­la­ti­on of the pro­vi­ded sys­tem, pro­duct or so­lu­ti­on. Fur­ther­mo­re, it is en­su­red that the products/systems/solutions are ad­ap­ted to the user’s re­qui­re­ments and have the­re­fo­re been crea­ted mee­ting the spe­ci­fi­ca­ti­ons (URS or func­tio­n­al spe­ci­fi­ca­ti­on) and that ade­qua­te do­cu­men­ta­ti­on exists as pro­of of this.

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CAPA (Corrective and Preventive Action)

De­fi­ni­ti­on of the term (“What is CAPA?”) A CAPA (Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion) is a mea­su­re wi­t­hin the qua­li­ty ma­nage­ment sys­tem (QMS) and is part of GMP compliant

EU GMP Guidelines Chapter 4

The chap­ter 4 re­la­tes to the do­cu­men­ta­ti­on. A good do­cu­men­ta­ti­on is an es­sen­ti­al part of the qua­li­ty ma­nage­ment. Mo­reo­ver, it con­sti­tu­tes a key func­tion for