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).

Specifications - 21 CFR 11
Material Number(s) | 51141639 |
Features and Benefits
Access controlThe primary role of access control is to limit system access to authorized individuals
User level management
Defines user rights and user roles
Electronic records
Covers the file integrity and electronic copies
Electronic signatures
The signature is linked to the record you sign and cannot be removed, copied or transferred
Audit trail
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
Documentation
Thermal analysis is a well-established analytical method that is widely used in many different fields. It provides laboratories with valuable results...
The LIMS Interface software option makes it possible to access the STARe software database and to control some features of the STARe System. This is d...
UserCom is a technical journal published twice a year. Written by thermal analysis experts worldwide, UserCom articles are intended to help scientists...
Customer and Supplier Roles and Responsibilities for Assessment of METTLER TOLEDO STARe Software Version V15.00, including 21 CFR 11 Compliance softwa...