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 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.

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Quality Management Representative (QMR)

De­fi­ni­ti­on of the term („What is a Qua­li­ty Ma­nage­ment Re­pre­sen­ta­ti­ve?“)  A qua­li­ty ma­nage­ment re­pre­sen­ta­ti­ve (QMR) ser­ves as a qua­li­ty ma­nage­ment con­sul­tant in a com­pa­ny. As

IQ (Installation Qualification)

De­fi­ni­ti­on of the term („What is an In­stal­la­ti­on Qua­li­fi­ca­ti­on?“)  The in­stal­la­ti­on qua­li­fi­ca­ti­on (IQ) do­cu­ments the im­ple­men­ta­ti­on of the re­qui­re­ments pre­vious­ly spe­ci­fied (e.g. in the design