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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GAMP5

GAMP stands for Good Au­to­ma­ted Ma­nu­fac­tu­ring Prac­ti­ce. The num­ber five re­pres­ents ver­si­on 5 which is cur­r­ent­ly the most up-to-date im­ple­men­ta­ti­on. GAMP5 of­fers a prag­ma­tic and

Quality management handbook

De­fi­ni­ti­on of the term („What is a qua­li­ty ma­nage­ment hand­book?“) The qua­li­ty ma­nage­ment ma­nu­al ser­ves as an in­ter­nal com­pi­la­ti­on and re­cord of the qua­li­ty management