Day

June 26, 2017
FDA issues a new draft guidance in June 2017 titled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 – Questions and Answers”.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...
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FDA CDRHLearn released a new tutorial entitled ‘Electronic Submission of 806 Reports of Corrections and Removals”. The full tutorial is at the link provided. FDA Tutorial E-submission of 806 reports
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CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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