eDMS

Elec­tro­nic do­cu­ment ma­nage­ment system

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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

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