FDA Issues New Part 11 Scope Draft Guidance

Today, FDA issued a new Part 11 guidance draft that reduces the scope and burden of Part 11 significantly.  It essentially suspends enforcement on legacy systems existing prior to the rule’s effective date in 1997 and eliminates:

  • enforcement related to audit trails,
  • electronic copies, and
  • maintenance of electronic records

by focusing on meeting the intent of predicate rule requirements and allowing paper or pdf copies to suffice in many cases.  It also limits scope of Part 11 significantly and allows for alternative approaches to assuring record integrity.

A full copy of the guidance is at the link provided and this supersedes all previously issued FDA Part 11 guidances.  Part11 draft Scope Guidance 020203

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