21 CFR 11
The "21 CFR 11 Compliance" STARe software option ensures that the technical controls are compliant with the regulations, issued in 1997 by the U.S. Federal Food and Drug Administration (FDA).
The primary role of access control is to limit system access to authorized individuals
User level management
Defines user rights and user roles
Covers the file integrity and electronic copies
The signature is linked to the record you sign and cannot be removed, copied or transferred
There are two audit trails in the STARe software implemented: the system audit trail and the analysis audit trail. Each has a specific function within the software