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The FDA in conjunction with their new GMP initiative has issued a draft guidance document outlining their new approach to the scope and applicability of 21 CFR Part 11. This approach is based on the FDA's risk-based assessment for regulatory compliance. Upon reviewing this latest draft guidance document, you will see many changes to the previous FDA interpretations of Part 11 as well as modification to the Agency's enforcement of the rule.
The Fictrix Digital Pen is CFR part 11 compliant. http://www.21cfrpart11.com Validation will be performed for each application by authorized EDP auditors.
For more information on the FDA, please go to their website at http://www.fda.gov