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. 
Live insight into the GxP-compliant document management system by d.velop Life Sciences

Share now!

Share on email
Share on facebook
Share on linkedin
Share on twitter
Share on whatsapp

Learn more about

Medical Device Regulation

Me­di­cal De­vice Re­gu­la­ti­on (MDR) – Re­gu­la­ti­on 2017/745 (EU) on Me­di­cal De­vices The Ger­man coun­ter­part to the term “Me­di­cal De­vice Re­gu­la­ti­on” is “Me­di­zin­pro­duk­te­ver­ord­nung”. The re­gu­la­ti­on 2017/745

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