UNC School of Medicine IT worked with UNC Research to contract with a validation expert to perform a system validation of DocuSign. Validation was necessary to be 21 CFR Part 11 compliant, a requirement to submit study findings for FDA approval. The process to validate DocuSign required the documentation of four Standard Operating Procedures (SOPs), a vendor audit, documenting user requirements, a gap analysis, creating a validation plan, testing, and drafting a validation summary report.
