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 an in­te­gra­ted 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 of Digital Life Sciences

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De­fi­ni­ti­on of the term (“What does va­li­da­ti­on mean?”)  Va­li­da­ti­on plays a spe­cial role in all re­gu­la­ti­ons of the GxP en­vi­ron­ment. Fun­da­men­tal­ly, the va­li­da­ti­on me­ans providing

Functional specification

De­fi­ni­ti­on of the term („What is a func­tion­al spe­ci­fi­ca­ti­on?“)  A func­tion­al spe­ci­fi­ca­ti­on con­ta­ins a contractor’s de­tail­ed de­scrip­ti­on how he in­tends to sol­ve the cus­to­mers requirements.