FDA 21 CFR Part 11

n  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.

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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 qua­li­fi­ca­ti­on) as