EU GMP Guideline Annex 11

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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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Glossary overview

Enterprise Content Management System (ECM)

De­fi­ni­ti­on of the term (“What is ECM?”)  ECM is the ab­bre­via­ti­on of En­ter­pri­se Con­tent Ma­nage­ment. This is the ma­nage­ment of all data and in­for­ma­ti­on ge­ne­ra­ted in