EU GMP guideline

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EU GMP guideline

The EU GMP gui­de­li­ne sum­ma­ri­zes all re­gu­la­ti­ons and ope­ra­ting in­st­ruc­tions that have ever been spe­ci­fied for phar­maceu­ti­cal com­pa­nies in the Fe­deral Re­pu­blic of Ger­ma­ny. This gui­de­li­ne and all it an­ne­xes are all le­gal­ly binding.

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Glossary overview

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

Document Management System (DMS)

De­fi­ni­ti­on of the term (“What is DMS?”) A do­cu­ment ma­nage­ment sys­tem (DMS) can be un­ders­tood as the ma­nage­ment of elec­tro­nic do­cu­ments in a da­ta­ba­se. In