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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ISO 13485:2016

The ISO 13485 is an ISO norm con­tai­ning the re­qui­re­ments for a com­pre­hen­si­ve ma­nage­ment sys­tem of the crea­ti­on of me­di­ci­nal pro­ducts. The most re­cent edition

User Requirement Specification (URS)

De­fi­ni­ti­on of the term („What is an user re­qui­re­ment spe­ci­fi­ca­ti­on?“) A URS or User Re­qui­re­ment Spe­ci­fi­ca­ti­on con­tains a com­pre­hen­si­ve de­scrip­ti­on of the cus­to­mer re­qui­re­ments with re­fe­rence to the products