FDA 21 CFR Part 11

FDA 21 CFR Part 11 , the Ame­ri­can Food and Drug Ad­mi­nis­tra­ti­on (FDA) spe­ci­fies re­qui­re­ments for elec­tro­nic do­cu­ments, elec­tro­nic si­gna­tures and hand­writ­ten si­gna­tures ap­p­lied to elec­tro­nic do­cu­ments re­gar­ding trust­wort­hi­ness, re­lia­bi­li­ty, and equi­va­lence to pa­per do­cu­ments and hand­writ­ten si­gna­tures ap­p­lied on pa­per. The re­qui­re­ments al­ways ap­p­ly, if in­for­ma­ti­on is crea­ted, chan­ged, stored, trans­mit­ted or ac­ces­sed elec­tro­ni­cal­ly. If the do­cu­ments ge­ne­ra­ted, stored, trans­mit­ted or mo­di­fied in this way ser­ve to pro­ve com­pli­an­ce with re­gu­la­to­ry ob­li­ga­ti­ons, the re­qui­re­ments must be met. Howe­ver, 21 CFR Part 11 is to be ap­p­lied espe­cial­ly, if elec­tro­nic re­cords re­place paper.

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. 
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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

Audit

De­fi­ni­ti­on of the term (“What is an au­dit?”) An au­dit checks, if the re­qui­re­ments, pro­ces­ses, and gui­de­li­nes meet pre­scri­bed stan­dards or norms. Due to the high