FDA Final Electronic Source Data Guidance

FDA issued a FINAL”Guidance for Industry and Food and Drug Administration Staff – Electronic Source Data in Clinical Investigations” Spetember 2013. The full document is at the link provided. It discusses the value of electronic source data for clinical investigations as well as types of controls to ensure integrity and trace origin. AMong other requirements it states: “When data elements are transcribed from paper sources into an eCRF, the clinical investigator(s) must also retain the paper sources, or certified copies, for FDA review. Other records (electronic and paper) required to corroborate data in the eCRF (see section III.A.2.a) may also be requested by FDA during an inspection.

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

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