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.

Your path to digitization — Discover our software

Our di­gi­ta­liz­a­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is a ho­listic ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company. 
Live insight into the GxP-compliant document management system of d.velop Life Sciences

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EU GMP guideline

The EU GMP gui­de­li­ne sum­ma­ri­zes all re­gu­la­ti­ons and ope­ra­ting in­st­ruc­tions that have ever been spe­ci­fied for phar­maceu­ti­cal com­pa­nies in the Fe­deral Re­pu­blic of Ger­ma­ny. This

Corrective Actions

De­fi­ni­ti­on of the term („What is a cor­rec­ti­ve ac­tion?“)  The ISO 9000 de­scri­bes a cor­rec­ti­ve ac­tion as a “mea­su­re to eli­mi­na­te the cau­se of a