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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Personnel File (digital)

De­fi­ni­ti­on of the term („What is a Di­gi­tal Per­son­nel File?“) The di­gi­tal per­son­nel file is a soft­ware so­lu­ti­on used to ma­na­ge staff-re­la­­ted do­cu­ments. It con­tains scan­ned documents