Last week, The Eagle's Nest Blog ran an article on Final Submission QC. It discussed challenges and ideas around ensuring final quality of an electronic submission. For medical translators, there are a couple of interesting tidbits here.
First off, medical translators - especially those who translate regulatory submissions - need to know what their clients are doing after the linguistic piece is done.
Second, it's interesting to note that much of the QC is done manually. There are file viewers and such but QC staff use good old checklists and manual checks.
For another look at how to compile an effective eCTD submission, take a look at SOPs to Adequately Cover an eCTD Based Compilation and Submission Process [PDF link].
[Tip of the hat to Kathy Clark!]
If you want to keep reading, here are three related articles:
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.