FDA Food Safety Presentation- Part 11 Redirection

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”.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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