Electronic Records and Electronic Signatures (21 CFR Part 11)

The regulations in 21 CFR Part 11 set forth the criteria under which FDA 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.

MCIT Source Documentation Information
MiChart Certification Letter
MiChart Compliance Checklist
CareWeb Certification Letter
CareWeb Compliance Checklist
eResearcher Certification Letter
eResearch Compliance Checklist

 

 

 

 

 

 

Created 4/8/2013