date:May 30, 2016
to the nature of the actionable process step and the nature of the mitigation strategy.
We made the requirement for verifying proper implementation of mitigation strategies more flexible by providing for other activities appropriate for verification of proper implementation of mitigation strategies.
We exempted records required by this rule from the requirements of 21 Code of Federal Regulations, part 11.
We provided for the use of existing records if certain conditions are met.