FDA Issues Q&A Draft Guidance: Use of Electronic Records and Electronic Signatures in Clinical Investigations
On June 20, 2017, FDA issued the document Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers Guidance for Industry DRAFT GUIDANCE. The goals of this guidance are as follows: • Update recommendations for applying and implementing part 11 requirements in the current environment of[…]
