FDA Public Meeting on Part 11

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FDA Public Meeting on Part 11
John C. McKenney President and CEO SEC
Associates, Inc. www.secassociates.com
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Three Key Part 11 Issues

• Should implied records be exempt from Part 11?
• Should the use of printouts exempt systems or
  records from Part 11?
• Are the predicate rules sufficient?(i.e., is
  Part 11 superfluous)?