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Post: Part 11 Guidance Document (Topic#430)

Anonymous

09-05-03 09:39 AM - Post#430

In its release of the final guidance, the FDA defines and clarifies the scope of Part 11 with three main elements: definitions, enforcement discretion and strict adherence to predicate rule requirements. How does this affect your future compliance strategies? To maintain compliance, you must be able to demonstrate control of electronic systems used for regulatory submissions through a justified and documented risk assessment.
See the Federal Docket: http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2003/03-22574.htm
And the Guidance Document:
http://www.fda.gov/OHRMS/DOCKETS/98fr/5667fnl.pdf

Comments welcomed!