Published Jun 04, 2026
21 CFR Part 11 Compliance & Electronic Audit Trails in SICORG
How SICORG satisfies US FDA 21 CFR Part 11 and EU Annex 11 requirements using immutable server audit logs, dual-credential electronic signatures, and Segregation of Duties (SoD).
Immutable Audit Logging
Every batch record change, QC test result edit, and inventory status override logs user ID, timestamp, previous value, new value, and mandatory reason for change following ALCOA+ principles.
Segregation of Duties (SoD)
Strict system-enforced permission controls ensure makers cannot self-approve GRN releases or final batch releases.
Provider: SICORG LLPView Plain Text llms.txt