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Compliance In Focus
Posted by John Lehmann on Tue, Sep 24, 2013

FDA Issues Final Guidance on Electronic Source Documentation

FDA Issues Final Guidance on Electronic Source DocumentationThe FDA issued its final guidance on electronic source documentation.  Back in January 2012 the FDA published its draft guidance to much criticism and debate. The new guidance broadly follows the second draft of the guidance which was released in November 2012.

The guidance has been reworked to cut the risk of the document being misinterpreted.  The section outlining electronic data capture had an extensive rewrite, with the FDA making changes to address industry concerns. The guidance now states that paper-based documents should be kept only if they were part of the original data-reporting process.

Even though the clinical trial industry has been slow to embrace electronic formats, the technologies are beginning to be utilized.  The benefits of electronic capture are numerous:

  • Reduces duplication of data
  • Minimizes transcription mistakes
  • Other short-comings of paper based systems

The FDA guidance provided a framework for using electronic based systems.  The increasing recognition of the benefits of these systems is driving demand for electronic systems.

What are your thoughts on the new guidance?  Share your thoughts below.

Photo Credit:Emil Schrøder

Documentation in Devices

Topics: FDA Guidance, Draft Guidance, Electronic Source Documentation


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