An EU Annex 11 compliance checklist is a practical framework used to evaluate whether an eClinical system supports the requirements for computerized systems outlined in EU GMP Annex 11. It helps sponsors, CROs, and clinical research organizations verify that regulated software includes the controls needed to protect electronic records, maintain data integrity, and support regulatory i... https://www.clinion.com/insight/eu-annex-11-compliance-checklist-eclinical-systems/