FDA Draft Part 11 for Clinical Investigations

FDA issues a new draft guidance in June 2017 titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.  This guidance while scoped for clinical investigations has information that is probably useful and defensible for assessing or ensuring compliance with other types of systems subject to Part 11 as well.  It is presented in Q&A format and addresses cloud systems, mobile devices, outsourcing and many other topics.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM563785.pdf

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