FDA Keeps Narrow Interpretation of Rule in E-Records Guidance

The FDA will continue to tread lightly when enforcing electronic signature and record-keeping requirements for agency-regulated clinical trials, according to a new draft guidance.

The Food and Drug Administration released the draft guidance, “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11—Questions and Answers,” June 20 to account for cloud computing services and other advances in technology since the agency first issued the rule (21 C.F.R. 11) and accompanying guidance on electronic records and electronic signatures in 2003.

The agency said in the new draft guidance that its oversight of ...