GxP

All gui­de­li­nes for good working prac­ti­ce, which are par­ti­cu­lar­ly im­portant in me­di­ci­ne, phar­ma­cy and phar­maceu­ti­cal che­mi­stry, are sum­ma­ri­sed by the ab­bre­via­ti­on GxP.

The “G” stands for “good(s)” or “Good” and the “P” for “prac­ti­ce” and “Prac­ti­ce. The “x” in the midd­le is re­pla­ced by the re­spec­ti­ve ab­bre­via­ti­on for the spe­ci­fic ap­p­li­ca­ti­on area.

Gui­de­li­nes in the GxP en­vi­ron­ment are set, for ex­amp­le, by the Eu­ro­pean Me­di­ci­nes Agen­cy and the Ame­ri­can Food and Drug Ad­mi­nis­tra­ti­on, or FDA for short. Com­pli­an­ce with the es­tab­lis­hed gui­de­li­nes is re­gu­lar­ly che­cked by the mo­ni­to­ring aut­ho­ri­ties of the re­spec­ti­ve countries.

“L” for Laboratory
“D” for distribution
“C” for Clinical
“M” stands for “Ma­nu­fac­tu­ring”

Your path to digitization — Discover our software

Our di­gi­ta­liz­a­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the d.3 life sci­en­ces sys­tem is a ho­listic ECM/DMS sys­tem. The ECM/DMS sys­tem can be lin­ked to your exis­ting ERP sys­tem (e.g. SAP), thus en­ab­ling you to im­ple­ment al­most all do­cu­ment-ba­sed pro­ces­ses in your company. 
Live insight into the GxP-compliant document management system by d.velop Life Sciences

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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

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