At a Food Safety Conference FDA’s CDRH Software Compliance and Part 11 Representative (John Murray) gave a new presentation on FDA’s changes in its approach to Part 11. The presentation is an improvement to a presentation Mr. Murray gave at the March 2003 AAMI standards conference. The slides from this presentation are at the link provided.
Mr. Murray verbally expressed that this is a significant shift and he believes FDA is committed to resolving the problems and burden of prior Part 11 interpretations.
A Part 11 Redirection Q&A presentation by Alan Kusinitz of SoftwareCPR and an implementation presentation by Carl Wyra presented and a presentation by Mr. Murray at the March 2003 AAMI Standards Conference are also available in the library portion of www.softwarecpr.com. Just search for “redirection”.