21 CFR 11 - Overview - METTLER TOLEDO

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).

STARe Software Option 21 CFR 11
Specifications - 21 CFR 11
Material Number(s) 51141639

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Features and Benefits
Access control
The 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


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21 CFR Part 11 Frequently Asked Questions (FAQ)
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21 CFR 11
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