SW-Option 21 CFR Part 11 Conformity

Electronic Records and Signatures.STARe Software-Option 21 CFR Part 11 Conformity

Access control and user level management

Restricts system access to authorized individuals only. Customize user access profiles to reduce the probability of data manipulation.

Electronic signatures

Replaces traditional signatures

Audit trail

Records all activities and changes to data

Material No.: 51141639

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Specifications - SW-Option 21 CFR Part 11 Conformity
Technique
Thermomechanical Analysis (TMA)
Differential Scanning Calorimetry (DSC)
Dynamic Mechanical Analysis (DMA)
Thermogravimetry (TGA)
Included Features
Electronic signatures
User Level Management
Access Control
Audit trail

Electronic Records and Signatures

The CFR STARe software option ensures that the technical controls are compliant with FDA 21 CFR Part 11 regulation.

Documentation

Product Brochures

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

Datasheets

Datasheet: STARe Software Option 21 CFR 11 Compliance
The U.S. Federal Food and Drug Administration (FDA) has issued regulations that provide criteria for acceptance by the FDA, under certain circumstance...

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 FAQs STARe Software
Customer and supplier roles and responsibilities for assessment of METTLER TOLEDO STARe Software.

Accessories

Consumables

Software

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SW-Option 21 CFR Part 11 Conformity