Collect 21 CFR Part 11 and EU Annex 11 compliant electronic signatures on quality agreements and controlled documents from sponsors, vendors, and external collaborators—even without ZenQMS accounts.

Assign GCP training and role-specific SOPs automatically, with retraining triggered by major document revisions. Track completion, on-the-job training, and qualifications across clinical research teams.

Use the no-code Workflow Designer to configure protocol deviation investigations, CAPAs, and vendor qualifications for different sponsor requirements. Trigger follow-up workflows automatically and maintain traceable GCP quality records.

Organize clinical quality SOPs, deviations, CAPAs, and audit records into sponsor- or study-specific folders. Share current, controlled records with sponsors and auditors without creating uncontrolled copies or exposing unrelated information.