Case Study

Delivery of an efficient and secure electronic archive solution for eTMF documents

Delivery of an efficient and secure electronic archive solution for eTMF documents

Pages 2 Pages

Case Study / Delivery of an efficient and secure electronic archive solution for eTMF documents Data archiving and eTMF The electronic archiving (e-Archiving) of clinical trial data is a regulatory requirement for many authorities: UK S.I. 2006 No. 1928, Trial Master File and archiving; EU Rules governing medicinal products, Vol.10, Ch.5 recommendation on the content of the Trial Master File and archiving, and the principles as defined b

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