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
Description

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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

Documentation

Product Brochures

STARe Excellence Software Brochure
Thermal analysis is a well-established analytical method that is widely used in many different fields. It provides laboratories with valuable results...
STARe Software Option LIMS Interface
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

Thermal Analysis UserComs from the Technology Leader
UserCom is a technical journal published twice a year. Written by thermal analysis experts worldwide, UserCom articles are intended to help scientists...

Know-how

21 CFR Part 11 Frequently Asked Questions (FAQ)
Customer and Supplier Roles and Responsibilities for Assessment of METTLER TOLEDO STARe Software Version V15.00, including 21 CFR 11 Compliance softwa...
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21 CFR 11

Accessories

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21 CFR 11
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