FDA to Conduct Inspections to Evaluate Industry’s Electronic Signatures Compliance

The Food and Drug Administration July 8 announced that it will be conducting a series of inspections in an effort to evaluate the drug industry’s compliance and understanding of the 21 C.F.R. 11 requirements for electronic records and electronic signatures.

The agency said it expects to begin conducting the inspections soon. Part 11 sets forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper, FDA said.

This regulation, which applies to all FDA program ...