EU GMP Guideline Annex 11

An­nex 11 of EU GMP gui­de­li­ne. It de­scri­bes re­qui­re­ments for all kinds of com­pu­te­ri­zed sys­tems used as part of GMP-re­gu­la­ted ac­ti­vi­ties.
A com­pu­ter-ba­sed sys­tem is a com­bi­na­ti­on of soft­ware and hard­ware com­pon­ents which tog­e­ther ful­fill cer­tain func­tions. The ap­p­li­ca­ti­on should be va­li­da­ted, the IT in­fra­st­ruc­tu­re should be qualified.

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Validation

De­fi­ni­ti­on of the term (“What does va­li­da­ti­on mean?”)  Va­li­da­ti­on plays a spe­cial role in all re­gu­la­ti­ons of the GxP en­vi­ron­ment. Fun­da­ment­al­ly, the va­li­da­ti­on me­ans providing

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